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  1. 1. Bio-medical Waste Management And Handling Rules Presented byDR ANWAR AHMAD Community Medicine & Public health Department KGMU U.P LUCKNOW
  2. 2. NEED OF BIOMEDICAL WASTE MANAGEMENT AND HANDLING  Biomedical wastes, if not handled in a proper way, is a potent source of diseases, like AIDS, Tuberculosis, Hepatitis and other bacterial diseases.  Nosocomial infections in patients from poor infection control practices and poor waste management.  Drugs & Syringes which have been disposed of, being repacked and sold off to unsuspecting buyers. Owing to the discussed potential threats this waste needs prime attention for its safe and proper disposal.
  3. 3. MAGNITUDE OF THE PROBLEM Developed countries generate 1 to 5 kg/bed/day BMW INDIA:- No national level study Local/regional level study showshospitals generate roughly 1-2 kg/bed/day According to WHO total BMW consist of: 85% non infectious/non hazardous waste : 10% infective waste : 5% non-infectious but hazardous.
  4. 4. BIO-MEDICAL WASTE MANAGEMENT & HANDLING RULES NOTIFICATIONS AND AMENDMENTS On 20th July 1998 Ministry of Environment and Forests (MoEF), Govt. of India, Framed a rule known as ‘Bio- medical Waste (Management and Handling) Rules, 1st Amendment Dated 06/03/2000 2nd Amendment Dated 17/09/2003 The MoEF has notified the new Draft “Bio-Medical Waste (Management & Handling) Rules 2011” on 24TH August, 2011 under the Environment Protection Act, 1986 to replace the earlier Rules. Provide uniform guidelines and code of practice for management and handling of biomedical wastes generated from Hospitals, clinics & other institutions generating Biomedical Waste.
  5. 5. Major Difference between BMW Rules 1998 & 2011 1998 2011 1 Occupiers with more than 1000 beds required to obtain authorisation Every occupier generating BMW, requires to obtain authorisation 2 Operator duties absent Duties of the operator listed 3 Biomedical waste divided in ten categories Biomedical waste divided in 8 categories 4 Rules restricted to HCEs with more than 1000 beds Treatment and disposal of BMW made mandatory for all the HCEs 5 No format for annual report A format for annual report appended with the rules 6 Form VI is absent Form VI i.e. the report of the operator on HCEs not handing over the BMW added to the Rules
  6. 6. Bio-medical Waste Management And Handling Rules 2011  RULES- 1 to 17  SCHEDULES- I to VI  FORMS- I to VI
  7. 7. 1. SHORT TITLE AND COMMENCEMENT:  (1) These rules may be called the Bio-Medical Waste (Management and Handling) Rules, 2011.  (2) They shall come into force on the date of their publication in the official Gazette.
  8. 8. 2. APPLICATION:  These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste in any form & shall not apply to- a) b) c) d) e) Radioactive waste as covered under the “Atomic energy Act 1962” Hazardous chemicals covered under the “Manufacture, storage & import of hazardous chemicals Rules 1989” Wastes covered under the Municipal solid wastes Rules 2000 The lead acid batteries covered under the “Batteries Rules 2001” Hazardous wastes covered under the “Hazardous waste Rules 2008”
  9. 9. 3. DEFINITIONS: (1) "Act" means the Environment (Protection) Act, 1986 (29 of 1986); (2) "Animal House" means a place where animals are reared/kept for experiments or testing purposes; (3) "Authorisation" means permission granted by the prescribed authority for the generation, collection, reception, storage, transportation, treatment, disposal of bio-medical waste. (4) "Authorised person" means an occupier or operator authorised by the prescribed authority to generate, collect, receive, store, transport, treat, dispose and/or handle bio-medical.
  10. 10. (5) "Bio-medical waste" means any waste, which is generated during the diagnosis, treatment or immunisation of human beings or animals or in research activities & including categories mentioned in Schedule I of these rules; (6) "Biologicals" means any preparation made from organisms or microorganisms or product of metabolism and biochemical reactions intended for use in the diagnosis, immunisation or the treatment of human beings or animals or in research activities; (7) "Bio-medical waste treatment and disposal facility" means any facility wherein treatment, disposal of bio-medical waste is carried out; (8) "Occupier" means a person having administrative control over the institution and the premises generating biomedical waste; (9) "Operator of a bio-medical waste treatment facility" means a person who controls or operates a facility handling the bio-medical waste; (10) "Schedule" means schedule appended to these rules; (11) “Form” means form appended to these rules;
  11. 11. 4. DUTIES OF THE OCCUPIER: It shall be the duty of every occupier1. To take all steps to ensure that BMW is handled without any adverse effect to human health & environment. 2. To provide training for all its health care workers. 3. To immunize all its health care workers. 4. To ensure segregation of BMW at the point of generation. 5. To ensure occupational safety of all its heath care workers by providing personal protective equipments. 6. To conduct health care check-up annually for all its workers & maintain the records for the same. 7. To install necessary equipments & regular supply of materials required for handling BMW.
  12. 12. 4. DUTIES OF THE OCCUPIER: cont.. 8. To maintain & update everyday BMW management register according to quantity, categories & final mode of disposal as specified in SCHEDULE-1. 9. To develop a system of reporting of unintended accidents like sharp injuries, mercury spills, fire hazards which are likely to occur during BMW handling. Such records shall be maintained and reported in Form III along with annual report and should indicate even the nil report. 10. To inform the prescribed authority immediately in case the operator of a facility does not collect the BMW within the intended time. 11. To establish a BMW management cell or unit if the facility has more than 30 beds. Such unit or cell shall meet once in six months & the records of minutes of such meetings shall be submitted along with the annual report to the prescribed authority.
  13. 13. 5. DUTIES OF THE OPERATOR: 1. 2. 3. 4. 5. 6. 7. 8. To take all necessary steps to ensure that the BMW collected from the occupier is transported, handled, stored, treated & disposed of without any adverse effect to human health & environment. To ensure timely collection of BMW from the health care facilities. To inform the prescribed authority immediately regarding the health care establishments/facilities, which are not handling over the segregated BMW. To provide training of all its workers. To undertake appropriate pre-placement & periodic medical examination and immunize all its workers and records for the same. To ensure occupational safety by providing protective equipments. To develop system of reporting of unintended accidents in Form III with annual report even the nil reporting. To maintain a log book of treatment equipment according to weight of batch; categories of waste treated; time; date; duration of treatment cycle & total hours of operation.
  14. 14. 6.RESPOSIBILITIES OF AUTHORITIES:  The authority specified in column 2 of the ScheduleVI shall perform the duties as specified in column 3 of the said Schedule as per the provisions of these Rules.
  15. 15. 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 prescribed in Schedule V.  (2) Any person including an occupier/operator of a BMW treatment facility intends to promote new technologies for treatment of BMW shall approach the Central Government/Central Pollution Control board for prior approval.  (3) Every occupier shall either set up his own BMW treatment equipment, prior to commencement of its operation or ensure treatment of BMW through an authorised common BMW treatment facility.  (4) Every operator of a common BMW treatment facility shall set up BMW treatment equipments, prior to commencement of its operation.
  16. 16. 7. TREATMENT AND DISPOSAL: cont.  (5) Use of chlorinated plastic bags for handling of BMW shall be prohibited & the occupier/operator of a common BMW facility shall not dispose of such plastics by incineration.  (6) The occupier/operator of a BMW treatment facility shall dispose of the recyclable BMW such as plastics & glass etc. through authorised recyclers. The occupier shall maintain a record of such recyclable wastes auctioned or sold.  (7) In the event of breakage of mercury containing medical instruments, necessary precautions shall be taken by the occupier to segregate such waste as per guideline.
  17. 17. 8. SEGREGATION, PACKAGING, TRANSPORTATION AND STORAGE: (1) Untreated BMW shall not be mixed with other wastes. (2) Bio-medical waste shall be segregated into containers/bags at the point of generation in accordance with Schedule II. (3) The containers shall be labelled according to Schedule III. (4) The transporter shall transport the BMW from the premises of an occupier to any off-site BMW treatment facility only with label as prescribed in schedule III along with the necessary information prescribed in Schedule IV. (5) Untreated BMW shall be transported only in specific vehicle authorised by the competent authority. (6) No untreated BMW of categories 1,2,3&6 shall be kept stored beyond a period of 48 hours. If for any reason it becomes necessary to store the waste beyond such period, the authorised person must take permission of the prescribed authority . (7) The municipal body of the area shall continue to pickup & transport segregated non BM solid waste as well as dully treated BMW for disposal at municipal dump site.
  18. 18. 9. PRESCRIBED AUTHORITY: The prescribed authority shall be the State Pollution Control Boards in respect of State & Pollution control Committees in respect of Union Territories. 2) The prescribed authority in respect of all health care establishments of the Armed Forces shall be the Director General, Armed Forces Medical Services. 3) The prescribed authority shall function under the supervision & control of the respective Government of the state. 4) The prescribed authorities shall comply with the responsibilities as stipulated in Schedule VI of the Rules. 1)
  19. 19. 10. PROCEDURE FOR AUTHORISATION: 1) 2) 3) 4) 5) 6) 7) Every occupier/operator of BMW treatment facility shall make an application in Form-1 to the prescribed authority for grant of authorization. The prescribed authority shall on receipt of Form-1 make such enquiry as it deems fit & if it is satisfied may grant /renew an authorization. A provisional authorization in Form-IV shall be granted for trial run for a period of one year. On satisfactory performance during trial period , the authorization shall be renewed for a further period of five year. The prescribed authority, after giving reasonable opportunity to the applicant, may refuse to grant/renew authorization & to be recorded in writing. Every application for authorization shall be disposed of by the prescribed authority within ninety days. The prescribed authority may cancelled/suspend an authorization. Every occupier/operator shall intimate the prescribed authority about any change/variation in the activity relating to BMW management & shall submit a fresh application in Form-I.
  20. 20. 11. ADVISORY COMMITTEE: The government of every state shall constitute an Advisory Committee under the chairmanship of State Health secretary. The committee shall include representatives from state department of health, environment, urban development, animal husbandry & veterinary sciences, State Pollution Control Board, local bodies/urban/municipal corporation, representative from Indian Medical Association, common BMW treatment facility & non government organization. The advisory committee shall meet once in six months & review all the matters related to implementation of Rules. 2) Ministry of defence shall constitute an advisory committee under chairmanship of Additional Director General of Armed Forces Medical Services. 3) The Government of every State shall constitute District Level Monitoring Committee in the districts under the chairmanship of District Medical Officer. 1)
  21. 21. 12. ANNUAL REPORT: 1) Every occupier/operator shall submit an annual report to the prescribed authority in Form-II by 31st January every year, to include information about the categories and quantities of BMW handled during the preceding year. 2) The prescribed authority shall send this information in a compiled form to the Central Pollution Control Board by 31 March of every year. 3) The Central Pollution Control Board shall send this information in a compiled Form to the Ministry of Environment and Forest by 30th June of every year
  22. 22. 13. MAINTENANCE OF RECORDS: 1) Every authorised person shall maintain records related to the generation, collection, reception, storage, transportation, treatment, disposal and/or any form of handling of bio-medical waste. 2) All records shall be subject to inspection and verification by the prescribed authority at any time.
  23. 23. 14. ACCIDENT REPORTING: When any accident occurs at any institution or facility or any other site where biomedical waste is handled or during transportation of such waste, the authorised person shall report the accident in Form-III to the prescribed authority forthwith.
  24. 24. 15. APPEAL: 1) Any person aggrieved by an order made by the prescribed authority under these rules, may prefer appeal within 30 days in Form-V to the Secretary (Environment) of State Government. 2) Any person aggrieved by an order of the Director General Armed Forces Medical Services under these rules, may prefer an appeal within 30 days in Form-V to the Ministry of Environment and Forest.
  25. 25. 16. COMMON DISPOSAL /INCINERATION SITES: The Municipal Corporation, Municipal Boards, Urban or Local Bodies, shall be responsible for providing suitable common disposal/incineration sites for the biomedical wastes generated in the area under their jurisdiction.
  26. 26. 17. LIABILITY OF THE OCCUPIER, OPERATOR OF A FACILITY 1) The occupier/operator of a BMW treatment facility shall be liable for all the damage caused to the environment or the public due to improper handling of BMW. 2) The occupier/operator of BMW treatment facility shall be liable for action under section 5 and 15 of Environment Protection Act 1986. This is punishable with imprisonment for a term which may extend to five years or with fine which may extend to one lakh rupees, or with both, and in case the failure or contravention continues, with additional fine which may extend to five thousand rupees for every day during which such failure or contravention continues after the conviction for the first such failure.
  27. 27. SCHEDULE I CATEGORIES OF BIO-MEDICAL WASTE Category Waste category (type) Treatment & disposal option Category No. 1 Human Anatomical Waste Incineration Category No. 2 Animal waste Incineration Category No. 3 Microbiology & Biotechnology Waste & their laboratory waste Disinfection at source by chemical treatment/autoclaving/microwaving followed by mutilation/shredding then final disposal in secured landfill or disposal of recyclable waste through authorised recyclers Category No. 4 Waste Sharps Disinfection by chemical treatment/autoclaving/microwaving or destruction by needle tip cutter followed by mutilation/shredding & final disposal through authorised CBWTF or in secured landfill or designated concrete waste sharp
  28. 28. SCHEDULE I CATEGORIES OF BIO-MEDICAL WASTE cont. Category Waste category (type) Treatment & disposal option Category No. 5 Discarded Medicine & Cytotoxic drugs Disposal in secured land fill/Incineration Category No. 6 Solid Waste ( item contaminated with blood & body fluids) Incineration Category No. 7 Infectious solid waste (such as catheters, hand gloves, tubings, saline bottles etc.) Disinfection by chemical treatment/autoclaving/microwaving followed by mutilation/shredding then disposal through authorised recyclers Category No. 8 Chemical Waste (disinfection, insecticides etc.) Chemical treatment & discharge into drains meeting the norms & solid disposal in secured landfill  Chemical treatment using at least 1% hypochlorite solution or any other equivalent chemical reagent.  Mutilation/shredding must be such that so as to prevent unauthorised reuse.  There may be no chemical treatment before incineration.
  29. 29. SCHEDULE-II COLOUR CODING & TYPE OF CONTAINER FOR DISPOSAL OF BIO-MEDICAL WASTES COLOR CODE TYPE OF CONTAINER WASTE CATEGORY TREATMENT OPTIONS Yellow Non chlorinated plastic bags 1, 2, 5 and 6 Incineration Red Non chlorinated plastic bags/puncture proof container for sharps 3, 4 & 7 As per Schedule-I Blue Non chlorinated plastic bags containers 8 As per schedule -I Black Non chlorinated plastic bags Municipal Waste Disposal in municipal dump sites 2/10/2014 Biomedical Waste (BMW) Management 29
  30. 30. 2/10/2014 30
  32. 32. SCHEDULE-IV LABEL FOR TRANSPORT OF BIO-MEDICAL WASTE CONTAINERS/BAGS Label shall be non-washable & prominently visible Day………………. Month…………….day Year……………… Date of generation…………………… Waste Category No……………… Waste quantity……………………. Sender’s Name and Address Receiver’s Name and Address Phone No……… Phone No……………… Telex No……….. Telex No……………….. Fax No………….. Fax No…………………… Contact Person………. Contact Person…….. In case of emergency please contact Name and Address: Phone No. 2/10/2014 32
  34. 34. SCHEDULE-VI List of authorities and the corresponding duties 1) Ministry of Environment & forests 2) Central/State Ministry of Health Family Welfare, Veterinary and Animal Husbandry 3) Ministry of Defence 4) Central Pollution Control Board 5) State Gov./Union Territory Gov./Administration 6) State Pollution Control Boards/Committees 7) Local bodies such as Gram Panchayat, Municipalities
  35. 35. Bio-Medical Waste (Management and Handling) Rules, 2011 FORM I APPLICATION FOR AUTHORISATION (To be submitted in duplicate.) To The Prescribed Authority (Name of the State Govt/UT Administration) Address. 1. Particulars of Applicant (i) Name of the Applicant (In block letters & in full) (ii) Name of the Institution: Address: Tele No., Fax No. Telex No. 2. Activity for which authorisation is sought: (i) Generation (ii) Collection (iii) Reception (iv) Storage (v) Transportation (vi) Treatment (vii) Disposal (viii) Any other form of handling 3. Please state whether applying for fresh authorisation or for renewal: (In case of renewal previous authorisation-number and date) 4. (i) Address of the institution handling bio-medical wastes: (ii) Address of the place of the treatment facility: (iii) Address of the place of disposal of the waste: 5. (i) Mode of transportation (in any) of bio-medical waste: (ii) Mode(s) of treatment: 6. Brief description of method of treatment and disposal (attach details): 7. (i) Category (see Schedule 1) of waste to be handled (ii) Quantity of waste (category-wise) to be handled per month 8. Declaration; I do hereby declare that the statements made and information given above are true to the best of my knowledge and belief and that I have not concealed any information. I do also hereby undertake to provide any further information sought by the prescribed authority in relation to these rules and to fulfil any conditions stipulated by the prescribed authority. Date : Signature of the Applicant Place : Designation of the Applicant
  36. 36. Bio-Medical Waste (Management and Handling) Rules, 2011 FORM II ANNUALREPORT (To be submitted to the prescribed authority by 31 January every year) 1 . Particulars of the Occupier: (i) Name of the authorised person (occupier/operator): (ii) Name of the institution: Address Tel. No 2. Type of health care facility: 3. Categories of Bio-medical waste generated: 4. Category-wise quantity of waste treated: 5. Additional details: 6. Any other relevant information: 7. Certified that the above report is for the period from……… Date ............................... Place.............................. Name and Signature of the Head of the Institution
  37. 37. Bio-Medical Waste (Management and Handling) Rules, 2011 FORM III ACCIDENT REPORTING 1. Date and time of accident: 2. Sequence of events leading to accident: 3. The waste involved in accident : 4. Assessment of the effects of the accidents on human health and the environment: 5. Emergency measures taken: 6. Steps taken to alleviate the effects of accidents: 7. Steps taken to prevent the recurrence of such an accident: Date ............................... Place.............................. Signature ......................... Designation......................
  38. 38. OTHER FORMS FORM-IV: Authorization for operating a facility for collection, reception, treatment, storage, transport and disposal of BMW FORM-V: Application for filing appeal against order passed by the prescribed authority FORM-VI: Report of the Operator of the Common BMW treatment & disposal facility/ Establishment not handing over BMW