Bio-Medical Waste Management Rules, 2016 comes into force from 28th March

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.