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Gradient CORPORATION
Corrales Environmental Air Quality Health
EvaluationPrepared for New Mexico Environment Department
By Chris Long, ScD; Mara Seeley, Ph.D., DABT; Peter Valberg, Ph.D.
Presented byMara Seeley, Ph.D., DABT
Senior ToxicologistGradient Corporation
April 1, 2004
Gradient CORPORATION
Purpose of Health Evaluation Determine whether chemicals in
outdoor air in the vicinity of Corrales, New Mexico are likely to cause adverse health effects
Gradient CORPORATION
Overview of Health Evaluation Comprehensive analysis
Evaluated 81 chemicals Monitoring data – for both ambient chemicals and
chemicals in Intel emissions Modeling data – for chemicals in Intel emissions
Maximum air concentrations compared to health-protective toxicity criteria (i.e. air concentrations at which adverse health effects are unlikely to occur)
Both monitored and modeled maximum air concentrations are below health-protective toxicity criteria
Gradient CORPORATION
Outline Background on Toxicology and Risk
Assessment Corrales Environmental Air Quality Health
Evaluation Chemicals of Concern Air Concentrations Acute (Short-term) Exposures Chronic (Long-term) Exposures Chemical Interactions Uncertainties
Toxicology Guiding Principle:
The dose makes the poison
“All substances are poisons: there is none which is not a poison. The right dose differentiates a
poison from a remedy.”Paracelsus (1493-1541)
Gradient CORPORATION
The Dose Response Relationship
The larger the dose, the greater the effect
Gradient CORPORATION
The Dose Response Relationship (cont.)
100
00
Liv
er
Eff
ects
Dose
Lowest Observed Adverse Effect Level (LOAEL)
No Observed Adverse Effect Level (NOAEL)
Example: Aspirin
Therapeutic Effect Level
Risk Assessment
Determine whether a specified level of exposure to a chemical may cause adverse health effects
Gradient CORPORATION
Identify potential toxic effects
The Four Components of Risk Assessment
Hazard Identification
How much of each chemical causes what effects?
Identify levels of concern
Identify chemicals of concern
Who is exposed and how?
Estimate exposure level
Compare exposure levels with levels of concern
Dose-Response
ExposureAssessment
RiskCharacterization
Gradient CORPORATION
Hazard Identification – Typical Health Endpoints Cancer
Any site Non-cancer effects:
Nervous system Development of offspring Reproduction Respiratory system Immune system Specific organs
Gradient CORPORATION
The Reference Concentration (RfC)
Concentration of a chemical in air at which adverse health effects are not likely to occur in humans, including susceptible individuals
RfC =NOAEL or LOAEL
Uncertainty Factors
Gradient CORPORATION
No-Observed Adverse Effect
Level
Lowest-Observed Adverse Effect
Level
Dealing with Uncertainty Make health-protective assumptions about
toxicity Reduce allowable exposure by factors of 10 to
account for: Inter-species variation (animal human) Intra-species variation (human human) Use of lowest-observed adverse effect level
(LOAEL) instead of no-observed adverse effect level (NOAEL)
Can result in a reference concentration (RfC) 10 – 1,000-fold lower than the NOAEL
Gradient CORPORATION
Evaluation of Non-Cancer Inhalation Hazards
Calculate a hazard quotient
Gradient CORPORATION
If hazard quotient 1, then adverse health effects not likely
Hazard Quotient =
Exposure Concentration
Reference Concentration (RfC)
Evaluation of Inhalation Cancer Risks
Gradient CORPORATION
Excess Lifetime Cancer Risk = EC x UR
Exposure Concentration
Unit Risk = Cancer risk per unit concentration of chemical
in air
Acceptable Target Range for Excess Risk: < 1 in a million to 1 in 10,000
Background Lifetime Cancer Risk in General Population: 1 in 3
Effects of Combined Exposures Independence
2 + 3 = 3 Additivity
2 + 3 = 5 Synergism
2 + 3 = 15 e.g., lung cancer due to smoking and asbestos
Potentiation 0 + 3 = 6 e.g., isopropyl alcohol and carbon tetrachloride
Antagonism 2 + 3 = 1 e.g., ethanol and ethylene glycol
Gradient CORPORATION
Gradient CORPORATION
Key Elements of Corrales Health Evaluation Identify chemicals of concern based on
available air monitoring and modeling data
Estimate air exposure concentrations based on available air monitoring and modeling data
Identify reference concentrations (RfCs) for chemicals of concern
Evaluate potential for adverse health outcomes based on estimated exposure concentrations and toxicity
Fugitive Dust
ExposureSources
ExposureEnvironments
Effects
Industrymodeling data
Agriculture
Heating & Combustion
Traffic
Ambient(Outdoor) AirMonitoring data
PotentialHealth
Response
Indoor Airat Home
School/WorkplaceIndoor Air
Hobbies, Pets,and Lifestyle
Activities
PersonalExposure Air
Gradient CORPORATION
Identify Chemicals of Concern Air Monitoring Data (NMED, TRC-Intel)
Short-term ambient air concentrations Chemicals frequently detected:
Common criteria pollutants (e.g., carbon monoxide, nitrogen dioxide, ozone), ammonia, methanol, tetrafluoromethane, hexafluoroethane
Air Modeling Data (Desert Research Institute) Short-term and chronic exposure concentrations Chemicals present in Intel emissions:
Isopropyl alcohol (rubbing alcohol), methanol, hydrogen fluoride, hexafluoroethane, hydrogen chloride, propylene glycol monoethyl ether acetate (PGMEA)
Gradient CORPORATION
Identify Chemicals of Concern (cont.)
Included: All positively identified chemicals detected at least
once in 1-hour and 24-hour canister samples Both frequently and occasionally detected chemicals
from OP-FTIR sampling All chemicals, including tentatively identified
chemicals, detected in 15-second citizen canister samples
Chemicals present in Intel emissions
Did not include: Tentatively identified chemicals detected only once in
1-hour and 24-hour canister samples (consistent with USEPA guidance)
Summary of Chemicals of Concern (COCs) in the Risk EvaluationAcetaldehyde Chloroform Hydrogen chloride Phosphine
Acetone Chloromethane Hydrogen cyanide Propane
Acetylene Total Cresols Hydrogen fluoride 2-Propanol (isopropyl alcohol)
Acrylonitrile Cyclohexanone Methanol Propionaldehyde
Ammonia Decanal 2-Methyl Butane Propylyene glycol monomethyl ether acetate
Ammonium chloride 1,2-Dichloroethene Methyl methacrylate Silicon tetrahydride
Arsine Dicholorodifluoromethane (Freon 12) Methyl n-amyl ketone Styrene
Benzaldehyde 1,1-Difluoroethane Methylene Chloride Sulfur dioxide
Benzene Ethanol 2-Methylpentane Sulfur hexafluoride
Bromoform Ethyl silicate 2-Methylpropane (isobutane) Sulfuric acid
Butane 3-Ethyl-2,2-dimethylpentane Nitric acid Tetrachloroethene
2-Butanone Ethylbenzene Nitric oxide 1,1,1,2 Tetrafluoroethane
n-Butyl acetate Ethylcyclobutane Nitrogen dioxide Tetrafluoromethane
n-Butyl alcohol Ethylene Nitrogen trifluoride Toluene
n-Butyraldehyde Ethylene glycol Nitrous oxide Trichlorofluoromethane (Freon 11)
Carbon Monoxide Formaldehyde Nonanal 1,2,4-Trimethylbenzene
Carbon Tetrachloride Heptanal Octafluorocyclobutane 3,6,6-Trimethylbicyclo 3.1.1 hetp-2-ene
Carbonyl fluoride Hexafluoroethane Octanal Undecane
Carbonyl Sulfide Hexanal Ozone Total Xylenes
Chlorine n-Hexane Pentane
Chlorodifluoromethane Hydrogen bromide Phosgene
Gradient CORPORATION
Estimate Air Exposure Concentrations
Short-term Exposures Assume individuals present at all times and locations
coinciding with short-term peak air concentrations (monitored or modeled)
Use maximum 1-hour data wherever possible Chronic Exposures
Assume individuals present at all times and locations coinciding with maximum modeled air concentrations
24 hours/day 350 days/year 30 years
Gradient CORPORATION
Reference Concentrations (RfCs) for Evaluating Short-term Inhalation Hazards
1-hour exposure period Non-cancer and cancer effects Protective of susceptible
populations (e.g., infants, the elderly)
Level 1 – lowest, most protective values
Group 1 (most preferred)
ERPG-1(Emergency Response Planning
Guidelines) American Industrial Hygiene
Association
AEGL-1 (Acute Exposure Guideline
Level) National Academy of
Sciences
Gradient CORPORATION
Reference Concentrations (RfCs) for Evaluating Short-term Inhalation Hazards (cont.)
Non-cancer effects Protective of sensitive
subgroups
Group 2
Acute Inhalation MRL
(Minimal Risk Level) Agency for Toxic
Substances and Disease Registry
1-14 day exposure period
Acute REL (Reference
Exposure Level) California EPA Office of
Environmental Health Hazard Assessment
1 – several hours, intermittent exposure
Gradient CORPORATION
Reference Concentrations (RfCs) for Evaluating Short-term Inhalation Hazards (cont.)
Group 3 TEEL-0 (Temporary Emergency Exposure Limit)
U.S. Department of Energy 15 minute exposure
Group 4 (when other sources not available) Short-term ESL (Effects Screening Level)
Texas Commission on Environmental Quality 1-hour exposure Adverse health effects, odor, environmental,
corrosion Gradient-derived values
Based on acute toxicity criteria for structurally similar compounds
Gradient CORPORATION
Evaluate Potential for Acute Health Effects
Acute hazard quotients for individual chemicals summed for total acute hazard index
Assumes exposures to maximum air concentrations occurred simultaneously and at the same location
If acute hazard index 1, then adverse effects not expected If hazard index > 1, there may be concern for potential
health effects
RfCacute
CacuteHQacute
Acute hazard quotient (unitless)
Acute (i.e., 1-hour maximum) air concentration
Acute reference concentration
Gradient CORPORATION
0
0.2
0.4
0.6
0.8
1
NMED OP-FTIR
Max. 1-Hour
Average Conc.
NMED 15-sCitizen
CanisterMeasurements
NMEDMaximum 1-hour and
24-hourCanister
Measurements
NMEDMaximum
1-hourAverageModelingResults
Sampling Datasets
Ove
rall
Su
mm
ed H
I
Summary of Hazard Indices – Sampling Locations Outside Intel Property
Ove
rall
Su
mm
ed H
I
Sampling Datasets Modeling Data
0.00
0.05
0.10
0.15
0.20
0.25
0.30
0.35
0.40
Benzaldehyde Nitric Acid Ozone
Compound
Haz
ard
Quo
tien
t (H
Q) f
or
Max
imum
1-H
our
Exp
osur
e
Summary of Hazard Indices – TRC-Intel Property Line Data
Haz
ard
Qu
otie
nt
(HQ
) fo
rM
axim
um
1-H
our
Exp
osu
re
0.00
0.05
0.10
0.15
0.20
0.25
0.30
0.35
0.40
0.45
0.50
Benzaldehyde Nitrogen Dioxide Ozone 2-Propanol(isopropyl alcohol)
Propylene glycolmonomethyl ether
acetate
Compound
TRC 8/1 – 8/9/03 NW-S Intel Property Line TRC 8/12 – 8/21/03 NW-E Intel Property Line
Haz
ard
Qu
otie
nt
(HQ
) fo
rM
axim
um
1-H
our
Exp
osu
re
TRC 8/21 – 9/7/03 SE Intel Property Line
Haz
ard
Qu
otie
nt
(HQ
) fo
rM
axim
um
1-H
our
Exp
osu
re
00.05
0.10.15
0.2
0.250.3
0.350.4
0.45
Nitric Oxide Nitrogen Dioxide Ozone
Compound
Haz
ard
Quo
tien
t (H
Q) f
orM
axim
um 1
-Hou
r E
xpos
ure
Gradient CORPORATION
Criteria for Evaluating Chronic Inhalation Hazards Reference Concentrations (RfCs) – for
non-cancer hazards USEPA values Derive from inhalation or oral reference
dose (RfD) Inhalation Unit Risks (URs) – for
cancer risks USEPA values
Gradient CORPORATION
Evaluate Potential for Chronic Non-Cancer Health Effects
Chronic hazard quotients (CHQ) for individual chemicals summed for total hazard index for all chemicals
If chronic hazard index 1, then adverse effects not expected If hazard index > 1, there may be concern for potential health
effects
RfCchronic
CHQchronicchronic
Chronic hazard
quotient
Average annual air concentration
Chronic reference concentration
Gradient CORPORATION
Summary of Chronic Non-Cancer Health Hazards
Compound Hazard Quotient
Acetone 0.000 000 2
Ammonia 0.000 39
Chlorine 0.043
1,2-Dichloroethylene (mixed cis/trans) 0.000 005
Ethylene Glycol 0.000 000 11
Hydrogen chloride 0.000 005 5
Hydrogen cyanide 0.000 005 2
Methanol 0.000 000 61
Sulfuric Acid 0.000 004 5
Total Xylenes (mixed o,m,p) 0.000 000 43
Total Summed Hazard Index 0.043 411 55
Gradient CORPORATION
Evaluate Potential for Cancer Risks Cancer Risk = Air Exposure Concentration
x (Cancer Risk per Unit Concentration in Air)
Cancer risk for carbon tetrachloride:
= 8 in 10 billion
(in addition to background cancer risk of 0.33)
Gradient CORPORATION
Effects of Combined Exposures Synergistic effects are unlikely to
occur Our analysis assumed effects are
additive For concentrations at or below no-
observed adverse effect level, effects of combined exposure are usually either independent or additive
Gradient CORPORATION
Uncertainties in Health Evaluation Not Likely to Underestimate Health Effects Uncertainties in Data Collection and Analysis
Utilized limited monitoring data to maximum extent possible Monitoring data confirmed by modeling results
Included tentatively identified chemicals in health evaluation Exposure Assessment
Used maximum concentrations detected for monitoring data Used maximum predicted concentrations from modeling
results Toxicity Assessment
Uncertainty factors account for potential differences in sensitivity between animals-humans and humans-humans
Chronic reference concentrations (RfCs) not available for all chemicals evaluated for chronic exposure scenario
Maximum modeled annual average concentrations without chronic RfCs all well-below TCEQ long-term ESLs
Gradient CORPORATION
Conclusions Acute health effects are unlikely to
occur due to Intel emissions Acute hazard indexes for exposures
occurring simultaneously all < 1 Chronic health effects are unlikely to
occur due to Intel emissions Total chronic hazard index < 1 Cancer Risk = 8 in 10 billion (compared to
background cancer risk of 1 in 3)