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FACTS ABOUT NIOH REPORT ON ENDOSULFAN

Raw data obtained by application under Right To Information Act, 2005, reveal that the Final Report of NIOH is erroneous, incorrect, unacceptable and unreliable. Final Report suffers from incorrect representation of facts and inconsistency of calculation methodology as given below:

[corresponding pages of final report are given in Annex-1]

1. Refer to page 95 of the raw data provided by NIOH under Right to Information Act [Annex-2]. It shows that contribution from blank i.e., plain solvent is higher than the highest residue level of Endosulfan reported in NIOH report. As per raw data, contribution from blank is equivalent to 1.27 ppb for α-Endosulfan, 9.4 ppb for β-Endosulfan and 23.22 ppb for Endosulfan sulfate. However, in the entire report, the levels of residue reported for any of the samples never exceed 1 ppb for α-Endosulfan, β-Endosulfan or Endosulfan sulfate.

2. In the analysis of Top Soil for α – Endosulfan, mean value for control/reference obtained as per raw data is shown as the value for exposed/study in the final report.

3. In the analysis of Top Soil for α – Endosulfan, mean value for exposed/study obtained in raw data is not same as the value for exposed/study reported in the final report.

4. In the analysis of Top Soil for β – Endosulfan, the raw data pertaining to control/reference shows that only one value is obtained out of 6 samples analyzed and remaining 5 are below detection limit or not detectable (N.D.). In residue analysis, in such a case, the single value is generally considered as “outlier”. However, in the final report, a value of 0.002±0.004 has been reported as a representative value for 6 samples.

In the raw data, in analysis of Top Soil for β – Endosulfan, in case of control/reference, while calculating mean of a single value (0.0113) and rest 5 “N.D.”, the single value of 0.0113 is divided by 6 and the outcome 0.002±0.004 is reported in the final report.

However, in the analysis of top soil for Endosulfan sulfate, raw data shows that there are 3 values and 3 N.D. for control/reference. In this case, the sum of 3 values is divided by 3 for calculating mean and 0.051 figure is obtained as shown in the raw data. If the sum would have been divided by 6, the value would have been 0.0257±0.039. Even this value (0.0257±0.039) is not reported in the final report. What is reported in the final report is

0.007±0.012.

6. In the analysis of top soil for Endosulfan sulfate, the raw data shows that there is only one value obtained out of 6 in case of exposed/study. This should be considered as outlier. Mean is 0.0017±0.004, however even this value is not reported. What is reported in final report is 0.025±0.03.

7. In the analysis of mid soil for α –Endosulfan, the value for control/reference is reported in the Final Report as 0.089±0.096. The raw data indicates that the mean value should be 0.104±0.098.

8. In the analysis of mid soil for β –Endosulfan, the raw data shows that there is only one value obtained for exposed/study, and remaining 5 are N.D. Therefore, ideally in the final report, N.D. should be reported since a single value should be considered as an “outlier”. If you calculate mean, it will be 0.0005±0.0012. The value was first printed in the final report as 0.005±0.001, which was corrected (see Annexure-8 in the final report) as 0.0005±0.0012. However, this value is below detection limit.

9. In

the

analysis

of

mid

soil

for

Endosulfan

sulfate,

the

value

for

control/reference

is

reported

in

the

final

report

as

0.007±0.012.

However,

the

raw

data

indicates

that

said

value

should

be

0.0042±0.0065.

 

10.In

the

analysis

of

lower

soil

for

α

Endosulfan,

the

value

for

control/reference is reported in the final report as 0.0623±0.06. However, raw data indicates that the value should be 0.086±0.053.

11.In the analysis of lower soil for Endosulfan sulfate, the value for control/reference is reported in the final report as 0.0005±0.001. However, the raw data shows that all values are N.D. and hence it should be reported as N.D.

In NIOH study, analytical method is not validated and results reported therein are incorrect and unacceptable as explained below:

Limit of quantification is not established.

Instrument is not calibrated. As per standard practice, measurements must be made within the calibrated range of the detection system used.

Results could not be confirmed by GC-MS by NIOH scientists. As per the standard practice, only confirmed data should be reported.

Recovery of analyte at limit of quantification cannot be ascertained in NIOH study, as limit of quantification is not established.

Certain residue quantities reported in NIOH report fall below detection limit.

Very high standard deviation from mean implies that data is skewed and hence most of the residue levels fall below detection limit.

In addition to this, in the results shown in Table-18 in NIOH final report in respect of subjects showing SMR grade-2 or more for pubic hair, penis and testes, except age group of 5-9 years, the sample size is too small to draw any conclusion. Age group of 5-9 years is not relevant for SMR.

Chromosomal aberration and sister chromatid exchange per cell in study and reference population is given in Table-22. The results in respect of study group fall within standard deviation from mean of the reference group.

Annex-1

Information below is reported in NIOH Final Report

Annex-1 Information below is reported in NIOH Final Report 5
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7

Some values reported in NIOH report are below detection limit. Detection limits for alpha-Endosulfan, beta-Endosulfan and Endosulfan-sulfate are reported to be 1, 1 and 3 ppb respectively in NIOH report. However, values as low as 0.0004 ppb have been reported. Even after concentrating as described in the procedure given in the report, this is far below detection limit. Moreover, for many of the values, standard deviation is several hundred times greater than the mean (please see below). This implies that the data is highly skewed. Under circumstances, most of the values will fall below detection limit. This is not scientifically valid and hence it is unacceptable.

Examples of high standard deviation from mean

I.

In Table No 4 of NIOH report:

Mean ± SD

Β Endosulfan (ppb) in top soil (reference)

: 0.002 ± 0.004

Endosulfan sulphate (ppb) in top soil (reference) Total Endosulfan in top soil (study) α Endosulfan (ppb) in mid soil (reference) Endosulfan sulphate (ppb) in mid soil (reference) Endosulfan suplhate (ppb) in mid soil (study)

: 0.007 ± 0.012 : 0.030 ± 0.18 : 0.089 ± 0.096 : 0.007 ± 0.012 : 0.008 ± 0.018

II.

In Table No 24 of NIOH report

Growth hormone in female (reference group)

:

1.27 ± 2.24

Growth hormone in female (study group)

: 1.41± 2.19

Growth hormone in male (reference group)

:

0.55 ± 0.80

Growth hormone in female (study group)

:

0.52 ± 1.09

III.

In Table No 28 of NIOH report

Levels of testosterone (ppb) in study group (12 years)

: 0.29 ± 0.33

Levels of testosterone (ppb) in study group (13 years) Levels of testosterone (ppb) in study group (14 years)

: 0.73 ± 1.20 : 1.17 ± 1.18

Levels of testosterone (ppb) in reference group (15 years)

: 1.30 ± 1.44

Annex-2

Raw Data Obtained from NIOH

Annex-2 Raw Data Obtained from NIOH 9
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