BIO-MEDICAL WASTE (MANAGEMENT
AND HANDLING) RULES, 1998
1. Short title and commencement
2. Application
3. Definitions
6. Segregation, Packaging, Transportation and
Storage
10. Annual Report
13. Appeal
BIO-MEDICAL WASTE (MANAGEMENT AND
HANDLING) RULES, 1998
S.O. 630 (E), dated 20th
July, 1998.1-Whereas a notification in exercise of the
powers conferred by Secs. 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 Secs. 6, 8 and 25
of the Environment (Protection) Act, 1986 the Central Government hereby
notifies the rules for the management and handling of biomedical waste.
1. Published in the Gazette
of lndia, Extraordinary, Pt.II, Sec. (ii), dated 27th July, 1998.
1. Short Title and Commencement. -
(1) These rules may be called the
Bio-Medical Waste (Management and Handling) Rules, 1998.
(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 biomedical 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
biomedical 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 microorganisms or product of
metabolism and biochemical reactions
intended for rise 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 biomedical waste or processes
incidental to such treatment or disposal is carried out;
(8) “Occupier”
in relation to any institution generating biomedical 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 biomedical 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 biomedical 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 biomedical waste
which includes a hospital, nursing home, clinic, dispensary, veterinary
institution, animal house, pathological laboratory, blood batik 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.
(l) Bio-medical
waste shall be treated and disposed of in accordance with Schedule I, and in
compliant 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 biomedical waste treatment facilities like incinerator,
autoclave, microwave system for the treatment waste, or, ensure requisite
treatment 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 in
accordance to Schedule III.
(3) If a
container is transported from the premises where biomedical 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 biomedical 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.
(l)
The Government of every State and
Union Territory shall establish a prescribed authority with such members as may
be specified for granting authorisation and implementing these rules. If the prescribed authority comprises of
more than one member, a chairperson for the authority shall be designed.
(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 I make such enquiry as it deems
fit and if it is satisfied that the applicant possesses the necessary capacity
to handle biomedical 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’s 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.
(l)
Every occupier of an institution
generating, collecting, receiving, storing, transporting, treating, disposing
and/or handling biomedical 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 I to the prescribed authority for grant of
authorisation.
(2) Every
operator of a biomedical waste facility shall make an application in Form I to
the prescribed authority for grant of authorisation.
(3) Every
application in Form I for grant, of authorisation shall be accompanied by a fee
as may be prescribed by the Government of the State or Union Territory.
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 Organisation including non-governmental
organisations. The State Pollution
Control Board Pollution Control Committee shall be represented. 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 II by 31 January every year, to include information about the
categories and quantities of biomedical waste 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.
(l) Every
authorised person shall maintain records related to the generation, collection,
reception, storage, transportation, treatment, disposal and/or any form of
handling of biomedical 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 biomedical waste is handled or during transportation of such waste,
the authorised person shall report the accident in Form III to the prescribed
an 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 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.
(See rule 5)
Categories of Bio-Medical Waste
|
Option
|
Waste
Category |
Treatment
and Disposal |
|
Category No. 1 Category No. 2 |
Human Anatomical Waste (Human tissues, organs, body parts) Animal Waste (Animal
tissue, organs, body parts carcasses, bleeding parts, fluid, blood and experimental
animals used in research, waste generated by Veterinary hospitals colleges,
discharge from hospitals, animal houses) |
Incineration1/deep burial2 Incineration1/deep
burial2 |
|
No. 3 Category |
Microbiology and Biotechnology Waste (Wastes from laboratory cultures, stocks or specimens of micro-organisms live or Attenuated
vaccines, human and animal cell culture used in research and infectious
agents from research and industrial laboratories, wastes from production of
biologicals, toxins, Dishes and devices used for transfer of
cultures) |
Local autoclaving/micro- waving/incineration3 |
|
No. 4 Category |
Waste Sharps (Needles,
syringes, scalpels, blades, glass, etc., that may cause puncture and cuts.
This includes both used and unused sharps) |
Disinfections / chemical Treatment3/auto craving/ Micro-waving and Mutilation/shredding4 |
|
No. 5 Category |
Discarded
Medicines and Cytotoxic drugs (wastes comprising of outdated, contaminated
and discarded medicines) |
Incineration5/destruction
and drugs disposal in secured landfills |
|
No. 6 Category |
Solid Waste (Items contaminated with blood, and body fluids including cotton, dressing, soiled plaster casts, lines, beddings, other material contaminated with blood) |
Incineration5 autoclaving/ micro waving |
|
No. 7 Category |
Solid Waste (Wastes generated from disposable items other
than the waste sharps such as tubings, catheters, intravenous sets etc.). |
Disinfections
by chemical treatment3/ autoclaving/ micro waving and Mutilation/shredding4 |
|
No. 8 Category |
Liquid Waste (Waste generated from laboratory and washing, cleaning, house-keeping and disinfecting activities) |
Disinfection by chemical Treatment3 and discharge into drains. |
|
No. 9 Category |
Incineration Ash (Ash from incineration of any biomedical
waste) |
Disposal in municipal landfill |
|
No. 10 Category |
Chemical Waste (Chemicals
used in production of biologicals, chemicals used in disinfection, as
insecticides, etc.) |
Chemical treatment3 and Discharge
into drains for Liquids
and secured landfill for solids |
1. There will be no chemical pretreatment
before incineration. Chlorinated
plastics shall not be incinerated.
2. Deep
burial shall be an option available only in towns with population less than
five lakhs and in rural areas.
3. Chemicals
treatment using at least 1% hypochlorite solution or any other equivalent
chemical reagent. It must be ensured
that chemical treatment ensures disinfection.
4. Multilation/shredding
must be such so as to prevent unauthorised reuse.
5. There
will be no chemical pretreatment before incineration. Chlorinated plastics
shall not be incinerated.
(See rule 6)
Colour Coding and Type of Container for
Disposal of Bio-Medical Wastes
|
Colour
Coding |
Type
of Container |
Waste
Category |
Treatment
options as per Schedule I |
|
Yellow |
Plastic
Bag |
Cat.1,
Cat. 2, and Cat.3, |
Incineration/deep
burial |
|
Red |
Disinfected
container/plastic bag |
Cat.3,
Cat.6, Cat.7, |
Autoclaving/Microwaving/Chemical
Treatment |
|
Blue/White
Translucent |
Plastic
bag/puncture proof container |
Cat.4,
Cat.7. |
Autoclaving/Microwaving/Chemical
Treatment
and destruction/shredding |
|
|
|
|
|
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.
(see rule 6)
Label for Bio-Medical Waste Containers/Bags
BIOHAZARD SYMBOL CYTOTOXIC HAZARD SYMBOL
BIOHAZARD
CYTOTOXIC
HANDLE WITH CARE
Note:
Label shall be non-washable and prominently visible.
(see rule 6)
Label for Transport of Bio-Medical Waste
Containers/Bags
Day Month
Day………….Month…………..
Year………..
Date of
generation…………..
Waste category
No…………..
Waste class
Waste description
Sender's Name and
Address
Phone No…………….
Telex No……………
Fax No
Contact Person
In case of emergency
please contact
Name and Address:-
Phone No.
Note:
Label shall be non-washable and prominently visible.
(See rule 5 and Schedule I)
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
C.E.= %CO2 x 100
% C02 + % CO
3. The temperature of the
primary chamber shall be 800 ± 50 deg.
C0.
4. The
secondary chamber gas residence time shall be at least 1 (one) second at 1050
50 C0, 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 limit, 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.O./L.S.H.S./Diesel shall be used as fuel in the
incinerator.
STANDARDS FOR WASTE AUTOCLAVING:
The autoclave should be dedicated for the
purposes of disinfecting and treating biomedical waste.
(1) When
operating a gravity flow autoclave, medical waste shall be subjected to
(i) A temperature of not less than 121 C0
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 C0
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 C0
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 C0
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 C0
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 a Bacillus stearothermophilus spore using vials or spore
strips, with at least I x 104 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 C0
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.
STANDARDS FOR LIQUID WASTE:
The effluent
generated from the hospital should conform to the following limits:
|
PARAMETERS |
PERMISSIBLE LIMITS |
|
Ph Suspended solids Oil and grease BOD COD Bio-assay test |
6.5-9.0 100 mg/1 10mg/1 30 mg/1 250 mg/1 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 not public sewers
with terminal facilities, the general standards as notified under the
Environment (Protection) Act, 1986 shall be applicable.
STANDARDS
OF MICROWAVNG:
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 efficacy test/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
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 1 x 104 spores per
millilitre.
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 with 50 cm of the surface, before filling the
rest the pit with soil.
2. It
must 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.
(See rule 5)
Schedule for Waste Treatment Facilities
Like Incinerator/
Autoclave/Microwave System
|
A. Hospitals and nursing homes in towns with by 31st December,
1999 or earlier population of 30 lakhs and above B. Hospital
and nursing homes in towns
with population of below 30 lakhs (a) With 500 beds and above (b) With 200 beds and above but less than 500 beds (c) With 50 beds and above but
less than 200 beds (d) With less than 50 beds C. All other institutions generating
biomedical waste not included in A and B above |
By 31st December, 1999 or earlier By 31st December, 1999 or earlier By 31st December, 2000 or earlier By 31st December, 2001 or earlier By
31st December, 2002 or earlier By
31st December, 2002 or earlier |
(See rule 8)
Application for 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 and 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 resh
authorisation or for renewal (In case of renewal previous authorisation-number
and date)
4.
(i) Address of the institution handling biomedical 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
biomedical waste
(ii) Mode(s)
of treatment
6. Brief description of method of
treatment and disposal (attach details):
7. (i) Category (see Schedule I) of waste to
be handled
(ii) Quantity
of waste (category-wise) to be handled per month
8.
Declaration
I do hereby declare that the statement 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
(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………….
(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 alleviate the effects of accidents
Date ……….. Signature:………….
Place ……….
Designation:………….