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The powers confirmed
by section 6, 8, and 25 of the Environment (Protection)
Act 1986, the Central Govt. has made The Biomedical
Waster (Management & Handling) Rules to safeguard
the public and health care workers from the risk arising
due to Biomedical Waste. The penalties are same as specified
in Environment (Protection) Act 1986. |
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Delhi hospitals alone produce more than 30 tonnes of
biomedical waste every day. None of them has satisfactory
biomedical waste management (CPCB 2001). There is a need
to have centralized facility which will enable the authority
to monitor and maintain in a better way. |
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1. Application |
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These rules apply to all persons who generate, collect,
receive, store, transport, treat, dispore, or handle bio-medical
waste in any form |
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2. Defination:
In these rules unless the context otherwise requires:
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1. “Act” means the Environment (Protection)
Act, 1986 (29 of 1986); |
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2. “Animal House” means a place where animals
are reared/kept for experiments or testing purposes; |
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3. “Authorization” 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; |
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4. “Authorized 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; |
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5. “Bio-medical waste” means any waste,
which is generated during the diagnosis, treatment or
immunization of human beings or animals or in research
activities pertaining to in the production or testing
of biologicals, and including categories mentioned in
Schedule 1; |
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6. “Biologicals” means any preparation made
from organisms or micro organisms or product of metabolism
and biochemical reaction intended for use in the diagnosis,
immunization or the treatment of disposal of human beings
or animals or in research activities pertaining, hereto; |
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7. “Bio-medical waste treatment facility”
means any facility wherein treatment, disposal of bio-medical
waster or processes incidental to such treatment or disposal
is carried out; |
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8. “Occupier” in relation to any institution
generation bio-medical waster, which includes a hospital,
nursing home, clinic, dispensary, veterinary institutions,
animal house, pathological laboratory, blood bank by whatever
name called, means a person who has control over that
institution and/or its premise. |
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9. “Operator of a bio-medical waster 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; |
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10. “Schedule” means schedule appended to
these rules; |
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3. Duty of
Occupier |
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It shall be the duty of every occupier of an instituion
generating bio-medical waste, which includes a hospital
nursing home, clinic, dispensary, veterinary institutions,
and 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. |
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4. Treatment and Disposal |
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a. Bio-medical waste shall be treated and disposal of
in accordance with Schedule 1, and in compliance with
the sandards prescribed in Schedule V. |
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b. Every occupier, where required, shall set up 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. |
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5. Segregation, Packing,
Transportation and Storage |
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a. Bio-medical waste shall not be mixed with other wastes. |
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b. 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. |
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c. 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. |
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d. Notwithstanding anything contained in the Motor Vehicle
Act, 1988, or rules there under, untreated biomedical
waste shall be transported only in such vehicles as may
be authorized for the purpose by the competent authority
as specified by the government. |
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e. 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.
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6. Prescribed Authority |
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a. The Government of every State and Union Territory
shall establish a prescribed authority with such members
as may specified for granting authorization and implementing
these rules. If the prescribed authority comprises of
more than one member, a chairperson for the authority
shall be designated. |
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b. The prescribed authority for the State or Union Territory
shall be appointed within one month of the coming into
force of these rules. |
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c. The prescribed authority shall function under the
supervision and control of the respective Government of
the State or Union Territory. |
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d. 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 authorization as the case may be. |
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e. 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. |
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f. The prescribed authority may after giving reasonable
opportunity of being heard to the application and for
reasons thereof to be recorded in writing, refuse to grant
or renew authorization. |
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g. Every application for authorization shall be disposal
of by the prescribed authority within ninety days from
the date of receipt of the application. |
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h. The prescribed authority may cancel or suspend an
authorization, if for reason, to be recorded in writing,
the occupier/operator has failed to comply with any provision
of the Act or these rules. |
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Provided that no authorization shall be cancelled or
suspended without giving a reasonable opportunity to the
occupier/operator of being heard. |
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7. Authorization |
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a. 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 clinic, 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 authorization. |
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b. Every operator of a bio-medical waste facility shall
make an application in Form 1 to the prescribed authority
for grant of authorization. |
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c. Every application in Form 1 for grant of authorization
shall be accompanied by a fee as may be prescribed by
the Government of the State of Union territory. |
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8. Advisory Committee |
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The Government of every State/Union Territory shall
constitute and 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 Board/ Pollution Control Committee
shall be represented. As and when required, the committee
shall advise the Union Territory /State Government about
matters related to the implementation of these rules. |
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9. Annual Report |
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Every occupier/operator 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 preceding year.
The prescribed authority shall send this information in
a compiled form to the Central Pollution Control Board
by 31 March every year. |
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10. Maintenance of Records |
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a. 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 rules and any guidelines
issued. |
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b. All records shall be subjected to inspection and
verification by the prescribed authority at any time. |
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11. Accident Reporting |
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When any accidents occur 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 forth with. |
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12. Appeal |
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Any person aggrieved by an order by the prescribed authority
under these rules may, within thirty days from date on
which the order is communicated to them, refer an appeal
to such authority as the Government of State/Union Territory
may think fit to constitute: |
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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 of prevent by sufficient
cause from filing the appeal in time. |
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SCHEDULE 1 (See Rule 5)
CATEGORIES OF BIO-MEDICAL WASTE, TREATMENT & DISPOSAL
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| Category |
Biomedical waste |
Treatment & Disposal |
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Human Anatomical Waste (Human
tissues, organs, body parts) |
Incineration/deep burial * |
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Animal Waste (Animal tissues,
organs, body parts carcasses, bleeding parts, fluid,
blood
and experimental animals used in
research, waste generated by veterinary
hospitals colleges, discharge from
hospitals, animals houses).
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Incineration/deep burial * |
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Microbiology & Biotechnology Waste
(Wastes from lab. Cultures, stocks of specimens
of micro-organisms live or attenuated vaccines,
human and animal incineration* cell culture used
in research and infectious agents from research
and industrial laboratories, wastes from production
of biologicals, toxins, dishes and devices sued
for transfer of cultures) |
Autoclaving/ micro-waving. |
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Waste Sharps Needles, syringes,
scalpels, blades, glass etc. that may cause puncture
andcuts. This includes both used and unused sharps) |
Chemical/ disinfection autoclave/ micro-waving
and mutilation/shredding |
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Discarded Medicines & Cytotoxic drugs
(Wastes comprising of outdated contaminated
and discarded medicines) |
incineration/destruct & drugs disposal in
secured landfills |
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Soiled Waste (Items contaminated
with blood, and body fluids including cotton, dressing,
soiled plaster casts, lines, beddings, other material
contaminated with blood) |
incineration/ autoclave micro-waving |
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Sold Waste (Waste generated
from disposable items other than sharps such as
tubings catheters, intravenous sets, etc.) |
Chemical disinfection autoclave/micro-waving and
mutilation/shredding |
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Liquid Waste (Waste generated
from laboratory and washing, cleaning house-keeping
and disinfecting activities) |
Disinfect-chemically & discharge into drains |
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Incineration Ash (Ash from incineration
of any bio-medical waste) |
disposal in municipal landfill |
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Chemical Waste (Chemical used
in production of biologicals, chemicals used in
insecticides etc.) |
Chemically treatment disinfection and discharge
of drains for liquid and secured landfill for solids. |
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Note:
1. Chemicals treatment using at least 1% hypochlorite
solution or any other equivalent chemical reagent should
ensure disinfection.
2. Mutilation/shredding must be such so as to prevent
unauthorized reuse.
3. There will be no chemical pretreatment before incineration.
PVC shall not be incinerated. |
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The Central Pollution Control Board has recommended
two types of incinerators:
- Incinerators or individual hospitals/nursing homes/medical
establishements.
- Common incinerator to handle waste from a number of
hospitals/nursing homes/ pathological laboratories etc.
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Site for Incinerator
Incinerators should be installed at appropriate location
to avoid nuisance to patients and neighbourhood. |
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COLOUR CODING AND TYPE OF CONTAINER FOR DISPOSAL
OF BIO-MEDICAL WASTE |
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| Colour Coding |
Type of Container |
Waste Category |
Treatment options |
| Yellow |
Plastic Bag |
Categories 1, 2, 3 & 6. |
Incineration deep burial Red. |
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Plastic Bag |
Categories 3, 6, 7 |
Autoclaving/Micro-waving Chemical
Treatment |
| Blue/White Translucent |
Plastic Bag /punctproof containers |
Cat. 4, Cat. 7 |
Autoclaving/Micro-waving/ Chemical Treatment &
Destruction / shredding |
| Black |
Plastic Bag |
Categories 5, 9, 10 |
Disposal in secured landfill. |
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Notes:
1. Colour coding of waste categories with multiple treatment
options as defined in schedule 1, 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. |
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STANDARDS FOR INCINERATORS
All incinerators shall meet the following operating and
emission shandards. |
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A. Operating Standards
Combustion efficiency (CE) shall be at least 99.0%
The compustion efficiency is computed as follows:
%CO2
X 100
C.E. =
-----------------------------
%
COS + % CO
1. The temperature of the primary chamber shall be 800+_
50 deg C
2. The secondary chamber gas resistance time shall be
at least 1 (one) second at 1050 deg + - 50 deg C, with
a minimum of 3% Oxygen in the stack gas.
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B. Emission Standards
Parameters Concentration mg/Nm3
at (12% CO2 correction)
1. Particulate matter 150
2. Nitrogen Oxide 450
3. HCl 50
4. Minimum stack height shall be 30 meters above ground.
5. Volatile organic compounds in ash shall not be more
than 0.01 %.
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References
Jugal Kishore. Joshi TK. Biomedical Waste Management.
Employment News 2000. Govt of India. Feb 19-25.
The Gazette of India. Biomedical Waste (Management &
Handling) Rule 1998. No 460 July 27th 1998 and Amended
No. 375, June 2nd 2000 |
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