BIOMEDICAL WASTE (MANAGEMENT AND HANDLING) RULES, 1998:

 

ITS INAPPROPRIATENESS IN THE PRESENT CONTEXT

 

AND

 

 NEW APPROPRIATE MANAGEMENT OPTIONS DEVELOPED BY CUSAT:

 

A DISCUSSION NOTE

 

 

1. Inappropriateness of BMW Rules 1998 in force

 

The rules came out only in1998. Even the latest technological developments at that time will not find a place in the Rules as it takes several years for the new technologies to appear in text books and to be known to the decision makers.  The said ‘Rules’ is for the entire country having very different geographical and climatic conditions (temperature, rainfall etc) and having very different citywide infrastructure facilities like water supply and sanitation facilities. Thus, a methodology of solution for a hilly area may not be suitable in a coastal area; a methodology suitable for an area having sufficient water supply and with citywide complete wastewater collection, treatment and disposal system may not be appropriate in a place where these facilities are not available. Incineration that is an accepted option in the Rules is considered inappropriate worldwide. Safe disposal of highly infected human excreta and urine generated from sick inpatients in hospitals situated in areas where citywide wastewater collection and disposal system is not in existence is very complicated. But this dangerous waste does not find a place in any of the categories of BM wastes in Schedule I of the Rules. These materials are not considered BM wastes as per definition given in the Rules. Solutions appropriate for the specific areas are needed and flexibility for applying suitable appropriate variations in solutions are not incorporated in the present Rules. More importance should be given to the objectives and Rules should be understood only as guidelines and not the ends. On account of these aspects, the ‘Rules’ 1998 which is in force appears to be inappropriate in the present technological and environmental scenarios with deficiencies and short falls.

 

2. Definition of Bio-medical waste 

 

In the Rules, it is stated,  “ Bio-medical waste means any waste, which is generated during the diagnosis, treatment or immunization of human beings or animals or in research activities pertaining thereto or in the production or testing of biologicals, including categories in Schedule I”. In Schedule I, for example, Category No. 1 includes   ‘Human anatomical waste – human tissues, organs, body parts’. When the definition and category are combined, there is no provision to differentiate   wanted and unwanted materials generated from the treatment activities. For organ transplantation wanted organs removed are wanted materials and unwanted organs removed are unwanted materials; definition in the Rules categorizes both the materials as one category – wastes. But organ transplants, blood transfusion, biopsy for further tests etc. are being carried out. Thus, in reality, Authorities enforcing Rules allow wanted materials to be sorted out from unwanted materials. Again, all the unwanted materials cannot be termed wastes as such. One meaning of ‘waste’ in Chambers Dictionary is as ‘rejected’. Thus, waste can be explained as something unwanted and discarded from the premises. In the environmental management context, waste generated at one point need not be a waste in another context. Thus, the meaning of waste depends on the conditions and could change from place to place. An appropriate definition of bio-medical waste appears to be “ any unwanted material generated from various sources and activities in the hospital which is discarded outside the place of generation and that may cause adverse environmental effect, if not handled properly”. In the Rules, 1998, clear distinction is not made between generation of unwanted material and when it should be considered as waste.  Materials that can be used again (blood transfusion, biopsy for further tests, organ transplants etc) or materials that go for further processing cannot be termed as wastes. Only those unwanted materials that are to be discarded or which persist and threatens the quality of the environment as such alone are wastes.  

 

3. Disposal of infected human excreta and urine generated from sick patients admitted 

    in hospitals in areas where citywide sanitation facilities are not available

 

In areas where citywide sanitation facilities are available, the highly infected sewage and urine generated in hospitals can be directly let into the city sewers without causing any environmental problems. But in other areas, human excreta and urine generated from infected/sick persons are very dangerous unwanted organic materials. The diseases like cholera, typhoid, dysentery, jaundice, viral hepatitis, amebiasis, worm infestation etc are transmitted through infected feacal and urine contamination. Such dangerous materials are to be properly managed to avoid environmental pollution and to protect human beings from the dangers of health hazards. Unfortunately in areas where citywide sanitation facilities are not available, these materials are not Bio-medical wastes as per Rules and not categorized in Schedule I of the Rules. Usually in such areas, these materials that are collected in properly designed containers called water closets for excreta and urine and urinals for urine are conveyed in water medium as liquid and further processed at institution level in biological reactors (septic tank/treatment units) resulting in the conversion of gas, digested sludge and liquid effluent. The gas which is not harmful is vented out; digested sludge which also is not harmful is periodically collected and disposed off suitably; and liquid effluent which is the real waste causing pollution is to be discarded adhering to the prescribed norms. This dangerous liquid waste also is not included in the Schedule I under the category ‘liquid waste’ or any other category. In the Schedule I Category 8 is liquid waste: waste generated from laboratory and washing, cleaning, house keeping and disinfecting activities. The treatment and disposal suggested is disinfection by chemical treatment and discharge into drain. This confirms that harmful and infected human excreta and urine converted into wastewater are excluded from category no.8. In other words, the Authorities allow the dangerous and infectious human excreta and urine generated in hospitals situated in the areas where citywide sanitation facilities are not available, to be collected in appropriate containers, permit further processing in biological reactors at institution level and allow the end products to be discarded into the environment. This acceptance is a proof that unwanted materials can be processed within the hospital premises and the resulting wastes can be disposed off suitably without causing environmental problems even if there is no specific mention in the Rules regarding such an option.

 

4. Inappropriateness of Incineration as a method of disposal of bio-medical wastes

 

       Realizing the adverse environmental effects of incineration, the developed countries are in the process of phasing out incinerators already installed. It was in May 2002 that the Union Ministry of Environment and Forests had signed ‘The Stockholm Convention’ in Geneva for phasing out incinerators. The Stockholm Convention, initiated by the United Nations Environment Program identified 12 of the most dangerous Persistent Organic Pollutants (POP’s), commonly known as the ‘dirty dozen’, including dioxins and furans which are generated on incineration, and focuses on reducing and eliminating their use. India has also signed and ratified the Kyoto Protocol regarding the same. India, thus, is committed to phase out the already installed incinerators. Installing new incinerators anywhere in the country is against the Stockholm declaration of which India is a party. Installing incinerators is against the accepted policy of Central Government; and therefore, incineration will become unlawful when the existing rules are amended. Unfortunately, in the bio-medical waste management Rules, incineration, even today - after three years of signing the Stockholm declaration - is an accepted important disposal option. The concerned authorities in Kerala are forcing to install the costly and outdated incinerators for the disposal of bio-medical wastes as the Rules in force permit such a discarded option even though they are aware of the environmental dangers of incineration.

 

       5. Management of bio-medical wastes under category 1 &2

 

According to the Biomedical (Management & Handling) Rules 1998, there are only two independent options for the safe disposal of human anatomical wastes, organs and body parts (wastes of category 1&2). These are: a) Incineration and b) Deep burial.   These options are entirely two different technological processes.

             

Incineration: Burning wet organic matter at very high temperature is an artificial process and therefore, not at all a natural one. Such unnatural processes are associated with several environmental problems. Also, it has been found that incineration is not a suitable process for the conditions prevailing in Kerala with regard to climate, wind, vegetation  (leaves of coconut trees prevent uniform dispersal of the fumes) etc in addition to unaffordable capital cost of installations and other maintenance costs for the small and medium sized hospitals. (There are many reports regarding the unsuitability of incineration as an option for the disposal of bio-medical waste.)          

 

Deep burial:  The process of degradation of organic body parts in the deep burial process is biological and hence the process is natural. But in the coastal belt of Kerala, where the ground water table is very high, deep burial in ground is not suitable, as the contamination of ground water is almost a certainty. In addition, in the deep burial process, it is not known how long it takes for the degradation of the body parts, on account of   the delay in   the   development   of    appropriate    consortium   of micro- organisms for degradation. Moreover, biochemical degradation is influenced by moisture level of the substrate. A loss of moisture content by absorption into dry soil layer or a recession of groundwater table would affect the degradation process. Addition of lime, as per the section under ‘Standards of Deep Burial’ in the Biomedical (Management and Handling) Rules 1998, will destroy the microbial consortium, and thus delay the process of microbial degradation. Moreover, there is no provision of containing the leachate that will contaminate groundwater in due course. There are no standards prescribed or mechanisms envisaged to ensure effective performance of the deep burial process. There is no report available on the performance safety of deep burial facility in relation to ground water contamination. In the coastal belt and thickly populated midlands of Kerala, where the ground water table is high, deep burial is not suitable as the contamination of ground water that is abundantly in use, is a certainty. More over, deep burial is a permitted option only in towns with population less than five lakhs. Thus, for a city like Kochi, both the options in the Rules, viz., incineration and deep burial are not appropriate.

 

6.Need for the development of alternatives for the disposal of category 1&2 bio-

   medical wastes

 

The alternative options (not in Rules) based on thermal technologies developed in the developed countries like USA for category 1 & 2 wastes are very expensive to install and maintain. These energy intensive options are inappropriate in Kerala State that is power hungry. In these circumstances, it was very necessary to develop some other simple and financially viable alternative for the safe disposal of bio-medical wastes most suitable to Kerala conditions and particularly for the conditions prevailing at Kochi, where deep burial option is not permitted for category 1 & 2 wastes. It is in these circumstances that Qualified Private Medical Practitioners and Hospital Association, Kerala (QPMPA) sponsored a study at the School of Environmental Studies. Cochin University of Science and Technology, Kochi. The Study Team of the School of Environmental Studies developed a complete management system of collection, processing and disposal of all the BM Wastes that are generated in hospitals. These are presented in two reports: Part-I: ‘Identification and quantification of Biomedical Wastes’ and Part- II: ‘Present Scenario of Biomedical Waste Management and Proposals for Biomedical Solid Waste Management including Segregated Collection’.   The study team was headed by

1.      Dr. V. N Sivasankara Pillai, Professor & Director, School of Environmental

Studies, a specialist in Environmental Chemistry and Environmental

Management.

     The other members of the team were

2.      Dr. I .S. Bright Singh, Reader and specialist in environmental Microbiology

3.      Dr. V. Sivanandan Achari, lecturer and specialist in Environmental Chemistry and Environmental Modeling, and

4        Dr. (Prof) T.V.Jacob, Retired Chief Engineer of Kerala Water Authority, Govt. of  

      Kerala and member of Faculty, Environmental Studies, CUSAT, a specialist in  

            Environmental Engineering.

They were assisted by a team of doctoral and post doctoral fellows.

 

7. Development of PAB and BPAB Reactors

 

For the total management of Biomedical Wastes the study team developed four types of Reactors/equipments; out of these PAB and BPAB Reactors for category 1 & 2 wastes are the breakthroughs.  The management of bio-medical anatomical wastes classified as Category 1 and 2 are the most problematic wastes for the hospital managements. For the management of these wastes, the study team worked on the principles of natural degradation of anatomical parts in the ground and developed PAB Reactor (Placenta Anaerobic Bio-Reactor) and BPAB Reactor (Body Parts Anaerobic Bio-Reactor).

 

PAB Reactor: The development of PAB Reactor (Placenta Anaerobic Bio-Reactor) is a great break-through in the management of BMW. Even though, the Reactor is designed for the management of placenta, the Reactor can also be used for other anatomical materials, organs and body parts without bones. Thus, the Reactor is of multipurpose one and is inevitable for both small and large hospitals for easy and safe disposal of unwanted anatomical materials. Reactor can be designed for any capacity depending on requirements.

 

The degradation process, in the deep burial procedure, is a natural one. But, it is more or less, a crude one without much engineering concepts involved. The principle of the same natural process is adopted in the PAB Reactor incorporating certain engineering concepts for improved performance. This makes the Reactor well controlled for quick degradation of the anatomical organic matter with high degree of protection to the environment. (Such degree of protection is not available in the natural deep burial procedures). Properly conceived and engineered design of the Reactor makes the PAB Reactor most suitable for any hospital environment.

 

In the design of the Reactor, both   supernatant liquid and the liquidized fine sludge formed in the Reactor are proposed to be sent directly to the citywide sewer system for appropriate treatment and disposal, if such facilities are available. In other areas where citywide sewer system is not in existence, the effluents from the Reactor are to be combined with the liquid waste stream of human excreta and urine for further treatment and stabilization within the hospital premises. The procedure of sending partly stabilized liquids into the liquid waste stream for further treatment within the hospital will provide more dilution and more retention time of these effluents from the Reactor. During this retention in the liquid waste stream, the   pathogens in the effluent will be experiencing very unfavorable conditions for their survival. This environment will almost destroy most of the dangerous pathogens.  More over, the disinfecting of the final effluent from the hospital level treatment system will eliminate any harmful pathogens that might survive during the entire process. This will ensure complete safety of the treated liquid effluent to be discharged into the roadside drains. Thus, PAB Reactor enables safe processing for disposal of unwanted anatomical materials, body parts etc. classified under Category No.1&2 in a very simple and safe manner and without much financial costs and operational problems enabling the hospital management to carry out the procedure willingly. There is nothing in the Bio-medical Waste (Management and Handling) Rules, 1998 that prohibits the installation of Reactors for further processing and degradation of unwanted anatomical human organic materials.

 

The working models of the PAB Reactor are functioning in several hospitals for evaluation of the performances. The objective of liquefaction of the placenta and body parts is taking place effectively. The operation and maintenance of the Reactor is effortless and simple.

 

BPAB Reactor: The development of BPAB Reactor (Body Parts Anaerobic Bio-Reactor) is another break-through in the management of Bio-Medical Waste (BMW). The Reactor is designed for processing of anatomical materials with bones generated in hospitals.  The Reactor developed works in the same principles as that of PAB Reactor. The BPAB Reactor is a multipurpose one as the Reactor can handle small quantities of anatomical materials of both body parts without bones, placenta etc. and body parts with bones.

 

8. Appropriateness of installing the newly developed Reactors in hospitals

 

Bio-medical Waste  (Management and Handling) Rules 1998 applies only to the Bio- medical Wastes. In other words, the Rules do not apply to Bio-medical materials, if these materials are not wastes. As explained earlier, the unwanted materials are not discarded but undergo further processing in biological reactors in the hospital premises as in the case of human excreta and urine for hospital level treatment and disposal. Since the Authorities consider and permit processing of human excreta and urine containing harmful and dangerous pathogens in reactors/treatment units within the hospital premises, as within the Rules 1998, the unwanted materials classified under Category 1&2 can also undergo biological process for liquefaction in PAB& BPAB Reactors. One of the end products of gas that is very similar to that generated in septic tanks/anaerobic Reactors can be vented out. The liquid effluent from the PAB/BPAB Reactors is allowed to mix with the liquid waste stream of human excreta and urine for further processing. In Schedule I of the Rules, independent disposal is proposed for both category 1 and category 2 wastes. If both the options of incineration and deep burial are not adopted, there is no relevance for independent disposal. Technologically, there is no harm in the combined processing of different types of liquid wastes if these are compatible. The liquid organic wastes of human excreta and urine can very well be combined with that of the effluents from PAB/BPAB Reactors. This has the advantage of diluting the highly concentrated effluent from PAB/BPAB Reactors. The combined liquid waste is amenable for further processing and treatment according to standard procedures usually adopted in hospitals.  The effluent from the treatment process is to be disinfected as per rules. Thus, the process very much meets the objective of eliminating the harmful pathogens and makes the effluent eco-friendly before final disposal, ensuring complete safety of the environment. (Placenta from healthy women, generally, is not infectious; but from sick women may contain harmful pathogens but will be less than that in human excreta and urine. HIV virus that might be found occasionally in placenta from HIV infected women cannot survive for long periods. These will be destroyed in PAB/BPAB Reactors, as the detention time in the Reactors is more than twenty-four hours. More over, transmission of disease by HIV virus other than by sexual intercourse, is only through blood through wounds unlike that of pathogens from human excreta and urine which can be transmitted through flies, insects etc.). The Reactors developed has the additional advantage that these are financially affordable for both small and medium sized hospitals for installation and maintenance. They are also eco-friendly and needs only very little space.

 

Both PAB and BPAB Reactors are developed with the prime objective of the safety of the environment. These Reactors will be acceptable to all hospitals.  Ignoring appropriate innovations developed and evaluated by experts, on the plea that such options are not specifically mentioned in the rules will be of great loss to the society, which are necessarily to be prevented; the Rules can be considered only as guidelines to achieve the prime objectives.

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