National Green Tribunal
Veterans Forum For Transparency In ... vs State Of Himachal Pradesh on 23 June, 2021
Author: Adarsh Kumar Goel
Bench: Adarsh Kumar Goel
Item No. 03 (Court No. 1)
BEFORE THE NATIONAL GREEN TRIBUNAL
PRINCIPAL BENCH, NEW DELHI
(By Video Conferencing)
Original Application No. 136/2020
(With reports dated 10.03.2021 & 05.05.2021)
Veterans Forum for Transparency in Public Life Applicant
Versus
State of Himachal Pradesh & Ors. Respondent(s)
Date of hearing: 23.06.2021
CORAM: HON'BLE MR. JUSTICE ADARSH KUMAR GOEL, CHAIRPERSON
HON'BLE MR. JUSTICE SUDHIR AGARWAL, JUDICIAL MEMBER
HON'BLE MR. JUSTICE M. SATHYANARAYANAN, JUDICIAL MEMBER
HON'BLE MR. JUSTICE BRIJESH SETHI, JUDICIAL MEMBER
HON'BLE DR. NAGIN NANDA, EXPERT MEMBER
Applicant: Dr. Bishwanath Prasad Singh, Wing Commander (Retd.), in
Person
Respondent: Mr. Nalin Kohli, Advocate for HPSPCB
ORDER
1. Prayer in this application is for remedial action against discharge of waste from CETP at Baddi and from Acme Life Sciences, Nalagarh and Helio Pharmaceuticals at Solan, to prevent pollution of rivers Sirsa and Satluj. According to the applicant, the CETP is not connected to pharmaceutical units at Barotiwala and Nalagarh who are discharging their effluents directly into the rivers. It is further stated that even after treatment in ETP/STPs, pharmaceutical ingredients may still be coming out from the industries unless ETP/STPs are specialized for the purpose.
It is further stated that present CETP is not designed to neutralize Active Pharmaceutical Ingredient (API). The TSDF does not receive sludge generated from the industrial units at Nalagarh. The industries located at 1 Baddi area are generating 20779 KLD of industrial effluent, out of which 17894 KLD is being treated at CETP and remaining 2885 KLD is being disposed of by the occupiers directly into river Sirsa. There is no existing sewerage system in BBN area and no demarcation in residential and industrial area. Presence of Ciprofloxacin in the concentration of 296.1 ug/l was found on chemical analysis. Concentration of Ciprofloxacin in the effluent discharge of M/s Acme Life Sciences work out to be 13455 times of the prescribed limit. The increasing occurrence of multi-resistant pathogens is a serious global threat to human health and it is finding its way into the water bodies and drinking water through industrial discharge and also due to heavy use of antibiotics in human and veterinary medicine.
2. The matter was considered on 22.07.2020. The Tribunal constituted a joint Committee of CPCB, State PCB and District Magistrate, Solan to furnish a factual and action taken report in the matter.
3. The matter was last considered on 04.01.2021 in the light of the report of State PCB dated 30.12.2020 noticing the violations of environmental norms. The Tribunal directed remedial action and filing of compliance report. The operative part of the discussion and order of the Tribunal are reproduced below:-
"3. Accordingly, the Himachal Pradesh State PCB has filed its report dated 30.12.2020 to the effect that the joint Committee visited the area and noticed as follows:
"xxx xxx xxx i. The CETP has not installed the system to completely treat category IV effluent (High TDS/FDS Stream). Despite the fact that CETP does not have the capacity to treat this type of effluent, CETP has entered into the tripartite agreement with the Industries generating Category IV effluent has been receiving this category of effluent since 2016.2
ii. As per Environmental Clearance granted to CETP Baddi by the Ministry of Environment, Forests and Climate Change (MoEF&CC), the member industries with hydraulic loading more than 200 KLD shall treat the effluent in the existing onsite ETPs and then discharge into CETP for further treatment and discharge. However, it was informed that Units with hydraulic loading of 200 KLD are not treating effluent in the onsite ETPs and supplying primary treated effluent to CETP. Therefore, CETP has not been complying with this condition of the Environmental Clearance granted by MoEF&CC for the last 04 years. Accordingly, the sampling of these units was done by HPPCB team on 10/12/2020 and the samples were sent to HPPCB Central Laboratory. The results of the analysis are expected by 10/01/2021.
iii. The observations made by the Joint Committee during visit to the two Pharma units i.e. M/s Acme Life Sciences and M/s Helios Pharmaceuticals mentioned in the original application are as follows:
Both the pharma units have connectivity with the CETP for supplying the primary treated effluent, for further treatment at CETP.
No effluent was found to be discharged directly by the Units, in the drain.
The Joint Committee collected the samples from the final outlet of the pharma units under reference, to see the concentration of residual antibiotics in the primary treated effluent which is being sent to CETP for further treatment. The results of the analysis are expected by 09/02/2021.
iv. The evaluation of the results of the analysis of the CETP samples collected by the Joint Committee on 12-13 October, 2020, indicated intended dilution by CETP so as to achieve the prescribed norms. Therefore, the Joint Committee conducted unannounced re-sampling and sent the samples for analysis from three different laboratories.
v. The results of analysis for the samples collected by the Joint Committee have been analyzed in HPPCB Regional Laboratory, Paonta Sahib and evaluation of the results indicated that CETP is not meeting the norms prescribed for COD (264 mg/l> 250 mg/), BOD (35 mg/l > 30 mg/l), FDS (2252 mg/l> 2100 mg/l) and Chloride (1838 mg/l> 1000 mg/l). Therefore, it is concluded that CETP is discharging the effluent into the Sirsa River without complying with the prescribed norms. The results of the analysis of the samples are awaited from two other laboratories.
vi. The samples from CETP, upstream and downstream of Sirsa River and the pharma units under question, were 3 collected by the joint committee on 09/12/2020 for analysis of 12 Nos. residual antibiotic residues from Shri Ram Institute of Industrial Research, Delhi. The results of analysis of effluent samples for residual antibiotics is expected by 09/02/2021. The issue of discharge of residual antibiotics as raised by the applicant may be concluded by the Joint Committee after receipt of the analysis results.
In view of the fact that complete analysis reports will be available by 09/02/2021, it is humbly prayed to Hon'ble National Green Tribunal that Joint Committee may kindly be permitted to file the final conclusive report by 15/02/2020."
4. Accordingly, further action taken report may be separately filed by the State PCB before the next date by e-mail at judicial- [email protected] preferably in the form of searchable PDF/OCR Support PDF and not in the form of Image PDF. The directions in the connected matter being OA No. 801/2018, Jasmeet Singh v. State of Himachal Pradesh, dealt with by a separate order, to the extent relevant for the present matter, may also be followed."
4. The State PCB has filed its report dated 10.03.2021 giving the analysis results of samples calculated from the units as follows:-
"Supplementary Report:
The analysis results from the remaining two laboratories w.r.t samples collected by the Joint Committee have been received (Annexure-2 and Annexure-3), Further, the report of analysis w.r.t. samples collected by the Joint Committee from CETP, Pharma Units and Sirsa River for the presence of antibiotics from the approved external laboratory has also been received (Annexure-4). Accordingly, supplementary report in this matter is being filed by the Joint Committee as follows:
i) The results of analysis as received from three different laboratories of HPPCB, indicated that CETP is not meeting the norms prescribed for BOD (41, 35 & 38 mg/l > 30 mg/l), FDS (2252 & 3190 mg/l > 2100 mg/l) and Chloride (1209, 1838 & 1209 mg/l > 1000 mg/l). Therefore, it may be concluded that CETP is discharging the effluent into the Sirsa River without complying with the prescribed norms.
ii) The results of analysis of the samples collected from various stages of CETP and also final discharge point in River Sirsa for the presence of residual antibiotics indicate that two antibiotics viz. Ciprofloxacin and Ofloxacin are present in the final treated effluent of CETP as a concentration of 22.8 ug/l and 69.8 ug/l respectively.
iii) There are no standards notified by MoEF&CC for residual antibiotics in industrial effluents. However, these values are 4 1140 time higher for Ciprofloxacin (22.8 ug/l Vs. 0.02 ugh) and 349 times higher for Ofloxacin (69:8 ug/l Vs. 0.2 ugh) when compared with the proposed standards in the draft notification issued by MoEF&CC vide No. CG-DL-E-27012020- 215690 dated January 23, 2020 (Annexure-5), for pharmaceutical industry effluent arid CETPs with membership of Bulk drug and formulation units.
iv) Similarly, the samples collected by the Joint Committee from the outlets of two Pharmaceutical Industries viz. Helios Pharmaceutical and M/s Acme City Tech LLP, leading to CETP, were found be much higher than the standards proposed in the draft notification issued by MoEF&CC. Also, the values reported as below quantification limit (BQL), in the analysis report of the external laboratories may not be considered as conclusive and within the proposed limits as draft notified by MoEF&CC, since the BQLs of external laboratory for various antibiotics tested in the samples, as shared with the Joint Committee, are much higher than the proposed standards.
v) As per reports and research data available in the literature, the concentration of residual antibiotics has been found to be reduced by 60-90 % in conventional biological treatment plant. In view to assess the performance of the biological treatment system installed by CETP, the samples were collected from various stages of CETP. The results of analysis indicated that the performance of biological treatment system installed by CETP is not in line with the reports and data available in the literature, w.r.t. treatment of residual antibiotics. The inefficient performance of biological treatment system is also evident from the noncompliance of CETP with regard to biochemical oxygen demand (BOD).
Conclusion and Recommendations:
In view of the fact that:
i) There are no standards notified by MoEF&CC w.r.t. residual antibiotics in industrial effluents;
ii) Draft notified standards are yet to be decided by MoEF&CC;
iii) The concentration of residual antibiotics at outlet of CETP in Sirsa River, is much higher than the draft notified standards;
iv) The treatment efficiency of CETP w.r.t residual antibiotics is not at par with the reports and data available in the literature;
v) The CETP is not meeting the prescribed norms of BOD, FDS and chloride and discharging effluent into Sirsa River without complying with the prescribed norms.
It is recommended that Pharmaceutical (both bulk drug and formulation units) may be directed by Himachal Pradesh Pollution Control Board to provide primary treatment to the level of predicted no effect concentration (PNEC) as developed by members of AMR 5 Industry Alliance (Annexure-6), as a site (Baddi) specific preventing measure, so that there is no adverse impact of residual antibiotics on the environment and also to prevent development of antimicrobial resistance (AMR)."
5. The report is followed by further report dated 05.05.2021 as follows:-
"It is further submitted that now the joint committee has submitted its supplementary report which is annexed as Annexure R-1/1. Based on the inspections and sampling conducted the conclusion and recommendations made by the joint committee are as under:-
"i) There are no standards notified by MoEF & CC w.r.t.
residual antibiotics in industrial effluents.
ii) Draft notified standards are yet to be decided by MoEF & CC.
iii) The concentration of residual antibiotics at outlet of CETP in Sirsa river is much higher than the draft notified standards.
iv) The treatment efficiency of CETP w.r.t. residual antibiotics is not at par with the reports and data available in the literature.
v) The CETP is not meeting the prescribed norms of BOD, FDS and chloride and discharging effluent into Sirsa River without complying with the prescribed norms........"
The copy of Supplementary Report submitted by the joint committee dated 10-03-2021 (annexed as Annexure R-1/1) may be placed on record please.
It is submitted that as of now there are no specific standards notified by the Govt. of India for residual antibiotics parameters in the existing notification of standards for pharmaceutical (Manufacturing and Formulation Industry). However, it is worthwhile to mention here that all the bulk drugs/pharmaceutical manufacturing units (if not connected with CETP) are being regulated for the compliance as per standards notified in MoEF & CC Notification dated 9- 7-2009 (copy annexed as Annexure R-1/2). If the pharmaceutical (manufacturing and formulation industry) is member of CETP, then the unit is bound to comply with inlet quality standards notified by the Govt. of HP vide notification dated 17-3-2018 and 26-12-2019 (copies annexed as Annexure R-1/3 and R-1/4) The notification of specific standards for residual antibiotics (annexed as Annexure -5 with joint report) is still under proposed stage and shall be implemented for regulatory aspect as and when finalized by the MoEFF & CC."
6. The industrial units in question have also filed their Counter Affidavits. The said Counter Affidavits are of no assistance.
67. As against the above, the applicant has filed written submission on 11.06.2021 pointing out that the analysis of the samples shows presence of antibiotics in the water.
8. The conclusion drawn from the analytical results is as follows:-
"
1. Ciprofloxacin (22.8µg/L) and Ofloxacin(69.8µg/L) were detected in higher concentrations in the effluent released to Sirsa river from CETP (Sr. no 4), i.e.,1139 and 348 times higher than the prescribed MoEF& CC draft notification limits.
2. The higher concentrations of antibiotics in the effluent released to Sirsa river (Sr. no 4) clearly indicate that CETP is unable to completely remove or degrade these antibiotics.
3. Ofloxacin (960µg/L) was found in the effluent from M/S Helios Pharmaceutical (Sr. no 13) release to CETP, which is much higher than the draft notification limit (0.2 µg/L). It clearly raises doubt on the level of pre-treatment of the pharma effluent from this industry before it is released to the CETP.
4. The samples drawn from the effluent of M/S Acme City Tech LLP (Sr. no 14 and 15) release to CETP shows reasonably high concentrations of Ofloxacin (170 µg/L) and Azithromycin (423µg/L) even after primary treatment, indicate inefficient pre- treatment at this industry.
5. In the research methodology Limit of quantification (LOQ) for a compound by any method indicates the lowest concentration that can be quantified with accuracy and precision. The values below LOQ cannot be correctly quantified during the analysis and are reported as Below Quantification Limit (BQL). In the present analysis, the LOQs of the compounds fixed for the analysis by the lab are very high; namely, Ciprofloxacin (5 µg/L), Ofloxacin (5 µg/L), Piperacillin (5 µg/L), Azithromycin (10 µg/L), Tazobactum (5 µg/L), Ceftazidime (50 µg/L), Cefixime (20 µg/L), Amoxicillin (10 µg/L), Ampicillin (10 µg/L), Cefpodoxine (10 µg/L), Sulbactum (10 µg/L), Ceftriaxone (50 µg/L) and Cefoperazone (10 µg/L). The above LOQs of the compounds are much higher than even the antibiotic discharge limits set by the MoEF & CC draft notification for these compounds; except for Tazobactam.
6. Incidentally Piperacillin and Amoxicillin are the antibiotics are known for the very adverse impact on the human health even in the very low concentration. In this laboratory analysis, BQL limit for these compounds are set as (5 µg/L) and (10 µg/L) which is significantly higher than the limit fixed in the draft standards. In the draft standards the limit set for these two compounds are (0.1µg/L).
77. This implies that the Limit of Quantification (LOQ) set up by the lab is significantly higher than the limit set by the draft notification and therefore many of the compounds are not being detected as has been marked as BQL in the analysis results.
8. Therefore, the samples analysis should be conducted using an analytical method to precisely and accurately quantify lower concentrations of the compounds (LOQs should be kept as close or even lower than the draft notification limits) to quantify all the compounds at lower concentrations with accuracy and precision. This raises the question mark on integrity of the overall analysis by the lab.
9. Further the findings also imply that the CETP is not designed to efficiently treat class IV effluents; however, operator of CETP has entered into agreement with various pharma manufacturing units who are releasing class IV effluents to the CETP since 2017."
9. Further submissions are reproduced below:-
"14. The migration of antimicrobials into the environment has significant impacts. They can disrupt wastewater treatment processes and adversely affect ecosystem because they are toxic to beneficial bacteria. Some antimicrobials also bio accumulates; for example, erythromycin has been found to have both a high bio accumulation factor of 45.31 and a tendency to accumulate in soil. Antimicrobials can also be persistence for extended periods of time, the environmental persistence of erythromycin for example, is longer than one year.
15. Although not well studied, the presence of antimicrobials in natural waters may be exerting selective pressure leading to the development of antibiotics resistance in bacteria. The threat of growing antibiotics resistance has been recognised by, among others, the WHO, the National Academy of Science, the American Medical Association, the American Public Health Association and the US government Accountability. In fact the Centre for Disease Control and prevention (CDC) has identified antibiotics resistance as one of the most pressing public health problem facing the nation. Infections caused by bacteria with resistance to at least one antibiotic have been estimated to kill over 60,000 hospitalized patients each year. Methicillin resistant strains of Staphylococcus aureus, although previously limited primarily to hospital and health facilities, are becoming more widespread. In 2007, Consumer Reports tested over 500 whole chickens for bacterial contamination and antibiotic resistance. They found wide spread bacterial contamination in their samples and 84 percent of the salmonella and 67 percent of the campylobacter organisms that were isolated showed resistance to one or more antibiotic.
16. Antibiotic resistance is caused by a number of factors including repeated and improper use of antibiotics in both humans and animals.8
Half of the antibiotics used in livestock are in the same classes of drug that are used in humans and animals. The U.S. institute of Medicine and the WHO have both stated that widespread use of antibiotics in agriculture is contributing to antibiotic resistance.
17. The above study done by the HPPCB shows that from whichever place samples have been taken by HPPCB these are having antibiotics discharge which should not have been there. There is not a single sample in which the aforesaid antibiotics discharging into surface water and also seeping into the subsoil water is not there. This would lead to harmful antibiotic resistance amongst human and animal population and, thus, reducing the chances of their recovering from diseases where absence of resistance from these antibiotic would have helped. The above table and the subsequent narration would show that the antibiotics found in the discharge include some of the ultimate antibiotics developing resistance of which may be a death warrant for different life forms - human and animal - if infected with diseases where these antibiotics could have provided a cure.
18. A situation where all random samples show the same results, in technical terms, is called '100% random test positivity'. In view of the '100% random test positivity', the study conducted by HPPCB cannot be stated to be complete and conclusive. It only indicates that a whole lot of polluting antibiotics are being discharged into the surface and subsoil water which is harmful for human and animal population.
19. As per information available at internet, there are more than 270 Pharmaceutical Companies operating in Baddi-Barotiwala- Nalagarh area. List of such Pharmaceutical Companies along with their addresses, as obtained through internet sites, is placed at Annexure A.
20. This necessarily requires a further and more detailed study as a sequel to 'the sample study' done by HPPCB to understand the entire extent of damage because of the aforesaid antibiotic discharge into the water bodies. It is being called 'sample study' because of the fact that it has '100% random test positivity' and therefore, in scientific tradition, there is an absolute need for following it up with a detailed, wide and more in depth study of the antibiotic discharge into river sirsa."
10. We have heard the applicant in person and the Learned Counsel for State PCB.
11. We find that there is gross failure on the part of the State PCB to act as per public trust doctrine in preventing discharge of toxic effluents containing harmful residue of antibiotics in water posing threat to aquatic life (reference: "biomonitoring of Sirsa River in Baddi area of Himachal 9 Pradesh by Bhagat S. Chauhan, et al, International Journal of Theoretical and Applied Sciences 5 (1): 183-185(2013)) which is also in violation of the Water (Prevention and Control of Pollution) Act, 1974. Such failure of statutory duties is at the cost of public health and protection of environment for which Chairman and Member Secretary of the PCB owe an explanation which may be furnished before the next date. Mere fact that standards have not been revised by MoEF&CC of the residual antibiotics in industrial effluents can be no justification for State PCB not taking steps to prevent. Pending finalization of standards by MoEF&CC, State PCB can go by earlier standards or lay down standards by itself under section 17 of the Water Act. MoEF&CC needs to expedite the process of finalizing the standards in the interest of protection of environment.
12. Accordingly, MoEF&CC and the State PCB may take further remedial action expeditiously. The State PCB may ensure that no harmful components in the effluents are discharged into the water by the units in question or any other API unit. A joint Committee of nominee of MoEF&CC, CPCB, State PCB and District Magistrate, Solan may conduct inspection of the area and give a report of the status of violations and the remedial action taken within three months by e-mail at [email protected] preferably in the form of searchable PDF/ OCR Support PDF and not in the form of Image PDF. The State PCB will be the nodal agency for compliance. The Committee may interact with the concerned stake holders, including the concerned Industries. The report may inter alia give status of performance of individual pharmaceutical units, particularly with reference to removal of API residue by them and by the CETP, the number of pharma industries connected to CETP and those discharging effluents directly into the drain and the river. The report may further indicate chemical and biological water quality of rivers in 10 question - Sirsa and Satluj, including the status of residue at relevant locations. CPCB may also suggest monitoring mechanism for API residue through a credible system so as to cover all pharma industries in the country discharging API residue directly or indirectly in river systems.
CPCB may propose the timelines to undertake monitoring which may also take a note of water quality monitoring guidelines of CPCB titled "Guidelines on Water Quality Monitoring, 2017" and the performance audit report dated 18.09.2020 filed by CPCB in OA 95/2018, Aryavart Foundation v. M/s Vapi Green Enviro Ltd. & Ors. and the directions of the Tribunal dated 05.02.2021. Relevant direction is reproduced below:
"22. The directions on the subject are summed up as follows:
i to vi xxx..................................xxx......................xxx vii. CPCB and State PCBs/PCCs, as directed earlier, may utilise EC funds on laboratory set up/upgradation, and on the mentioned areas in the report as well as on approved District Environment Plans. No approval of Central/State Government will be necessary in this regard in view of section 33 of the NGT Act, supra."
CPCB may file report on the above aspects before the next date of hearing by e-mail at [email protected] preferably in the form of searchable PDF/ OCR Support PDF and not in the form of Image PDF.
List for further consideration on 05.10.2021.
A copy of this order be forwarded to MoEF&CC, State PCB District Magistrate Solan and CPCB by e-mail for compliance.
Adarsh Kumar Goel, CP Sudhir Agarwal, JM 11 M. Sathyanarayanan, JM Brijesh Sethi, JM Dr. Nagin Nanda, EM June 23, 2021 Original Application No. 136/2020 SN 12