16 dic 2016, 10:20
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ATTN: ing. Luciano Bologna, Responsabile del Settore Sviluppo Normative di Radioprotezione dell'ISPRA
Justification of radiation exposures of members of the public and workers: review of existing practices.
New and important information.
Dear Sir/Madam,
1. This request requires the re-justification of
historic and currently on-going practices involving exposures of members
of the public and workers to ionizing radiation principally from
radionuclide contamination of the environment.
2. Under Article 6.2 of the Council Directive 96/29/Euratom of 13 May 1996:
Existing classes or types of practice may be reviewed
as to Justification whenever new and important evidence about their
efficacy or consequences is acquired
3. Under Article 19(2) of the Council Directive 2013/59 of 5th Dec 2013:
Member States shall consider a review of existing
classes or types of practices with regard to their justification
whenever there is new and important evidence about their efficacy or
potential consequences.
4. New and important evidence on the safety of the radiation risk model upon which EU Directives and domestic regulation depend.
4.1 Background
The issue of the genotoxic hazard from
internal radionuclides was considered sufficiently important for UK
Environment Minister Michael Meacher and Health Ministers Yvette Cooper
to set up the Committee Examining Radiation Risks of Internal Emitters
CERRIE in 2001. Mr Meacher was removed from office before CERRIE
completed its deliberations and two initially agreed joint studies which
would have assisted the process were cancelled. The final report was
not agreed by all the members. Since CERRIE new and important evidence
which informs this issue has been published in the peer-review
literature.
4.2. Evidence for the failure of the Hiroshima Studies.
Directives in the European Union and
Regulations in the UK depend upon cancer risk factors published by the
International Commission on Radiological Protection, an independent NGO.
These risk factors are based primarily on the doses and cancer yield of
the Japanese Lifespan Study (LSS). This epidemiological study was set
up to depend upon comparison of exposed and unexposed individuals and
the cancer yield in those exposed compared with unexposed controls.
Forensic examination of the methodology and decisions made over the
period of the study reveals that significant errors were introduced
which resulted in incorrect conclusions being drawn. In particular it
appears that the original control group, those who were not in the city
at the time of the bombing, was discarded in 1973 when it appeared that
their inclusion was suggesting a high level of cancer in the exposed
groups. Furthermore, evidence presented in the Royal Courts of Justice
in the Pensions Appeals Tribunal (Abdale and Others vs. Secretary of
State for Defence; June 13th 2016) showed that all the
epidemiological groups were exposed to rainout and subsequent
contamination of the city by Uranium nanoparticles. The LSS study did
not address internal contamination resulting from inhalation of the
nanoparticles. This evidence and the manifest failure of the ICRP model
was not denied nor rebutted in Court by the Secretary of State for
Defence. New evidence which has emerged since CERRIE reported in 2004
demonstrates that exposure to Uranium particulates carries levels of
genetic hazard which are not incorporated into the ICRP risk model. The
matter is outlined in a letter which has been published by the leading
peer-review journal Genetics on December 1st 2016. The publication which was reviewed for the Journal by three referees is attached as Appendix A.
4.3. Evidence of genetic damage leading to heritable effects in those exposed to Chernobyl fallout in Europe.
A review of evidence relating to the
genetic effects of chronic internal exposure to contamination from the
Chernobyl accident was published in a leading peer-review journal in
January 2016 [Schmitz-Feuerhake et al., 2016]. It examined the
considerable evidence relating to increases in congenital defects and
other heritable conditions in Chernobyl-exposed individuals but also
discussed other situations where significant excess risk was shown to
exist in offspring of exposed parents. The current ICRP radiation risk
factor for such effects is obtained from mice because the LSS study
(above) was unable to find any heritable effects in children of the
exposed groups. However we now see that the chosen comparison groups
were unsafe for the purposes of obtaining evidence of harm (see 1
above). The aggregated evidence presented in Schmitz-Feuerhake et al
2016 demonstrates unequivocally an error in the current risk factor for
heritable defects of approximately 1000-fold. It shows that heritable
defects occur in offspring of those exposed to internal doses of less
than 10mSv and furthermore that the dose response is not linear, as
assumed by the ICRP and current legislation.
4.4. The ethical basis of the ICRP and regulations which depend on it.
EU Directives and UK Regulations which
control radiation exposures encapsulate a decision to tolerate low
levels of risk of cancer and genetic damage. The current 1mSv annual
dose limit for members of the public enshrined in EU Council Directive
96/29/euratom and its successor 2013/59/euratom is based on a permitted
level of absolute cancer risk of 1 in 1 million. The current relative
cancer risk factor of the ICRP is about 0.5 per Sievert. Thus an
exposure of 1 mSv carries with it an excess risk of 0.5/1000 or 1 in
2000. This is considered acceptable to Society. Regarding heritable
damage, the current doubling dose published by the ICRP and agreed also
by the United Nations Scientific Committee on the Effects of Atomic
Radiation UNSCEAR is 1Sv. Thus an annual dose of 1mSv, the limit for
effective dose for public exposures under Directive 2013/59euratom,
carries an excess risk of 1 in 500 of heritable effects in the offspring
of parents exposed. This is considered to be acceptable as a side
effect of the agreed development of nuclear technology. The new and
important evidence referred to above shows that this factor is in error
by approximately 1000-fold when applied to internal chronic exposures.
This issue is relevant to releases of radioactivity from nuclear plant
and other sources, to contamination of the sea and watercourses, and
other releases which are currently controlled on the basis of the 1mSv
level. The issue may be less relevant to external exposures from X-rays
or other external sources.
Reference Section 4:
Schmitz-Feuerhake, Busby C, Pflugbeil P Genetic Radiation Risks-A Neglected Topic in the Low Dose Debate. Environmental Health and Toxicology. 2016. 31Article ID e2016001.http://dx.doi.org/10. 5620/eht.e2016001.
5. (In Italian) Sono particolarmente
preoccupato per l'applicazione dei parametri aggiornati in vista degli
effetti del grave incidente di Fukushima - sul quale in Italia non c'è
stata adeguata copertura della stampa - e per gli effetti sui civili
dell'aerosol radioattivo derivante dall'uso di proiettili di uranio sia
nei poligoni nazionali che nelle guerre pacifinte e specialmente alla
luce di quanto emerso nel cablogramma segreto dell'ambasciata USA a Roma
del settembre 1978, dove si riferiva di attività di lobbying riuscita
nei confronti del governo italiano allo scopo di contenere eventuali
rivelazioni da parte dei media italiani.
Reference Section 5:ITALY AGREES TO COORDINATED STABALLOY PRESS TREATMENT
Four Italians were involved in the "coordination":
- Generale Giuseppe Alessandro D'Ambrosio, Capo Gabinetto del Ministero Difesa (later nominated by Cossiga as segretario generale del Consiglio Supremo di Difesa) (Collega del generale Carlo JEAN...)
- Ministro della Difesa Attilio Ruffini
- Vice direttore generale degli affari politici del Ministero degli Esteri Bruno Bottai
- Consigliere diplomatico Ministero Difesa Pietro Rinaldi
Reference Section 5:ITALY AGREES TO COORDINATED STABALLOY PRESS TREATMENT
Four Italians were involved in the "coordination":
- Generale Giuseppe Alessandro D'Ambrosio, Capo Gabinetto del Ministero Difesa (later nominated by Cossiga as segretario generale del Consiglio Supremo di Difesa) (Collega del generale Carlo JEAN...)
- Ministro della Difesa Attilio Ruffini
- Vice direttore generale degli affari politici del Ministero degli Esteri Bruno Bottai
- Consigliere diplomatico Ministero Difesa Pietro Rinaldi
6. Summary
The issue of re-Justification involves
historic practices. For new practices, new Justification is required by
Member State and European law. Both require full, accurate and
scientifically plausible assessments on the basis of the new and
important evidence which I refer to above.
I look forward to your response.
Yours faithfully
Marco SABA
Appendix A to Section 4
Below is the paper by Dr Busby which was published by Genetics on 1st December 2016.
Published at:
Letter to the Editor on “The Hiroshima/ Nagasaki Survivor Studies: Discrepancies between Results and General Perception” by Bertrand R Jordan.
Christopher Busby
Environmental Research SIA, 1117 Latvian Academy of Sciences, Riga, Latvia
In his recent article [1] Jordan
addresses the public’s “unreasonable” fears of radiation. He claims that
the Lifespan Study (LSS) of the Japanese A-Bomb survivors in Hiroshima
and Nagasaki has given definitive information on the relation between
exposure and genetic damage, expressed as cancer and heritable effects
in offspring of those exposed. He presents the LSS as the gold standard
in radiation epidemiology, and he is not alone in this [2]. The LSS
results are the basis of legal limits for exposure and are employed to
dismiss evidence showing that health effects from Chernobyl [3],
Fukushima thyroid cancers [4] and child leukemias near nuclear sites [5]
etc. somehow cannot be causal because the “dose is too low”. How can
the public not accept that the Science on this issue is clear? Jordan
observes that according to the LSS study you have to get a dose of 1Sv
(1000mSv, 500 times natural background) to have a 42% excess chance of
cancer, and as for the offspring, there have been no increased
frequencies of abnormalities or genetic effects detected. Unfortunately
there are some worrying problems with the epidemiological methods
employed, specifically with the key issue of the choice and later
abandonment of the control group.
The common understanding of the LSS
study is that groups of individuals with known doses are compared over
their lifespan with zero dose control groups who were not there. Jordan
explains:
The ABCC and later RERF assembled a
lifespan study LSS cohort of 120,000 individuals (100,000 exposed at
various known levels and 20,000 controls Not in the City (NIC) at the
time of the bombing).
But what is not generally known is that
the NIC controls were discarded in 1973 because they were apparently
“too healthy”. The 1973 ABCC report wrote:
In order to ascertain the effects of
radiation exposure it is necessary to compare the mortality experience
of the population exposed to ionizing radiation with a comparison
control population. For this purpose a group of people who were not
present in the cities was included in the sample. . . .
The mortality experience of the NIC
comparison group has been very favourable. . . [and] would have the
effect of exaggerating the difference in mortality between the heavily
exposed population and the control group. . .
[ [6] pp 6-7, ABCC LSS Report 7, 1973]
At that point, in 1973, the original
control was discarded in favour of shifting to the lowest dose group as
the control, something which should never be done in the middle of an
epidemiological study. The substitution with a new lowest-dose control
group was followed by the use of mathematical regression methodology.
This approach was questionable because of inbuilt assumptions which I
list below. Many of these are now known to be wrong.
These are:
-
The concept of “absorbed dose” employed by the study was a legitimate measure of biological damage from internal exposures i.e internal exposures can be translated into “dose” and this carries the same biological hazard as the identical external exposure dose.
-
The dose response relation was linear or at least monotonic, a necessity for regression.
-
There was no fallout which would have contaminated all the exposed groups equally
-
Internal exposure from fallout was therefore considered to be negligible and was ignored.
-
Acute exposures carry the same proportional hazard as chronic exposures.
-
The Japanese survivor population was representative of the general (western) public
These arguments have been reviewed
elsewhere [7,8]. The use of the lowest dose group as control is now also
standard in all the nuclear worker studies [9] which (like the LSS)
employ linear regression to establish risk factors. Why? Because if the
national population is employed as a control, the nuclear workers show a
“healthy worker effect” (HWE) and their relative risks for cancer are
lower than the general public. But this does not permit the lowest dose
group to be valid as a control unless it is also known that there is a
linear or monotonic dose response. Also the true value of the HWE is
unknown. Let me unpack this. The risk factor for cancer obtained from
regression is the gradient of the best straight line that can be fitted
to the excess cancer risk in groups aggregated according to their
external dose as measured by a film badge. The bigger the dose, the
bigger the effect, is the assumption, though the data do not show this.
The other problem is that nuclear workers are from a different Social
Class than the National Population. They are fundamentally healthier, as
are e.g. physicians, optometrists, soldiers, university lecturers etc.
So their Relative Risk for cancer should be lower. But how much lower?
The epidemiological method used now is to assume (and this is an
unfounded assumption) that the effects of radiation on the lowest dose
group can be set at zero. It is the point (0,0) for the regression line.
But two observations are relevant here. First, the lowest dose group
(usually with the most individuals in it) is still a group of workers
who mostly work on the contaminated sites (rather like the Hiroshima
survivors did) perhaps inhaling radioactive particles. So strictly they
should be compared with similar workers who are from a completely
different industry where there is no radioactive contamination (or with
the national population, adjusting for the healthy worker effect). There
is some evidence about the real HWE value from data published by the UK
National Radiological Protection Board of the relative risk of cancer
in UK nuclear workers stratified by length of time working in the
nuclear industry [10]. The level of healthiness (HWE) shifted from about
64% of the National rate at start of employment to nearer 90% after 10
years i.e. the healthy worker effect rapidly disappeared. This could be
seen as an effect of exposure. Use of 64% for the HWE results in
significant 30-40% excess risk in the lowest dose group for nuclear
workers.
To return to the linear dose response
regression point, all the published data stratified by dose group define
a dose response which is biphasic: it goes up at the lowest dose, then
comes down, then goes gently up again at the high doses. There are
plausible biological reasons for this (especially in the case of
congenital effects where the end point is seen only after birth and at
some dose level pre-birth viability stops). Drawing a straight line
though these data points results in the wrong answer to the question of
risk: there are different risk factors at low dose, medium dose and high
dose and plausible biological reasons for this.
Thus it is not epidemiologically valid
to employ regression methods for nuclear workers, any more than it is
for the Hiroshima survivors which I now turn to.
The LSS dose group populations, like the
nuclear workers, whatever their assumed doses, all lived on the
contaminated sites of the bombed towns for many years after the bomb.
Contamination was a consequence of the black rain. My description is
based on Expert and Disclosed evidence presented recently by Prof.
Sawada and others in the Royal Courts of Justice in London in the 3 week
hearing of the British Nuclear Test Veterans vs. the UK Secretary of
State for Defence [11]. The up-draught from the rising fireball at
Hiroshima and Nagasaki sucked in moist maritime air which cooled with
altitude and condensed on the 95% un-fissioned Uranium nano-particles
created in the plasma. This produced black rain over an area which
included all of the dose groups used for the LSS study where dose was
calculated by distance from the hypocentre. Uranium was measured later
in the contaminated areas [12]. The existence of any fallout was denied
and external acute doses were calculated based on distance using
experiments carried out in the Nevada desert. The last twenty years has
seen massive changes in the understanding of the biological effects of
radiation. This includes realisation that for internal exposures to
elements which have chemical affinity for DNA, and to nanoparticles, the
concept of absorbed dose is worthless [13]. Uranium has a high affinity
for DNA and a large number of studies have now shown effects which
define large errors in the “dose” based approach [8, 14]. The European
Union has recently funded research on this issue [15].
The black rain contamination of
Hiroshima and Nagasaki resulted in continuous chronic internal exposure
of all the dose groups and controls by inhalation and ingestion of
Uranium particles. Thus the only accurate way to establish the real
effects is to employ a truly unexposed group and abandon regression
methods. In 2009 Wanatabe et al, employed the adjacent Okayama
prefecture as control [16] and compared age and sex specific cancer
rates between 1971 and 1990. This period was chosen according to the
authors because apparently there were insufficiently accurate cancer
data prior to 1971. It was found that there were significantly greater
levels of cancer in all the exposed groups, including the LSS lowest dose controls
compared with the Okayama control group but also (to a lesser extent)
compared with an all Hiroshima control group. When compared with
Okayama, the highest cancer effect per unit dose was seen in the 0-5mSv
group, the lowest dose LSS group, where there was a 33% excess risk of
all cancer in men at external doses estimated at 0-5mSv. The authors
write: the contribution of residual radiation, ignored in LSS is suggested to be fairly high.
This immediately falsifies all the LSS epidemiology. Similar criticisms
were made by Sawada [11, 17] who examined immediate deterministic
effects of radiation (epilation, diarrhea) which were reported from
areas more than 5km from the hypocentre where black rain fell but where
the prompt gamma doses were effectively zero.
Since this journal focuses on genetics,
and Jordan also discusses this issue, I mention that similar control
group errors in the LSS genetic studies were addressed long ago by de
Bellefeuillle [18] who criticised the sex-ratio results. The LSS
researchers focused on sex-ratio, the number of boys born to the number
of girls, which is a well-accepted measure of genetic damage [19]. The
direction of the effect depends on whether the mother (egg) or father
(sperm) are irradiated. But the LSS geneticists analysed results from
families where both parents were irradiated and thus effects cancelled:
they also employed the wrong controls. That is why they reported that
there was no apparent genetic damage seen. Use of the NIC controls gives
a sex-ratio effect in the correct direction [20]. This issue is
discussed in a recent review by Schmitz-Feuerhake et al (2016) of
heritable effects reported at very low doses of internal exposure.
Results from Chernobyl in many countries clearly demonstrate that the
current genetic risk factor is in error by about 1000-fold and that the
dose response is not linear. There are significant increases in major
congenital malformations in offspring of those exposed to internal doses
less than 1mSv [21].
I suggest that this adherence to the LSS
as a definitive answer to the public’s fears is a result of a
scientific culture of acceptance that goes back over a long period, and
that few researchers have had the time or funding to forensically
examine the many (often obscure) reports needed to open up the
methodological black boxes. However, I submit that Jordan’s (and the
legislators’) belief in the validity of the Japanese A-Bomb studies, I
am sure innocently held, is unsafe, and that the health effects of low
level internal exposures to radioactivity should be re-evaluated.
1. Jordan, Bertrand R. 2016.The
Hiroshima/Nagasaki Survivor Studies: Discrepancies between Results and
General Perception. Genetics 203 1505-1512
2. Kamiya K, Ozasa K, Akiba S, Niwa O,
Kodama K, Takamura N, Zaharieva EK, Kimura Y and Wakeford R, 2015 Long
term effects of radiation exposure on health. The Lancet 386 (9992):
469-478
3. Yablokov A V, Nesterenko V B, Nesterenko A V., 2009 Chernobyl:
Consequences of the Catastrophe for people and the environment. Annals
of the New York Academy of Sciences; 1181 Massachusetts USA: Blackwell
4. Tsuda T, Tokinobu A, Yamamoto E,
Suzuki E., 2016 Thyroid Cancer Detection by Ultrasound among residents
ages 18 years and younger in Fukushima Japan: 2011 to 2014.
Epidemiology; 27(3): 316-322
5. Kaatsch P, Spix C, Schulze-Rath R, Schmiedel S, Blettner M, 2008
Leukaemias in young children living in the vicinity of German nuclear
power plants. Int J Cancer 122: 721-726.
6. Moriyama I M, Kato H., 1973.
Mortality experience of A-Bomb survivors 1970-72, 1950-72. JNIH-ABCC
Life Span Study Report 7 (Technical Report 15-73); pp 6-7. Hiroshima
Japan: ABCC
7. Busby Christopher.
2013 Aspects of DNA Damage from Internal Radionuclides, New Research
Directions in DNA Repair, Prof. Clark Chen (Ed.), ISBN:
978-953-51-1114-6, InTech, DOI: 10.5772/53942. Available from: http://www.intechopen.com/ books/new-research-directions- in-dna-repair/aspects-of-dna- damage-from-internal- radionuclides
8. Busby
C, Yablolov AV, Schmitz Feuerhake I, Bertell R and Scott Cato M. 2010
ECRR2010 The 2010 Recommendations of the European Committee on Radiation
Risk. The Health Effects of Ionizing Radiation at Low Doses and Low
Dose Rates. Brussels: ECRR Aberystwyth Green Audit
9. Richardson DB, Cardis E, Daniels RD,
Gillies M, O’Hagan JA et al. 2015. Risk of cancer from occupational
exposure to ionising radiation: retrospective cohort study of workers in
France, the United Kingdom and the United States (INWORKS). British
Medical Journal: 351: h5359
10. Muirhead CR, Goodill AA, Haylock RGE
et al. 1999. Second analysis of the National Registry of Radiation
Workers. Occupational exposure to ionising radiation and mortality. NRPB
R-307. Table 6.2 Chilton UK: National Radiological Protection Board.
11. Abdale and Ors. Vs The Secretary of State for Defence. Pensions Appeals Tribunal; Royal Courts of Justice, London June 13th -July 4th 2016
12. Takada J, Hoshi M, Sawada S and Sakanoue M., 1983 Uranium isotopes in black rain soil. J. Radiat.Res: 24(3) 229-36
13. CERRIE, 2004 Report
of the Committee Examining Radiation Risk from Internal Emitters.
Chilton, UK: National Radiological Protection Board
14. Busby Christopher, 2015 Editorial: Uranium Epidemiology. Jacobs Journal of Epidemiology and Preventive Medicine: 1(2)- 009; http://jacobspublishers.com/ index.php/journal-of- epidemiology-articles-in-press
15. Laurent O, Gomolka M, Haylock R et al 2016 Concerted Uranium Research in Europe (CURE): toward a collaborative project integrating dosimetry, epidemiology and radiobiology to study the effects of occupational uranium exposure. J.Radiol.Prot: 36(2):319-45
16. Wanatabe T, Miyao M, Honda R and
Yamada Y., 2008 Hiroshima survivors exposed to very low doses of A-Bomb
primary radiation showed a high risk of cancers. Env. Health. Prev. Med.
13: 264-270
17 Sawada S., 2007 Cover up of the
effects of internal exposure by residual radiation from the atomic
bombing of Hiroshima and Nagasaki. Med. Confl. Surviv. 23: 58-74
18. De Bellefeuille Paul., 1961 Genetic hazards of radiation to man Part I. Acta Radiologica: 56: 65-80
19. Scherb H, Voigt K 2011. The human
sex odds at birth after the atmospheric atomic bomb tests, after
Chernobyl, and in the vicinity of nuclear facilities. Environ Sci Pollut
Res. 18:697-707
20. Padmanabhan VT 2012. Sex Ratio in
A-Bomb survivors. Evidence of radiation induced X-linked lethal
mutations. In Busby C, Busby J, Rietuma D and de Messieres M Eds.
Fukushima: What to Expect. Proceedings of the 3rd International
Conference of the European Committee on Radiation Risk May 5/6th Lesvos
Greece. Brussels: ECRR; Aberystwyth UK: Green Audit, 2012
21. Schmitz-Feuerhake, Busby C, Pflugbeil P, 2016 Genetic Radiation Risks-A Neglected Topic in the Low Dose Debate. Environmental Health and Toxicology: 31Article ID e2016001. http://dx.doi.org/10.5620/eht. e2016001.