DELHI POLLUTION CONTROL COMMITTEE (DPCC)

BIO MEDICALWASTE(MANAGEMENT & HANDLING) RULES, 1998/

BACKGROUND:

With a view to control the indiscriminate disposal of hospital waste/bio medical waste, the Ministry ofEnvironment & Forest, Govt. ofIndia has issued a notification on Bio Medical Waste Management under theEnvironment (Protection) Act. Govt. ofNCT Delhi in its notification dated 6th July, 1999 has authorisedDelhi Pollution Control Commit~ee (DPCC) for the purpose of granting authorisation for collection,reception, storage, treatment and disposal of bio medical waste and to implement the Bio Medical Waste(Management & Handling) Rules. 1998. Govt of NCT of Delhi has also constituted advisory committee,appellate authority in exercise of powers conferred under the said rules. Some of salient features of these rulesare:

RULESARE ApPLICABLETo:

i) These Rules will apply to hospitals, Nursing Homes, veterinary hospitals, animal houses, pathological labs& blood banks, generating hospital wastes. (except such occupier of clinics, dispensaries, pathological labs,blood banks providing treatment/ service to less than 1000 (one thousand) patients per month).

DuTY:

ii) It shall be the duty of every occupier of an institution generating bio medical waste which includes ahospital, nursing home, clinic, dispensary, Veterinary institution animal house, pathological laboratory,blood bank by whatever name called to take all steps to ensure-that such waste is ha~dled without anyadverse effect the humari health and the environment.

MANAGEMENT OF BIO-MEDICAL WASTE:

iii) Every occupier generating the bio-medical waste need to install an appropriate facility'in the premises orset up a common faci1ityto ensure requisite treatment of waste by 30.6.2000 in accordance with Schc;dule

I (copy enclosed) and in compliance with standards prescribed with Schedule V (copy,enclosed).

The bio medical waste need to be segregated into container/bags at the point of generation in accordancewith Schedule Il (copy enclosed), prior to its storage, transportation, treatment and disposal. Thecontainer shall be labelled according to Schedule III (copy enclosed).

MANDATORY I LEGAL REQUIREMENT:

iv) Every occupier of an institution, generating, collecting, receiving, storing, transporting, treating,disposing andlor handling bio medical waste in any other manner, shall make an application in Form I(copy enclosed) alongwith the following fee structure to the Delhi Pollution Control Committee forgrant of authorisation. The Form I can be obtained after paying an amount ofRs. 1001- in the form of

'i' Segregate waste at point of generation, dispose in bags with correct colour coding. 'i'

4. Operator of the facility of bio-medical waste

(excluding transportation)

Transporter of bio-medical w~ste

1,000/- per annum

1.000/- per annum

1,000/- per annum upto 4 beds and additional

Rs. 100 pet bed per annumfrom fifth bed onwards

10,000/- per annum

1.2.

3.

Clinics, pathological laboratories and blood banks

Veterinary institutions, dispensaries and animal houses

Hospitals, Nursing Homes, and Health care establishments

5. 7,500/- per annum

An operator of bio-medical waste facility may also engage in transportation of bio-medical waste onpayment of additional fees prescribed for a transporter of biomedical waste.

An application in Form-I appended to the aforesaid rules shall be made to the prescribed authority i.e. theChairman, Delhi Pollution Control Committee, for grant of authorization along with the checklist ofdocuments as given in Annexure-I, wherever applicable.

An authorization shall be granted for a period of three years, including an initial trial period of one year forwhich a provisional authorization will be granted. All subsequent authorizations shall be for a period of

three years. Fee shall be payable for three years at time.

The above fee structure is subject to revision from time to time. .

The Government's notification No. E23 (522)/95-Env/99 dated the 6th July 1999, issued in pursuance of

rule 8(3) ibid shall stand superseded with immediate effect).

An operator of a facility shall make an application form in Form -I with the fee as applicable for grant ofauthorisation. ~ . .

In addition, they shall also submit an annual reR°rt to DPCC in form II (copy enclo~ed) by 3 IstJanuary everyyear to include information about the categories and quantities of bio medical'wastes handled during theproceeding year and also maintain records related to the generation, collection, reception, storage,transportation, treatment, disposal, and/or any form of handing ofbio medical waste in accordance with rulesand guidelines issued. All records shall be subject to inspection and verification by the D PCC at any time.

The transporter, operator of a facility shall label the Bio-Medical Waste strictly in accordance with therprocedure given in Schedule-IV:

PENALTY:

v) The defaulting hospitals/nursing homes etc. are liable to be penalised as per the provisions ofEnvironment (Protection) Act, 1986 and other pollution control Acts.

ApPEAL:

vi) Appeal: Any person aggrieved by an order made by the D PCC under these rules may within thirty daysfrom date on which the order is communicated to him, prefer an appeal to the Financial Commissioner,Govt. ofNCT of Delhi. .

Ii? Transport BMW in covered trolleys. Ii? Disinfect and sterilise and dispose critical items Ii?

SCHEDULE I

CATEGORIES OF BIO-MEDICAL WASTE

~ Vaccinationagainst Hepatitis B/Tetanus. ~ Safe disposal of waste. ~

\

Option Waste Category Treatment & Disposal

Category No. 1 Human Anatomical Waste

(human tissues, orans, body parts) incineration @/deep burial*

Category No. 2 Animal Waste

(animal tissues, organs, body parts carcasses, incineration @/dcep burial*

bleeding parts, fluid, blood and experimental animals

used in research, waste generated by veterinary hospitals,

colleges, discharge from hospitals, animal houses)

CategoryNo. 3 Microbiology & Biotechnology Waste

(wastes from laboratory cultures, stocks or micro-organisms local autoclavingl micro

live or vaccines, human and animal cell culture used in waving/incineration@

research and infectious agents from research and industrial

laboratories, wastes from production of bioIogicaIs, toxins,

dishes and devices used for transfer of cultures)

CategoryNo. 4 Waste Sharps

(needles, syringes, scalpels, blade, glass, etc. that may disinfection (chemical

cause puncture and cuts. This includes both used and treatment@@@ Iauto

unused sharps) clavingl microwaving and

mutiltidnl shredding##

CategoryNo. 5 Discarded Medicines and Cytotoxic drugs

(waste comprising of outdated, contaminated nd incineration@/destructionand

discarded medicines) drugs disposal in secured

landfills""--

CategoryNo. 6 Soiled Waste

(items contaminated with blood, and body fluids including incineration@1

cotton, dressings, soiled plaster casts, lines, bedding, other- autoclavingl microwaving

material contaminated with blood)

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

It musts be ensured that chemical treatment ensures disinfection.

## Multilation/shredding must be such so as to prevent unauthorised reuse.

@ There will be no chemical pretreatment before incineration. Chlorinated plastics shall not be incinerated.

*Deep burial shall be an option available only in towns with population less than five lakhs and in rural

areas.

'et?Waste handlers to use gloves, apron, respirator (mask), boots, while transporting waste. 'et?

CategoryNo. 7 Solid Waste

(waste generated from disposable items other than disinfection by chemical

the sharps such as tubings, catheters, treatment@@

intravenous sets etc.) autoclaving/ microwaving

and mutilation/ shredding##

Category No. 8 Liquid Waste

(waste generated from laboratory and washing, cleaning, disinfection by chemical

house-keeping and disinfecting activities) treatment@@

and discharge into drains.

CategoryNo. 9 Incineration Ash

(ash from incineration of any bio-medical waste) disposal in municipallandfill

Categoiy No; 10 Chemical Waste

(chemicals used in production of biologicals, chemicals chemical treatment@@ and

used in disinfection, as insecticides, etc.) discharge into drains for

liquids and secured landfill for

solids

SCHEDULE 11COLOUR CODING AND THE TYPE OF CONTAINER

FOR DISPOSAL OF BIO-MEDlCAL WASTES

.. Notes:

Colour coding of waste categories with multiple treatment options as defined in Schedule I, shall beselected depending on treatment option chosen, which shall be as specified in Schedule I.Waste collection bags for waste types needing incineration shall not be made of chlorinated plasticsCategories 8 and 10 (liquid) do not require containers/bags.Category 3 if disinfected locally need not be put in containers/bags.

....SCHEDULE III

LABELFOR BIO-MEDlCAL WASTE CONTAINERS/BAGS

BIOHAZARD SYMBOL CYTOTO~CHAZARDSYMBOL

BIOHAZARD CYTOTOXIC

HANDLE WITH CARE

Note; Lable shall be non-washable 'and prominendy visible.

'Ii Never recap, bend or break disposable 'Ii Always dispose of your own sharps. 'Ii

Colour Coding Type of Container Waste Category Treatment options as perSchedule I

Yellow Plastic lng Cat. 1, Cat. 2, and Incineration/deep burialCat. 3, Cat. 6.

Red Disinfected container Cat. 3, Cat. 6, Cat. 7. Autoclaving/Microwaving/Plastic bag Treatment Chemical

BluelWhite Plastic bag/puncture proof Cat. 4, Cat. 7. Autodaving/Microwavingtransl ucent contamer Chemical Treatment and

destruction/ shrediding

Black Plastic bag Cat. 5 and Cat. 9 Disposal in securedand Cat. 10. (solid) landfill

SCHEDULE N(See Rule 16)

LABELFOR TRANSPORT OF BIO-MEDICAL WASTE CONTAINERS/BAGS

Waste Category No. ..... Day Month .........................

Waste Class......................................................... Year , .

Waste Description.. ................................. Date of generation ........................................

Sender's Name & Address ..... Receiver's Name &Address ...........................

............................................................................. ,...................

,................................ .

PhoneNo. ............ Phone No. ...........

TelexNo. .............................................................. TelexNo. ,.............................................

FaxNo. ... ....,........... FaxNo. :.........................................

CQntact Person..................................................... Contact Person ..~....1.....................................

In case of emergency please contact:

Name &Address ..................................................

............................................................................

.............................................................................

Phone No. ............................................................

Note: Label shall be non-washable and prominently visible.

If? Wear respirator (marks) to protect against aerosols & splashes. If?

---

SCHEDULE V

STANDARDS FOR TREATMENT AND DISPOSAL OF BIO-MEDICAL WASTES

STANDARDSFR INCINERATORS:

All incinerators shall meet the following operating and emission standards:

A. Operating Standards

1.

2.

Combustion efficiency (CE) shall be at least 99.00%.

The Combustion efficiency is computed as follows:

% CO2C.E. = x 100

%CO2+ % CO

The temperature of the primary chambershallbe 800 :t 50 C*.3.

4. The secondary chamber gas residence time shall be at least 1 (one) second at 1050 :t 50C*,with minimum 3% oxygen in the stack gas.

Volatile organic compounds in ash shall not be more than 0.01 %.5.

.B. Emission Standards

Parameters Concentration mg/Nm3 at (12% CQ2 correction)

1) Particulate matter

2) Nitrogen Oxides

3) HCL

4) Minimum stack height shall be 30 metres above ground.

5) Volatile organic compounds in ash shall not be more than 0.01.0/001

150

450

50

Notes:

. Suitably designed pollution control devices should be installedlretrofitted with the incinerator to

achieve the above emission limits, if necessary.

. Waste to be incinerated shall not be chemically treated with any chlorinated disinfectants.

. Chlorinated plastics shall not be incinerated.

. Toxic metals in incineration ash shall be limited within the regulatory quantities as defined

under the Hazardous Waste (Management and Handling Rules,) 1989.

"",

'i' Wear respirator (marks) to protect against aerosols & splashes. 'i'

STANDARDS FORWASTEAUTOCIAVING:

The autoclave should be dedicated for the purposes of disinfecting and treating bio-medical waste,

(I) When operating a gravity flow autoclave, medical waste shall be subjected to:

(i) a temperature of not less than 1210 C and pressure of 15 per square inch (psi) for an autoclaveresidence time of not less than 60 minutes; or

(ii) a temperature of not less than 1350 C and pressure of 31 per square inch (psi) for an autoclaveresidence time of not less than 45 minutes; or

(iii) a temperature of not less than 1490 C and pressure of 52 per square inch (psi) for an autoclaveresidence time of not less than 30 minutes.

(IV)

(V)

(VI)

(11) When operating a vacuum autoclave, medical waste shall be subjected to a minimum of one pre

vacuum pulse to purge the autoclave of all air.The waste shall be subjected to the following:

(i) a temperature of not less than 1210C and pressure of 15 psi per an autoclave residence time of notlessthan 45 minutes; or

(ii) a temperature of not less than 1350 C and pressure of31 psi for an autoclave residence time of notlessthan 30 minutes;

(Ill) Medical waste shall not be considered properly treated unless that time, temperature and pressure

indicators indicate that the required time, temperature and pressure were reached during the autoclave

process. If for any reasons, time temperature or pressure indicator indicates that the required

temperature, pressure or residence time was not reached, the entire load of medical waste must be

autoclaved again until the proper temperature, pressure and residence time were achieved.

Recording of Operational parameters

Each autoclave shall have graphic or computer, recording devices which will automatically and

continuously monitor and record dates time of day, load identificarlon number and operating

parametersthroughout the entirelengthofthe autoclavecycle. .

Validation test

Spore testing:

the autoclave should completely and consistently kill the approved biological indicator at the

maximum design capacity of each autoclave unit. Biological indicatOr for autoclave shall be Bacillus

. stearothermophilus spores using vials or spore strips, with at least 1x 10\pores per millilitre. Under nocircumstances will an autoclave have minimum operating parameters less than a residence time of 30

minutes, regardless of temperature and pressure, a temperature less than 1210 C or a pressure less than15 psi.

Routine Test

A chemical indicator stripltape that changes colour when a certain temperature is reached can be used

to verifYthat a specific temperature has been achieved. It may be necessary to use more than one strip

over the waste package at different location to ensure that the inner content of the package has beenadequatelyautoclaved.

'i' Segregate the waste at source; it will reduce the management burden to a great wxtent 'i'

STANDARDSFOR LIQUID WASTE

The effluentgeneratedfromthe hospitalshouldconformto the-followinglimits:Parameters Permissiblelimits Limits whenconnectedto terminal treatmentplant

pH 6.50-9.0 5.5-9.0Suspendedsolids 100mg/l 600Oil andgrease 10mg/l 20BOD 30mg/l 350COD 250mg/l -Bio-assayteS( 90% survivaloffishafter96 hoursin 100%effluent.

these limits are app}icable to those hospitals which are either connected with sewers without terminal sewagetreatment plant or not connected to public sewers. For discharge into public sewerswith terminal facilities, thegeneral standards as notified under the Environment (Protection) Act, 1986, shall be applicable.

1.STANDARDS OF MICROWAVING

Microwave treatment shall not be used for cytotoxic, hazardous or radioactive wastes, contaminated

animal carcasses,body parts and large metal items.

2. The microwave system shall comply with the efficacytest!routine tests and a performance guarantee maybe provided by the supplier before operation of the unit.

3. The microwave should completely and consistently kill the bacteria and other f1athogenicorganisms that

is ensured by approved biological indicator at the maximum design capaCllYof eacq microwave unit.Biological indicators for microwave shall be Bacillus Subtilis spores using vials or spore strips with at least

Ix 104spores per millilitre.

1.STANDARDSFOR DEEP BURIAL

A pit or trench should be dug about 2 metersdeep.It should be half filledwith waste:then coveredwithlimewithin 50cmof thesurface,beforefillingthe restof thepit with soil.

2. It must be ensured that animals do not have any access to burial sites. covers.ofgalvanised iron/wiremeshesmaybeused. . .

3.. . I

On each occasion when wastes are added to the pit, a layer of 10 cm of soil shalfbe added to cover thewastes.

4. Burial must be performed under close and dedicated supervision.

5. The deep burial site should be relatively impermeable and shallow well should nol be close to the site.

6. The pits should be distan t from habitation, and sited so as to ensure that no contamination occurs of anysurfacewater or ground water. The area should not be prone to flooding or erosion.

7. The location of the deep burial site will be authorised by the prescribed authority.

8. The institution shall maintain a record of allpits for deep burial

Iir Never pass sharps diii:cdy from one person to another. Iir

IIIII ToIIIIII 1.IIIIIIII 2.IIIIIIIIIIII 3.II 4.II . Address of the institution handling bio-medical wastes:I . Address of the place of the treatment facility :

I . Address of the place of disposal of the waste:

: 5. . Mode of transportation (in any) ofbio-medical waste:I . Mode(s) of treatment: ..

: 6. . Brief description of method of treatment and disposal (attach detailsJ.:I 7. . Category (seeSchedule I) of waste to be handled. .

I . Quantity of waste (category-wise) to be handled per month

: 8. DeclarationI I hereby declare that the statements made and information given above are true to the best of myI knowledge and belief and I have not concealed any information.

I I do also hereby undertake to provide any further information sought by the prescribed authority in

: relation to these rules and to fulfill any conditions stipulated by the prescribed authority.

1III

FORM IAPPLICATION FOR AUTHORISATION

(To be submitted in duplicate)

4

The Delhi Pollution Control Committee, ISBT, 4th Floor, Delhi-!! 0006

(Name of the State Govt./UT Administration)

Address.

Particulars of Applicant

. Name of the Applicant. (In block letters & in full). Name of the Institution:Address:

Tele No., Fax No.,Telex No.

Activity for which authorisation is sought:

. Generation. Collection

. Reception

. Storage

. Transportation. Treatment

. Disposal

. Any other form of handling

Please state whether applying for fresh authorisation or for renewal:(In case of renewal previous authorisation-number and date)

Date: ................................ Signature: ...........................

Place: ............. Designation: .

<§I Wear respirator (marks) to protect against aerosols & splashes. IiI

IIIIIIIIIIIIIIIIIIIIIIIIIIIIIILIIIIIIIIIIIIIIIIIII

iIII

FORM II(Seerule 10)

ANNUAL REPORT

(To be submitted to the prescribed authority by 31 January every year)

1. Particulars of the applicant:

0) Name of the authorised person(occupier/operator):

Oi) Name of the institUtion:

Address

Tel. No.

Telex No.

Fax No.

2.

3.

Categories of waste generated and quantity on a monthly average basis:

Brief details of the treatment facility:

In case of off~site facility:

(i)

(ii)

Name of the operator

Name of the address of the facility:

Tel. No., Telex No., Fax No.

4.

5.

6.

Category~wise quantity of waste treated:

Mode of treatment with details:

7.

Any other information:

Certified that the above report is for the period from

.................................................................................................................................................

Date: ................................ Signature: ...........................

Place: ............................. Designation: .

..,

c§? Introduce incentives to the lower staff, safaikaramcharis for motivating them. c§?

ANNEXURE - I

Check List

Enclosures required to be submitted with the authorization application form before June 30,2001

1. Application form, duly completed, [Form-I of the Bio-Medical Waste (Management & Handling)

Rules, 1998.]

2. Fee as prescribed/Applicable to be paid through Bank draft only in favour of Delhi Pollution Control

Committee. (Forthreeyears).

3. Affidavit on non-judicial Stamp paper of Rs. 10/- duly attested by notary public with a stamp

of Rs.5/- indicating

a. Authorized person (with Name and designation) to sign the authorization application form

and other enclosures.

b. Number of beds.

4. Copy the Agreement, if any, with operator of a facility / transporter of the Bio- Medical Waste

~ Bio-medicalwaste management is more of administrative rather than technical ~

Performa of Affidavit to be submitted with Application for seeking "Authorization"under Bio Medical Waste (Management & Handling) Rules, 1998.

AFFIDAVIT

I (With name and designation) Slo ...........................................................RI0 do solemnly affirm and declare as under:-

1. That I am responsible for operating the Hospital I Nursing Home I Clinic I Dispensary I Pathologicallab, etc. named MI s ..................................................................................................................Address , ...

2. That I , (with name & designation) am

authorized to sign the authorization application form and the other enclosure with the application.3. That the number of Beds are............................................................................................................

4. That all the Conditions mentioned in the previous authorization for compliance of various provisions

of the Bio-Medical Waste (Management & Handling) Rules, 1998 have been complied.

5. That the agreement with operator of facilityl transporter of the Bio-Medical Waste has been

completed. (if applicable).

6. That the Bio-Medical Waste generated is managed effectively in accordance with the handling and

disposal methods mentioned in Bio-Medical Waste (Management & Handling) Rules, 1998.

7. That in case of any change in the location or information provided above, a fresh application foraUthorization shall be submitted.

8. An application for renewal of authorization shall be submitted to DPCC one month in advance of thedate of expiry the authorization granted by the 0 Pcc.

9. That annual report in Form No. ITshall be submitted on or before 31January of every year indicating

thewastequantitydetailsof previousyear. !

10. That a copy of agreement with operator of facility shall be submitt~d within 15 days of entering intoagreement, wherever applicable.

Note:- Pleaseomit whatever isnot applicable.

VERIFICATION DEPONENT

Verified at Delhi on this (day, month and year), that the above contents of this

affidavit are true and correct to the best of my knowledge and belief and nothing has been concealedtherefrom.

DEPONENT

Note: The aforementioned Affidavit must be duly signed by the deponent and duly attested by the NotaryPublic thereof.

c£> Hospitals shall 'cure more diseases rather than producing them. c£>