risk assessment due to environmental exposure to fibrous particulates in taconite ore richard wilson...
TRANSCRIPT
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Risk Assessment due to Risk Assessment due to Environmental Exposure to Environmental Exposure to
Fibrous Particulates in Fibrous Particulates in Taconite OreTaconite Ore
Richard WilsonRichard WilsonHarvard UniversityHarvard University
Cambridge, MassachusettsCambridge, Massachusetts
RP Nolan & CW AxtenRP Nolan & CW AxtenEnvironmental Sciences LaboratoryEnvironmental Sciences Laboratory
Brooklyn College of The City University of New YorkBrooklyn College of The City University of New YorkBrooklyn, NYBrooklyn, NY
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Problems with Risk Assessment
Direct data at present levels impossible to attain.
Historical cohorts had risk ratio ≈ 5
Present estimated risk ratio ≈ 1.002
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If Risk Ratio < 2 in epidemiology studies are not believed,
unless same material gives higher Risk Ratio with a higher dose.
Then RR ~ 1.3 is often believed (air pollution;
second hand cigarette smoke;Childhood leukemia's caused by in utero X ray)
But RR < 1.05 would NOT be believed
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Origin of the Origin of the ProblemProblem
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Map of N. E. MinnesotaMap of N. E. Minnesota
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Disposal of Taconite Tailings in Disposal of Taconite Tailings in Lake SuperiorLake Superior
67,000 tons in 67,000 tons in 700 million gallons of water 700 million gallons of water
each dayeach day
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15,000 - 20,000 lb/hour of 15,000 - 20,000 lb/hour of Particulate MatterParticulate Matter
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Initial ConcernInitial ConcernEcological Ecological
ImpactImpact
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Fiber Size Distribution for Duluth
Drinking Water SamplesMean Length 1.98µmRange 5-10µm 6.3%
≥ 10µm 0.8%Mean Width0.3µm
Cook et al. 1976
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June 8, 1973June 8, 1973Grunerite Fibers in Drinking WaterGrunerite Fibers in Drinking Water
leads to a leads to a
Potential for Asbestos-Related GI Potential for Asbestos-Related GI CancerCancer
Exposure to Asbestos among Exposure to Asbestos among
insulation workers have increased insulation workers have increased risk of GI Cancerrisk of GI Cancer
(Dr Gamble’s presentation puts this (Dr Gamble’s presentation puts this to rest)to rest)
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Talc -Treated rice might be Talc -Treated rice might be etiological in Stomach Canceretiological in Stomach Cancer
Mesliss 1971Mesliss 1971
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Japanese have higher Japanese have higher stomach cancer incidencestomach cancer incidence
Etiological-Etiological-Amphibole Asbestos in Talc ?Amphibole Asbestos in Talc ?
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Public Health Cancer (1970)Public Health Cancer (1970)Latency Period for Asbestos-Related Latency Period for Asbestos-Related
DiseaseDisease
may lead to an unnoticed build-up may lead to an unnoticed build-up of the carcinogen in the of the carcinogen in the
EnvironmentEnvironment
This has not happenedThis has not happened
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Dr. Arnold Brown, the Principal Court-appointed expert opined:
“…that no adverse health consequencescould be scientifically predicted on thebasis of existing medical knowledge.”
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If the distribution of If the distribution of fiber type, size and shape fiber type, size and shape
is identical in the is identical in the occupational occupational
epidemiological studies epidemiological studies and in the environmental and in the environmental
samples of interest, samples of interest, extrapolation to low extrapolation to low
doses is comparatively doses is comparatively simple simple
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The Length and Diameters of the Taconite fibersare not
Consistent with the Population ofRespirable Amphibole Asbestos
Used in experimental animal studies
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Question that should be answerable
What is the concentration at the place of interest?
What is the carcinogenic potency ( at high concentrations)
For the taconite fibers? (or other postulated agent?)
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Question that are hard to answer
Are some asbestos fibers worse or better then others?
What is the relative potency of a cleavage fragment?
How does one extrapolate to low doses?
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What indirect data can be used?
Animal Data
In Vitro Data
Surface Chemistry
Biopersistence in Target Tissue (including such issues as splitting)
DNA Tests
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Our subject is Interdisciplinary“Definitions are important”
If it moves – it is Biology
If it stinks – it is Chemistry
If it Doesn’t work – it is Physics
If it sends you to sleep – it is Statistics
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Pathogenicity of Long Vs. Short Pathogenicity of Long Vs. Short Fibers Fibers
Samples of Amosite Asbestos in Rats Samples of Amosite Asbestos in Rats
Davis et al. Br. J. Exp. Path (1986)Davis et al. Br. J. Exp. Path (1986)
(see also Dr. McConnell’s discussion (see also Dr. McConnell’s discussion for ingestion in animals)for ingestion in animals)
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12 Months of Inhalation ExposureLong: Widespread Pulmonary FibrosisShort: No Fibrosis
Tumor Type
Lung Cancer
Mesothelioma
PleuralPeritoneal
Amosite
Long
27%
Short
0%
Controls
1.7%
5%2.5%
0%2.4%
0%0%
Experimental Animal Study
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Experimental Animal Study
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Size Distribution Short and Long Amosite
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Concentration at Site No 7(Oct-Dec 1998)(Nearest to community)
By TEM
178 liters measured19 taconite fibers > 5µm61 taconite fibers total
Mean Concentration
0.00034 f/mL Total0.00011 f/mL > 5µm± 0.00003
Lower end of Axten’s list
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This concentration is small andThis concentration is small and I could stop here.I could stop here.
But I will underline the issue.But I will underline the issue.
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Risk Coefficients. (K)(Continuous Exposure)
Effect = K x CWhere C is in (f/mL) – yrs
Which is the concentration in f/ml for an 80 yrs exposure
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Low Dose Behavior
Slope in Measurable Range depends on internal or external control.
Evidence for Non- Linearity depends using external control for lowest point (Limited).
Problem comparing asbestos workers & rest of population (different smoking habits)
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Low Dose Linearity
Lash et al. allow the intercept ( ratio of internal to external control) to vary & find linearity fits.
Hodgson does not allow intercept to vary and finds non-linearity (also Brown & others earlier)
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Risk coefficient Kml/f-yr
OSHA
NAS MS
NAS MNS
IRIS
LASH
CAMUS(Chrysotile)
HODGSON(Amphibole Asbestos)
0.01
0.0022
0.001
0.0033
0.0026
0.0003
0.0025
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Site No 7 / Risk (Lifetime)
OSHA 7.5 x 10-5
IRIS 2.5 x 10-5
NAS (smoker) 1.8 x 10-5
NAS (non smoker) 0.8 x 10-5
LASH 2.3 x 10-5
CAMUS 3 x 10-6
HODGSON 0.23 x 10-5
Lower if non-linear at low concentrations
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Mereweather (1938) asked:
Is it asbestos Itself that Causes Lung Cancer
Or
Is it the Asbestosis that is the Proximate Cause?
(cf. Benzene – Pancytopenia; Arsenic – Dyspigmentation or keratosis)
Still not definitely answered (Dr Kane yesterday).
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Julian Peto raised the linearity issue in 1988
Richard Doll accepted it (even in Sept. 2002)
General argument by Guess, Crump, Peto (Richard)
If medical outcome is indistinguishable from a naturally occurring outcome (& the asbestos acts at one stage in the process similarly to natural agents) then Taylor’s theorem says there is low (incremental) dose linearity
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Effect Incremental Effect
slopeassuming linearity
Conc.
NaturalEffect
datum
IncrementalConc.
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Why not do a DNA matching analysis on:
Asbestos Lung CancerNatural Lung Cancer
Smoking Lung Cancer
Are they really indistinguishable?
(cf. Janet Rowley compared DNA of AML
naturally occurring and as a consequence of radiotherapy)
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US EPA (simplified)
1980: tried to regulate risks of 1 in 1,000,000 perlifetime calculated pessimistically.
This can not be done consistently. Attempts areinherently arbitrary and capricious.
1990: EPA back off to 1 in 10,000 per lifetime.
2000: Spend $ 5.1 million to avoid a “statistical death” (arsenic rule).
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Other Lifetime Risks > 10-4
Smoking 0.3
Obesity ≈ 0.3
Car accidents ~ 0.02
Particulate Air Pollution ~ 0.01
Nuclear War ~ 0.01
Worst case Natural Outcroppings of Cleavage Fragments ~ 0.0001 ~ 10-4