BIO-MEDICAL WASTE (MANAGEMENT AND HANDLING) 
(SECOND AMENDMENT) RULES, 2000

MINISTRY OF ENVIRONMENT AND FORESTS
NOTIFICATION

New Delhi, the 2nd June, 2000

S.O. 630 (E).-Whereas a notification in exercise of the powers conferred by Sections 6, 8 and 25 of the Environment (Protection) Act, 1986 (29 of 1986) was published in the Gazette vide S.O. 746 (E) dated 16 October, 1997 inviting objections from the public within 60 days from the date of the publication of the said notification on the Bio-Medical Waste (Management and Handling) Rules, 1998 and whereas all objections received were duly considered..

Now, therefore, in exercise of the powers conferred by section 6, 8 and 25 of
 the Environment (Protection) Act, 1986 the Central Government hereby notifies the rules for the management and handling of bio-medical waste.

1. SHORT TITLE AND COMMENCEMENT:

(1) These rules may be called the Bio-Medical Waste (Management
and Handling) (Second Amendment) Rules, 2000.

(2) They shall come into force on the date of their publication in the official Gazette.

2. APPLICATION:

These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste in any form.

3. DEFINITIONS: In these rules unless the context otherwise requires

(1) "Act" means the Environment (Protection) Act, 1986 (29 of 1986);

(2) "Animal House" means a place where animals are reared/kept for
experiments or testing purposes;

(3) "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 these rules and any guidelines issued by the Central Government.

(4) "Authorised person" means an occupier or operator authorised by the prescribed authority to generate, collect, receive, store, transport, treat, dispose and/or handle bio-medical waste in accordance with these rules and any guidelines issued by the Central Government;

(5) "Bio-medical waste" means any waste, which is generated during the
diagnosis, treatment or immunisation of human beings or animals or in
research activities pertaining thereto or in the production or testing of
biologicals, and including categories mentioned in Schedule I;

(6) "Biologicals" means any preparation made from organisms or micro-
organisms or product of metabolism and biochemical reactions
intended for use in the diagnosis, immunisation or the treatment of human beings or animals or in research activities pertaining thereto;

(7) "Bio-medical waste treatment facility" means any facility wherein
treatment. disposal of bio-medical waste or processes incidental to
such treatment or disposal is carried out and includes common
treatment facilities;
    (7a) "Form" means Form appended to these rules;

(8) "Occupier" in relation to any 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, means a person who has control over that institution and/or its premises;

(9) "Operator of a bio-medical waste facility" means a person who owns or controls or operates a facility for the collection, reception,storage, transport, treatment, disposal or any other form of handling of bio-medical waste;

(10) "Schedule" means schedule appended to these rules;

4. DUTY OF OCCUPIER:

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 handled without any adverse effect to human health and the environment.

5. TREATMENT AND DISPOSAL

(1) Bio-medical waste shall be treated and disposed of in accordance with
Schedule I, and in compliance with the standards prescribed in Schedule V.
(2) Every occupier, where required, shall set up in accordance with the time-schedule in Schedule VI, requisite bio-medical waste treatment
facilities like incinerator, autoclave, microwave system for the treatment of waste, or, ensure requisite treatment of waste at a common waste treatment facility or any other waste treatment facility.

6. SEGREGATION, PACKAGING, TRANSPORTATION AND STORAGE

(1) Bio-medical waste shall not be mixed with other wastes.

(2) Bio-medical waste shall be segregated into containers/bags at the
point of generation in accordance with Schedule II prior to its storage,
transportation, treatment and disposal. The containers shall be labelled
according to Schedule III.

(3) If a container is transported from the premises where bio-medical
waste is generated to any waste treatment facility outside the premises, the container shall, apart from the label prescribed in Schedule III, also carry information prescribed in Schedule IV.

(4) Notwithstanding anything contained in the Motor Vehicles Act, 1988,
or rules thereunder, untreated biomedical waste shall be transported
only in such vehicle as may be authorised for the purpose by the competent authority as specified by the government.

(5) No untreated bio-medical waste shall be kept stored beyond a
period of 48 hours provided that if for any reason it becomes necessary to store the waste beyond such period, the authorised person must take permission of the prescribed authority and take measures to ensure that the waste does not adversely affect human health and the environment.

(6) The Municipal body of the area shall continue to pick up and transport segregated non bio-medical solid waste generated in hospitals and nursing homes, as well as duly treated bio-medical wastes for disposal at municipal dump site.

7. PRESCRIBED AUTHORITY

(1) The prescribed authority for enforcement of the provisions of these rules shall be the State Pollution Control Boards in respect of States and the Pollution Control Committees in respect of the Union territories and all pending cases with a prescribed authority appointed earlier shall stand transferred to the concerned State Pollution Control Board, or as the case may be, the Pollution Control Committees.

(2) The prescribed authority for the State or Union Territory shall be appointed within one month of the coming into force of these rules.

(3) The prescribed authority shall function under the supervision and control of the respective Government of the State or Union Territory.

(4) The prescribed authority shall on receipt of Form 1 make such enquiry as it deems fit and if it is satisfied that the applicant possesses the necessary capacity to handle bio-medical waste in accordance with these rules, grant or renew an authorisation as the case may be.

(5) An authorisation shall be granted for a period of three years, including an initial trial period of one year from the date of issue. Thereafter, an application shall be made by the occupier/operator for renewal. All such subsequent authorisation shall be for a period of  three years. A provisional authorisation will be granted for the trial period, to enable the occupier/operator to demonstrate the capacity of the facility.

(6) The prescribed authority may after giving reasonable opportunity of being heard to the applicant and for reasons thereof to be recorded in writing, refuse to grant or renew authorisation.

(7) Every application for authorisation shall be disposed of by the prescribed authority within ninety days from the date of receipt of the application.

(8) The prescribed authority may cancel or suspend an authorisation, if for reasons, to be recorded in writing, the occupier/operator has failed to comply with any provision of the Act or these rules :

Provided that no authorisation shall be cancelled or suspended without giving a reasonable opportunity to the occupier/operator of being heard.

8. AUTHORISATION

(1) Every occupier of an institution generating, collecting, receiving, storing, transporting, treating, disposing and/or handling bio-medical waste in any other manner, except such occupier of clinics, dispensaries, pathological laboratories, blood banks providing treatment/service to less than 1000 (one thousand) patients per month, shall make an application in Form 1 to the prescribed authority for grant of authorisation.

(2) Every operator of a bio-medical waste facility shall make an application in Form 1 to the prescribed authority for grant of authorisation.

(3) Every application in Form 1 for grant of authorisation shall be accompanied by a fee as may be prescribed by the Government of the State or Union Territory.

(4) The authorization to operate a facility shall be issued in Form IV, subject to conditions laid therein and such other condition, as the prescribed authority, may consider it necessary.

9. ADVISORY COMMITTEE

The Government of every State/Union Territory shall constitute an advisory committee. The committee will include experts in the field of medical and health, animal husbandry and veterinary sciences, environmental management, municipal administration, and any other related department or organization including non-governmental organizations. As and when required, the committee shall advise the Government of the State/Union Territory and the prescribed authority about matters related to the implementation of these rules.

10. ANNUAL REPORT

Every occupier/operator shall submit an annual report to the prescribed authority in Form 11 by 31 January every year, to include information about the categories and quantities of bio-medical wastes handled during the preceding year. The prescribed authority shall send this information in a compiled form to the Central Pollution Control Board by 31 March every year.

11. MAINTENANCE OF RECORDS

(1) Every authorised person shall maintain records related to the generation, collection, reception, storage, transportation, treatment, disposal and/or any form of handling of bio-medical waste in accordance with these rules and any guidelines issued.

(2) All records shall be subject to inspection and verification by the prescribed authority at any time.

12. ACCIDENT REPORTING

When any accident occurs at any institution or facility or any other site where bio-medical waste is handled or during transportation of such waste, the authorised person shall report the accident in Form III to the prescribed authority forthwith.

13. APPEAL

Any person aggrieved by an order made by the prescribed authority under these rules may, within thirty days from the date on which the order is communicated to him, prefer an appeal in form V to such authority as the Government of State/Union Territory may think fit to constitute :

Provided that the authority may entertain the appeal after the expiry of the said period of thirty days if it is satisfied that the appellant was prevented by sufficient cause from filing the appeal in time.

14. Common disposal/incineration sites.

Without prejudice to rule 5 of these rules, the Municipal Corporations, Municipal Boards or Urban Local Bodies, as the case may be, shall be responsible for providing suitable common disposal/incineration sites for the biomedical wastes generated in the area under their jurisdiction and in areas outside the jurisdiction of any municipal body, it shall be the responsibility of the occupier generating bio-medical waste/operator of a
bio-medical waste treatment facility to arrange for suitable sites individually or in association, so as to comply with the provisions of these rules

SCHEDULE I

(See Rule 5)

CATEGORIES OF BIO-MEDICAL WASTE

+ Options given above are based on available technologies. Occupier/operator wishing to use other State-of-the-art technologies shall approach the Central Pollution Control Board to get the standards laid down to enable the prescribed authority to consider grant of authorisation

@@ Chemicals treatment using at least 1% hypochlorite solution or any other equivalent chemical reagent. It must be ensured that chemical treatment ensures disinfection.

## Mutilation/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.

SCHEDULE II

(see Rule 6)

COLOUR CODING AND TYPE OF CONTAINER FOR DISPOSAL OF
BIO-MEDICAL WASTES

Notes:

1. 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.

2. Waste collection bags for waste types needing incineration shall not be made of chlorinated plastics.

3. Categories 8 and 10 (liquid) do not require containers/bags.

4. Category 3 if disinfected locally need not be put in containers/bags.

SCHEDULE III

(see Rule 6)

LABEL FOR BIO-MEDICAL WASTE CONTAINERS/BAGS

                     Bio-Hazard Symbol            Cytotoxic Hazard Symbol

HANDLE WITH CARE

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

SCHEDULE IV

(see Rule 6)

LABEL FOR TRANSPORT OF BIO-MEDICAL WASTE
CONTAINERS/BAGS

                                    
                                                       
                                    Day ............  Month ..........

                                    
                                                       
                                    Year ...........

                                    
                                                        Date
                                    of generation ...............

Waste category No ........

Waste class

Waste description

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

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

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

Fax
                                    No ...............              
                                            Fax No .................

Contact Person ........      
                                                    Contact
                                    Person .........

In case of emergency
                                    please contact 

Name & Address :

Phone No. 

Note : 

Label shall be non-washable
                                    and prominently visible.

SCHEDULE V

(see Rule 5 and Schedule 1)

STANDARDS FOR TREATMENT AND DISPOSAL OF
BIO-MEDICAL WASTES

STANDARDS FOR 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

3. The temperature of the primary chamber shall be 800 ± 50°C.

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

B. Emission Standards

Parameters  Concentration mg/Nm³ at
 (12% CO₂ 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%

Note :

Suitably designed pollution control devices should be installed/retrofitted with the incinerator to achieve the above emission limits, if necessary.

Wastes 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.

Only low sulphur fuel like L.D.0dLS.H.S.1Diesel shall be used as fuel in the incinerator.

STANDARDS FOR WASTE AUTOCLAVING:

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 121°C and pressure of 15 pounds per square inch (psi) for an autoclave residence time of not less than 60 minutes; or

(ii) a temperature of not less than 135°C and a pressure of 31 psi for an autoclave residence time of not less than 45 minutes; or

(iii) a temperature of not less than 149°C and a pressure of 52 psi for an autoclave residence time of not less than 30 minutes.

(II) 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 121°C and pressure of 15 psi per an autoclave residence time of not less than 45 minutes; or

(ii) a temperature of not less than 135°C and a pressure of 31 psi for an autoclave residence time of not less than 30 minutes;

(III) Medical waste shall not be considered properly treated unless the 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 identification number and operating parameters throughout the entire length of the autoclave cycle.

(V) 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 1X10⁴ spores 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 121°C or a pressure less than 15 psi.

(VI) Routine Test

A chemical indicator strip/tape that changes colour when a certain temperature is reached can be used to verify that 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 adequately autoclaved

STANDARD FOR LIQUID WASTE:

The effluent generated from the hospital should conform to the following limits

            PARAMETERS                        PERMISSIBLE
                                    LIMITS

           
                                    PH                    
                                                      63-9.0

           
                                    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.

these limits are applicable 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 car casses, body parts and large metal items.

2. The microwave system shall comply with the efficacy test/routine tests and a performance guarantee may be provided by the supplier before operation of the limit.

3. The microwave should completely and consistently kill the bacteria and other pathogenic organisms that is ensured by approved biological indicator at the maximum design capacity of each microwave unit. Biological indicators for microwave shall be Bacillus Subtilis spores using vials or spore strips with at least 1X10⁴ spores per milliliter.

STANDARDS FOR DEEP BURIAL

1. A pit or trench should be dug about 2 metres deep. It should be half filled with waste, then covered with lime within 50 cm of the surface, before filling the rest of the pit with soil.

2. It must be ensured that animals do not have any access to burial sites. Covers of galvanised iron/wire meshes may be used.

3. On each occasion, when wastes are added to the pit, a layer of 10 cm of soil shall be 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 no shallow well should be close to the site.

6. The pits should be distant 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 all pits for deep burial.

SCHEDULE VI

(see Rule 5)

SCHEDULE FOR WASTE TREATMENT FACILITIES LIKE
INCINERATOR/AUTOCLAVE/MICROWAVE SYSTEM

FORM I

(see rule 8)

Application for Authorisation/Renewal of Authorisation

(To be submitted in duplicate.)

To

The Prescribed Authority
(Name of the State Govt/UT Administration)
Address.

1. Particulars of Applicant

(i) Name of the Applicant
(In block letters & in full)
(ii) Name of the Institution:
Address:
Tele No., Fax No. Telex No.

2. Activity for which authorisation is sought:

(i) Generation
(ii) Collection
(iii) Reception
(iv) Storage
(v) Transportation
(vi) Treatment
(vii) Disposal
(viii) Any other form of handling

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

4.

        (i) Address of the institution handling bio-medical wastes:

(ii) Address of the place of the treatment facility:

(iii) Address of the place of disposal of the waste:

5.

(i) Mode of transportation (in any) of bio-medical waste:

(ii) Mode(s) of treatment:

6. Brief description of method of treatment and disposal (attach details):

7.

(i) Category (see Schedule 1) of waste to be handled

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

8. Declaration

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

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.

Date :                    
                                          Signature of the Applicant

Place :                   
                                          Designation of the Applicant

FORM II

(see rule 10)

ANNUAL REPORT

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

1 . Particulars of the applicant:

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

(ii) Name of the institution:

Address

Tel. No

Telex No.

Fax No.

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

3. Brief details of the treatment facility:

In case of off-site facility:

(i) Name of the operator

(ii) Name and address of the facility:

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

4. Category-wise quantity of waste treated:

5. Mode of treatment with details:

6. Any other information:

7. Certified that the above report is for the period from

Date ............................... Signature ........................................... Place.............................. Designation..........................................

FORM III

(see Rule 12)

ACCIDENT REPORTING

1. Date and time of accident:

2. Sequence of events leading to accident

3. The waste involved in accident :

4. Assessment of the effects of the accidents on human health and the environment,.

5. Emergency measures taken

6. Steps taken to alleviate the effects of accidents

7. Steps taken to prevent the recurrence of such an accident

Date ............................... Signature ........................................... Place.............................. Designation..........................................

FROM IV

[see rule 8(4)]

(Authorisation for operating a facility for collection, reception, treatment, storage transport and disposal of biomedical wastes.)

1.   File number of authroisation and date of issue ......................................................

2. .....................................of ......................................
is hereby granted an authorisation to operate a facility for collection, reception, storage, transport and disposal of biomedical waste on the premises situated at ..............................................

3. This authorisation shall be in force for a period of ...........Years from the date of issue.

4. This authorisation is subject to the conditions stated below and to such other conditions as may be specified in the rules for the being in force under the Environment (Protection) Act, 1986.

                                  Signature.....................

Date......................                                                               Designation .............................

Terms and conditions of authorisation*

1. The authorisation shall comply with the provisions of the Environment (Protection) Act, 1986, and the rules made thereunder.

2. The authorisation or its renewal shall be produced for inspection at the request of an officer authorised by the prescribed authority.

3. The person authorised shall not rent, lend, sell, transfer or otherwise transport the biomedical wastes without obtaining prior permission of the prescribed authority.

4. Any unauthorised change in personnel, equipment or working conditions as mentioned in the application by the person authorised shall constitute a breach of his authorisation.

5. It is the duty of the authorised person to take prior permission of the prescribed authority  to close down the facility.

* Additional terms and conditions may be stipulated by the prescribed authority

FORM V

[see rule 13]

Application for filing appeal against order passed by the prescribed authority at district level or regional office of the Pollution Control Board acting as prescribed authority or the State/Union Territory level authority.

1. Name and address of the person applying for appeal :

2. Number, date of order and address of the authority which passed the order, against which appeal is being made (certified copy of order to be attached)

3. Ground on which the appeal is being made

4. List of enclosures other than the order referred in para 2 against which appeal is being filed.

Date :                              Signature ___________________
                               Name & Address__________________

                           [F. No. 23(2)/96-HSMD]
                            V. RAJAGOPALAN, Jt. Secy.

Note: -- The Principal rules were published in the Gazette of India vide number S.O. 630 (E) dated 20-7-98, and subsequently amended vide S.O. 201(E) dated 6-3-2000.

Source : Ministry of Environment and Forests

                         [F.No.23-2/96-HSMD]
                         VIJAY SHARMA, Jt.Secy.