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Bio-Medical Waste Management Rules 2016

Biomedical waste comprises human & animal anatomical waste, treatment apparatus likeneedles, syringes and other materials used in health care facilities in the process of treatment and research. This waste is generated during diagnosis, treatment or immunisation in hospitals, nursing homes, pathological laboratories, blood bank, etc. Total bio-medical waste generation in the country is 484 TPD from 1,68,869 healthcare facilities (HCF), out of which 447 TPD is treated.

Scientific disposal of Biomedical Waste through segregation, collection and treatment in an environmentally sound manner minimises the adverse impact on health workers and on the environment. The hospitals are required to put in place the mechanisms for effective disposal either directly or through common biomedical waste treatment and disposal facilities. The hospitals servicing 1000 patients or more per month are required to obtain authorisation and segregate biomedical waste in to 10 categories, pack five colour backs for disposal. There are 198 common bio-medical waste treatment facilities (CBMWF) in operation and 28 are under construction. 21,870 HCFs have their own treatment facilities and 1,31,837 HCFs are using the CBMWFs.

The quantum of waste generated in India is estimated to be 1-2 kg per bed per day in a hospital and 600 gm per day per bed in a clinic. 85% of the hospital waste is non-hazardous, 15% is infectious/hazardous. Mixing of hazardous results in to contamination and makes the entire waste hazardous. Hence there is necessity to segregate and treat. Improper disposal increases risk of infection; encourages recycling of prohibited disposables and disposed drugs; and develops resistant microorganisms.

The new bio-medical waste management rules has hence been notified to efficiently manage the generated biowaste in the country.

Salient features of BMW Management Rules, 2016

  • The ambit of the rules has been expanded to include vaccination camps, blood donation camps, surgical camps or any other healthcare activity;
  • Phase-out the use of chlorinated plastic bags, gloves and blood bags within two years;
  • Pre-treatment of the laboratory waste, microbiological waste, blood samples and blood bags through disinfection orsterilisation on-site in the manner as prescribed by WHOor NACO;
  • Provide training to all its health care workers and immunise all health workers regularly;
  • Establish a Bar-Code System for bags or containers containing bio-medical waste for disposal;
  • Report major accidents; (g) Existing incinerators to achieve the standards for retention time in secondary chamber and Dioxin and Furans within two years;
  • Bio-medical waste has been classified in to 4 categories instead 10 to improve the segregation of waste at source;
  • Procedure to get authorisation simplified. Automatic authorisation for bedded hospitals. The validity of authorization synchronised with validity of consent orders for Bedded HCFs. One time Authorisation for Non-bedded HCFs;
  • The new rules prescribe more stringent standards for incinerator to reduce the emission of pollutants in environment;
  • Inclusion of emissions limits for Dioxin and furans;
  • State Government to provide land for setting up common bio-medical waste treatment and disposal facility;
  • No occupier shall establish on-site treatment and disposal facility, if a service of `common bio-medical waste treatment facility is available at a distance of seventy-five kilometer.
  • Operator of a common bio-medical waste treatment and disposal facility to ensure the timely collection of bio-medical waste from the HCFs and assist the HCFs in conduct of training .

Major changes proposed in the Bio - Medical Waste Management Rules, 2016 and its likely implication

Bio-Medical Waste (Management and Handling)Rules, 2011 Bio-Medical Waste Management Rules, 2016 Reasons and likely implications
Bio-Medical Waste (Management and Handling) Rules,2011Bio-Medical Waste Management Rules, 2016.The word ‘Management’ includes Handling.
Application
These rules apply to all persons who generate, collect, receive,store, transport, treat, dispose, or handle bio medical waste in any form

These rules shall apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio-medical waste in any form and shall not apply to:

  • radioactive wastes,
  • wastes covered under the MSW Rules, 2000,
  • lead acid batteries,
  • hazardous wastes,
  • E-waste,
  • hazardous microorganisms

Modified to bring more clarity in the application.

Clarified that vaccination camps, blood donation camps, surgical camps or any other healthcare activity undertaken outside the healthcare facility, will be covered

Duties of the Health care facilities
Every occupier of an in stitution generating bio -medical waste which includes a hospital, nursing home, clinic, dispensary,veterinary institution, animal house, pathological laboratory,blood bank to take all steps to ensure that such waste is handled without any adverse effect to human health and the environment.

Additions:

Health care facilities (HCF) shall make a provision within the premises for a safe, ventilated and secured location for storage of segregated biomedical waste

pre-treat the laboratory waste, microbiological waste, blood samples and blood bags through disinfection or sterilisation on-site in the manner as prescribed by the World Health Organisation (WHO) or National AIDs Control Organisation (NACO) guidelines and then sent to the common bio-medical waste treatment facility for final disposal.

phase out use of chlorinated plastic bags, gloves and blood bags within two years from the date of notification of these rules

provide training to all its health care workers and others involved in handling of bio medical waste at the time of induction and thereafter at least once every year

immunise all its health care workers and others involved in handling of bio-medical waste for protection against diseases including Hepatitis B and Tetanus that are likely to be transmitted by handling of bio-medical waste,

establish a Bar-Code System for bags or containers containing bio-medical waste to be sent out of the premises

report major accidents including accidents caused by fire hazards, blasts during handling of bio-medical waste and the remedial action taken to SPCB

existing incinerators shall achieve the standards for retention time in secondary chamber and Dioxin and Furans within two years from the date of this notification

To ensure that there shall be no secondary handling, pilferage of recyclables or inadvertent scattering or spillage by animals and the bio-medical waste from such place or premises can be directly transported in to the common bio -medical waste treatment facility.

This is to prevent the possible microbial contamination.

 

 

 

 

Will eliminate the emission of dioxin and furans from burning of such wastes.

 

 

Will improve the management of BMW including collection, segregation.

 

To protect the health of workers

 

 

 

Will improve the segregation,transportation and disposal system.Also will eliminate pilferage on the way of BMW to disposal facility.

Help to monitor and improve the management

 

 

Will improve the environment in the vicinity treatment facility.

Duties of the operator of a common bio-medical waste treatment and disposal facility
Nil..Same as the duties of HCFs and additionally they shall ensure timely collection of bio-medical waste from the HCFs, assist the HCFs in conduct of trainingSpecific responsibility on the operator of a common bio -medical waste treatment and disposal facility will be make them clear to their duties
Treatment and disposal

Every HCFs, where required, shall set 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.

No occupier shall establish on -site treatment and disposal facility, if a service of `common bio-medical 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 bio medical waste treatment equipment like incinerator, autoclave or microwave,shredder prior to commencement of its operation, as per the authorisation given by the prescribed authority.

This is to make the installation and operation of common treatment facility a viable one.
Segregation, packaging, transportation and storage

Bio-medical waste classified in to 10 categories based on treatment options.

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 authorised 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.

Bio-medical waste classified in to 4 categories based on treatment options.

Untreated human anatomical waste, animal anatomical waste, soiled waste and, biotechnology waste shall not be stored beyond a period of forty–eight hours:

In case for any reason it becomes necessary to store such waste beyond such a period, the occupier shall take appropriate measures to ensure that the waste does not adversely affect human health and the environment and inform the SPCB along with the reasons.

Will improve the segregation of waste at source channelize proper treatment and disposal

Will eliminate obtaining permission within 48 hours which is not practically feasible.

Authorisation
Hospitals treating 1000 or more patients per month to obtain authorization from SPCBs/PCCsOne time Authorisation for Non-bedded HCFs. The validity of authorization shall be synchronised with validity of consent orders for Bedded HCFs

HCFs can make application along with consent and hence getting authorisation will not be additional burden for HCFs. and operator of treatment facility.

It will also help to SPCB in making single inspection / monitoring to consider both the consent and authorisation.

Advisory Committee

The Government of every State/Union Territory shall constitute an advisory committee with the experts in the field of medical and health, animal husbandry and veterinary sciences, environmental management, municipal administration, and any other related department or organisation including non -governmental organisations.

Ministry of Defence shall constitute, an Advisory Committee under Additional Director General of Armed Forces Medical Services with representative of Ministry of Defence, MoEFCC, for HCFs under Armed forces under the Ministry of Defence

No change in the concept except additional members.

Shall meet once in Six Months.

Advisory Committee has strengthened suitably with additional members
Standards for emission from incinerators

SPM in the Incinerator’s Emission 150 mg/nm3

Residence Time in Secondary chamber of incinerators is 1 second

Nil..

50 mg/nm3

2 second

Standards for Dioxin and furans prescribed.

The proposed stringent standards for emission from Incinerator (reduction of permissible limit for particulate matter,introduction of standards for Dioxin and Furans and increasing the residence time in the Incinerator Chambers) will improve the operation of incinerator and reduce the emission of pollutants in environment.
Site for common bio-medical waste treatment and disposal facility
Nil..The department dealing the allocation of land shall be responsible for providing suitable site for setting up of common biomedical waste treatment and disposal facility in the State GovernmentGetting suitable land is the problem in many States for establishment of waste management facility. Making the responsibility to provide land by the Department dealing the allotment of land would eliminate the issue of getting land for the waste management facility.
Monitoring of implementation
Nil..

Ministry of Environment, Forest and Climate Change shall review the implementation of the rules in the country once in a year through the State Health Secretaries and CPCB.SPCBs

State Government shall constitute District Level Monitoring Committee under the chairmanship of District Collector or District Magistrate or Deputy Commissioner or Additional District Magistrate to monitor the compliance of the provisions of these rules in the health care facilities.

The District Level Monitoring Committee shall submit its report once in six months to the State Advisory Committee, State Pollution Control Board for taking further necessary action.

The District Level Monitoring Committee shall comprise of District Medical Officer or District Health Officer, representatives from SPCB,

Public Health Engineering Department, local bodies or municipal corporation,

Indian Medical Association,common bio-medical waste treatment facility registered NGO working in the field of bio-medical waste management

District Medical Officer shall be the Member Secretary of this Committee.

The monitoring of the implementation was earlier only with SPCBs and review of implementation through the District Committee is likely to improve the implementations.

Source: Bio Medical Waste Management Rules, 2016

Amendments in Bio-Medical Waste Management Rules, 2016 Rules

Bio-Medical Waste Management Rules, 2016 Rules have been amended to improve compliance and strengthen the implementation of environmentally sound management of biomedical waste in India.

The amended rules stipulate that generators of bio-medical waste such as hospitals, nursing homes, clinics, and dispensaries etc will not use chlorinated plastic bags and gloves beyond March 27, 2019 in medical applications to save the environment. Blood bags have been exempted for phase-out, as per the amended BMW rules, 2018.

Salient features of Bio-Medical Waste Management (Amendment) Rules, 2018 are as follows:

  1. Bio-medical waste generators including hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses, pathological laboratories, blood banks, health care facilities, and clinical establishments will have to phase out chlorinated plastic bags (excluding blood bags) and gloves by March 27, 2019.
  2. All healthcare facilities shall make available the annual report on its website within a period of two years from the date of publication of the Bio-Medical Waste Management (Amendment) Rules, 2018.
  3. Operators of common bio-medical waste treatment and disposal facilities shall establish bar coding and global positioning system for handling of bio-medical waste in accordance with guidelines issued by the Central Pollution Control Board by March 27, 2019.
  4. The State Pollution Control Boards/ Pollution Control Committees have to compile, review and analyze the information received and send this information to the Central Pollution Control Board in a new Form (Form IV A), which seeks detailed information regarding district-wise bio-medical waste generation, information on Health Care Facilities having captive treatment facilities, information on common bio-medical waste treatment and disposal facilities.
  5. Every occupier, i.e. a person having administrative control over the institution and the premises generating biomedical waste shall pre-treat the laboratory waste, microbiological waste, blood samples, and blood bags through disinfection or sterilization on-site in the manner as prescribed by the World Health Organization (WHO) or guidelines on safe management of wastes from health care activities and WHO Blue Book 2014 and then sent to the Common bio-medical waste treatment facility for final disposal.
These amendments have been made vide Notification G.S.R. 234(E) dated March 16, 2018.


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