Under the Environment (Protection) Act, 1986, the 37 page long Bio-Medical Waste Management Rules,
2016 came into force from 28th March, 2016 in supersession of the Bio-Medical
Waste (Management and Handling) Rules, 1998.
The rules apply to all persons who
generate, collect, receive, store, transport, treat, dispose, or handle bio medical
waste in any form including hospitals, nursing homes, clinics, dispensaries,
veterinary institutions, animal houses, pathological laboratories, blood banks,
ayush hospitals, clinical establishments, research or educational institutions,
health camps, medical or surgical camps, vaccination camps, blood donation
camps, first aid rooms of schools, forensic laboratories and research labs.
These rules do not apply to radioactive wastes as covered under the
provisions of the Atomic Energy Act, 1962(33 of 1962) and the rules made there
under; hazardous chemicals covered under the Manufacture, Storage and Import of
Hazardous Chemicals Rules, 1989 made under the Act; solid wastes covered under
the Municipal Solid Waste (Management and Handling) Rules, 2000 made under the
Act; the lead acid batteries covered under the Batteries (Management and
Handling) Rules, 2001 made under the Act; hazardous wastes covered under the Hazardous Wastes (Management,
Handling and Transboundary Movement) Rules, 2008 made under the Act; waste
covered under the e-Waste (Management and Handling) Rules, 2011 made under the Act;
and hazardous micro organisms, genetically engineered micro organisms and cells
covered under the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms,
Genetically Engineered Micro organisms or Cells Rules, 1989 made under the Act.
The reference to the “e-Waste (Management and Handling) Rules, 2011” shows
that e-waste (Management) Rules, 2015 has not been factored in.
As per the Rules the "bio-medical waste" means any waste, which
is generated during the diagnosis, treatment or immunisation of human beings or
animals or research activities pertaining thereto or in the
production or testing of biological or in health camps, including the
categories mentioned in
Schedule I appended to these rules.
The Rules provides for “phase out use of chlorinated plastic bags, gloves
and blood bags within two years from the date of notification of these rules”.
It prohibits mixing of treated bio-medical waste with municipal solid waste.
It provides for ensure treatment and disposal of liquid waste in accordance
with the Water (Prevention and Control of Pollution) Act, 1974.
It provides for maintenance of all record for operation of incineration,
hydro or autoclaving etc., for a period of five years. It provides that existing
incinerators should “achieve the standards for treatment and disposal of
bio-medical waste as specified in Schedule II for retention time in secondary
chamber and Dioxin and Furans within two years from the date of this
notification.”
Clause 7 of the Rules 7 deals with Treatment and disposal of biomedical
waste. Bio-medical waste shall be treated and disposed of in accordance with
Schedule I, and in compliance with the standards provided in Schedule-II by the
health care facilities and common bio-medical waste treatment facility. Occupier
shall hand over segregated waste as per the Schedule-I to common bio-medical
waste treatment facility for treatment, processing and final disposal: Provided
that the lab and highly infectious bio-medical waste generated shall be
pre-treated by equipment like autoclave or microwave. No occupier shall
establish on-site treatment and disposal facility, if a service of ` common
biomedical waste treatment facility is available at a distance of seventy-five
kilometer. In cases where service of the common bio-medical waste treatment
facility is not available, the Occupiers shall set up requisite biomedical
waste treatment equipment like incinerator, autoclave or microwave, shredder
prior to commencement of its operation, as per the authorisation given by the
prescribed authority.
Any person including an occupier or operator of a common bio medical waste
treatment facility, intending to use new technologies for treatment of bio
medical waste other than those listed in Schedule I shall request the Central
Government for laying down the standards or operating parameters. On receipt of
a request referred to in sub-rule (5), the Central Government may determine the
standards and operating parameters for new technology which may be published in
Gazette by the Central Government. Every operator of common bio-medical waste
treatment facility shall set up requisite biomedical waste treatment equipments
like incinerator, autoclave or microwave, shredder and effluent treatment plant
as a part of treatment, prior to commencement of its operation. Every occupier
shall phase out use of non-chlorinated plastic bags within two years from the
date of publication of these rules and after two years from such publication of
these rules, the chlorinated plastic bags shall not be used for storing and
transporting of bio-medical waste and the occupier or operator of a common
bio-medical waste treatment facility shall not dispose of such plastics by
incineration and the bags used for storing and transporting biomedical waste shall
be in compliance with the Bureau of Indian Standards. Till the Standards are
published, the carry bags shall be as per the Plastic Waste Management Rules,
2011. After ensuring treatment by autoclaving or microwaving followed by
mutilation or shredding, whichever is applicable, the recyclables from the
treated bio-medical wastes such as plastics and glass shall be given to such
recyclers having valid authorisation or registration from the respective
prescribed authority. The Occupier or Operator of a common bio-medical waste
treatment facility shall maintain a record of recyclable wastes referred to in
sub-rule (9) which are auctioned or sold and the same shall be submitted to the
prescribed authority as part of its annual report. The record shall be open for
inspection by the prescribed authorities. The handling and disposal of all the mercury
waste and lead waste shall be in accordance with the respective rules and
regulations.
Clause 17
deals with the “Site for common bio-medical waste treatment and disposal
facility”. It provides that Without prejudice to rule 5 of these rules, the
department in the business allocation of land assignment shall be responsible
for providing suitable site for setting up of common biomedical waste treatment
and disposal facility in the State Government or Union territory
Administration. The selection of site for setting up of such facility shall be
made in consultation with the prescribed authority, other stakeholders and in
accordance with guidelines published by the Ministry of Environment, Forest and
Climate Change or Central Pollution Control Board.
Clause 18 of
the Rules deals with ‘Liability of the occupier, operator of a facility’. The
occupier or an operator of a common bio-medical waste treatment facility shall
be liable for all the damages caused to the environment or the public due to
improper handling of bio- medical wastes. The occupier or operator of common
bio-medical waste treatment facility shall be liable for action under section 5
and section 15 of the Act, in case of any violation.
Schedule I
read with rules 3 (e), 4(b), 7(1), 7(2), 7(5), 7 (6) and 8(2) Part-1 deals with
Biomedical wastes
categories
and their segregation, collection, treatment, processing and disposal options.
The Rule
states, “Disposal by deep burial is permitted only in rural or remote areas
where there is no access to common bio-medical waste treatment facility. This
will be carried out with prior approval from the prescribed authority and as
per the Standards specified in Schedule-III. The deep burial facility shall be
located as per the provisions and guidelines issued by Central Pollution
Control Board from time to time.” There is an urgent need to undertake environmental
health impact of such practices undertaken in the past to decide whether such
permissions are reasonable and sane.
Schedule II
read with Rule 4(t), 7(1) and 7(6)] Standards for treatment and disposal of bio-medical
wastes. Among other aspects it provides Standards for Incineration. It provides
that minimum stack height shall be 30 meters above the ground and shall be
attached with the necessary monitoring facilities as per requirement of
monitoring of ‘general parameters’ as notified under the Environment
(Protection) Act, 1986 and in accordance with the Central Pollution Control Board
Guidelines of Emission Regulation Part-III.
At page 19
of the Rules it provides that “The ash or vitrified material generated from the
‘Plasma
Pyrolysis or
Gasification shall be disposed off in accordance with the Hazardous Waste
(Management,
Handling and
Transboundary Movement) Rules 2008 and revisions made thereafter in case the constituents
exceed the limits prescribed under Schedule II of the said Rules or else in
accordance with
the
provisions of the Environment (Protection) Act, 1986, whichever is applicable.”
The Rules
states that “Medical waste shall not be considered as 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.”
It states
that microwave treatment shall not be used for cytotoxic, hazardous or radioactive
wastes,
contaminated
animal carcasses, body parts and large metal items.
It provides
that for deep burial “A pit or trench should be dug about two meters 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.”
Schedule III
read with Rule 6 and 9(3)] provides List of Prescribed Authorities and the
Corresponding Duties.
Besides Union
Ministry of Environment, Forest and Climate Change it provides the authorities and
duties of Central or State Ministry of Health and Family Welfare, Central Ministry
for Animal Husbandry and Veterinary or State Department of Animal Husbandry and
Veterinary, Ministry of Defence, Central Pollution Control Board, “State
Government of Health or Union Territory Government or Administration”, State
Pollution Control Boards or Pollution Control Committees, Municipalities or
Corporations, Urban Local Bodies and Gram Panchayats.
The
reference to “State Government of Health or Union Territory Government or Administration”
shows a proofing error in the drafting.
Schedule IV
read with Rule 8(3) and (5)] Part A provides “Label for bio-medical waste containers
or bags” and Part B deal with “Label for transporting bio-medical waste bags or
containers.” There are five forms dealing with accident reporting, application
for authorisation or renewal of authorization to be submitted by occupier of
health care facility or common bio-medical waste treatment facility, authorisation
for operating a facility for generation, collection, reception, treatment,
storage, transport
and disposal
of biomedical wastes, Annual Report to be submitted to the prescribed authority
on or before 30th June every year for the period from January to December of
the preceding year, by the occupier of health care facility (HCF) or common
bio-medical waste treatment facility (CBWTF) and Application for filing appeal
against order passed by the prescribed authority.
+ comments + 1 comments
It is a great blog. Thanks! There are a huge Blood Bank Equipments List list which are mostly used in blood testing.
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