Disposed

Dr.J.Umarani, v. The State of Tamil Nadu

Madras HC5 Aug 2019WP/43370/2016

Case brief

AI extract

What is this about?

Biomedical waste management in hospitals required effective enforcement. The court directed compliance with Supreme Court directions and government guidelines, functional sewerage treatment plants, inspections every two months, committee reports, rectification of defects and action for noncompliance. The petition was disposed of.

What did the court decide?

Directed functional sewerage treatment plants, inspections every two months, committee reports, rectification of defects and action for noncompliance with biomedical waste requirements.

Dr.J.Umarani, Vs The State of Tamil Nadu — Environment and Pollution | Madras HC (2019)

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IN THE HIGH COURT OF JUDICATURE AT MADRAS

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DATED : 05.08.2019

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CORAM

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THE HONOURABLE MR.JUSTICE S.MANIKUMAR and THE HONOURABLE MR.JUSTICE SUBRAMONIUM PRASAD

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Writ Petition No.43370 of 2016 and W.M.P. No.37228 of 2016

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Dr.J.Umarani ...Petitioner Vs 1. The State of Tamil Nadu, Rep.by its Secretary, Health & Family Welfare Department, Fort.St.George, Chennai 600 009. 2. Tamil Nadu Pollution Control Board, By its Member Secretary, 76, Mount Salai, Guindy, Chennai 600 032. 3. The Union of India, Rep.by its Secretary, Ministry of Environment, Forest & Climate Change, New Delhi. ... Respondents

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Writ Petition filed under Article 226 of The Constitution of India praying for the issuance of a Writ of Mandamus directing the respondents herein to take appropriate steps towards effective implementation of Bio-Medical Waste Management Rules, 1998 and as amended in GSR 343 (E) dated 28.03.2016 issued by the third respondent on 2016 including issuance of license to any person or concern authorizing to treat the category Bio Medical Waste viz., soiled linen, beddings and items contaminated with blood or body fluid.

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For Petitioner : Mr.R.S.Jeeva Rathinam, Senior Counsel for M/s.Madhuri Donti Reddy

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For Respondents: Mr.E.Manoharan

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Additional Government Pleader for R1 Mr.H.Yasmeen Ali for R2

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O R D E R

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[Order was delivered by S.MANIKUMAR,J]

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The present writ petition has been filed as a Public Interest Litigation for a Writ of Mandamus, directing the respondents herein to take appropriate steps towards effective implementation of Bio-Medical Waste Management Rules, 1998 and as amended in GSR 343(E) dated 28.03.2016, issued by Union of India, represented by its secretary, Ministry of Environment, Forest & Climate Change, New Delhi/third respondent herein, including issuance of licence to any person or the concerned authorizing to treat the category, bio-medical Waste viz., soiled linen, beddings and items contaminated with blood or body fluid.

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Petitioner is a doctor and has put in 32 years of practice in the field of Medicine. She has worked as a Professor in Madras Medical College and Kilpauk Medical College, Chennai and holder of a Post Graduate Degree in Micro-Biology. The petitioner states that, Union of India has framed rules with respect to treatment of Bio-Medical Waste, wherein, each and every occupier is mandated to maintain the standards as mentioned therein, in treating Bio-Medical Waste. Tamil Nadu Pollution Control Board, Guindy, Chennai/second respondent herein, being the prescribed statutory authority, has not issued license to any one or any concerned to treat Bio-Medical Waste and the State of Tamil Nadu, represented by its Secretary, Health & Family Welfare Department, Chennai/first respondent herein, being the Chairman of the Advisory Committee is bound to see whether the rules are implemented. Since there is no authorised person to handle Bio-Medical waste in the State of Tamil Nadu, the same are not treated, as per the provisions of Bio-Medical Waste Rules. According to the petitioner, impact of the same is posing a serious threat to the environment as well as health hazardous to the public. There is no separate provision made in any hospital for collection of Bio-Medical Waste. In most of the hospitals, the infectious wastes are not transported as per the provisions.

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According to the petitioner, in view of the undisputed fact that the second respondent, Tamil Nadu Pollution Control Board, Chennai, has not issued any licence to any hospital or any individual to treat Bio-Medical Waste, it is obvious that Bio-Medical Waste are treated against the provisions, causing serious threat to the environment and health of the public at large. In view of non-usage of authorised persons, who have licence to treat soiled linens, there is so much of health hazards. Unauthorised washing of these linens/clothes is exposed to danger, as washing is done in public water bodies and that the water gets contaminated with the untreated Bio-Medical

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Waste. The water so contaminated can very well categorised as chemical liquid waste and all these contamination stand in contravention of the Water Act, but also invites health hazards to humans.

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According to the petitioner, the ordinary washers/launderers are not well informed of the impact of washing soiled linen, whereas all the hospitals are well informed and educated with respect to the impact of treating the soiled linen. The hospitals are not caring about the impacts, for the simple reason of the cost cutting factors alone. It is also a matter of concern, as water is also mixed with the drainage and effluents which contain toxicants, pathogens, and is at the risk of causing numerous health hazards to humans. The impact of the effluent from washing of soiled linen would contain Bio-Medical Waste and pose a direct threat to life of people at large. Since the rules framed, which according to the petitioner, are not implemented, the present writ petition is filed.

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Per contra, Mr.E.Manoharan, learned Additional Government Pleader, appearing for the Health and Family Welfare Department, State of Tamil Nadu/first respondent submitted that, in Government Hospitals, bio medical wastes are segregated into colour coded plastic bags placed in bins and managed, as per Schedule I of Bio Medical Waste Management Rules, 2016. In all the Government Hospitals in Tamil Nadu, bio medical waste is segregated, at the source like wards, IMCU, Operation theatre etc., and transported to a common storage area, inside the campus of every institution and from there, bio medical wastes are handed over to the government authorised Common Bio Medical Waste Treatment Facility provided for final disposal, as per the norms. They have an agreement with Common Bio Medical Waste Treatment Facility Provider for disposing the segregated bio medical wastes. There are 11 common bio medical waste treatment facility providers approved by the Tamil Nadu Pollution Control Board/second respondent herein. Agreement has been made between the hospital administration (occupier) and Common Bio Medical Waste Treatment Facility (CBWTF) provider, according to the districts allotted to them.

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He has further submitted that 46 hospitals under the control of Directorate of Medical Education, 29 District Head Quarters hospital, 206 Taluk Hospitals and 68 Non Taluk Hospitals have obtained authorisation for handling Bio Medical Wastes from the Tamil Nadu Pollution Control Board. Bio Medical Waste Management Rules, 2016, has been issued in super-session of the Bio Medical Waste (Management and Handling) Rules, 1998 and is not an amendment to the earlier Rules, as wrongly stated by the petitioner and Bio Medical Waste Management Rules, 2016,

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speak about wastes, such as discarded/condemned/soiled linen wastes, and not about soiled or regular hospital linen.

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As per Bio Medical Waste Management Rules, 2016 Schedule - I - Category Yellow-(c) Soiled Waste, consists of items contaminated with blood, body fluids like dressings, plaster casts, cotton swabs and bags containing residual or discarded blood and blood components. The treatment and disposal option for this category, is incineration or Plasma Pyrolysis or deep burial. In the absence of above facilities, autoclaving or micro-waving/hydro-claving is followed by shredding or mutilation or combination of sterilization and shredding. Treated waste has to be sent for energy recovery. Soiled and regular hospital linens are managed, as per World Health Organisation Practical Guidelines for infection control in Health Care facilities SEARO Publication-no 41-WPRO regional publication 2004-page 26. Soiled and regular hospital linen are disinfected with Sodium Hypochlorite solution and washed with detergent in the steam laundry (70C-80C).

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It is his further contention that, as per the minutes of meeting of the Tamil Nadu Pollution Control Board (TNPCB) on 22.09.2016, it was decided that larger hospitals, in consultation with TNPCB, may provide laundry facilities, on their own for treatment of disinfected and soiled linen and can also tie up with other hospitals for the treatment of the same. However hospitals shall strictly comply with the standards prescribed by the Board. Chairman, TNPCB has informed that the facilities provided by the hospitals, will be inspected by TNPCB officials and necessary guidelines/instructions would be provided for any further improvement.

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Government Hospitals under the control of Directorate of Medical Education, have laundry and CSSD (Central Sterile Supply Department) through which soiled linen are disinfected, washed and autoclaved. Soiled Linen has not come under the scope of Bio Medical Waste Management Rules, 2016, Schedule-I-category Yellow-(c). All the government hospitals have Bio Medical Waste Management Committees and Hospital infection control committees. Every month, Hospital infection Control Committees, audit the situation and initiate necessary corrective measures are taken. There are 11 Common Bio Medical Waste Treatment facility providers approved by the Tamil Nadu Pollution Control Board. The occupier (Hospital Administration) would not do on-site treatment for Bio Medical Waste except, pre-treatment of the laboratory waste, microbiological waste, blood samples and blood bags through disinfection or sterilisation on-site, in the manner, as prescribed by the World Health Organisation (WHO) or National AIDs Control Organisation (NACO) guidelines, and then sent to the common bio-medical waste treatment facility for

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final disposal, as per the Bio Medical Waste Management Rules, 2016.

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According to Mr.E.Manoharan, learned Additional Government Pleader, in Government Hospitals, Bio Medical Waste is segregated into colour coded plastic bags placed in bins and managed, as per the Schedule-I of Bio Medical Waste Management Rules, 2016. In Tamil Nadu, State Level Advisory Committee for Bio Medical Waste Management has been constituted as per G.O.Ms.No.277 Health and Family Welfare (H1) Department dated 29.11.2016 and District and Hospital level Bio Medical Waste Committees have been constituted as per G.O. (Ms) No.179 Health and Family Welfare (H1) Department dated 06.07.2016 to monitor Bio Medical Waste Management in the State. State Level Advisory Committee has been constituted, as per rule 11 of the Bio Medical Waste Management Rules, 2016, under the Chairmanship of the Principal Secretary to the Government, Health & Family Welfare Department, Government of Tamil Nadu. The Member Secretary, Tamil Nadu Pollution Control Board is also one among the members of the said Advisory Committee.

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Mr.H.Yasmeen Ali, learned counsel for the Tamil Nadu Pollution Control Board, represented by its Member Secretary, Guindy, Chennai/second respondent, submitted that the Ministry of Environment, Forest and Climate Change, Government of India, in exercise of the powers conferred by sections 6, 8 and 25 of the Environment (Protection) Act, 1986 (Act 29 of 1986) and in super-session of the Bio-Medical Waste (Management and Handling) Rules, 1998, have notified Bio-Medical Waste Management Rules, 2016. In the said rules, duties of the occupier, Common biomedical waste treatment and disposal facility and authorities, have been prescribed. Section 2 (n) of the Biomedical Waste Management Rules, 2016, defines operator, as "operator of a common bio-medical waste treatment facility" means a person who owns or controls a Common Bio-Medical Waste Treatment Facility (CBMWTF) for the collection, reception, storage, transport, treatment, disposal or any other form of handling of bio-medical waste".

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As per Rule 7(1) of the said Rules, "Bio-Medical wastes shall be treated and disposed of in accordance with schedule I, and in compliance with the standards provided in Schedule-II by the health care facilities and common bio-medical waste treatment facility. "Whereas schedule I refers to the Biomedical wastes categories and their segregation, collection, treatment, processing and disposal options. As per yellow category, waste under section (g) clearly refers to "Discarded Linen, Mattresses, Beddings contaminated with blood or body fluid”. As per the schedule, the said waste has to be collected in a nonchlorinated yellow plastic bags or suitable packing material and

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to be subjected to non-chlorinated chemical disinfection followed by incineration or plasma pyrolysis or for energy recovery by the respective Common Bio-Medical Waste Treatment Facilities.

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It is the further contention of the learned counsel for the Tamil Nadu Pollution Control Board that, in pursuance of the orders of the Hon'ble High Court order dated 23.12.2016, bio medical waste generated from the hospitals and the health centres are treated through 11 Common Bio Medical Waste treatment facilities located in various parts of Tamil Nadu.

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He has further submitted that discarded linen, mattresses, beddings contaminated with blood or body fluid generated from the health care facilities are collected by the respective Common Bio Medical Waste Treatment Facilities and subjected to incineration. Of the 11 Common Biomedical Waste Treatment Facilities, 9 facilities have the provision of incinerator. All the 11 Common Biomedical Waste Treatment Facilities have obtained authorisation from TNPCB for collection, treatment and disposal of biomedical wastes including the discarded linen, mattresses, beddings contaminated with blood or body fluid. TNPCB is continually addressing the Health Secretary for effective handling of bio-medical waste, as per the said Rules.

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He has further submitted that, after the notification of the Biomedical Waste Management Rules, 2016, Chairman, TNPCB vide DO letter dated 28.04.2016 has addressed the Secretary to the Government, Health and Family Welfare Department, Secretariat, Chennai, to issue necessary instructions, to all the Government Health Care Institutions including medical colleges in the State, to comply with the provisions of the Bio Medical Waste Management Rules, 2016. TNPCB has addressed the common biomedical waste treatment facilities in Tamil Nadu, to strictly adhere to all the provisions of Biomedical Waste Management Rules, 2016.

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In the rejoinder, the petitioner has averred that Tamil Ndu Pollution Control Board, Guindy, Chennai/second respondent has approved 11 common Bio Medical Waste Treatment facilities. However the State of Tamil Nadu, represented by its Secretary, Health & Family Welfare Department, Chennai/first respondent herein, is under a total misconception that rules for treatment of Bio Medical Waste relate only to those that need to be discarded and be governed, as per section 2 (f) of the Bio Medical Waste Management Rules, 2016.

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Petitioner has contended that the responsibility of the respondents, do not end with merely enacting laws & granting

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licences to Common Bio Medical Waste Treatment Facility.

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According to the petitioner, the respondents till date, have not mentioned, as to whether they have granted licence to any person, individual or corporate entity, for the purpose of disinfecting soiled and regular hospital linen. The Secretary, Health & Family Welfare Department, Chennai/first respondent has only dealt with only that aspect of the Act and the Rules but failed to respond to the query raised as to the methods adopted by the hospitals, dispensaries and laboratories in treating soiled linen through outsourced launderers or their own washing machines or local dhobi.

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By way of reply to the rejoinder, State of Tamil Nadu, represented by its Secretary, Health & Family Welfare Department, Chennai/ first respondent has stated that BioMedical Waste (Management and Handling) Rules, 1998 have come into force on 20.07.1998 and amended in 2000. Modification of 1998 rules have come into force on 28.03.2016 with many changes. The short title of the rules itself, change from Bio Medical Waste (Management and Handling) Rules, to Bio Medical Waste Management Rules, 2016. The number of Bio-Medical Waste categories has changed from 10 to 4. The categories are classified with the well defined treatment option. This is being strictly followed. As of now, the chemical liquid waste generated from the government hospitals in Tamil Nadu are disinfected and drained into sewer lines. Government of Tamil Nadu is in the process of installing Effluent Treatment Plants as per the provisions contained in the Bio-Medical Waste Management Rules, 2016 in consultation with Tamil Nadu Pollution Control Board. Until then, chemical liquid/waste are disinfected and drained into sewer lines.

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In schedule III, in serial No.2 of the Bio-Medical Waste Management Rules 2016, the corresponding duties of the authorities, namely, the Central or State Ministry of Health and Family Welfare is to grant license to health care facilities or nursing homes or veterinary establishments, with a condition to obtain authorisation from the prescribed authority for BioMedical Waste Management. This is the only licence to be given by the Central or State Ministry of Health and Family Welfare. It is submitted that all the Government Hospitals have got BioMedical Waste authorisation from Tamil Nadu Pollution Control Board. Licence for the purpose of disinfecting and laundering of soiled linen and regular hospital linen, provision is not under the scope of Bio-Medical Waste Management Rules, 2016. According to the said rules, schedule I, part 1, prescribes Bio-Medical Wastes categories and their segregation, collection, treatment, processing and disposal options under the Heading “Schedule – I” in part – 1 in the tabular column against the category “Yellow”

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specified in column (1) and the entries relating to Chemical Liquid Waste (f) specified in column (2) that the 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, housekeeping and disinfecting activities etc., Hence chemical liquid waste category covers all the infectious liquid waste generated from the hospitals.

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Heard the learned counsel for the parties and perused the materials available on record.

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On this day, when the matter came up for hearing, Mr.R.S.Jeeva Rathinam, learned Senior Counsel appearing for M/s.Madhurai Donti Reddy, learned counsel on record for the petitioner, by inviting the attention of this court, to certain photographs taken in the hospitals and by referring to the judgment dated 22.02.2017 in W.P. No.375 of 2012 in the case of Paryavaran Suraksha Samiti and another Vs Union of India and others paragraph Nos.13 to 17, submitted that though Sewerage Treatment Plants are stated to be established in hospitals, they are not functional and that washing linen is not done as per the decision of the Hon'ble Supreme Court, which is extracted as hereunder:-

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"13. We are of the view, that mere directions are inconsequential, unless a rigid implementation mechanism is laid down. We therefore hereby provide, that the directions pertaining to continuation of industrial activity only when there is in place a functional "primary effluent treatment plants", and the setting up of functional " common effluent treatment plants" within the time lines, expressed above, shall be of the Member Secretaries of the concerned pollution control Boards. The Secretary of the Department of Environment, of the concerned State Government (and the concerned Union Territory, shall be answerable in case of default. The concerned Secretaries to the Government shall be responsible of monitoring the progress, and issuing necessary directions to the concerned Pollution Control Board, as may be required, for the implementation of the above directions. They shall be also responsible for collecting and maintaining records of data, in respect of the directions contained in this Order. The said data shall be finished to the Central Ground Water Authority. which shall evaluate the data, and shall furnish the same to the Bench of the jurisdictional National Green Tribunal.

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To supervise complaints of non-implementation of the instant directions, the concerned Benches of the

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National Green Tribunal, will maintain running and numbered case files, by dividing the jurisdictional area into units. The above mentioned case files, will be listed periodically. The concerned pollution case files, will be listed periodically. The concerned Pollution Control Board is also hereby directed, to initiate such civil or criminal action, as may be permissible in law, against all or any of the defaulters.

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Liberty is granted to private individuals, and organizations, to approach the concerned Bench of the jurisdictional National Green Tribunal, for appropriate orders, by pointing out deficiencies in implementation of the above directions.

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It however needs to be clarified, that the instant directions and time lines, shall not in any way dilute any time lines and directions issued by courts or Benches of the National Green Tribunal, hitherto before, wherein the postulated time lines would expire before the ones expressed through the directions recorded above. It is clarified, that the time lines, expressed herein above will be relevant, only in situations where there are no prevalent time line(s)and also, where a longer period, has been provided for.

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It would be in the interest of implementation of the objective sought to be achieved, to also require each concerned State ( and each, concerned Union Territory) to make provision for "online, real time, continuous monitoring system" to display emission levels, in the public domain, on the portal of the concerned State Pollution Control Board. We are informed, that atleast three State Governments have already adopted the aforesaid measures. Such measures shall be put in place by all the concerned State Government (including, the concerned Union Territories), within six months from today."

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Per contra, Mr.E.Manoharan, learned Additional Government Pleader, appearing for the State, submitted that Sewerage Treatment Plants are available in the institutions, coming under the Directorate of Medical Education and Director of Medical & Rural Health Services, and that the same are extracted hereunder:-

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STP availability in DME Institutions

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Tirunelveli Medical College Hospital.

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Theni Medical College Hospital.

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Tiruvarur Medical College Hospital.

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Villupuram Medical College Hospital.

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Tiruvannamalai Medical College Hospital.

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6.Government Mohan Kumaramangalam Medical College Hospital, Salem.

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Sivagangai Medical College Hospital.

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Tamil Nadu Multi Speciality Hospital, Omandurar, Chennai.

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TB Hospital, Tambaram.

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DMS Institutions

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Govt. Hospital, Cuddalore. 2. Govt. Hospital, Tiruppur.

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Govt. Hospital, Tiruvallur.

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Govt. Hospital, Kallacurichi.

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Govt. Hospital, Manaparai.

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Govt. Hospital, Erode.

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Govt. Hospital, Padmanabapuram.

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Govt. Hospital, Tenkasi.

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Govt. Hospital, Ramanathapuram.

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Govt. Hospital, Mayiladuthurai.

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Govt. Hospital, Tambaram.

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Govt. Hospital, Hosur.

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Govt. Hospital, Sholingar

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Govt. Hospital, Arupukkottai.

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It is the further contention of Mr.E.Manoharan, learned Additional Government Pleader that, Government have issued orders in G.O. Ms.No.179, Health and Family Welfare (H1) Department, dated 06.07.2016 for Constitution of District and Hospital Level Committee, for Bio Medical Waste Management. He also added that the issue of washing linen is not in accordance with the direction of the Hon'ble Supreme Court, but the same is pending before the National Green Tribunal. Submission of the learned Additional Government Pleader is placed on record.

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Biomedical Waste (Management & Handling) Rules, 1998, as amended on 2000, is extracted hereunder:

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BIOMEDICAL WASTE

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(MANAGEMENT & HANDLING) RULES 1998

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Amended on 2000

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The powers confirmed by section 6, 8, and 25 of the Environment (Protection) Act 1986, the Central Govt. has made The Biomedical Waster (Management & Handling) Rules to safeguard the public and health care workers from the risk arising due to Biomedical Waste. The penalties are same as specified in Environment (Protection) Act 1986. Delhi hospitals alone produce more than 30 tonnes of biomedical waste every day. None of them has satisfactory biomedical waste management (CPCB 2001). There is a need to have centralized facility which will enable the authority to monitor and maintain in a better way.

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Application

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

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Definition: In these rules unless the context otherwise requires: -

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“Act” means the Environment (Protection) Act, 1986 (29 of 1986);

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“Animal House” means a place where animals are reared/kept for experiments or testing purposes;

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“Authorization” means permission granted by the prescribed authority for the generation, collection, reception, storage, transportation, treatment, disposal and/or any other form of handling of bio-medical waste in accordance with these rules and any guidelines issued by the Central Government;

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“Authorized person” means an occupier or operator authorized by the prescribed authority to generate, collect, receive, store, transport, treat, dispose and/or handle biomedical waste in accordance with these rules and any guidelines issued by the Central Government;

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“Bio-medical waste” means any waste, which is generated during the diagnosis, treatment or immunization of human beings or animals or in research activities pertaining to in the production or testing of biologicals, and including categories mentioned in Schedule 1;

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“Biologicals” means any preparation made from organisms or micro organisms or product of metabolism and biochemical reaction intended for use in the diagnosis, immunization or the treatment of disposal of human beings or animals or in research activities pertaining, hereto;

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“Bio-medical waste treatment facility” means any facility wherein treatment, disposal of biomedical waster or processes incidental to such treatment or disposal is carried out;

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“Occupier” in relation to any institution generation bio-medical waster, which includes a hospital, nursing home, clinic, dispensary, veterinary institutions, animal house, pathological laboratory, blood bank by whatever name called, means a person who has control over that institution and/or its premise.

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“Operator of a bio-medical waster facility” means a person who owns or controls or operates a facility for the collection, reception, storage, transport, treatment, disposal or any other form of

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handling of bio-medical waste;

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“Schedule” means schedule appended to these rules;

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Duty of Occupier

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It shall be the duty of every occupier of an instituion generating bio-medical waste, which includes a hospital nursing home, clinic, dispensary, veterinary institutions, and animal house, pathological laboratory, blood bank by whatever name called to take all steps to ensure that such waste is handled without any adverse effect to human health and the environment.

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Treatment and Disposal

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a. Bio-medical waste shall be treated and disposal of in accordance with Schedule 1, and in compliance with the sandards prescribed in Schedule V.

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b. Every occupier, where required, shall set up requisite bio-medical waste treatment facilities like incinerator, autoclave, microwave system for the treatment of waste, or, ensure requisite treatment of waste at a common waste treatment facility or any other waste treatment facility.

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Segregation, Packing, Transportation and Storage a. Bio-medical waste shall not be mixed with other wastes. b. Bio-medical waste shall be segregated into containers/bags at the point of generation in accordance with Schedule II prior to its storage, transportation, treatment and disposal. The containers shall be labelled according to Schedule III.

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c. If a container is transported from the premises where bio-medical waste is generated to any waste treatment facility outside the premises, the container shall, apart from the label prescribed in Schedule III, also carry information prescribed in Schedule IV.

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d. Notwithstanding anything contained in the Motor Vehicle Act, 1988, or rules there under, untreated biomedical waste shall be transported only in such vehicles as may be authorized for the purpose by the competent authority as specified by the government.

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e. No untreated bio-medical waste shall be kept/ stored beyond a period of 48 hours: Provided that if for any reason it becomes necessary to store the

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waste beyond such period, the authorized person must take permission of the prescribed authority and take measures to ensure that the waste does not adversely affect human health and the environment.

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Prescribed Authority

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a. The Government of every State and Union Territory shall establish a prescribed authority with such members as may specified for granting authorization and implementing these rules. If the prescribed authority comprises of more than one member, a chairperson for the authority shall be designated.

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b. The prescribed authority for the State or Union Territory shall be appointed within one month of the coming into force of these rules.

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c. The prescribed authority shall function under the supervision and control of the respective Government of the State or Union Territory.

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d. The prescribed authority shall on receipt of Form 1 make such enquiry as it deems fit and if it is satisfied that the applicant possesses the necessary capacity to handle biomedical waste in accordance with these rules, grant or renew an authorization as the case may be.

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e. An authorization shall be granted for a period of three years, including an initial trial period of one year from the date of issue. Thereafter, an application shall be made by the occupier/operator for renewal. All such subsequent authorization shall be for a period of three years. A provisional authorization will be granted for the trial period, to enable the occupier/ operator to demonstrate the capacity of the facility.

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f. The prescribed authority may after giving reasonable opportunity of being heard to the application and for reasons thereof to be recorded in writing, refuse to grant or renew authorization.

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g. Every application for authorization shall be disposal of by the prescribed authority within ninety days from the date of receipt of the application.

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h. The prescribed authority may cancel or suspend an authorization, if for reason, to be recorded in writing, the occupier/operator has failed to comply with any provision of the Act or these rules.

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Provided that no authorization shall be cancelled or suspended without giving a reasonable opportunity to the occupier/operator of being heard.

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Authorization a. Every occupier of an institution generating, collecting, receiving, storing, transporting, treating, disposing and/or handling bio-medical waste in any other manner, except such occupier of clinic, dispensaries, pathological laboratories, blood banks providing treatment/service to less than 1000 (one thousand) patients per month, shall make an application in Form 1 to the prescribed authority for grant of authorization.

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b. Every operator of a bio-medical waste facility shall make an application in Form 1 to the prescribed authority for grant of authorization.

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c. Every application in Form 1 for grant of authorization shall be accompanied by a fee as may be prescribed by the Government of the State of Union territory.

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Advisory Committee The Government of every State/Union Territory shall constitute and advisory committee. The Committee will include experts in the field of medical and health, animal husbandry and veterinary sciences, environmental management, municipal administration, and any other related department or organization including non-governmental organizations. The State Pollution Board/ Pollution Control Committee shall be represented. As and when required, the committee shall advise the Union Territory /State Government about matters related to the implementation of these rules.

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Annual Report

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Every occupier/operator submit an annual report to the prescribed authority in Form II by 31 January every year, to include information about the categories and quantities of bio-medical wastes handled during the preceding year. The prescribed authority shall send this information in a compiled form to the Central Pollution Control Board by 31 March every year.

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Maintenance of Records

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a. Every authorized person shall maintain records related to the generation, collection, reception, storage, transportation, treatment, disposal and/or any form of handling of bio-medical waste in accordance with these rules and any guidelines issued.

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b. All records shall be subjected to inspection and verification by the prescribed authority at any time. 11. Accident Reporting

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When any accidents occur at any institution or facility or any other site where biomedical waste is handled or during transportation of such waste, the authorized person shall report the accident in Form III to the prescribed authority forth with. 12. Appeal

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Any person aggrieved by an order by the prescribed authority under these rules may, within thirty days from date on which the order is communicated to them, refer an appeal to such authority as the Government of State/Union Territory may think fit to constitute: Provided that the authority may entertain the appeal after the expiry of the said period of thirty days if it is satisfied that the appellant of prevent by sufficient cause from filing the appeal in time.

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SCHEDULE 1 (See Rule 5) CATEGORIES OF BIO-MEDICAL WASTE, TREATMENT & DISPOSAL Category Biomedical waste Treatment & Disposal Human Anatomical Waste (Human tissues, organs, body parts) Incineration/deep burial * Animal Waste (Animal tissues, organs, body parts carcasses, bleeding parts, fluid, blood and experimental animals used in Incineration/deep burial *

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research, waste generated by veterinary hospitals colleges, discharge from hospitals, animals houses).

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Microbiology & Biotechnology Waste (Wastes from lab. Cultures, stocks of specimens of micro-organisms live or attenuated vaccines, human and animal incineration* cell culture

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Autoclaving/ micro-waving.

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used in research and infectious agents from research and industrial laboratories, wastes from production of biologicals, toxins, dishes and devices sued for transfer of cultures)

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Waste Sharps Needles, syringes, scalpels, blades, glass etc. that may cause puncture andcuts. This includes both used and unused and sharps) Chemical/disinfection autoclave/micro-waving mutilation/ shredding

¶143

Discarded Medicines & Cytotoxic drugs

¶144

https://hcservices.ecourts.gov.in/hcservices/

¶145

(Wastes comprising of outdated contaminated and discarded medicines)

¶146

incineration/destruct & drugs disposal in secured landfills

¶147

Soiled Waste (Items contaminated with blood, and body fluids including cotton,

¶148

incineration/ autoclave dressing, soiled plaster casts, lines, micro-waving beddings, other material contaminated with blood)

¶149

Sold Waste (Waste generated from Chemical disinfection disposable items other than sharps such as autoclave/micro-waving tubings catheters, intravenous sets, etc.) and mutilation/shredding

¶150

Liquid Waste (Waste generated from Disinfect-chemically & laboratory and washing, cleaning housekeeping discharge into drains and disinfecting activities)

¶151

Incineration Ash (Ash from incineration of disposal in municipal any bio-medical waste) landfill

¶152

Chemical Waste (Chemical used in production of biologicals, chemicals used in insecticides etc.)

¶153

Chemically treatment disinfection and discharge of drains for liquid and secured landfill for solids.

¶154

Note:

¶155

Chemicals treatment using at least 1% hypochlorite solution or any other equivalent chemical reagent should ensure disinfection.

¶156

Mutilation/shredding must be such so as to prevent unauthorized reuse.

¶157

There will be no chemical pretreatment before incineration. PVC shall not be incinerated.

¶158

The Central Pollution Control Board has recommended two types of incinerators:

¶159

Incinerators or individual hospitals/nursing homes/medical establishments.

¶160

Common incinerator to handle waste from a number of

¶161

https://hcservices.ecourts.gov.in/hcservices/

¶162

hospitals/nursing homes/pathological laboratories etc. Site for Incinerator

¶163

Incinerators should be installed at appropriate location to avoid nuisance to patients and neighbourhood.

¶164

COLOUR CODING AND TYPE OF CONTAINER FOR DISPOSAL OF BIOMEDICAL WASTE

¶165

Colour Coding Type of Container Waste Category Treatment options Yellow Plastic Bag Categories 1, 2, Incineration deep 3 & 6. burial Red.

¶166

Plastic Bag Categories3,6, Autoclaving/ 7 Microwaving Chemical Treatment Blue/White Plastic Bag / Translucent punctproof Cat. 4, Cat. 7 Treatment & containers Destruction / shredding Black Plastic Bag Categories 5,9, Disposal in secured 10 landfill.

¶167

Notes: 1. Colour coding of waste categories with multiple treatment options as defined in schedule 1, shall be selected depending on treatment option chosen, which shall be as specified in Schedule I.

¶168

Waste collection bags for waste types needing incineration shall not be made of chlorinated plastics. 3. Categories 8 and 10 (liquid) do not require containers/bags. 4. Category 3, if disinfected locally need not be put in containers/bags.

¶169

STANDARDS FOR INCINERATORS

¶170

All incinerators shall meet the following operating and emission shandards.

¶171

A. Operating Standards Combustion efficiency (CE) shall be at least 99.0% The compustion efficiency is computed as follows: %CO2 X 100

¶172

C.E. = -----------------------------

¶173

% COS + % CO 1. The temperature of the primary chamber shall be 800+_ 50

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https://hcservices.ecourts.gov.in/hcservices/

¶175

deg C

¶176

The secondary chamber gas resistance time shall be at least 1 (one) second at 1050 deg + - 50 deg C, with a minimum of 3% Oxygen in the stack gas.

¶177

B. Emission Standards

¶178

Parameters Concentration mg/Nm3 at (12% CO2 correction)

¶179

Particulate matter 150

¶180

Nitrogen Oxide 450

¶181

HCl 50

¶182

Minimum stack height shall be 30 meters above ground.

¶183

Volatile organic compounds in ash shall not be more than 0.01 %.

¶184

As per the directions of the Hon'ble Supreme Court, Government have issued an order in G.O.Ms.No.179, Health and Family Welfare (H1) Department, dated 06.07.2016 for Constitution of District and Hospital Level Committee for Bio Medical Waste Management. Duties and responsibilities of the officers, Bio Medical Management Committee, Medical Officers and others, are set out morefully in G.O.Ms.No.179, Health and Family Welfare (H1) Department, dated 06.07.2016. For brevity, the said G.O. is reproduced hereunder:-

¶185

ABSTRACT

¶186

Bio Medical Waste Management – constitution of District and Hospital Level Committee – Orders – Issued.

¶187

¶188

Health and Family Welfare (H1) Department G.O.(M.S)No.179 Dated : 06.07.2016 Thiruvalluvar Aandu-2047 Durmughi, Aani-22. Read:

¶189

1.G.O.(Ms) No.72, Environment and Forest Department, dated 06.04.2000

¶190

2.G.O.(2D) No.52, Health and Family Welfare Department, dated: 25.07.2005

¶191

3.From the Project Director, Tamil Nadu Systems Project, Chennai Letter no.481/HSP/BMWM/2005, dated: 09.12.2005

¶192

4.From the Project Director, Tamil Nadu Health Systems Project, Chennai Letter No.4385/HSP/BMWM/2009, dated:11.11.2009, 15.06.2013 and 26.11.2013

¶193

https://hcservices.ecourts.gov.in/hcservices/

¶194

ORDER:

¶195

The Project Director, Tamil Nadu Health Systems project in his letters third and fourth read above had stated that the Bio Medical Waste generated by the health institutions both in public and private sector needs to be regulated under the Bio Medical Waste (Management and Handling) (Second amendment) Rules 2000, Ministry of Environment and Forest, Government of India Notification, New Delhi, under the health care waste management plan developed by the Tamil Nadu Health Systems Project it was proposed to institutionalize a health care waste management system for the whole health care system in Tamil Nadu. To facilitate the above, the Project Director, has proposed that the Bio Medical Waste Management will be monitored at three levels viz., State level, District level and Hospital Level.

¶196

In the Government Order first read above orders have been issued for constitution of a State Level Advisory Committee for the implementation of Bio-Medical Waste (Management & handling) Rules, 1998 (as amended, from time to time) under the Chairmanship of Secretary to Government, health and Family Welfare Department.

¶197

Based on the proposal of the Project Director, Tamil Nadu Health Systems Project third and fourth read above and in accordance with the Bio Medical Waste (Management and handling) Rules 2000 and 2016 the Government Orders that the District Level and Hospital level Bio Medical Wast Management Monitoring Committee be constituted as follows:

¶198

Status District Bio Hospital Bio
Medical Waste Medical Waste
management Management
Monitoring Monitoring
Committee Committee
1. Chairperson District Collector 1. Hospital
superintendent
/ Chief Medical
Officer
2. Member Dean of Medical
College (Wherever
Applicable)

¶199

https://hcservices.ecourts.gov.in/hcservices/

¶200

Member Joint director of 2. Medical Officer
Secretary Medical and Rural (infection
Health Services and Control &
Family Welfare Environment
health)
4. Member Deputy Director of 3. Nursing
Medical and Rural Superintendent
Health Services and / Head Nurse /
Family Welfare Senior Nurse
5. Member Deputy Director of 4. Paramedical
Health Service Staff
(Nominated by
Hospital
Superintendent
/ Chief Medical
officer)
6. Member District 5. Assistant
Environment Engineer
Engineer / (Public Works
–
Assistant Department
Environmental Buildings)
Engineer / Heading
and district / All
District
Environmental
Engineer in the
District.
7. Member All Municipal
Commissioners
8. Member Indian Medical
Association (IMA)
Representative
9. Member Non Government
Organization (NCO)
Representative
(Nominated by the
Collector)
The Director of Medical an Rural Health Service will be the
state level coordinator of Health Department.

¶201

4)The duties and responsibilities of the Bio Medical
Management Committee and its members are annexed to this
Government Order.

¶202

https://hcservices.ecourts.gov.in/hcservices/

¶203

(BY order of the Governor)

¶204

J.RADHAKRISHNAN

¶205

PRINCIPAL SECRETARY TO GOVERNMENT

¶206

¶207

The Project Director, Tamil nadu Health systems Project, Chennai-6.

¶208

The Director of Medical and Rural health Services, Chennai-6. The Director of Medical Education, Chennai-10

¶209

Copy to:

¶210

The Environmental and forest Department, Chennai-9.

¶211

The Chairman, Tamil Nadu Pollution control Board, Chennai-106. The Health and Family Welfare (Data Cell) Department, Chennai-9. Stock file/ Spare copy

¶212

// FORWARDED/ BY ORDER // SECTION OFFICER

¶213

ANNEXURE

¶214

Duties and Responsibilities

¶215

I The State Level Co-ordinator

¶216

The Director of Medical and Rural Health Services as the State Level Co-ordinator will be responsible for the Management and monitoring of entire Bio Medical Waste Management Programme in Tamil Nadu in Coordination with the Tamil Nadu Pollution Control Board.

¶217

II Members of the District Bio Medical Management Committee 1. The Committee will meet once in 15 days and discuss about the proper functioning of Bio Medical Waste management mechanism in the hospitals in proper segregation, storage, transport, end disposal by Common Treatment Facility (CTF), Consumables availability CTF regularity, payments, daily HMIS entries.

¶218

The District Level Monitoring Committee shall submit its report once in six months to the State Advisory Committee and a copy thereof shall also be forwarded to State Pollution Control Board.

¶219

III Joint Director of Medical & Rural Health Services & Family Welfare in Districts

¶220

Joint Director of Medical and Rural Health Services and Family Welfare will be responsible for the Bio-Medical Waste Management System in the District.

¶221

The Joint Director is responsible for laying

¶222

down guidelines for the Hospital Waste Management System in the district and provide funds.

¶223

Joint Director of Medical and Rural Health Services

¶224

https://hcservices.ecourts.gov.in/hcservices/

¶225

will be responsible for monitoring the system at the district level and would take corrective action is required.

¶226

IV. Responsibilities of Hospital Bio Medical Waste Management Committee

¶227

Proper segregation and storage

¶228

Transport and end disposal by Common Treatment Facility (CTF)

¶229

Consumables availability

¶230

CTF regularity and payments. Daily HMIS entries

¶231

Duties and responsibilities of members of the Waste Management

¶232

committee/Team should be clearly defined to avoid any overlapping. The task could be divided as:

¶233

V. Superintendent/Chief Medical Officers

¶234

Apply for authorization

¶235

Formation of Hospital Bio Medical Waste Management Committee

¶236

Responsible for segregation, treatment, collection, transport and stroage of waste within the hospital and its final disposal.

¶237

Provide manpower and resources.

¶238

Will appoint Medical Officer (as infection Control & Environmental Health) to supervise the functioning.

¶239

To liaise with the department heads for coordination and implementation of activities.

¶240

VI. Medical Officer (Infection Control & Environment Health)

¶241

Directly report to the Head of the facility.

¶242

Ensure the availability and continuous supply of waste disposal bags and chemical disinfectants.

¶243

Ensure the availability of resources example Needle syringes destroyers, waster collection containers etc., at appropriate sites.

¶244

Ensure implementation at various levels.

¶245

To look into storage and transport of waste.

¶246

To maintain statistics.

¶247

To liaise with Departmental Heads and Nursing Superintendent

¶248

Surprise checks.

¶249

To liaise with Hospital Superintendent/Chief Medical Officer on control of infection.

¶250

To monitor standards of Waste Management.

¶251

To identify the training needs of all categories of staff.

¶252

To organize training programme of all categories of staff.

¶253

https://hcservices.ecourts.gov.in/hcservices/

¶254

VII. Nursing Superintendent/Head Nurse

¶255

Responsible for continuous monitoring of waste Management System through out the hospital. Shall liase with department heads, Medical Officer (Infection Control & Environment Health).

¶256

VIII. Role of Doctor and Paramedical Staff in Waste Management Doctors.

¶257

Always wear aprons properly buttoned while examining patients.

¶258

Stick to the golden rules of good hand washing.

¶259

Do not dispose dressing in patients bins.

¶260

Ask for colour coded bags.

¶261

Ensure all plastics and gloves are cut and put in bleach.

¶262

Ensure all used needles and syringes are destroyed using Needles and syringe cutter.

¶263

Ensure compliance during Ward visits.

¶264

Encourage patients and attendants to help follow segregation practices.

¶265

IX. Nurses

¶266

Identify the problem

¶267

Focus on Segregation

¶268

Sharps

¶269

Plastics

¶270

General Waste

¶271

Infected Waste

¶272

Ensure all gloves and plastic are cut and put in bleach Ensure the use of needle and syringe cutters Avoid injury from sharps Take care of spills Ensure

¶273

Worker education

¶274

Personal protection

¶275

Education of Patients

¶276

Reporting of accidents

¶277

Sanitary workers

¶278

To understand the risk and importance of segregation that it is in their own interest.

¶279

Use of protective coats example glove, aprons, masks etc.

¶280

Do not walk bare foot while handling waste

¶281

Do wet mopping

¶282

Wash hand properly after handling waste

¶283

Wash hand before eating and drinking

¶284

https://hcservices.ecourts.gov.in/hcservices/

¶285

Not to eat or drink near wastage dump

¶286

J.RADHAKRISHNAN, PRINCIPAL SECRETARY TO GOVENMEMNT

¶287

//True Copy//

¶288

SECTION OFFICER

¶289

We have gone through the pleadings and materials on record and prima facie satisfy that steps are being taken by the Government, as well as by the Tamil Nadu Pollution Control Board, Chennai, respondents 1 & 2, addressing the issue of Bio Medical Waste Management. Details furnished by Mr.E.Manoharan, learned Additional Government Pleader further shows that STPs (Sewerage Treatment Plants), in various Government run hospitals under the control of Directorate of Medical Education and Director of Medical & Rural Health Services. Though, Mr.R.S.Jeeva Rathinam, learned Senior Counsel for the petitioner submitted that still linen washing is not done, as per the directions of the Hon'ble Supreme Court, at this Juncture, we only observe that the directions of the Hon'ble Supreme Court, and guidelines issued in G.O.Ms.No.179, Health and Family Welfare (H1) Department, dated 06.07.2016 for the Constitution of District and Hospital Level Committees should be followed in letter and spirit. Respondents are directed to ensure proper implementation of the same and make the Sewerage Treatment Plants functional, if have not done earlier. Under the 141 of the Constitution of India, orders issued by the Hon'ble Supreme Court are binding, including Courts.

¶290

To ensure proper implementation of Bio Medical Waste Management rules, respondents 1 & 2 are directed to make a periodical inspection once in two months, of all the health institutions, both in public and private hospitals, required to implement the directions of the Hon'ble Supreme Court and suitable instructions be issued to the District and Hospital Level Committees, to make periodical inspection, as stated supra, and submit a report to both respondents 1 and 2. Defects pointed out by the respective Committees be addressed and rectified by the health institutions in public and private sector and appropriate action be taken, in the event of failure to follow the directions of the Hon'ble Supreme Court, and orders issued by the governemnt, action to be taken, as per the rules. Though the issue, regarding washing of linen discarded or not, as per the definition of Bio Medical Waste Management, Rules 1988, is stated to be pending before the National Green Tribunal. Power of the High Court under Article 226 of the Constitution of India, cannot be restricted.

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https://hcservices.ecourts.gov.in/hcservices/

¶292

Thus, we issue the above directions and accordingly the writ petition is disposed of. No costs. Consequently connected miscellaneous petitions are also closed.

¶293

Sd/Assistant Registrar(CS V)

¶294

//True Copy//

¶295

Sub Assistant Registrar

¶296

dpq/asr

¶297

To
1. The State of Tamil Nadu,
Rep.by its Secretary,
Health & Family Welfare Department,
Fort.St.George,
Chennai 600 009.
2. Tamil Nadu Pollution Control Board,
By its Member Secretary,
76, Mount Salai,
Guindy, Chennai 600 032.
3. The Union of India,
Rep.by its Secretary,
Ministry of Environment, Forest & Climate Change,
New Delhi.
+1cc to the Government Pleader, S.R.No.67068
Writ Petition No.43370 of 2016
and W.M.P.No.37228 of 2016
AD(CO)
CS/09/10/2019

¶298

https://hcservices.ecourts.gov.in/hcservices/

Dr.J.Umarani, v. The State of Tamil Nadu

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Dr.J.Umarani, v. The State of Tamil Nadu

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