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BIO-MEDICAL WASTE
(MANAGEMENT AND HANDLING)
RULES, 1998
The Biomedical Waste
Management & Handling) Rules, 1998 came into force on 1998. In exercise
of the powers conferred by section 6,8 & 25 of EP Act, 1986, the Central
Govt. notified these rules for the management and Handling of biomedical
wastes generated from Hospitals, clinics, other institutions for scientific
management of Biomedical Waste.
The Biomedical waste means
any waste, which is generated during the diagnosis, treatment or immunization
of human beings or animals or in research activities pertaining thereto or in
the production or testing of biological and including categories mentioned in
schedule I of the Rules.
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 what ever name called to take
all steps to ensure that such waste is handled without any adverse effect to
human health and the environment.
The Segregation, Packaging,
Transportation and Storage shall be done as under:-
1. Bio-medical waste shall
not be mixed with other wastes.
2. Bio-medical waste shall be
segregated into containers/bags at the points of generation in accordance with
Schedule II prior to its storage transportation, treatment and disposal. The
containers shall be labeled
according to Schedule III.
Every occupier of an
institution generating, collecting, receiving, storing, transporting, treating
and /or handling Biomedical Waste shall apply on Form 1 for Authorization to
the Board.
The State Pollution Control
Board are declared as prescribed Authority for grant of Authorization. The
Board grants authorizations after satisfying itself.
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
bio-medical wastes handled during the proceeding year. The prescribed
authority shall send this information in a complied form to the Central
Pollution Control board by 31 March every year.
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 authorized person shall
report the accident in Form III to the prescribed authority forthwith.
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. For violating the provisions of these Rules, the
Board can file a complaint under section 15 of EP Act which provide for
imprisonment which may extend upto 5 years with fine. The Board can also have
directions for closure of any defaulting hospital/clinic/institution under section
5 of EP Act as per powers delegated by the Central Govt.
BIO-MEDICAL WASTE
(MANAGEMENT
AND HANDLING)RULES, 1998
AS AMENDED 2000 – RELAVENT PROVISIONS
New Delhi, 20th July,
1998
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) 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 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 authorized 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;
(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 biomedical 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 labeled according 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 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.
7. PRESCRIBED AUTHORITY
(1) The Government of every
State and
(2) The prescribed authority
for the State or
(3) The prescribed authority
shall function under the supervision and control of the respective Government
of the State or
(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 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 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
(4) The authorization to
operate a facility shall be issued in Form IV subject to conditions laid
therein and such other conditions, as the prescribed authority.
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 nongovernmental 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 11 by 31 January
every year, to include information about the categories and quantities of
biomedical 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
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.
1. COMMON DISPOSAL
/INCINERATION SITES
Without prejudice to rule 5
of these rules, the Municipal Corporation, Municipal Boards or Urban Local
Bodies, as the case may be, shall be responsible for providing suitable
common disposal/incineration sires for the biomedical wastes generated in the
area under their jurisdication and in areas outside the jurisdiction of any
municipal body, it shall be the responsibility of the occupier generating.
CATEGORIES OF BIO-MEDICAL
WASTE
COLOUR CODING AND TYPE OF
CONTAINER FOR DISPOSAL OF
BIOMEDICAL WASTES
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Sunday, 6 July 2014
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