BIO-MEDICAL
WASTE MANAGEMENT RULES 1998
SHORT TITLE AND COMMENCEMENT
(1) These rules may be called the bio-medical waste
(management and handling) rules, 1998.
(2) They shall come in to force on the date of their
publication in the official gazette
APPLICATION
These rules apply to all persons who generate, collect,
receive, store, transport, treat, dispose, or handle
bio-medical waste in any form.
DEFINITIONS
In these rules unless the context otherwise requires
- Act - means the environment (protection)
act, 1986(29 of 1986);
- Animal house - means a place where animals
are reared/kept for experiments or testing purposes
- Authorization - means permission granted
by the prescribed authority for the generation,
collection, reception, storage, transportation,
treatment, disposal and/or handle biomedical waste
in accordance with these rules and any guidelines
issued by the central government;
- Authorized person" means an occupier or
operator authorized by the prescribed authority
to generate, collect, receive, store, transport,
treat, dispose and /or handle biomedical waste in
accordance with these rules and any guidelines issued
by the central government;
- 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 biological and including categories mentioned
in schedule 1;
- Biologicals" means any preparation made
from organisms or micro-organisms or product of
metabolism and biochemical reactions intended for
use in the diagnosis, immunization or the treatment
of human beings or animals or in research activities
pertaining thereto;
- 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;
- 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;
- 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, dispose or any other form of handling
of bio-medical waste;
(10)"Schedule" means schedule appended to
these rules;
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 steps to ensure that such
waste is handled without any adverse affect to human
health and the environment.
- Bio-medical waste shall be treated and disposed
of in accordance with schedule I, and in compliance
with the standards prescribed in schedule V
- Every occupier, wherever required shall set up
in accordance with the time-schedule in schedule
VI, requisite bio-medical waste treatment facilities
like incinerator, 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.
SEGREGATION, PACKING, TRANSPORTATION AND STORAGE
- Biomedical waste shall not be mixed with other
wastes.
- 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
- If a container is transported from the premises
where bio-medical waste is generate 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
- Notwithstanding anything contained in the motor
vehicles act, 1988, or rules hereunder, untreated
bio-medical waste shall be transported only in such
vehicle as may be authorized for the purpose by
the competent authority as specified by the government.
- 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 authorized 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.
- The government of every state and union territory
shall establish a prescribed authority with such
members as may be specified for granting authorization
and implementing these rules. If the prescribed
authority which such members as may be specified
for granting authorization and implementing these
rules. If the prescribed authority comprises of
more than one member, a chairperson of r the authority
shall be designated.
- The prescribed authority for the state or union
shall be appointed within one month of the coming
into force to these rules
- The prescribed authority shall function under
the supervision and control of the respective government
of the state or union territory
- The prescribed authority shall in receipt of form
I make such Enquirer as it deems fit and if satisfied
that the applicant possesses the necessary capacity
to handle bio-medical waste in accordance with these
rules, grant or renew an authorization as the case
may be
- An authorization 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 authorization shall
be for a period of three years. A provisional authorization
will be granted for the trial period, to enable
the occupier/operator to demonstrate the capacity
of the facility.
- The prescribed authority may after giving reasonable
opportunity of being heard to the applicant and
for the reasons thereof to the recorded in writing,
refuse the grant or renew authorization
- Every application for authorization shall be disposed
of by the prescribed authority within ninety days
from the date of receipt of the application
- The prescribed authority may cancel or suspend
an authorization, if for reason, to be recorded
in writing provided that no authorization shall
be cancelled or suspended without giving a reasonable
opportunity to the occupier/operator of being heard.
AUTHORIZATION
- 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 moth shall make an application in form
I to the prescribed authority for grant of authorization
for grant of authorization.
- Every application in Form I for grant of authorization
shall be accompanied by a fee as may be prescribed
by the government of state or union territory.
ADVISORY COMMITTEE
The Government of very 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.
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 on matters related
to the implementation of these rules.
ANNUAL REPORT
Every occupier/operator shall submit an annual report
to the prescribed authority in formII 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 complied form to the central pollution
control board by 31 march every year.
MAINTENANCE OF RECORDS
- Every authorized 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 rule s and any guidelines
issued.
- All records shall be subjected to inspection and
verification by the prescribed authority at any
time.
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 authorized
person shall report the accident in form iii to the
prescribed authority forthwith.
APPEAL
Any person aggrieved by an order made by the prescribed
authority under these rules may, within thirty days
form 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
the satisfied that the appellant was prevented by sufficient
cause from filling the appeal in time.
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