PETITIONED PUBLIC HEALTH ASSESSMENT
BURLINGTON NORTHERN LIVINGSTON COMPLEX
(a/k/a BURLINGTON NORTHERN RAIL YARD)
LIVINGSTON, PARK COUNTY, MONTANA

Figure 1. Burlington Northern Rail Yard Site Location Map

Figure 2. Location of private and city wells

Figure 4. River sediment sampling locations

Figure 5. Ambient air monitoring sites

Figure 6. Burlington Northern Rail Yard
Table 3: On-site soil gas contaminants at BNRYc
| Substance | Maximum level detected in | Comparison Values | ||
| electric shop areas | drainline areas | Value | Source | |
| (ug/m3) | ||||
| cis-1,2-DCE | 36,000 | 100,000 | 800* (200 ppb) |
Intermediate EMEG |
| Chlorobenzene | NDd | 92,000 | NONE | |
| 2-chlorotoluene | ND | 4,500 | NONE | |
| TCE | 48,000 | 49,000 | 0.6 | CREG |
| PCE | 1,900,000 | 1,300,000 | 2 | CREG |
| 1,1,1-TCA | 650 | 920 | 4,000* (700 ppb) |
Intermediate EMEG |
* Conversion factor for air:
| Cug/m3 = Cppb |
X MWg/mole 24.45 |
| where C = Concentration MW = Molecular Weight |
|
Table 4: Off-site soil gas contaminants at BNRY
| Substance | Highest level detected | Reference | Comparison Value | Source |
| PCE | 14 ug/m3 | 16 | 2 ug/m3 | CREG |
| TCE | 9.6 ug/m3 | 16 | 0.6 ug/m3 | CREG |
Table 5: Mean levels of on-site airborne organic compounds
| Substance | Level detected |
Reference | Comparison Values | |
| Value | Source | |||
|
|
||||
| Acenaphthene | 0.0039 | 16 | NONE | |
| Acenaphthylene | 0.0033 | 16 | NONE | |
| Anthracene | 0.0034 | 16 | NONE | |
| Benzo (b) fluoranthene | 0.0037 | 16 | NONE | |
| Chrysene | 0.0032 | 16 | NONE | |
| Fluoranthene | 0.0052 | 16 | NONE | |
| Fluorene | 0.0076 | 16 | NONE | |
| Napthalene | 0.9 | 5 | 10* (2 ppb) |
Chronic EMEG |
| Phenanthrene | 0.67 | 5 | NONE | |
| PCE | 1.52 | 16 | 2 | CREG |
| Pyrene | 0.0044 | 16 | NONE | |
* Conversion factor for air:
| Cug/m3 = Cppb |
X MWg/mole 24.45 |
| where C = Concentration MW = Molecular Weight |
|
Table 6: Mean levels of off-site airborne organic compounds
| Substance | Level detected | Reference | Comparison values | |
| Value | Source | |||
| Off-site volatile organic compounds (in ug/m3) | ||||
| PCE | 1.47 - 1.55 |
|
2 | CREG |
| 4.7 - 10.2 (upwind of BNRY) |
16
|
|||
| 1.0 (downwind of BNRY) | ||||
Table 7: Mean levels of on-site airborne metals
| Metal | Upwind | Downwind | Reference | Comparison value | |
|
|
Value (ug/m3) | Source | |||
| Antimony | 0.021 | 0.020 | 16 | NONE | |
| Arsenic | 0.001 | 0.006 | 16 | 0.0002 | CREG |
| Barium | 0.010 | 0.015 | 16 | NONE | |
| Bromine | 0.003 | 0.013 | 16 | NONE | |
| Cadmium | 0.008 | 0.024 | 16 | 0.0006 | CREG |
| Chlorine | ND | 0.174 | 16 | NONE | |
| Copper | 0.004 | 0.004 | 16 | NONE | |
| Germanium | 0.001 | 0.001 | 16 | NONE | |
| Indium | 0.016 | 0.013 | 16 | NONE | |
| Iron | 0.406 | 0.161 | 16 | NONE | |
| Lanthanum | 0.188 | 0.086 | 16 | NONE | |
| Lead | 0.005 | 0.070 | 16 | NONE | |
| Molybdenum | 0.106 | 0.106 | 16 | NONE | |
| Palladium | 0.015 | 0.003 | 16 | NONE | |
| Rubidium | 0.003 | 0.004 | 16 | NONE | |
| Selenium | 0.001 | ND | 16 | NONE | |
| Silver | 0.010 | 0.004 | 16 | NONE | |
| Strontium | 0.014 | 0.013 | 16 | NONE | |
| Sulphur | 0.130 | 0.042 | 16 | NONE | |
| Tin | 0.018 | 0.022 | 16 | NONE | |
| Titanium | 0.050 | 0.046 | 16 | NONE | |
| Vanadium | 0.001 | 0.002 | 16 | NONE | |
| Yttrium | 0.003 | 0.002 | 16 | NONE | |
| Zinc | ND | 0.089 | 16 | NONE | |
| Zirconium | 0.018 | 0.017 | 16 | NONE | |
Table 8: On-site groundwater samples
| Substance | Highest levels detected | Reference | Comparison values | |
| Value | Source | |||
|
|
||||
| Volatile organic compounds (in parts per billion; ppb) |
||||
| Chloroform | 4.6 | 16 | 400 | Chronic EMEG (adult) |
| TCE | 200 | 8 | 5 | MCL |
| 1,1,1-TCA | 0.85 | 16 | 200 | LTHA / MCL |
| PCE | 2,200 | 9 | 5 | MCL |
| Ethylbenzene | 11 | 16 | 700 | LTHA / MCL |
| sec-butylbenzene | 5.5 | 16 | NONE | |
| Chlorobenzene | 3,000 | 9 | 100 | LTHA / MCL |
| Cis-1,2-DCE | 2,550 | 1 | 70 | LTHA / MCL |
| Trans-1,2-DCE | 31 | 1 | 100 | LTHA / MCL |
| 2-chlorotoluene | 190 | 16 | 100 | LTHA |
| 4-chlorotoluene | 6 | 9 | 100 | LTHA |
| 1,2-dibromo-3-chloropropane | 32 | 9 | 0.2 | MCL |
| 1,2-DCB | 88 | 16 | 600 | LTHA / MCL |
| 1,3-DCB | 16 | 16 | 600 | LTHA |
| 1,4-DCB | 220 | 9 | 75 | LTHA / MCL |
| Isopropylbenzene | 6.9 | 16 | NONE | |
| Xylenes | 36 | 8 | 7,000 | Intermediate EMEG (adult) |
| On-Site | ||||
| Semivolatile organic
compounds (in parts per billion; ppb) |
||||
| Naphthalene | 45 | 16 | 20 | LTHA |
| 1-methylnaphthalene | 250 | 8 | NONE | |
| 2-methylnaphthalene | 170 | 8 | NONE | |
| Dibenzofuran | 21 | 10 | NONE | |
| Fluorene | 12 | 10 | 1,000 | RMEG (adult) |
| Phenanthrene | 9 | 10 | NONE | |
| bis(2-ethylhexyl)-phthalate | 5,600 | 10 | 6 | MCL |
| Metals (in parts per billion; ppb) |
||||
| Arsenic | 7 | 1 | 10 | Chronic EMEG (adult) |
| Barium | 100 | 1 | 2,000 | RMEG (adult) |
| Cadmium | 4 | 1 | 20 | Chronic EMEG (adult) |
| Lead | 20 | 1 | 15 | MCL |
| Selenium | 6 | 1 | 70 | Chronic EMEG (adult) |
Table 9: Off-site groundwater samples
| Substance | Maximum levels detected | Reference | Comparison values | |
| Value | Source | |||
|
|
||||
| Volatile organic compounds (in parts per billion; ppb) |
||||
| TCE | 30 | 10 | 5 | MCL |
| PCE | 530 | 1 | 5 | MCL |
| Cis-1,2-DCE | 190 | 16 | 70 | LTHA / MCL |
| Trans-1,2-DCE | 26 | 10 | 100 | LTHA / MCL |
| Toluene | 2 | 9 | 200 | Intermediate EMEG (child) |
| Chlorobenzene | 13 | 16 | 100 | LTHA / MCL |
| Metals (in parts per billion; ppb) |
||||
| Arsenic | 5 | 16 | 3 | Chronic EMEG (child) |
| Barium | 100 | 1 | 700 | RMEG (child) |
| Cadmium | 4 | 16 | 7 | Chronic EMEG (child) |
| Lead | 20 | 1 | 15 | MCL |
Table 10: Stream sediment and gravel from the Yellowstone
River: March 7 and March 21, 1990e
| Substance | Level detected | Comparison Values | ||
| River gravel | River sediment | Value | Source | |
| Organic compounds (ppm) |
||||
| 2-Chlorotoluene | 21 | BDLf | 1,000 | RMEG (child) |
| m+p-xylene | .018 | BDL | NONE | |
| o-xylene | .014 | BDL | NONE | |
| TPHs | 325 | 425 | NONE | |
| Toluene | BDL | .022 | 1,000 | Intermediate EMEG (child) |
| Metals (ppm) |
||||
| Arsenic | BDL | 13 | 20 | Chronic EMEG (child) |
| Barium | BDL | 130 | 4,000 | RMEG (child) |
| Chromium | BDL | 16 | 300 | RMEG (child) |
| Lead | BDL | 6 | NONE | |
Table 11: VOCs and Metals in private water well samplesg
| Substance | Level detected | Comparison Values | |
| Value | Source | ||
| VOCs (ug/L) | |||
| Chloroform | 1.2h | 100 | Chronic EMEG (child) |
| PCE | 96 | 5 | MCL |
| TCE | 15 | 5 | MCL |
| cis-1,2-DCE | 99 | 70 | LTHA / MCL |
| Chlorobenzene | 3.5 | 100 | LTHA / MCL |
|
Metals (ug/L) |
|||
| Arsenic | 15 | 3 | Chronic EMEG (child) |
Table 12: Indoor air sampling results
| Sampling Dates | August 1989 | October 1989 |
November 1990 | February, March 1992 |
January, February 1993 |
Comparison value | |
| References | (16) | (16) | (16) | (16) | (16) | Value | Source |
| Concentrations in ug/m3 | |||||||
| cis-1,2-DCE | NAi | NA | BDL | 0.22-0.63 | NA | 800* (200 ppb) |
Intermediate EMEG |
| trans-1,2-DCE | NA | 6 | BDL | 0.22 - 0.39 | NA | 800* (200 ppb) |
Intermediate EMEG |
| Ethylbenzene | NA | NA | 50 Basement | NA | NA | 1,000* (300 ppb) |
Intermediate EMEG |
| PCE | BDLj | BDL | BDL | 0.56-27.9 Upstairs | 4.5 - 19 | 2 | CREG |
| 0.58-82.1 Basement | |||||||
| 1,1,1-TCA | 6,000 -18,000 | 1 - 3 | NA | NA | NA | 4,000* (700 ppb) |
Intermediate EMEG |
| TCE | BDL | BDL | 73 - 567 Basement | 0.09-3.33 Upstairs | NA | 0.6 | CREG |
| 0.075-2.71 Basement | |||||||
| Toluene | 8,000-45,000 | BDL | BDL | NA | NA | 4,000* (1000 ppb) |
Chronic EMEG |
| Xylene | NA | NA | 139 Basement | NA | NA | 200* (50 ppb) |
Acute EMEG |
| Vinyl chloride | NA | NA | NA | 0.64 - 0.8 | NA | EPA Cancer Class: A |
|
* Conversion factor for air:
| Cug/m3 = Cppb |
X MWg/mole 24.45 where |
Table 13: Levels of VOCs, SVOCs, and total metals detected in on-site surficial soil: April and May 1992k
| Substance | Range (ppm) |
Comparison value | Exceed health guideline? |
|
|
|
Value (ppm) | Source | ||
| PCE | 0.0052 - 0.018 | 7,000 | RMEG (adult) | NO |
| Methylene chloride | 0.0105 - 1.5 | 40,000 | Chronic EMEG (adult) | NO |
| TCE | 0.0066 - 0.039 | 1,000 | Intermediate EMEG (adult) | NO |
| Chloromethane | 0.034 | NONE | NONE EXISTS | |
|
Semi-Volatile Organic Compounds (SVOCs) |
||||
| Fluoranthene | 0.42 - 27 | 30,000 | RMEG (adult) | NO |
| Pyrene | 0.44 - 27 | 20,000 | RMEG (adult) | NO |
| Benzo(b)fluoranthene | 0.48 - 29 | NONE | NONE EXISTS | |
| Phenanthrene | 0.66 - 3.6 | NONE | NONE EXISTS | |
| Chrysene | 0.66 - 3.3 | NONE | NONE EXISTS | |
| Benzo(a)anthracene | 0.69 - 2.7 | NONE | NONE EXISTS | |
| Benzo(a)pyrene | 0.71 - 2.3 | 0.1 | CREG | YES |
| Indeno(1,2,3-cd) pyrene | 0.48 - 1.5 | NONE | NONE EXISTS | |
| Benzo(ghi)perylene | 0.48 - 1.7 | NONE | NONE EXISTS | |
| Naphthalene | 0.70 - 1.0 | NONE | NONE EXISTS | |
| Anthracene | 0.34 | 200,000 | RMEG (adult) | NO |
| Dibenzo(a,h)anthracene | 0.77 | NONE | NONE EXISTS | |
|
|
||||
| Arsenic | 5 - 29 | 200 | Chronic EMEG (adult) | NO |
| Barium | 72 - 890 | 50,000 | RMEG (adult) | NO |
| Cadmium | 1 - 4 | 500 | Chronic EMEG (adult) | NO |
| Chromium | 4 - 220 | 4,000 | RMEG (adult) | NO |
| Lead | 18 - 1,250 | NONE | NONE EXISTS | |
| Selenium | 8 | 1,000 | Chronic EMEG (adult) | NO |
| Silver | 7 | 4,000 | RMEG (adult) | NO |
Table 14: Levels of VOCs, SVOCs, Pesticides, and total
metals detected in off-site surficial soil: April and May 1992
m
| Substance | Range (ppm) |
Comparison value | Exceed health guideline? |
|
| Volatile Organic Compounds (VOCs) | Value (ppm) | Source | ||
| PCE | 0.0098 - 0.0243 | 500 | RMEG (child) | NO |
| Methylene chloride | 0.0052 - 0.0105 | 3,000 | Chronic EMEG (child) | NO |
|
|
||||
| Pyrene | 4.2 | 2,000 | RMEG (child) | NO |
| Phenanthrene | 4 | NONE | NONE EXISTS | |
| Chrysene | 9.6 | NONE | NONE EXISTS | |
|
|
||||
| 4,4'-DDE | 0.011 | 2 | CREG | NO |
| 4,4'-DDT | 0.0074 - 0.018 | 2 | CREG | NO |
|
|
||||
| Arsenic | 6 - 11 | 20 | Chronic EMEG (child) | NO |
| Barium | 82 - 280 | 4,000 | RMEG (child) | NO |
| Chromium | 6 - 19 | 300 | RMEG (child) | NO |
| Lead | 28 - 100 | NONE | NONE EXISTS | |
Table 15: Yellowstone River water samples: September
20, 1989, and March 23, 1990.
| Substance | Level detected | Reference | Comparison value | |
| Value (ppb) | Source | |||
| TPHs (ppm) | 0.1 - 1.9 | 16 | NONE | |
| Organic compounds (ppb) |
||||
| PCE | 0.91 | 16 | 5 | MCL |
| 2-Chlorotoluene | 0.98 | 16 | 100 | LTHA |
| Metals (ppb) |
||||
| Arsenic | 14 - 28 | 16 | 50 | MCL |
| Cadmium | 2 | 16 | 5 | LTHA / MCL |
Table 16: On-site subsurface soil contaminants at BNRY
| Substance | Maximum Level Detected |
Reference | Comparison Values | |
| Value | Source | |||
|
|
||||
|
(in mg/kg) |
||||
| TCE | 1800 | 16 | 1,000 | Intermediate EMEG (adult) |
| cis-1,2-DCE | 710 | 16 | 200,000 | Intermediate EMEG (adult) |
| 1,2,4-trimethylbenzene | 2 | 16 | NONE | |
| n-propylbenzene | 1.5 | 16 | NONE | |
| sec-butylbenzene | 1.5 | 16 | NONE | |
| n-butylbenzene | 1.9 | 16 | NONE | |
| Isopropylbenzene | 0.49 | 16 | NONE | |
| 1,1-Dichloroethene | 30 | 16 | 6,000 | Chronic EMEG (adult) |
| PCE | 420 | 16 | 7,000 | RMEG (adult) |
| Vinyl Chloride | 11 | 16 | 10 | Chronic EMEG (adult) |
|
(in mg/kg) |
||||
| Naphthalene | 11 | 16 | NONE | |
| Fluorene | 17 | 16 | 30,000 | RMEG (adult) |
| Fluoranthene | 12 | 16 | 30,000 | RMEG (adult) |
| Benzo(b)fluoranthene | 9.6 | 16 | NONE | |
| 1,4-dichlorobenzene | 220 | 16 | NONE | |
| 1,2-dichlorobenzene | 1100 | 16 | 60,000 | RMEG (adult) |
| Chrysene | 5.5 | 16 | NONE | |
| Benzo(a)anthracene | 4.3 | 16 | NONE | |
| Benzo(a)pyrene | 3.3 | 16 | 0.1 | CREG |
| 1,3-dichlorobenzene | 120 | 16 | NONE | |
| Benzo(k)fluoranthene | 1.1 | 16 | NONE | |
|
(in mg/kg) |
||||
| Arsenic | 48 | 16 | 200 | Chronic EMEG (adult) |
| Barium | 450 | 16 | 50,000 | RMEG (adult) |
| Cadmium | 10.2 | 16 | 500 | Chronic EMEG (adult) |
| Chromium | 120 | 16 | 4,000 | RMEG (adult) |
| Lead | 790 | 16 | NONE | |
| Mercury | 0.51 | 16 | NONE | |
| Selenium | 43 | 16 | 1,000 | Chronic EMEG (adult) |
| PCB-1248 | 154 | 16 | 10 | Chronic EMEG (adult) |
a. One micron is equal to one-millionth of a meter or 0.000001 meter.
b. Contour plots are lines that run through sample collection points that show similar concentrations.
c. All values from reference (16).
d. ND = not detected.
e. All values from reference (16).
f. BDL = below detection limit.
g. All values from reference (16).
h. Detected at the same concentration in duplicate samples.
i. Not analyzed.
j. Below Detection Limit.
k. All values from reference (16).
l. All values from reference (16).
m. All values from reference (16).
APPENDIX C - COMPARISON VALUES
Comparison Values
ATSDR comparison values are media-specific concentrations that are considered to be safe under default conditions of exposure. They are used as screening values in the preliminary identification of site-specific "contaminants of concern". The latter term may be misinterpreted as an implication of "hazard". As ATSDR interprets the phrase, a "contaminant of concern" is merely a site-specific chemical substance that the health assessor has selected for further evaluation of potential health effects. Generally, a chemical is selected as a contaminant of concern because its maximum concentration in air, water, or soil at the site exceeds one of ATSDR's comparison values.
However, it must be emphasized that comparison values are not thresholds of toxicity. While concentrations at or below the relevant comparison value may reasonably be considered safe, it does not automatically follow that any environmental concentration that exceeds a comparison value would be expected to produce adverse health effects. The purpose behind highly conservative, health-based standards and guidelines is to enable health professionals to recognize and resolve potential public health problems before they become actual health hazards. The probability that adverse health outcomes will actually occur depends on site-specific conditions and individual lifestyle and genetic factors that affect the route and duration of actual exposure, and not on environmental concentrations alone.
Listed and described below are the various comparison values that ATSDR uses to select chemicals for further evaluation, along with the abbreviations for the most common units of measure.
| CREG | = Cancer Risk Evaluation Guides |
| MRL | = Minimal Risk Level |
| EMEG | = Environmental Media Evaluation Guides |
| IEMEG | = Intermediate Environmental Media Evaluation Guides |
| RMEG | = Reference Dose Media Evaluation Guide |
| RfD | = Reference Dose |
| RfD-C | = Reference Dose Concentration |
| EPA III | = EPA Region III |
| DWEL | = Drinking Water Equivalent Level |
| LTHA | = Drinking Water Lifetime Health Advisory |
| MCL | = Maximum Contaminant Level |
| PRG | = Permissible Remediation Goal (Action Level) |
| PEL | = Permissible Exposure Limit |
| TLV | = Threshold Limit Value |
| ppm | = parts per million (mg/L water or mg/kg soil) |
| ppb | = parts per billion (ug/L water or ug/kg soil) |
| kg | = kilogram (1,000 grams) |
| mg | = milligram (0.001 grams) |
| ug | = microgram (0.000001 grams) |
| L | = liter |
| m3 | = cubic meter (used in reference to a volume of air equal to 1,000 liters) |
Cancer Risk Evaluation Guides (CREGs) are estimated contaminant concentrations expected to cause no more than one excess cancer in a million persons exposed over a lifetime. CREGs are calculated from EPA's cancer slope factors.
Minimal Risk Levels (MRL) are estimates of daily human exposure to a chemical (i.e., doses expressed in mg/kg/day) that are unlikely to be associated with any appreciable risk of deleterious noncancer effects over a specified duration of exposure. MRLs are calculated using data from human and animal studies and are reported for acute (< 14 days), intermediate (15-364 days), and chronic (> 365 days) exposures. MRLs are published in ATSDR Toxicological Profiles for specific chemicals.
Environmental Media Evaluation Guides (EMEGs) are concentrations that are calculated from ATSDR minimal risk levels by factoring in default body weights and ingestion rates.
Intermediate Environmental Media Evaluation Guides (IEMEG) are calculated from ATSDR minimal risk levels; they factor in body weight and ingestion rates for intermediate exposures (i.e., those occurring for more than 14 days and less than 1 year).
Reference Dose Media Evaluation Guide (RMEG) is the concentration of a contaminant in air, water or soil that corresponds to EPA's RfD for that contaminant when default values for body weight and intake rates are taken into account.
EPA's Reference Dose (RfD) is an estimate of the daily exposure to a contaminant unlikely to cause noncarcinogenic adverse health effects. Like ATSDR's MRL, EPA's RfD is a dose expressed in mg/kg/day.
Reference Dose Concentrations (RfD-C) is a concentration derived from an EPA Reference Dose with assumed body and ingestion rates factored into the calculation.
Environmental Protection Agency Region III (EPA III) values are risk-based concentrations which take into account factors such as body weight, toxicity, and exposure duration and frequency for non-carcinogens and carcinogens, when applicable.
Drinking Water Equivalent Levels (DWEL) are based on EPA's oral RfD and represent corresponding concentrations of a substance in drinking water that are estimated to have negligible deleterious effects in humans at an intake rate of 2 L/day, assuming that drinking water is the sole source of exposure.
Lifetime Health Advisories (LTHA) are calculated from the DWEL and represents the concentration of a substance in drinking water estimated to have negligible deleterious effects in humans over a lifetime of 70 years, assuming 2 L/day water consumption for a 70-kg adult, and taking into account other sources of exposure. In the absence of chemical-specific data, the assumed fraction of total intake from drinking water is 20%. Lifetime health advisories are not derived for compounds which are potentially carcinogenic for humans.
Maximum Contaminant Levels (MCLs) represent contaminant concentrations in drinking water that EPA deems protective of public health (considering the availability and economics of water treatment technology) over a lifetime (70 years) at an exposure rate of 2 liters of water per day (for an adult).
Permissible Remediation Goal (PRG) are levels set by EPA under Superfund that trigger a response or action when the contaminant concentration exceeds this value. Also generically known as action levels.
Occupational Safety and Health Administration's Permissible Exposure Limit (PEL) for air is an 8-hour, time-weighted average developed for the workplace. The level of exposure may be exceeded (for brief periods), but the sum of the exposure levels averaged over 8 hours must not exceed the limit.
Threshold Limit Value (TLV), according to the American Conference of
Governmental Industrial Hygienists (ACGIH), is "the time-weighted average
concentrations for a normal 8-hour workday and a 40-hour workweek, to which
nearly all workers may be repeatedly exposed, day after day, without adverse
effect". Many of ACGIH's TLVs were adopted by OSHA for use as PELs. TLVs
and PELs, which were designed to protect healthy workers, are usually much higher
than the health-based values of ATSDR and EPA, which were designed to protect
the health of the general population, including the very young and the elderly.
Although the ATSDR does not base any of its community health decisions on TLVs
or PELs, agency health assessors and toxicologists may sometimes mention such
values in Public Health Assessments or consultations as a means of putting site-specific concentrations of contaminants into some kind of meaningful perspective for the reader.
References
Agency for Toxic Substances and Disease Registry. Health Assessment Guidance Manual. Atlanta: ATSDR, March, 1992.
PCE Carcinogenicity
PCE is a nongenotoxic animal carcinogen. In chronic bioassays (1.5-2.0 yrs), massive doses of PCE administered orally (up to 1,072 mg/kg/day) or by inhalation (100-200 ppm), have produced liver cancer in mice, but not in rats; administered by inhalation (200-400 ppm), it has also caused a statistically insignificant increase in kidney tumors in male, but not female rats (22,25,33,34). However, recent re-evaluations of these studies by various government agencies and independent scientists indicate that the tumors observed in animals were probably due to species-specific mechanisms that exhibit thresholds at near-toxic levels (33,34,36,37). That is to say that the induction of cancers in mice and rats by PCE required doses in excess of anything humans might reasonably be expected to encounter, and involved certain elements of rodent biology that are not likely to be shared by humans (peroxisome proliferation, alpha-2µ-globulin accumulation, glutathione-PCE conjugate formation). The implication is that the cancers observed in laboratory animals at very high doses of PCE have little or no relevance for human risk evaluation at environmental levels of exposure that are orders of magnitude lower. In fact, a number of epidemiological studies of men and women exposed occupationally to PCE have not identified an increased risk of cancer (27).
The International Agency for Research in Cancer (IARC) classifies PCE as "possibly carcinogenic to humans" based on "sufficient" evidence of carcinogenicity in animals and "inadequate" evidence of carcinogenicity in humans, and the National Toxicology Program (NTP) classifies PCE as Reasonably Anticipated to be a Carcinogen (RAC) in humans (27). However, both IARC and NTP use a "strength of evidence" basis of classification which, in contrast to the "weight of evidence" scheme used by the EPA, largely ignores negative studies and mechanisms of action. EPA's carcinogen classification scheme was developed at a time when little or no data on mechanism of action were available for consideration, with the result that the carcinogen category that would best accommodate such data often does not exist. This is the case with PCE.
EPA currently classifies PCE as a B2-C carcinogen, which is to say, somewhere between group B2 and group C (27). This is an unorthodox classification currently shared by only two other chemicals, trichloroethylene and styrene. Group B2 is reserved for chemicals defined as "probable" human carcinogens based on "sufficient" animal evidence. Group C is reserved for chemicals defined as "possible" human carcinogens based on "limited" animal evidence. The only other choices available (i.e., Groups A, B1, D, and E) require either reliable evidence of carcinogenicity in humans, which does not exist for PCE, or the absence of such evidence in animals, which does exist for PCE. However, there is no question that, at high enough doses and administered by the right route to the right species and sex, PCE can cause an elevated incidence of certain cancers by species-specific mechanisms in laboratory animals. Thus, EPA classified PCE as a B2-C carcinogen not because it could not decide whether the evidence for carcinogenicity in animals was "sufficient" or "limited", but rather because it's classification scheme does not include a more appropriate category for this type of carcinogen. The American Conference of Governmental Industrial Hygienists (ACGIH), which does have such a category, recently reclassified PCE as an A3 animal carcinogen, signifying that "the agent is carcinogenic in animals at a relatively high dose, by route(s) of administration, at site(s), of histological type(s), or by mechanism(s) that are not considered relevant to worker exposure" (31).
It is important to realize that formal cancer risk assessment has its limitations (23-25). Based on a withdrawn EPA risk assessment that is currently being re-evaluated (32), it has been estimated that the drinking water standard of 5 µg PCE/L corresponds to a theoretical lifetime cancer risk of 14 in a million. However, as is the case with all numerical estimates of low-dose cancer risk based on animal data, the true risk is unknown, and may be as low as zero (35). It is, in fact, a practical impossibility to determine experimentally the carcinogenicity of chemicals at very low doses, due to the enormous number of animals that would be required to achieve statistically reliable results. Instead, the assessment of cancer risk at low doses has traditionally involved linear extrapolation from the results of high-dose animal experiments with the aid of statistical models that incorporate highly conservative default assumptions. These include the assumptions that (1) carcinogens have no threshold, and (2) all animal carcinogens are likely to be human carcinogens. These assumptions are clearly defensible as prudent public health policy when used to provide a maximal margin of safety in the face of overwhelming uncertainties. However, they were never intended to take priority over new scientific data that could otherwise reduce those uncertainties. Nor were they ever intended to be used for the prediction of actual disease incidence.
The ATSDR recognizes that no single mathematical model is appropriate in all cases and that existing mathematical models for low-dose extrapolation may not be appropriate for nongenotoxic agents. Information on the biological mechanism is needed to determine if there are threshold exposure levels for nongenotoxic agents. The ATSDR, therefore, evaluates the relevance of the animal data to humans on a case-by-case basis. In the case of PCE, the available animal cancer data appear to reflect species-specific mechanisms that exhibit thresholds at near-toxic levels and, therefore, have little or no relevance for the evaluation of human risk at environmental levels of exposure. However, in the absence of compelling data to the contrary, the ATSDR policy considers it prudent to presume that a substance which causes cancer in animals may also pose a potential carcinogenic risk to humans, and that exposure to the substance should be minimized (30). (For a perspective on cancer risk assessment, see reference 41.)
APPENDIX E - PUBLIC HEALTH HAZARD CONCLUSION
CATEGORIES
| ATSDR PUBLIC HAZARD CONCLUSION CATEGORIES | ||
| CATEGORY | DEFINITION | CRITERIA |
| A. Urgent public health hazard | This category is used for sites that pose an urgent public health hazard as the result of short-term exposures to hazardous substances | evidence exists that exposures have
occurred, are occurring, or are likely to occur in the future AND estimated exposures are to a substance(s) at concentrations in the environment that, upon short-term exposures, can cause adverse health effects to any segment of the receptor population AND/OR community-specific health outcome data indicate that the site has had an adverse impact on human health that requires rapid intervention AND/OR physical hazards at the site pose an imminent risk of physical injury |
| B. Public health hazard | This category is used for sites that pose a public health hazard as the result of long-term exposures to hazardous substances | evidence exists that exposures have
occurred, are occurring, or are likely to occur in the future AND estimated exposures are to a substance(s) at concentrations in the environment that, upon long-term exposures, can cause adverse health effects to any segment of the receptor population AND/OR community-specific health outcome data indicate that the site has had an adverse impact on human health that requires rapid intervention |
| C. Indeterminate public health hazard | This category is used for sites with incomplete information | limited available data do not indicate
that humans are being or have been exposed to levels of contamination that
would be expected to cause adverse health effects; data or information are
not available for all environmental media to which humans may be exposed
AND there are insufficient or no community-specific health outcome data to indicate that the site has had an adverse impact on human health |
| D. No apparent public health hazard | This category is used for sites where human exposure to contaminated media is occurring or has occurred in the past, but the exposure is below a level of health hazard | exposures do not exceed an ATSDR chronic
MRL or other comparable value AND data are available for all environmental media to which humans are being exposed AND there are no community-specific health outcome data to indicate that the site has had an adverse impact on human health |
| E. No public health hazard | This category is used for sites that do not pose a public health hazard | no evidence of current or past human
exposure to contaminated media AND future exposures to contaminated media are not likely to occur AND there are no community-specific health outcome data to indicate that the site has had an adverse impact on human health |
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