Section E Rules and Policies

Overview E1 Bio-medical Waste (Management & Handling) Rules, 1998 The Rules apply to all persons who generate, collect, receive, store, transport, treat, dispose or handle bio-medical waste in any form The rules have been notified under the Environment (Protection) Act, 1986 First draft in 1995, Second draft in 1997 Final rules notified on July 27, 1998 First Amendment in March, 2000; Second amendment in June, 2000; Third amendment in Sept, 2003 Supported by three guidelines E1

Important definitions Bio-medical waste: Any waste which is generated during the diagnosis, treatment, or immunization of human beings or animals or in research activities or in the production or testing of biologicals, and including categories mentioned in Schedule 1 Occupier: A person who has control over an institution (and/or its premises) which is generating bio-medical waste E2

Important definitions Authorisation: 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 the rules Bio-medical waste treatment facility: Any facility wherein treatment, disposal of bio-medical waste or processes incidental to these are carried out and includes common treatment facilities E3

Provisions and clauses Duty of occupier: to ensure that bio-medical waste is handled without any adverse effect to human health and environment Treatment and disposal In accordance with Schedule I and in compliance with standards in Schedule V. Facility either on-site or off-site Segregation, packaging, transport and storage Bio-medical waste shall not be mixed with any other waste Shall be segregated at the point of generation as per the colour codes in Schedule II. Containers labeled according to Schedule III E4

Provisions and clauses In case of off-site treatment, container should also have information mentioned in Schedule IV Transportation only in authorized vehicles No untreated waste shall be stored beyond 48 hrs, incase of emergency permission must be sought from prescribed authority Municipal authorities shall continue to pick up and transport segregated non bio-medical waste from healthcare facilities, as well as duly treated bio-medical waste for disposal at municipal dump site E5

Prescribed authority E6 State Pollution Control Board/Committee Applications for seeking authorisation to be disposed within 90 days The authority may after giving reasonable opportunity of being heard to the applicant and for reasons thereof to be recorded in writing, refuse to grant/renew authorisation May cancel/suspend an authorization in case of non- compliance of rules by operator/occupier. Suspension/cancellation of authorisation, only after opportunity to the applicant to be heard, reasons to be recorded in writing Appeal against the order by the applicant within 30 days E6

Authorisation All facilities serving>1000 patients/month to seek authorization from Prescribed Authority as per Form I Facilities serving<1000, still in the framework of rules Authorisation to operate a facility would be issued in Form IV Authorisation form to be accompanied with fee Trial period/provisional: one year Subsequent/renewal: three years E7

Records E8 Annual reports Details of category and quantity of waste handled, mode of treatment with details. Submission to Prescribed Authority by January 31 every year Maintenance of records Records related to generation, collection, reception, storage, transportation, treatment, disposal or any other from of handling of bio-medical waste. Subject to inspection and verification at any time Accident Reporting Any accident during handling or transportation of bio-medical waste should be reported to the Prescribed Authority in Form III E8

Schedule for implementation In cities with population of 30 lakhs and above June 30, 2000 Below 30 lakhs 500 beds and above June 30, 2000 200-500 Dec 31, 2001 50-200 Dec 31, 2000 less than 50 Dec 31, 2002 All other facilities Dec 31, 2002 E9

Schedule I: Categories Waste category Treatment Human anatomical waste Inc/burial Animal waste Microbiology and biotechnolgy waste Inc/alternate Waste sharps Alternate Discarded medicines, cytotoxic drugs Inc/landfill Solid waste Liquid waste Disinfection Incineration ash Landfill Chemical waste Drain/secured landfill after treatment E10

Schedule II: Colour coding Type of container Waste type Yellow Plastic bag Human, animal, microbiology, soiled waste Red Disinfected container/Plastic Bag Microbiology, soiled and solid waste Blue/White Translucent Plastic Bag/ puncture proof container Waste sharps, solid waste Black Plastic Bag Discarded medicine, cytotoxic drugs, ash, chemical waste E11

Take note E12 No storage of untreated waste beyond 48 hrs No incineration of chlorinated plastics, no chemical pretreatment before incineration Bags for incineration should not be made of chlorinated plastic Labelling of waste Label shall be non-washable and visible Deep burial option Inclusion of new technologies E12

Role of municipal body E13 Municipal body to continue to pick up and transport segregated non-biomedical waste and treated medical waste Shall be responsible for providing suitable common disposal sites in the area under their jurisdiction E13

Technology standards E14 Incinerator Combustion Efficiency atleast 99% Temperature Primary Chamber-800+/-50oC Secondary Chamber- 1000+/-50oC Secondary chamber gas residence time at least 1 sec., with minimum 3% oxygen in the stack gas E14

Incinerator E15 Emission standards Parameters Conc.(mg/Nm3) Particulate matter 150 Nitrogen Oxides 450 HCL 50 Minimum Stack height shall be 30 meters above ground Volatile organics in ash not more than 0.01% Suitable pollution control equipment to achieve emission levels E15

Incinerator E16 Chlorinated plastics cannot be incinerated No chemical Pretreatment before incineration Low sulphur fuel to be used Toxic metal limit in ash, as specified in Hazardous Waste Rules E16

Standards for waste autoclaving Dedicated autoclave for waste treatment Time, temperature and pressure to the maintained Graphic/computer recording devices Validation test: Spore testing (bacillus stearothermophilus with atleast 1x104 spores/ml) Routine test: chemical indicator strip/tape which is colour sensitive Operating parameters Gravity flow: 121oC, 15psi, 60’; 135oC, 31psi,45’; 149oC, 52psi, 30’ Pre-vacuum: 121oC, 15psi, 45’; 135oC, 31psi, 30’ E17

Standards for microwaves Not to be used for cytotoxic, hazardous or radioactive wastes, contaminated animal carcasses, body parts and large metal items Should comply with efficacy and routine tests and should consistently kill bacteria and other pathogenic organisms Biological indicator: bacillus subtilis spores (using strips/vials of 1x104spores/ml) E18

Standards for liquid waste* Parameters Permissible limits pH 6.5-9 Suspended solids 100 mg/l Oil and grease 10 mg/l BOD 30 mg/l COD 250 mg/l Bio-assay test-90% survival of fish after 96 hours in 100% effluent * for hospitals connected with sewers without terminal sewage treatment plant or not connected to public sewers E19

Standards for deep burial In rural areas or in towns with population < 5 lakhs Authorisation for the site to be sought, waste added under supervision and records to be maintained The site should be relatively impermeable, distant from habitation, water contamination possibilities to be examined before 2 meters deep pit, half filled with waste, 50 cm lime layer, soil cover 10 cm soil layer with every addition No access to animals E20

Environment Protection Act, 1986 Section 5: Powers to give directions Section 6: Rules to regulate environmental pollution Section 8: Persons handling hazardous substances to comply with procedural safeguards Section 10: Powers of entry and inspection Section 11: Powers to take samples... E21

Environment Protection Act, 1986 Section 15: Penalty for contravention of the provisions of the Act and the rules, orders and directions Section 16: Offences by Companies Section 17: Offences by Government Departments Section 22: Bar of jurisdiction E22

Associated rules E23 Environment Protection Act, 1986 Municipal Waste (Management and Handling) Rules, 2000 Atomic Energy Act Hazardous Wastes (Management & Handling) Rules, 1989 E23