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The Current Pretty SAfe Rule on Radiation Protection (LNT) Versus the Lying Hormesis (Radiation is Good for You) Theory

Thursday, August 20, 2015 19:52

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Doctor Fairlie says nay one can use any part of this in response to NRC’s push to make “radiation safe and beneficial for you”, as long as you give him a citation.

Sorry for the horrible formatting, it was copied from a PDF.

http://www.ianfairlie.org/wp-content/uploads/2015/08/US-NRC-Consultation-4-1.pdf

Dr Ian Fairlie

Consultant on Radioactivity in the Environment

LONDON

United Kingdom

www.ianfairlie.org

US N

uclear

egulatory

ommission

(NRC)

Consultation

https://www.federalregister.gov/articles/2015/06/23/2015

15441/linear

threshold

model

and

standards

for

protection

against

radiation

Introduction

On June 26

2015,

the US

Nuclear Regulatory Commissio

n (

NRC

)

stated it

was

seeking

public comments

by September 8,

petitions

stating that the Linear No

Threshold theory of radiation’s effects was not a valid basis for setting radiation

standards and that the hormesis model should

be used instead

In mor

e detail, t

NRC

has received

three

petitions for rulemaking

requesting that

the NRC amend

its “Standards for Protection A

gainst Radiation” regulations and

change the basis of those regulations from the Linear No

Threshold (LNT) model of

radiation protect

ion to the hormesis model.

(

See

the

Appendix for details of the

petitions.

)

The LNT model

assume

s that biological damage from radiation is linearly related to

exposure and is always harmful, ie without a threshold.

The hormes

is model

assumes

that exposure

s to low radiation levels

is beneficial and protects the human

body against deleterious effects of high levels of radiation.

The NRC

has stated it

is examining these petitions to determine whether they sho

uld

be considered in rulemaking and is

req

uesting

public comments.

US environmental

groups

are concerned that

, if the NRC agreed wi

th the

petitions, it would introduce

rules to weaken radiation protection standards at US nuclear

facilities

On the other

hand,

according to two NRC staffers (Brock and Sher

bini, 2012),

the NRC apparently

pays attention to the evidence

risks of low levels of radiation

See references at

end.

Comments

on Hormesis

It is true that some cell and animal experiments indicate that if small

amounts of

radiation we

re administered

before later larger amounts, the

damage done is less

than if no previous

small

amount were given.

(The word “tickle” is used in

radiobiology lingo to denote such small amounts.)

On the other hand,

other

cell and

animal studies

using different doses, durat

ions and endpoints

fail to show this effect

nd there is no human evidence,

ie from epidemiol

But it is true that some

evidence from chemistry

indicates the same effect, a

nd there is some theoretical

support for an adaptiv

e effect in animals and plant

ormesis advocates

typically

argue that although radiation attacks DN

A and causes

mutations,

DNA repair mechanisms quickly correct these. These mechanisms are

certainly

numerous

and

busy

–

it is estimated over 15,000 repairs per hour are

carried out

each cell

–

but

from the sheer number of repairs, many misrepairs

occur and

it is the misrepairs that cause the damage.

But even if

the existence of hormesis

were accepted

, the question remains

–

what

relevance

would

it have for radiation protection?

The

answer

as stated

repeatedly

officia

l reports by UNSCEAR and BEIR

etc

is zero. For example, do we give

“

tickle

”

doses to people about to undergo radiation therapy

, or to nuclear workers

course, we don’t.

And what about background radiation?

All

of us receive small

“

tickle

”

doses of

radiation

–

about 3 mSv per

year

of which about 1 mSv is from external gamma

radiation

. Do these somehow protect us from

subsequent

radiation?

How would we

notice?

And if it did, so

what?

That is, what relevance would

it have for

radiation

protection

setting radiation standards?

The answer is

again

….none.

Indeed, as

we show below,

increasing

evidence exists that

even background radiation

itself

harmful.

Comments on LNT

On the other hand, the scientific evidenc

e for the LNT is plentiful, powerful and

persuasive.

It comes from epidemiological s

tudies

radiobiological e

vidence

, and

official

reports

Let’s examine these in turn.

A. Epidemiological Studies

Does the available epidemiological evidence show risks decli

ning linearly with dose

at low doses? Yes, recent epi

demiology

studies do indeed show this, and the

important new points are that these are (a)

very large

studies with

good confidence

intervals

, and (b) at

very low doses

, even down to background levels. In

other

words, the usual caveats about the validity of the linear shape of the dose response

relationship down to low doses

are

justified.

The most recent evidence is from

a particularly powerful study by

Leuraud

et al

(

2015

)

which shows linearly

risks

down to

very

low levels (average dose rate

1.1 mGy per year).

http://www.thelancet.com/journals/lanhae/article/PIIS2352

3026%2815%2900094

0/fulltext

The main findings

from the

Leuraud

study

are

shown in graph 1

Graph 1

Two interesting things about this study are

that

5 of the 13 authors

are

from US

scientific institutes, including the

Centers for Disease Control and Prevention,

the

National

Institute for Occupational Safety and Health,

the

Department of Health and

Human Services, U

niversity of North Carolina, and

Drexel Univer

sity S

chool of

Public Health. Also

that the study was funded by many international agencies,

including the

US Centers

for Disease Control and Prevention, US National Institute

for Occupational Safety and Health, US Department of Energy,

and the

Departme

nt of Health and Human Service.

It is legitimate to ask

whether the NRC is in

contact with these

official US agencies

about

its consultation

Leuraud

et al study is

merely the latest of many

studies

providing

good

evidence

for the LNT model.

Second is the

Zablotska study after Chernobyl

Graph 2

below,

reproduced from Zablotska et al

(2012)

, shows statistically signi

ficant risks for all

leukemias and for chronic lymphocytic leukemia (CLL) in over 110,000 Chernobyl

cleanup workers. It can also be seen that there are 6 data points showing increased

risks below 100 mSv

a commonly cited cut

off point

Graph

Six

th is the meta

analysis of 13 E

uropean studies in 9 EU countries on indoor radon

exposure risk

s by Darby et al (2005). This examined lung cancer risks at measured

residential Rn concentrations with over 7,000 cases of lung cancer and 14,000

controls. The action level for indoor radon in most EU countries is 200 Bq per m

corresponding to about 10

mSv

per year. (This is derived from a UNSCEAR (2000)

reference value of 9 nSv per Bq·h/m

. This means that people living 2/3rds of their

time indoors (5,780 h/year) at a Rn concentration of 200 Bq/m

would receive an

effective dose of ~10 mSv/year.

Graph 6

reproduced from the study shows elevated

risks at concent

rations well below this level.

The solid line is the a

uthors’ linear fit to

the data.

Graph 6

No evidence below 100 mSv?

It is

necessary at this point to

directly

address

the argument often raised

by hormesis

advocates

–

that there is little evidence of effects below 100 mSv. This is incorrect.

Older evidence

exists

see

http://www.ianfairlie.org/news/a

100

msv

hreshold

for

radiation

effects/

for a list of studies

and the newer evidence

as we have just seen

clearly shows this

fact

as well

B. Radiobiological Evidence

urrent radiobiological theory is consistent with a linear dose

response relationship

down to

low doses (ie below

10 mSv).

The radiobiological rationale for linearity comes from the stochastic

nature of

energy

deposition of ionising radiation. It was explained by 15 of the world’s most eminent

radiation biologists and epid

emiologists in a famous a

rticle

(Brenner et al, 2003) as

follows:

“1. Direct epidemiological evidence demonstrates that an organ dose of 10 mGy of

diagnostic x

rays is associated with an increase in cancer risk.

2. At an organ dose of 10 mGy of diagnostic x

rays, most irradiated

cell nuclei will be

traversed by one or, at most, a few physically distant electron tracks. Being so

physically distant, it is very unlikely that these few electron tracks could produce

DNA damage in some joint, cooperative way; rather, these electron trac

ks will act

independently to produce stochastic damage and consequent cellular changes.

3. Decreasing the dose, say by a factor of 10, will simply result in proportionately

fewer electron tracks and fewer hit cells. It follows that those fewer cells that

are hit

at the lower dose will be subject to (i) the same types of electron damage and (ii) the

same radiobiological processes as would occur at 10 mGy.

4. Thus, decreasing the number of damaged cells by a factor of 10 would be

expected to decrease the bi

ological response by the same factor of 10; i.e., the

response would decrease linearly with decreasing dose. One could not expect

qualitatively different biological processes to be active at, say, 1 mGy that were not

active at 10 mGy, or vice versa. The ar

gument suggests that the risk of most

radiation

induced endpoints will decrease linearly, without a threshold, from ~10

mGy down to arbitrarily low doses.”

C. Official Reports

Both

type

s of evidence (epidemiology and radiobiology) have been examined in

international official reviews:

UNSCEAR (2008)

US NCRP Report No 136 (2001)

US BEIR VII (200

) and

ICRP 99 (2006)

These reports

confirmed the LNT as being

the most prudent assumption for radiation protection purposes.

For example i

n 2006, the chair of

BEIR VII,

Richard R. Monson, associate dean for

professional education and professor of epidemiology, Harvard School of Public

Health, Boston

stated

“The scientific research base shows that there is no threshold

of exposure below which low

levels of ionizi

ng radiation can be demonstrated to be

harmless or beneficial”

http://hps.org/documents/BEIRVIIPressRelease.pdf

cently

the

based scientist Mark Little

and his colleagues (Little et al

, 2

009

)

examined

the

matter

considerable

detail. They discussed

(i)

the degree of

curvature in the cancer dose response within the Japanese atomic bomb survivors

and other groups, (ii)

the

consistency of risks between the Japanese and other low

dose cohort

s, and (iii)

biologic

data on mechanisms.

hey concluded linearity was

the best bet

Also in 2009, the head of the US Environmental Protection Agency’s radiation

section reviewed the matter in an influential article (Puskin, 2009). He stated

“Although

cent radiobiological findings indicate novel damage and repair

processes at low doses, LNT is supported by data from both epidemiology and

radiobiology. Given the current state of the science, the consensus positions of key

scientific and governmental bodi

es, as well as the conservatism and calculational

convenience of the LNT assumption, it is unlikely that EPA will modify this approach

in the near future”.

The Importance of LNT in Radiation Protection

Regardless of dissenting views on LNT, the reality is

that most

concepts used in

radiation protection today are

fundamentally

based on the LNT theory. For example,

LNT

underpins the concepts of absorbed dose, effective dose, committed dose, and

the use of dose coefficients (ie

Sv per Bq of a radionuclide).

also

allows radiation

doses (i) to be averaged within an organ or tissue, (ii) to be added from different

organs, a

nd (iii) to be added over time.

LNT also permits

annual dose limits

;

optimization

ie comparison of practices

;

radiation risk assessment at

low and very low doses

;

individual dosimetry with

passive detectors

;

collective dose, and

dose registers over long periods of time.

In fact, the LNT underpins all legal regulations in radiation protection

in the US

and

the

rest of the

world

. Indeed

the LNT were not used, it’s hard to imagine our

current radiation protection systems existing at all.

However this statement should

not be misconstrued to mean that the LNT i

s used

just

because it’

s convenient

the

LNT is used because the

scientific

eviden

ce for it is

comprehensive, cogent and

compelling

Statistical Significance

It is necessary to discuss the vexed issue of statistical signific

ance, as hormesis

advocates (eg

http://atomicinsights.com/leukemia

and

lymphoma

study

recently

published

lancet

being

strong

challenged

sari/

)

often dismiss studies stating

they show “no significantly” raised risks at low levels, or t

hat excess risks are “not

significant”

at low levels

, or similar phrases

Let’s

examine

these phrases because they can mislead readers into incorrectly

thinking that the reported increase is “unimportant” or “irrelevant”. The word

“significant” is a specia

list adjective used in statistical tests to convey the

narrow

meaning that the likelihood of

an observation

being a fluke

is less

than 5%

(assuming

a p = 5% test was used). It does not mean important or relevant.

Secondly, such phrases are often glibly

by hormesis advocates without

explaining that the

test level used is

quite

arbitrary. There is no scientific justification

for using a 5%

or any other

test level: it is merely a matter of convenience

In other

words, it is quite possible for results whi

ch are “not significant” when a 5% test is

applied, will become “significant” when a 10% test is used. For this reason,

good

epidemiologists

nowadays

have stopped using the words “significant” or

“significance” altogether. Instead they use confidence inter

vals:

hormesis advocates

should follow suit

There is a third reason

why

these phrases

shouldn’t be used. S

cientifically

speaking,

it’s bad practice t

o dismiss results (or to imply this) just because

they do not meet

statistical test

. This is because the

probability

(ie p value

)

that

observ

ed effect

may be

a fluke

affected by

both

magnitude of effect

and

size of study

(Whitely and

Ball

, 2002). This means statistical tests must be

cited

with caution

as the use of an

arbitrary cut

off

point

for stati

stical significance (

often

p = 5%) can lead to incorrectly

accepting the null hypothesis

at there’

s no

effect

(Sterne and Smith, 2001).

This is called

a type II error

in statistics

, and it

often occurs

in studies due to

low

numbers

of observed case

(Everett et al, 1998)

rather than lack of effect

In other

words,

the

rejection of findings for statistical reasons can often hide real

risks

(

Axelson,

2004

;

Whitley and Ball, 2002)

So what

should hormesis advocates

do with

a study having

positive

fin

dings

which

do not meet

their self

selected

test? First

of all

, they

should

NOT

reject the

findings

. Instead

they should report

the observed increase and add there’s a greater

than 5% possib

ility this

could

be a

chance

finding

And then they should disc

uss

It should be borne in mind that low case numbers are not the fault of researchers but

often

due to

the f

act that many conditions are rare (eg child

leukemia) and very large numbers of exposed people

are needed to pick up the few observed cases.

whether their interpretation would change if a slightly less strict 10% test were

chosen (as is increasingly used nowadays). And they should discuss

the confidence

interval

so that readers can make up their own minds.

For example, they could say

that t

he relative risk was, say, 1.55 with a 90% confidence interval of 1.01 to 1.98.

This would mean that the observed

relative

risk was 1.55 and that we are 90% sure

that the real value lies between 1.01 and 1.98. The key point is that the loaded words

“signif

icant” or “significance” are

therefore

avoided

Conclusion

(i) the debate

The validity

otherwise

LNT and hormesis have been the subject of hundreds of

scientific articles and debates over several decades.

Unfortunately

much of the

literature on

hormesis or adaptive response is based on faulty science

misconceptions

misinterpretations

all three

. Thi

s is particularly the case

with

several

and UK

journalists

who write with confidence on how radiation risks

are exaggerated

. T

eir

knowledge and experience of radiogenic risks ar

e limited

say the least, but

these journalists

almost on a weekly basis,

misinform and mis

lead

the public

about

radiation risks

, so

the existence of the US

petitions is per

haps

unsurprising.

However

real scientists are

increasingly

standing up

and opposing the poor science

by hormesis advocates.

Very recently,

four

Swiss scientists from the Institute of

Social and Preventive Medicine at the University of Bern; the Swiss Tropical and

Public Health

Institute, Basel and the University of Basel published a study which

revealed that exposure

to high rates of background radiation

resulted in increased

cancer risk

children

(Spycher et al, 2015).

http:/

/ehp.niehs.nih.gov/1408548/

In reply,

17 scientists

(Siegel et al, 2015)

mostly

from the US

some of whom were

members of a hormesis

pressure group

“Scientists for Accurate Radiation

Information”

objected

to these findings

. They

alleged that the

governme

would

have to evacuate children living in higher radiation areas and relocate them to lower

radiation

areas

They stated that s

tudies like this should not be taken seriously

without public health policy implications being examined.

(

http://ehp.niehs.nih.gov/1510111/

)

The Swiss scientists in turn responded (

http://ehp.niehs.nih.gov/1510111R/

)

that the

proposed evacuation was “nonsensical”

in view of the v

ery low numbers involved

a spirited rejoinder, t

hey

refuted the poor science cited and

added that

“

the Scientists

for Accurate Radiation Information

a priori

exclude the possibility that low

dose

radiation could increase the risk of cancer. They will t

herefore not accept studies that

challenge their foregone conclusion

”

(ii) the petitions

After

briefly

examining the

three

petitions, my conclusion is that

they

do not merit

serious consideration

It seems that

the petitioners,

who may

or may not

hav

e axes

to grind about radiation risks, have seized on the possible phen

omenon of hormesis

to make ill

considered

claims that radiation is protective or

even

good for you.

other words

, the petitions appear to be

based on

preconceptions

or even ideology

rather than the sc

ientific evidence which

points in the opposite direction.

The petitions

should

not be

used

by the

NRC

to justify

weaken

ing

regulatory

standards at US nuclear facilities.

A question remains whether the NRC should have

accepted the petit

ions for review. Presumably the NRC has discretion not to review

or to refer back spurious, mischievous, or ill

founded petitions.

he NRC should seek guidance from

the

five

scientific

agencies

and

Government departments

mentioned above

who

se scientist

have published

evidence on the matter.

Credits. Thanks to Dr Jan Beyea, Cindy Folker

, Dr Alfred Körblein, Xavier Rabilloud,

Dr Marvin

Reznikoff

and Dr Gordon Thompson for comments on drafts. Any errors are my responsibility.

References

Axelson O.

Nega

tive and non

positive epidemiological studies.

Int J Occup Med Environ Health.

2004;

17:

115

121.

BEIR VII (2006)

http://www.nap.edu/catalog/11340/h

ealth

risks

from

exposure

low

levels

ionizing

radiation

Brenner David J, Richard Doll, Dudley T. Goodhead, Eric J. Hall, Charles E. Land, John B. Little, Jay

H. Lubin, Dale L. Preston, R. Julian Preston, Jerome S. Puskin, Elaine Ron, Rainer K. Sachs

Jonat

han M. Samet, Richard B. Setlow

and Marco Zaider (2003) Cancer risks attributable to low

doses of ionizing radiation: Assessing what we really know. PNAS. vol.100 no.24. pp 13761

13766.

www.pnas.orgjcgijdoij10.1073jpnas.2235592100

Brock TA and Sherbini SS (2012)

Principles in practice: Radiation regulation and the NRC.

Bulletin of

the Atomic Scientists

2012 68: 36.

http://bos.sagepub.com/content/68/3/36

Cardis et al (2005) Risk of canc

er after low doses of ionizing radiation: retrospective cohort study in

15 countries. BMJ. 2005 Jul 9;331 (7508).

Darby et al (2005) Radon in homes and risk of lung cancer: collaborative analysis of individual data

from 13 European case

control studies. BM

J 2005;330:223.

Everett DC, Taylor S, Kafadar K.

Fundamental Concepts in Statistics: Elucidation and Illustration.

J of

Applied Physiology

1998;

85(3):

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786.

Kendall G M, M P Little, R Wakeford, K J Bunch, J C H Miles, T J Vincent, J R Meara and M F G

rphy (2012) A record

based case

–

control study of natural background radiation and the incidence

of childhood leukaemia and other cancers in Great Britain during 1980

–

2006. Leukemia

June

2012) | doi:10.1038/leu.2012.151

Leuraud, Klervi et al (2015) Ionis

ing radiation and risk of death from leukaemia and lymphoma in

radiation

monitored workers (INWORKS): an international cohort study. The Lancet Haematology

Published Online: 21 June 2015.

Little MP

Wakeford R

Tawn EJ

Bouffler SD

Berrington de Gonzalez A

. Risks associated with low

doses and low dose rates of ionizing radiation: why linearity may be (almost) the best we can do.

Radiology.

2009 Apr;251(1):6

12. doi: 10.1148/radiol.2511081686.

Muirhead et al (2009) Mortality and cancer incidence following occupational radiation exposure: third

analysis of the National Registry for Radiation Workers. Br J Cancer 2009;

100: 206

212.

Pearce et al

(2012)

Radiation exposure from CT

scans in childhood and subsequent risk of eukaemia

and brain tumours: a retrospective cohort study. The Lancet. June 7, 2012.

380

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505.

DOI:10.1016/S0140

6736(12)60815

http://press.thelancet.com/ctscanrad.pdf

Puskin J (2009) Dose

Response Vol 7:284

–

291.

Perspective On The Use Of LNT For Radiation

Protection And Risk Assessment by the U.S. E

nvironmental Protection Agency.

Siegel JA et al

(2015)

Comment on “Background Ionizing Radiation and the Risk of Childhood

Cancer: A Census

Based Nationwide Cohort Study”

Environ Health Perspect

;

OI:10.1289/ehp.1510111

Spycher BD,

Martin Röösli,

Matthias Egger and Claudia E. Kuehni (2015)

Response to

“Comment on

‘Background Ionizing Radiation and the Risk of Childhood Cancer: A Census

Based Nationwide

Cohort Study’.

Environ Health Perspect

; DOI:10.1289/ehp.1510111R

Sterne JAC, Smith GD.

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–

what’s wrong with significance tests?

Phys

Ther (

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81(8):

1464

1469.

United Nations Scientific Committee on the E

ffects of Atomic Radiation (2008

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Annex B, § 153.

Whitley E, Ball J.

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Online 8 November 2012.

Appendix: Views of

Petitioners

On February 9, 2015, Dr. Carol S. Marcus, a Professor of Radiation Oncology, of Molecular and

Medical Pharmacology (Nuclear Medicine), and of Radiological Sciences at the Da

vid

Geffen School

of Medicine at the University of California

Los Angeles, filed a petition for rulemaking with the

Commission, PRM

28 (ADAMS Accession No. ML15051A503). Dr. Marcus was a member of the

NRC’s Advisory Committee on the Medical Uses of Isot

opes from 1990 to 1994. The petitioner

indicated that “[t]here has never been scientifically valid support for this LNT hypothesis since its use

was recommended by the U.S. National Academy of Sciences Committee on Biological Effects of

Atomic Radiation (B

EAR I)/Genetics Panel in 1956” and that “[t]he costs of complying with these LNT

based regulations are enormous.”

On February 13, 2015, Mr. Mark L. Miller, a Certified Health Physicist, filed a petition for rulemaking

with the Commission, PRM

29 (ADAMS

Accession No. ML15057A349). The petitioner indicated

that “[t]here has never been scientifically valid support for this LNT hypothesis” and that “[t]he costs of

complying with these LNT

based regulations are incalculable.” In addition, the petitioner sugge

sts that

the use of the LNT hypothesis has “led to persistent radiophobia [radiation

phobia].”

On February 24, 2015, Dr. Mohan Doss, filed a petition for rulemaking with the Commission, PRM

30 (ADAMS Accession No. ML15075A200). Dr. Doss filed this petit

ion on behalf of Scientist for

Accurate Radiation Information, whose mission is to “help prevent unnecessary, radiation

phobia

related deaths, morbidity, and injuries associated with distrust of radio

medical diagnostics/therapies

and from nuclear/radiolog

ical emergencies through countering phobia

promoting misinformation

spread by alarmists via the news and other media including journal publications

Source: http://nukeprofessional.blogspot.com/2015/08/the-current-pretty-safe-rule-on.html

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Smart Meter Cover - Reduces Smart Meter radiation by 96%! (See Video).

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