-Sneha Phalle

PGD-HCM R.N.:23

The Central Govt. considers it necessary in the public interest, to address the environmental and health concerns, to review the rules published earlier, to enable the prescribed authorities to implement the rules more effectively, thereby, reducing the bio-medical waste generation and also for its proper treatment and disposal and to ensure environmentally sound management of these wastes. These rules shall apply to all persons who generate, collect, receive, store, or handle bio-medical waste in any form.

Definitions Act means the Environment (Protection) Act, 1986

Authorisation means permission granted by the

prescribed authority for generation, reception, collection, storage, transportation, treatment, disposal and/or any other form of handling bio-medical waste in accordance with these rules and guidelines issued by Central Pollution Control Board, Ministry of Environment and Forests, Ministry of Health and Family Welfare, Govt of India. Authorised Person means an occupier or operator authorised by prescribed authority. Biomedical waste means any waste, which is generated during diagnosis, treatment or immunisation of human beings or animals or in research activities pertaining to or in production or testing of biologicals, including categories mentioned in Schedule I of these rules.

 Biologicals means any preparation made from

organisms or micro-organisms or product of metabolism or biochemical reactions. Bio-Medical Waste Treatment and Disposal Facility means any facility wherein treatment, disposal of biomedical waste or processes incidental to such treatment and/or disposal is carried out and includes common treatment facilities. Occupier means any person having control over the institution and premises generating bio-medical waste, which includes a hospital, nursing home, clinic, dispensary, animal house, path lab, blood bank, healthcare facility and clinical establishment by whatever name it may be called. Operator of a common bio-medical waste treatment facility means a person who owns or controls or operates a common facility.

Duties of ensure that bio-medical waste is handled the Operator To take steps to

without any adverse effect to human health or environment in accordance with these rules. To provide training, immunization and occupational safety to all healthcare workers and others involved in handling of waste. To ensure segregation of waste at point of generation. To install necessary equipments and regular supply of materials required for proper in house handling of the waste. To maintain and update everyday the waste management register. To develop a system of reporting of unintended accidents. To establish a bio-medical waste management cell or unit

Duties necessary steps to ensure that the waste collected of Operator To take all
from occupier is transported, handled, stored, treated and disposed off without any adverse effects. To inform the prescribed authority immediately regarding the facilities which are not handing over the waste in accordance with the rules as prescribed in Form VI. To ensure training, immunisation and safety of all the workers. To maintain a log book for each of its treatment equipment.

Responsibility of Authorities
The Authority specified in column 2 of Schedule VI shall perform the duties as specified in column 3 as per provision of the rules.

Treatment should be treated and disposed off in & Disposal Biomedical waste
accordance with Schedule I, and in compliance with standards prescribed in standard V. Every occupier shall set up his own requisite treatment equipments or ensure treatment through an authorised common treatment facility. (prescribed authority may authorise the occupier havin 500+ capacity to install an incinerator) Use of chlorinated plastic bags for handling of waste shall be prohibited and the facility shall not dispose off such plastics by incineration. Treatment facility shall dispose recyclable wastes through authorized recyclers with permission from respective Pollution Control Boards.

Segregation, packaging, transportation, storage

Untreated waste shall not be mixed with other wastes.

Waste shall be segregated into containers or bags at the

point of generation according to Schedule II. The waste shall be transported from premises to facility only with label as in Schedule III. No untreated waste of categories 1,2,3,6 shall be kept stored beyond 48hrs. The municipal body shall continue to pick up and transport segregated waste for disposal at municipal dump site.

Prescribed Authority
The prescribed authority for enforcement of these rules

shall be State Pollution Control Boards and Pollution Control Committees. The authority for enforcement of these rules for institutions of the Armed Forces under Ministry of Defence shall be Director General, Armed Forces Medical Services. The authority shall function under supervision and control of respective Govt of state or Union territory. They should comply with responsibilities as stipulated under serial no. 6 under Schedule VI.

Procedure for Authorisation

The facility shall make an application in Form I to

authority for grant of authorisation. The authority, on receipt of Form I, shall make an enquiry and if it is satisfied, may grant or renew an authorisation. A provisional authorisation shall be granted for a trial run period to demonstrate adequacy of the system. On satisfactory performance, the authorisation shall be renewed for further 5 yrs. The authority may refuse to grant or renew authorisation. Every application shall be disposed off within 90 days, failing which it is deemed granted. The authority may cancel or suspend authorisation if facility has failed to comply with any provision.

The Govt of every state or union territory shall constitute an advisory committee under the chairmanship of State Health Secretary. Every occupier/ operator of a treatment facility shall submit an annual report to the prescribed authority in prescribed Form II or IIA by 31st day of January every year. Every authorised person shall maintain records related to generation, collection, reception, storage, transportation, treatment, disposal or any other form of handling. The Municipal Corporation or Local Bodies shall be responsible for providing suitable common disposal or incineration sites in the area under their jurisdiction. The occupier/ operator shall be liable for all damages caused to environment or public due to improper handling of waste. The occupier/ operator shall be liable under section 5 and 15 under Environment Protection Act, 1986.

Schedule I Categories of Bio-medical Waste Category Waste Category (type)

Cat. No. 1 Human Anatomical Waste (human tissues, organs, body parts) Animal Waste (animal tissues, organs, body parts, carcasses, bleeding parts, fluids, blood and experimental animals used in research, waste generated by veterinary hosp/colleges,discharge from hosp, animal houses.
Microbiology & Biotechnology Waste (Wastes from laboratory cultures, stocks or micro-organisms live or vaccines,

Treatment & disposal option

Incineration @ Deep burial* Incineration@ deep burial*

Cat. No. 2

Cat. No. 3

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) Cat. No. 4 Waste Sharps (needles, syringes, scalpels, blade, glass, etc. that may cause punture and cuts. This includes both used and unused sharps)

local autoclaving/microwaving/incineration@

disinfection (chemical treatment @@@/auto claving/microwaving and mutilation/shredding##

Cat. No. 5

Discarded Medicines and Cytotoxic incineration@/destruction drugs and drugs disposal in (Waste comprising of outdated, secured landfills contaminated and discarded medicines) Soiled Waste (items contaminated with blood, and body fluids including cotton, dressings, soiled plaster casts, lines, bedding, other material contaminated with blood) incineration@autoclaving/ microwaving

Cat. No. 6

Cat. No. 7

Solid Waste (Waste generated from disposal items other than the sharps such a tubings, catheters, intravenous sets etc.)

disinfection by chemical treatment@@ autoclaving/microwavin g and mutilation/shredding##

Cat. No. 8

Liquid Waste disinfection by chemical (Waste generated from laboratory treatment@@ and and washing, cleaning, housekeeping discharge into drains and disinfecting activities) Incineration Ash Ash from incineration of any biomedical waste) Chemical Waste (Chemicals used in production of biologicals, chemicals used in production of biologicals, chemicals used in disinfection, as insectricides, etc.) disposal in municipal landfill chemical treatment@@ and discharge into drains for liquids and secured landfill for solids

Cat. No. 9

Cat. No. 10

Note : @ There will be no chemical pretreatment before incineration. Chlorinated plastics shall not be incinerated. * Deep burial shall be an option available only in towns with population less than five lakhs and in rural areas. @@ Chemicals treatment using at least 1% hypochlorite solution or any other equivalent chemical reagent. It musts be ensured that chemical treatment ensures disinfection. ## Multilation/shredding must be such so as to prevent unauthorised reuse .

Schedule II Colour coding and type of container for disposal

Colour Coding
Yellow

Type of container used

Non-chlorinated plastic bags

Waste category no.

Category 1,2,5,6

Treatment options as per schedule I

Incineration

Red

Non-chlorinated plastic bags/ puncture proof container for sharps

Non-chlorinated plastic bags container Non-chlorinated plastic bags

Category 3,4,7

As per schedule I (autoclaving/ microwaving)

As per schedule I (autoclaving/micr owaving/shreddin g) Disposal in municipal waste sites

Blue

Category 8

Black

Municipal wastes

Schedule III Label for Bio-medical waste Containers/Bags

Thank You!