1. Section E
Rules and Policies

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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
Dec 31, 2001
Dec 31, 2000
less than 50 Dec 31, 2002
All other facilities Dec 31, 2002 E9

11. 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
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12. 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
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13. 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
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14. 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
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15. Technology standards E14 Incinerator Combustion Efficiency atleast 99%
Temperature
Primary Chamber-800+/-50oC
Secondary Chamber /-50oC
Secondary chamber gas residence time at least 1 sec., with minimum 3% oxygen in the stack gas
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16. 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
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17. 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
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18. 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’
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19. 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)
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20. Standards for liquid waste*
Parameters Permissible limits pH
Suspended solids 100 mg/l
Oil and grease 10 mg/l
BOD 30 mg/l
COD 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
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21. 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
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22. 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...
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23. 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
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24. Associated rules E23 Environment Protection Act, 1986
Municipal Waste (Management and Handling) Rules, 2000
Atomic Energy Act
Hazardous Wastes (Management & Handling) Rules, 1989
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