Section E

Rules and policies

Section ERules and Policies

Section E

Rules and policies

OverviewBio-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

Section E

Rules and policies

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

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Section E

Rules and policies

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

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Section E

Rules and policies

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 o In accordance with Schedule I and in

compliance with standards in Schedule V. Facility either on-site or off-site

o Segregation, packaging, transport and storage

o Bio-medical waste shall not be mixed with any other waste

o Shall be segregated at the point of generation as per the colour codes in Schedule II. Containers labeled according to Schedule III E4

Section E

Rules and policies

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

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Section E

Rules and policies

Prescribed authority 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

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Section E

Rules and policies

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

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Section E

Rules and policies

RecordsAnnual 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

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Section E

Rules and policies

Schedule for implementation

In cities with population of 30 lakhs and above June 30, 2000

Below 30 lakhs o 500 beds and above June 30, 2000o 200-500 Dec 31, 2001o 50-200 Dec 31, 2000o less than 50 Dec 31, 2002

All other facilities Dec 31, 2002

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Section E

Rules and policies

Schedule I: CategoriesWaste category TreatmentHuman anatomical waste Inc/burialAnimal waste Inc/burialMicrobiology and biotechnolgy waste

Inc/alternate

Waste sharps AlternateDiscarded medicines, cytotoxic drugs

Inc/landfill

Solid waste AlternateLiquid waste DisinfectionIncineration ash LandfillChemical waste Drain/secured

landfill after treatment E10

Section E

Rules and policies

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

Schedule II: Colour coding

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Section E

Rules and policies

Take note

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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Section E

Rules and policies

Role of municipal body

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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Section E

Rules and policies

Technology standards

Incinerator

Combustion Efficiency atleast 99% Temperature

o Primary Chamber-800+/-50oCo Secondary Chamber- 1000+/-50oC

Secondary chamber gas residence time at least 1 sec., with minimum 3% oxygen in the stack gas

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Section E

Rules and policies

IncineratorEmission standards

Parameters Conc.(mg/Nm3)

Particulate matter 150Nitrogen Oxides 450HCL 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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Section E

Rules and policies

Incinerator

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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Section E

Rules and policies

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

Section E

Rules and policies

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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Section E

Rules and policies

Standards for liquid waste*

Parameters Permissible limitspH 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

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Section E

Rules and policies

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

Section E

Rules and policies

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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Section E

Rules and policies

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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Section E

Rules and policies

Associated rules

Environment Protection Act, 1986 Municipal Waste (Management and

Handling) Rules, 2000 Atomic Energy Act Hazardous Wastes (Management &

Handling) Rules, 1989

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