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 of Environment & Forest, Govt. ofIndia has issued a notification on Bio Medical Waste Management under the Environment (Protection) Act. Govt. ofNCT Delhi in its notification dated 6th July, 1999 has authorised Delhi 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 rules are: RULESARE ApPLICABLE To: 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 a hospital, 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 any adverse 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 or set 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 accordance with Schedule Il (copy enclosed), prior to its storage, transportation, treatment and disposal. The container 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 for grant 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'

1. 2. 3.

Clinics, pathological laboratories and blood banks Veterinary institutions, dispensaries and animal houses Hospitals, Nursing Homes, and Health care establishments

1,000/- per annum 1.000/- per annum 1,000/- per annum up to 4 beds and additional Rs. 100 pet bed per annum from fifth bed onwards

4.

Operator of the facility of bio-medical waste (excluding transportation)

10,000/- per annum

5.

Transporter of bio-medical w~ste

7,500/- per annum

An operator of bio-medical waste facility may also engage in transportation of bio-medical waste on payment 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. the Chairman, Delhi Pollution Control Committee, for grant of authorization along with the checklist of documents 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 for which 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 of authorisation. ~ .. In addition, they shall also submit an annual reR°rt to DPCC in form II (copy enclo~ed) by 3 IstJanuary every year to include information about the categories and quantities of bio medical'wastes handled during the proceeding 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 rules and 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 ther procedure given in Schedule-IV: PENALTY:

v)

The defaulting hospitals/nursing homes etc. are liable to be penalised as per the provisions of Environment (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 days from 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 \

Option

Waste Category

Category No. 1

Human Anatomical Waste

Treatment & Disposal

(human tissues, orans, body parts)

Category No. 2

incineration @/deep burial*

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

discarded medicines)

incineration@/destructionand 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) ~ Vaccination against Hepatitis B/Tetanus. ~

Safe disposal of waste. ~

CategoryNo. 7

Solid Waste

the sharps such as tubings, catheters,

disinfection by chemical treatment@@

intravenous sets etc.)

autoclaving/ microwaving

(waste generated from disposable items other than

and mutilation/ shredding## Category No. 8

Liquid Waste

(waste generated from laboratory and washing, cleaning, house-keeping and disinfecting activities)

disinfection by chemical treatment@@ and discharge into drains.

CategoryNo. 9

Incineration Ash (ash from incineration of any bio-medical waste)

Categoiy No; 10

disposal in municipallandfill

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

@ @ 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?

SCHEDULE 11 COLOUR CODING AND THE TYPE OF CONTAINER FOR DISPOSAL OF BIO-MEDlCAL WASTES Colour Coding

Type of Container

Waste Category

Treatment options as per Schedule I

Yellow

Plastic lng

Cat. 1, Cat. 2, and Cat. 3, Cat. 6.

Incineration/deep burial

Red

Disinfected container Plastic bag

Cat. 3, Cat. 6, Cat. 7.

Autoclaving/Microwaving/ Treatment Chemical

BluelWhite transl ucent

Plastic bag/puncture proof contamer

Cat. 4, Cat. 7.

Autodaving/Microwaving Chemical Treatment and destruction/ shrediding

Black

Plastic bag

Cat. 5 and Cat. 9 and Cat. 10. (solid)

Disposal in secured landfill

.. .. ..

Notes: Colour coding of waste categories with multiple treatment options as defined in Schedule I, shall be selected 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 plastics Categories 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

CYTOTO~CHAZARDSYMBOL

BIOHAZARD SYMBOL

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

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.

Telex No. ..............................................................

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.

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

2.

The Combustion efficiency is computed as follows:

% CO2 C.E. =

x 100 %CO2 + % CO

.B.

3.

The temperature of the primary chambershall be 800 :t 50 C*.

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.

5.

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

Emission Standards Parameters

Concentration mg/Nm3 at (12% CQ2 correction)

1) Particulate matter

150

2) Nitrogen Oxides

450

3)

HCL

50

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 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 autoclave residence 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 autoclave residence 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 autoclave residence time of not less than 30 minutes. (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 not lessthan 45 minutes; or (ii) a temperature of not less than 1350 C and pressure of31 psi for an autoclave residence time of not lessthan 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.

(IV)

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

(V)

Spore testing: the autoclave maximum .

(VI)

should

completely

and consistently

kill the approved

biological

indicator

at the

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 no circumstances 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 than 15 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 been adequatelyautoclaved. 'i'

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

'i'

STANDARDS FOR LIQUID WASTE The effluentgeneratedfromthe hospitalshouldconformto the-followinglimits: Parameters Permissiblelimits Limits whenconnectedto terminal treatmentplant pH 6.50-9.0 5.5-9.0 Suspendedsolids 100mg/l 600 Oil and grease 10mg/l 20 BOD 30mg/l 350 COD 250mg/l Bio-assayteS( 90% survivaloffish after96 hoursin 100%effluent. these limits are app}icable to those hospitals which are either connected with sewers without terminal sewage treatment plant or not connected to public sewers. For discharge into public sewers with terminal facilities, the general standards as notified under the Environment (Protection) Act, 1986, shall be applicable. STANDARDS OF MICROWAVING 1.

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 may be 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 I x 104spores per millilitre.

1.

STANDARDS FOR DEEP BURIAL A pit or trench should be dug about 2 metersdeep. It should be half filledwith waste:then coveredwith limewithin 50 cmof thesurface,beforefillingthe restof thepit with soil.

2.

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

meshesmaybeused.

.

.

.

.

I

3.

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

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 any surface water 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

I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I

FORM I APPLICATION FOR AUTHORISATION (To be submitted in duplicate) To The Delhi Pollution Control Committee, ISBT, 4th Floor, Delhi-!! 0006 (Name of the State Govt./UT Administration) Address. 1.

2.

3.

I

5.

I :

I I

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)

4.

I I :

4

6. 7.

. . . . . . . .

Address of the institution handling bio-medical wastes: Address of the place of the treatment facility : Address of the place of disposal of the waste: Mode of transportation (in any) ofbio-medical Mode(s) of treatment:

waste: ..

Brief description of method of treatment and disposal (attach detailsJ.: Category (seeSchedule I) of waste to be handled. . Quantity of waste (category-wise) to be handled per month

:

8.

I I

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

I

I do also hereby undertake to provide any further information

:

relation to these rules and to fulfill

1 I I I

Declaration

any conditions

stipulated

sought by the prescribed authority in by the prescribed

authority.

Date: ................................

Signature: ...........................

Place:

Designation:

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

Hospitals

shall 'cure more diseases rather than producing

them.

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