Bio Medical Waste Rules made stringent

Ministry of Environment and Forests has revised the Bio Medical Waste    (Management and Handling) Rules promulgated under the Environment Protection Act of 1986. The Rules now called the Bio Medical Wastes (Management and Handling) Rules 2011 has been notified for information of the masses and feedback received from all fronts would be considered by the Central Government.

Present scenario
Hospitals generate various kinds of wastes from wards, operation theatres and outpatient areas. These wastes include bandages, cotton, soiled linen, body parts, sharps (needle, syringes etc), medicines (discarded or expired), laboratory wastes etc which carry infection and should be properly collected, segregated, stored, transported, treated and disposed to prevent contamination and nosocomial infection. India generates a huge quantity of Bio Medical Waste (BMW) every year. According to the Ministry of Environment and Forests (MoEF) gross generation of BMW in India is 4,05,702 kg/day of which only 2,91,983 kg/day is disposed, which means that almost 28% of the wastes is left untreated and not disposed finding its way in dumps or water bodies and re-enters our system.

In terms of quantum of waste generated from the states, Karnataka tops the chart with 62,241 kg/day of BMW. Uttar Pradesh, Maharashtra and Kerala come close on the heels with 44,392 kg/day, 40,197 kg/day and 32,884 kg/day of BMW generation respectively. According to another report of MoEF almost 53.25% of Health Care Establishments (HCEs) are in operation without the adequate authorization from State Pollution Control Board (SPCB)/Pollution Control Committee (PCC) which means that waste generated from such facilities goes unaccounted and is dumped without any adequate treatment illegally. Management of BMW thus involves lot of complexity and a range of issues to be addressed. The new Rules have definitely cleared certain ambiguities of the previous one but still lacks on many fronts.

Bio-Medical Waste Rules 2011: Key Provisions
The new Rules on BMW are elaborate, stringent and several new provisions have been added in it. The Rules are not applicable for the radioactive waste, hazardous waste, municipal solid waste and battery waste which would be dealt under the respective rules.

Table 1. BMW Rules 2011 vs. 1998

2011 1998
Every occupier generating BMW, irrespective of the quantum of wastes comes under the BMW Rules and requires to obtain authorisation Occupiers with more than 1000 beds required to obtain authorisation
Duties of the operator listed Operator duties absent
Categories of Biomedical Waste reduced to Eight Biomedical waste divided in ten categories
Treatment and disposal of BMW made mandatory for all the HCEs Rules restricted to HCEs with more than 1000 beds
A format for annual report appended with the Rules No format for Annual Report
Form VI i.e. the report of the operator on HCEs not handing over the BMW added to the Rules Form VI absent

One of the features of the new rules is that now every occupier, operator regardless of the number of patients being serviced has to seek prior authorization from the prescribed authority which is the State Pollution Control Board for States and Pollution Control Committee for Union Territories. Earlier hospitals serving thousand or more patients only required to obtain authorization from the concerned authorities. The present Rules also specifies that irrespective of the quantum of wastes generated, every occupier such as from the hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses, pathological laboratories and blood banks generating, collecting, receiving, storing, transporting, disposing or handling bio medical wastes needs to obtain authorization from the prescribed authority. “Such a change has been proposed because earlier hospitals did not give a clear picture of the number of patients being served and thus evaded authorization and were exempted from treating their wastes. It was also difficult to ascertain the number of patients being treated in any hospital” says J C Babu, Scientist at Hazardous Waste Management Division of Central Pollution Control Board. However given the fact that there are a large number of HCEs and other medical facilities operating in every nook and corner of cities, towns and villages it is very difficult for the regulatory bodies to keep a tab on their activities. Also considering the capacity of regulators, it is more likely to remain a paper work. Dr Amandeep Agarwal of Indian Medical Association (Sangrur), questions “how is it justified to make hospitals and owner of the facility liable for all the damages caused due to improper handling of wastes, since hospitals dispose their waste through government licensed treatment facilities?” He further claims that “most untreated Bio Medical Waste is generated by quacks, pharmacists doing open practice at chemist shops.” Rules should take into account everyone engaged in the business. One way it can be done is that every medical practitioner must be listed with their local regulatory/monitoring bodies. Rules should also add a clause on the same so that every medical facility and practitioner comes under the ambit of the law.

The new Rules have incorporated State Ministry of Health for grant of license to HCEs after they get authorization from the SPCBs. The new Rules have bridged the gap since earlier the HCEs only required to obtain license from State Ministry of Health and carried out their functions but now they have to obtain prior authorization before commencing their activities. SPCBs would make sure that the HCEs have the necessary capacity and adequate equipments and then grant them the authorization or renew their authorization.

Occupier and Operators duties flagged
Duties of the occupier have been elaborated in the present Rules.  Proper training has to be imparted by the occupier to the health care workers engaged in handling BMW. The training for staff involved in the hospital waste management involves a number of parameters. The Rules merely mention proper training but there are no details as such on what kind of training should be imparted to the health care workers. A set of guidelines or regulations needs to be drafted by the HCEs in consultation with health and safety experts as a part of training module. There should also be a benchmark for training imparted to health care workers of both the HCEs and Common Treatment Facility (CTF) which would facilitate entry of people of right competence in BMW management. Such guidelines are missing from the rules.

Apart from the duties of the occupier the present rules have also listed duties for the operators of common BMW treatment facility. The operators now have to ensure that the BMW is collected from all the HCEs and is transported, handled, stored, treated and disposed in an environmentally sound manner. The operators also have to inform the prescribed authority if any HCEs are not handing the segregated BMW as per the guidelines prescribed in the rules. 

Accident reporting a must
Accidents that take place during the management of wastes have been defined in the new Rules. Accidents like injuries from sharps, mercury spills and fire hazards now have to be reported in Form III along with the remedial action taken. The Rules have also made mandatory for all the HCEs with 30 or more beds to set up a cell or unit to deal with the BMW management. The cell has to meet every six months and minutes of the meeting have to be submitted along with the Annual Report to the prescribed authority. “The move to set up a cell for BMW handling and making them meet every six months and reporting was initiated since most of the hospitals in various states did not had a separate unit to deal with such wastes” says Babu of CPCB

Mandatory treatment and disposal     
The new Rules have made the treatment and disposal of Bio Medical wastes mandatory for all the institutions generating them. The Rules clearly mention that every occupier should set up adequate treatment facilities like autoclave/microwave/incinerator/hydroclave, shredder prior to commencement of its operation or ensure that the wastes are treated at a common bio medical waste treatment facility or an authorized waste treatment facility. Another conspicuous feature of the rule is the clause on promotion of new technologies. The rules state that if an occupier or operator intends to install new technologies for treatment and disposal of wastes, they can approach the Central Government or Central Pollution Control Board (CPCB) for prior approval. The concerned authorities after considering the suitability and feasibility may grant approval to the proposed technology. The previous Rules had made mandatory for all the occupiers to set up requisite BMW treatment facilities like incinerator, autoclave, microwave and shredder within its premises. However, the new Rules have omitted incinerator as one of the pre requisites for on-site treatment of BMW. The omission is owing to the various environmental impacts of incineration. The new Rules say that the occupier having 500 or more beds may install incinerator subject to compliance of all the guidelines. However studies in the past have shown that even the state of the art incinerators leads to some emission of toxic gases. It is also observed that incinerators in India are not operated at right temperatures and without the requisite air pollution control measures. Thus there should be certain mechanisms to allow the use of incinerators for disposing BMW. Incinerators can be allowed for a cluster of hospitals or positioned in major part of cities so that HCEs can transport their waste to them instead of having one.

Deep burial for disposal of BMW has also been removed from the Rules. The Rules says it can be an option only in rural areas with no access to CTF with prior approval from the prescribed authority. However it is not mentioned in the rules as to what kind of wastes can be deep buried. Hospitals generate a lot of wastes which are hazardous and in the absence of CTF deep burial certainly could not be an option. Rules needs to be clearer and list what kind of wastes can be buried.

New rules have included a clause saying that the occupier or operators now have to monitor the stack emissions from incinerator quarterly as per the norms specified and the results have to be recorded and submitted to the prescribed authority. Reporting the results of emissions would help operators and occupiers to achieve compliance and strive for further improvement in the operation of incinerator.

Mandatory treatment and disposal of BMW would require more treatment and disposal facilities in the country. There are states like Jharkhand where there is no CTF till date and some states like Manipur where there is only one CTF in the entire state. “Rules should push towards setting up of more treatment facilities for BMW. Currently only 168 CTF caters to the need of more than 95,000 hospitals in the country” says Ragini Kumari of Toxics Link. 

Ambiguities cleared  
The Bio Medical Waste (Management and Handling) Rules 1998 contained ten categories of wastes which have been reduced in the present rules to eight. The 2011 Rules have discarded Category No. 8 (containing liquid waste generated from laboratory, cleaning, washing and disinfection activities) and Category No. 9 (containing incineration ash). However, laboratory wastes listed in Category 8 has been included in the present Category 3. The current rules have also cleared the confusion over the colour coding of the containers used for disposal of BMW. The Schedule II of the 1998 Rules creates a confusion regarding the disposal of Category 3 and Category 6 wastes which could either be disposed in yellow or red coloured bags. Similarly, Category 7 wastes could also be disposed in red or blue bags. The present Rules have thus clarified the ambiguity and allotted one colour code to each category of waste.

Table 2. Colour Coding and Type of Container for Disposal of BMW

Colour Coding Type of container to be used Waste Category Number
Yellow Non Chlorinated plastic bags Category 1,2,5,6
Red Non Chlorinated plastic bags/puncture proof container for sharps Category 3,4,7
Blue Non Chlorinated plastic bags container Category 8
Black Non Chlorinated plastic bags Municipal Waste

Apart from the various categories of wastes, Schedule II of the Rules has also incorporated the storage and disposal of municipal solid waste (MSW) generated from the hospitals. The Rules expounds that the MSW such as paper waste, food waste and other non infectious wastes generated from the hospitals should be stored in black coloured bags/containers and disposed as per the Municipal Solid Waste (Management and Handling) Rules 2000.

Loose protocol for cytotoxic drugs
Although the Rules have given details on treatment and disposal of different wastes from the hospitals it has been lax in drafting a proper protocol for cytotoxic drugs. Discarded medicines and cytotoxic drugs comprise Category no. 5 in the Schedule 1 of the Rules and are described as wastes consisting of outdated, contaminated and discarded medicines. Cytotoxic drugs are drugs that are used in the treatment of cancer and are used in the chemotherapy. It is termed so because it is toxic to the cells and inhibits the growth of cancer cells. The present Rules have neglected the severity of exposure to cytotoxic drugs and the perils of unsafe disposal of such drugs. It is highly toxic and extreme care is required in the handling of such drugs for treatment and disposal. The occupier should provide a thorough training and information explaining in detail the hazards of cytotoxic drugs to the people handling such wastes in their facilities. Hospitals should devise safest and best available system for the management of such toxic waste. The rules should put in place a separate protocol for collection, packaging, storage, treatment and disposal of cytotoxic drugs. Apart from the cytotoxic drugs the Rules also fails to give proper guidelines on the disposal of bed linens and mattresses which are discarded after certain period of use. According to the rules the linens and mattresses comes under Category no. 6 and incineration is suggested for treatment and disposal. “Soiled linen and mattresses may contain pathogenic microorganisms from one diseased person which can easily be transferred to the other patients using it. However owing to its bulkiness it is difficult to dispose it off” says Anu Agarwal of Toxics Link.  Incineration for such wastes is not a feasible option, a separate mechanism to dispose linens and mattresses should be devised and incorporated in the rules.

New Inclusion
The previous rules merely instructed the occupiers and operators to submit an annual report to the Prescribed Authority but no information on what data should be furnished in the report was mentioned. A detailed format for Annual Report has thus been included in the new Rules.

Form VI is again a new addition in the Rules. It empowers the operator of CBMWTF to report against the HCEs who are not carrying out proper segregation of their wastes.
For conducting the validation test during autoclaving certain changes have been introduced. For Spore testing frequency has been stipulated. It has to be conducted once in three months and records have to be maintained. Routine Test which is carried out by placing chemical indicator strips on the waste package to check whether a certain temperature has been reached has been made mandatory for every batch of wastes being autoclaved.

One of the directives in the rules talks about setting up of ‘District Level Monitoring Committees’ in the districts to scrutinize the compliance to the new Rules in the hospitals and other agencies generating BMW and facilities engaged in treatment and disposal of BMW. As per the rules, the District Level Monitoring Committee would be headed by District Medical Officer or his nominee. The Committee is also entrusted with the task to prepare and submit a half yearly report on the status of health care facilities lying in its jurisdiction to the State Level Advisory Committee. A copy of the report should also be sent to Central Pollution Control Board or Ministry of Environment and Forests and State Pollution Control Board/Pollution Control Committee as the case may be for necessary action.

The Rules have also considered the Government hospitals and their lack of capacity and resources. These hospitals generally charge pittance and serve a large proportion of populace. Managing the BMW wastes in these hospitals would require adequate infrastructure, manpower and expertise which they lack. The Rules have instructed the State Government or Union Territory to allocate separate funds to all such health care facilities for appropriate management of their BMW. The State Government is also instructed to procure and allocate treatment equipments for government HCEs.

Needed interventions

Technological intervention in systems management could be included in the Rules. “Hospitals can display their annual reports with details of waste generated and authorization on their website. Also the CTF can display category wise waste collected each day from each waste generator” says an official from Andhra Pradesh Pollution Control Board. Operators in states like Gujarat have installed GPS enabled tracking system and display movement of vehicles on internet. Such intervention will ensure more transparency and increase efficiency.

A stringent guideline for disposal of blood bags, pressurized containers should also be incorporated in the rules. The pressurized containers like spray cans used in pain killers will explode in incinerator so it must be included as a separate category.

The CTFs are inadequate in comparison to the HCEs in most of the States of the country and in house management of wastes in HCEs remains far from satisfactory. The status of CTF in major states is as follows:

Table 3. Number of CTF against HCEs in major states

State Health Care Establishments Common Treatment Facility
Maharashtra 12,753 38
Gujarat 21,779 13
Karnataka 11,248 14
Delhi 1900 3
West Bengal 2747 6

The State government should thus ensure that the wastes from all the hospitals in their jurisdiction reach the CTF and also be responsible for setting up more treatment facilities in rural areas which still rely on deep burial for disposing their wastes.
With a multitude of health care units operating, monitoring and implementation certainly would be a challenge for the regulators. There is also a scarcity of manpower in most Pollution Control Boards in the country. The states like West Bengal have a total of 111 staff including technical and scientific, Karnataka has 251 technical staff and 146 scientific staff and Gujarat has 100 technical and 106 scientific staff in total.

These limited staffs in the Pollution Control Boards are allotted with various responsibilities and with new Rules on E-wastes and amendments in Rules on Plastic Wastes their responsibilities have certainly multiplied manifolds. The scope of the Rules demands greater implementation, continuous monitoring and development of large scale infrastructure. One of the measures suggested by J C Babu was that the SPCBs can create separate cell for BMW management and can seek additional manpower from the concerned stating their enhanced responsibilities. Unless this deficit is met compliance would be a great fortitude for our environmental regulators. 

Written by: Sadia Sohail

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