NYS DOH PROCEDURE FOR EVALUATING POTENTIAL HEALTH RISKS FOR CONTAMINANTS OF CONCERN
To evaluate the potential health risks from contaminants of concern associated with the Anitec
Imaging, Inc. site, the New York State Department of Health assessed the risks for cancer and
noncancer health effects.
Increased cancer risks were estimated by using site-specific information on
exposure levels for the contaminant of concern and interpreting them using cancer
potency estimates derived for that contaminant by the US EPA or, in some cases,
by the NYS DOH. The following qualitative ranking of cancer risk estimates,
developed by the NYS DOH, was then used to rank the risk from very low to very
high. For example, if the qualitative descriptor was "low", then the excess
lifetime cancer risk from that exposure is in the range of greater than one
per million to less than one per ten thousand. Other qualitative descriptors
are listed below:
Excess Lifetime Cancer Risk
Risk Ratio
Qualitative Descriptor
equal to or less than one per million
very low
greater than one per million to less than one per ten thousand
low
one per ten thousand to less than one per thousand
moderate
one per thousand to less than one per ten
high
equal to or greater than one per ten
very high
An estimated increased excess lifetime cancer risk is not a specific estimate
of expected cancers. Rather, it is a plausible upper bound estimate of the probability
that a person may develop cancer sometime in his or her lifetime following exposure
to that contaminant.
There is insufficient knowledge of cancer mechanisms to decide if there exists a level of exposure to a
cancer-causing agent below which there is no risk of getting cancer, namely, a threshold level.
Therefore, every exposure, no matter how low, to a cancer-causing compound is assumed to be
associated with some increased risk. As the dose of a carcinogen decreases, the chance of developing
cancer decreases, but each exposure is accompanied by some increased risk.
There is general consensus among the scientific and regulatory communities on what level of estimated
excess cancer risk is acceptable. An increased lifetime cancer risk of one in one millionor less isgenerally not considered a significant public health concern.
For noncarcinogenic health risks, the contaminant intake was estimated using exposure assumptions for
the site conditions. This dose was then compared to a risk reference dose (estimated daily intake of a
chemical that is likely to be without an appreciable risk of health effects) developed by the US EPA,
ATSDR and/or NYS DOH. The resulting ratio was then compared to the following qualitative scale of
health risk:
Qualitative Descriptions for Noncarcinogenic Health
Risks
Ratio of Estimated Contaminant Intake to Risk Reference
Dose
Qualitative Descriptor
equal to or less than the risk reference dose
minimal
greater than one to five times the risk reference dose
low
greater than five to ten times the risk reference dose
moderate
greater than ten times the risk reference dose
high
Noncarcinogenic effects unlike carcinogenic effects are believed
to have a threshold, that is, a dose below which adverse effects will not occur.
As a result, the current practice is to identify, usually from animal toxicology
experiments, a no-observed-effect-level (NOEL). This is the experimental exposure
level in animals at which no adverse toxic effect is observed. The NOEL is then
divided by an uncertainty factor to yield the risk reference dose. The uncertainty
factor is a number which reflects the degree of uncertainty that exists when
experimental animal data are extrapolated to the general human population. The
magnitude of the uncertainty factor takes into consideration various factors
such as sensitive subpopulations (for example, children or the elderly), extrapolation
from animals to humans, and the incompleteness of available data. Thus, the
risk reference dose is not expected to cause health effects because it is selected
to be much lower than dosages that do not cause adverse health effects in laboratory
animals.
The measure used to describe the potential for noncancer health effects to occur in an individual is
expressed as a ratio of estimated contaminant intake to the risk reference dose. A ratio equal to or less
than one is generally not considered a significant public health concern. If exposure to the contaminant
exceeds the risk reference dose, there may be concern for potential noncancer health effects because the
margin of protection is less than that afforded by the reference dose. As a rule, the greater the ratio of
the estimated contaminant intake to the risk reference dose, the greater the level of concern. This level
of concern depends upon an evaluation of a number of factors such as the actual potential for exposure, background exposure, and the strength of the toxicologic data.
APPENDIX C
Interim Public Health Hazard Categories
CATEGORY / DEFINITION
DATA SUFFICIENCY
CRITERIA
A. Urgent Public Health Hazard
This category is used for sites where short-term
exposures (< 1 yr) to hazardous substances or
conditions could result in adverse health effects
that require rapid intervention.
This determination represents a professional judgement based
on critical data which ATSDR has judged sufficient to support
a decision. This does not necessarily imply that the available
data are complete; in some cases additional data may be
required to confirm or further support the decision made.
Evaluation of available relevant information* indicates that site-specific conditions or likely exposures have had, are having, or are
likely to have in the future, an adverse impact on human health that
requires immediate action or intervention. Such site-specific
conditions or exposures may include the presence of serious physical
or safety hazards.
B. Public Health Hazard
This category is used for sites that pose a public
health hazard due to the existence of long-term
exposures (> 1 yr) to hazardous substance or
conditions that could result in adverse health
effects.
This determination represents a professional judgement based
on critical data which ATSDR has judged sufficient to support
a decision. This does not necessarily imply that the available
data are complete; in some cases additional data may be
required to confirm or further support the decision made.
Evaluation of available relevant information* suggests that, under
site-specific conditions of exposure, long-term exposures to site-specific contaminants (including radionuclides) have had, are
having, or are likely to have in the future, an adverse impact on
human health that requires one or more public health interventions.
Such site-specific exposures may include the presence of serious
physical or safety hazards.
C. Indeterminate Public Health Hazard
This category is used for sites in which
"critical" data are insufficient with regard to
extent of exposure and/or toxicologic
properties at estimated exposure levels.
This determination represents a professional judgement that
critical data are missing and ATSDR has judged the data are
insufficient to support a decision. This does not necessarily
imply all data are incomplete; but that some additional data are
required to support a decision.
The health assessor must determine, using professional judgement,
the "criticality" of such data and the likelihood that the data can be
obtained and will be obtained in a timely manner. Where some
data are available, even limited data, the health assessor is
encouraged to the extent possible to select other hazard categories
and to support their decision with clear narrative that explains the
limits of the data and the rationale for the decision.
D. No Apparent Public Health Hazard
This category is used for sites where human
exposure to contaminated media may be
occurring, may have occurred in the past, and/or
may occur in the future, but the exposure is not
expected to cause any adverse health effects.
This determination represents a professional judgement based
on critical data which ATSDR considers sufficient to support a
decision. This does not necessarily imply that the available
data are complete; in some cases additional data may be
required to confirm or further support the decision made.
Evaluation of available relevant information* indicates that, under
site-specific conditions of exposure, exposures to site-specific
contaminants in the past, present, or future are not likely to result in
any adverse impact on human health.
E. No Public Health Hazard
This category is used for sites that, because of
the absence of exposure, do NOT pose a
public health hazard.
Sufficient evidence indicates that no human exposures to
contaminated media have occurred, none are now occurring,
and none are likely to occur in the future
*Such as environmental and demographic data; health outcome data; exposure data; community health concerns information; toxicologic, medical, and epidemiologic data; monitoring and management plans.
APPENDIX D
Summary of Public Comments and Responses
This summary was prepared to address comments and questions on the public comment draft of the Public
Health Assessment for the Hiteman Leather Site, Village of West Winfield, Herkimer County. The public
was invited to review the draft during the public comment period, which ran from July 14, 2000 - August 18,
2000. We received four responses from citizens in the Village of West Winfield. Some statements were
reworded, combined or summarized for clarity and to avoid repetition. If you have any questions about this
summary, you can contact the New York State Department of Health's (NYS DOH) Outreach Unit at the
toll-free number 1-800-458-1158, extension 27530.
Comment #1 - Several residents expressed concern about the appearance of the property.
Response #1 - The removal of the remaining building rubble will be incorporated into the final site closure
plan.
Comment #2 - A resident expressed concern about testing of the West Winfield Public Water Supply.
Response #2 - Although the public water supply wells are upgradient (in the opposite direction from
groundwater flow) from the Hiteman Leather site, there is an ongoing mandated monitoring program. To
date, no site-related contamination has been detected.
Comment # 3 - Historically, the Hiteman Leather property was used for purposes other than a tannery. Other
site users included a machine shop, a tire recapping company and a cookie company.
Response # 3 - These additional site uses were verified by Mr. Stephen Davis, Town of Winfield Historian,
and are included in the revised background section.
Comment # 4 - A resident reported past unauthorized trespassing and site use. The installation of a
perimeter fence, which has been done, was noted by the resident as an appropriate deterrent.
Response # 4 - The fence will remain in place and maintained at least until after final site clean up and
closure.
Comment # 5 - A resident questioned whether the median household income level listed in the
Demographics section was accurate. The resident believes that the income level for the residential area
around the site is lower than that listed.
Response # 5 - The Demographics section lists the median household income for the area within a one mile
radius of the site. We expect some local variations in median income within that one mile radius.
Comment # 6 - One resident was concerned about weed growth along the Unadilla River.
Response # 6 - Although environmental conditions at the Hiteman
Leather site are not believed to be a cause of weed growth along the river,
soil eroding from the site into the river can increase weed growth. The US Environmental
Protection Agency installed rip rap along the stream banks to prevent further
erosion at the site.
APPENDIX E
ATSDR Plain Language Glossary of Environmental Health Terms
Absorption:
How a chemical enters a person's blood after the chemical has been swallowed,
has come into contact with the skin, or has been breathed in.
Acute Exposure:
Contact with a chemical that happens once or only for a limited period of
time. ATSDR defines acute exposures as those that might last up to 14 days.
Additive Effect:
A response to a chemical mixture, or combination of substances, that might
be expected if the known effects of individual chemicals, seen at specific
doses, were added together.
Adverse Health Effect:
A change in body function or the structures of cells that can lead to disease
or health problems.
Antagonistic Effect:
A response to a mixture of chemicals or combination of substances that is
less than might be expected if the known effects of individual chemicals,
seen at specific doses, were added together.
ATSDR:
The Agency for Toxic Substances and Disease
Registry. ATSDR is a federal health agency in Atlanta, Georgia that
deals with hazardous substance and waste site issues. ATSDR gives people information
about harmful chemicals in their environment and tells people how to protect
themselves from coming into contact with chemicals.
Background Level:
An average or expected amount of a chemical in a specific environment. Or,
amounts of chemicals that occur naturally in a specific environment.
Biota:
Used in public health, things that humans would eat - including animals,
fish and plants.
CAP:
See Community Assistance Panel.
Cancer:
A group of diseases which occur when cells in the body become abnormal and
grow, or multiply, out of control
Carcinogen:
Any substance shown to cause tumors or cancer in experimental studies.
CERCLA:
See Comprehensive Environmental Response, Compensation,
and Liability Act.
Chronic Exposure:
A contact with a substance or chemical that happens over a long period of
time. ATSDR considers exposures of more than one year to be chronic.
Completed Exposure Pathway:
See Exposure Pathway.
Community Assistance Panel (CAP):
A group of people from the community and health and environmental agencies
who work together on issues and problems at hazardous waste sites.
Comparison Value (CVs):
Concentrations or the amount of substances in air, water, food, and soil
that are unlikely, upon exposure, to cause adverse health effects. Comparison
values are used by health assessors to select which substances and environmental
media (air, water, food and soil) need additional evaluation while health
concerns or effects are investigated.
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA):
CERCLA was put into place in 1980. It is also known as Superfund.
This act concerns releases of hazardous substances into the environment, and
the cleanup of these substances and hazardous waste sites. ATSDR was created
by this act and is responsible for looking into the health issues related
to hazardous waste sites.
Concern:
A belief or worry that chemicals in the environment might cause harm to
people.
Concentration:
How much or the amount of a substance present in a certain amount of soil,
water, air, or food.
Contaminant:
See Environmental Contaminant.
Delayed Health Effect:
A disease or injury that happens as a result of exposures that may have
occurred far in the past.
Dermal Contact:
A chemical getting onto your skin. (see Route of Exposure).
Dose:
The amount of a substance to which a person may be exposed, usually on a
daily basis. Dose is often explained as "amount of substance(s) per body weight
per day".
Dose / Response:
The relationship between the amount of exposure (dose) and the change in
body function or health that result.
Duration:
The amount of time (days, months, years) that a person is exposed to a chemical.
Environmental Contaminant:
A substance (chemical) that gets into a system (person, animal, or the environment)
in amounts higher than that found in Background Level, or what would
be expected.
Environmental Media:
Usually refers to the air, water, and soil in which chemical of interest
are found. Sometimes refers to the plants and animals that are eaten by humans.
Environmental Media is the second part of an Exposure Pathway.
U.S. Environmental Protection Agency (EPA):
The federal agency that develops and enforces environmental laws to protect
the environment and the public's health.
Epidemiology:
The study of the different factors that determine how often, in how many
people, and in which people will disease occur.
Exposure:
Coming into contact with a chemical substance.(For the three ways people
can come in contact with substances, see Route of Exposure.)
Exposure Assessment:
The process of finding the ways people come in contact with chemicals, how
often and how long they come in contact with chemicals, and the amounts of
chemicals with which they come in contact.
Exposure Pathway:
A description of the way that a chemical moves from its source (where it
began) to where and how people can come into contact with (or get exposed
to) the chemical.
ATSDR defines an exposure pathway as having 5 parts:
Source of Contamination,
Environmental Media and Transport Mechanism,
Point of Exposure,
Route of Exposure; and,
Receptor Population.
When all 5 parts of an exposure pathway are present, it is called a Completed
Exposure Pathway. Each of these 5 terms is defined in this Glossary.
Frequency:
How often a person is exposed to a chemical over time; for example, every
day, once a week, twice a month.
Hazardous Waste:
Substances that have been released or thrown away into the environment and,
under certain conditions, could be harmful to people who come into contact
with them.
Health Effect:
ATSDR deals only with Adverse Health Effects (see definition in this
Glossary).
Indeterminate Public Health Hazard:
The category is used in Public Health Assessment documents for sites where
important information is lacking (missing or has not yet been gathered) about
site-related chemical exposures.
Ingestion:
Swallowing something, as in eating or drinking. It is a way a chemical can
enter your body (See Route of Exposure).
Inhalation:
Breathing. It is a way a chemical can enter your body (See Route of Exposure).
LOAEL:
Lowest Observed Adverse Effect Level.
The lowest dose of a chemical in a study, or group of studies, that has caused
harmful health effects in people or animals.
Malignancy:
See Cancer.
MRL:
Minimal Risk Level. An estimate of daily human exposure
- by a specified route and length of time -- to a dose of chemical that is
likely to be without a measurable risk of adverse, noncancerous effects. An
MRL should not be used as a predictor of adverse health effects.
NPL:
The National Priorities List. (Which is part of Superfund.)
A list kept by the U.S. Environmental Protection Agency (EPA) of the most
serious, uncontrolled or abandoned hazardous waste sites in the country. An
NPL site needs to be cleaned up or is being looked at to see if people can
be exposed to chemicals from the site.
NOAEL:
No Observed Adverse Effect Level. The
highest dose of a chemical in a study, or group of studies, that did not cause
harmful health effects in people or animals.
No Apparent Public Health Hazard:
The category is used in ATSDR's Public Health Assessment documents for
sites where exposure to site-related chemicals may have occurred in the past
or is still occurring but the exposures are not at levels expected to cause
adverse health effects.
No Public Health Hazard:
The category is used in ATSDR's Public Health Assessment documents for sites
where there is evidence of an absence of exposure to site-related chemicals.
PHA:
Public Health Assessment. A report or document that
looks at chemicals at a hazardous waste site and tells if people could be
harmed from coming into contact with those chemicals. The PHA also tells if
possible further public health actions are needed.
Plume:
A line or column of air or water containing chemicals moving from the source
to areas further away. A plume can be a column or clouds of smoke from a chimney
or contaminated underground water sources or contaminated surface water (such
as lakes, ponds and streams).
Point of Exposure:
The place where someone can come into contact with a contaminated environmental
medium (air, water, food or soil). For examples:
the area of a playground that has contaminated dirt, a contaminated spring
used for drinking water, the location where fruits or vegetables are grown
in contaminated soil, or the backyard area where someone might breathe contaminated
air.
Population:
A group of people living in a certain area; or the number of people in a
certain area.
PRP:
Potentially Responsible Party. A company, government
or person that is responsible for causing the pollution at a hazardous waste
site. PRP's are expected to help pay for the clean up of a site.
Public Health Assessment(s):
See PHA.
Public Health Hazard:
The category is used in PHAs for sites that have certain physical features
or evidence of chronic, site-related chemical exposure that could result in
adverse health effects.
Public Health Hazard Criteria:
PHA categories given to a site which tell whether people could be harmed
by conditions present at the site. Each are defined in the Glossary. The categories
are:
Urgent Public Health Hazard
Public Health Hazard
Indeterminate Public Health Hazard
No Apparent Public Health Hazard
No Public Health Hazard
Receptor Population:
People who live or work in the path of one or more chemicals, and who could
come into contact with them (See Exposure Pathway).
Reference Dose (RfD):
An estimate, with safety factors (see safety factor) built in, of
the daily, life-time exposure of human populations to a possible hazard that
is not likely to cause harm to the person.
Route of Exposure:
The way a chemical can get into a person's body. There are three exposure
routes:
- breathing (also called inhalation),
- eating or drinking (also called ingestion), and
- or getting something on the skin (also called dermal contact).
Safety Factor:
Also called Uncertainty Factor. When scientists don't have enough
information to decide if an exposure will cause harm to people, they use "safety
factors" and formulas in place of the information that is not known. These
factors and formulas can help determine the amount of a chemical that is not
likely to cause harm to people.
SARA:
The Superfund Amendments and Reauthorization Act
in 1986 amended CERCLA and expanded the health-related responsibilities of
ATSDR. CERCLA and SARA direct ATSDR to look into the health effects from chemical
exposures at hazardous waste sites.
Sample Size:
The number of people that are needed for a health study.
Sample:
A small number of people chosen from a larger population (See Population).
Source (of Contamination):
The place where a chemical comes from, such as a landfill, pond, creek,
incinerator, tank, or drum. Contaminant source is the first part of an Exposure
Pathway.
Special Populations:
People who may be more sensitive to chemical exposures because of certain
factors such as age, a disease they already have, occupation, sex, or certain
behaviors (like cigarette smoking). Children, pregnant women, and older people
are often considered special populations.
Statistics:
A branch of the math process of collecting, looking at, and summarizing
data or information.
Superfund Site:
See NPL.
Survey:
A way to collect information or data from a group of people (population).
Surveys can be done by phone, mail, or in person. ATSDR cannot do surveys
of more than nine people without approval from the U.S. Department of Health
and Human Services.
Synergistic effect:
A health effect from an exposure to more than one chemical, where one of
the chemicals worsens the effect of another chemical. The combined effect
of the chemicals acting together are greater than the effects of the chemicals
acting by themselves.
Toxic:
Harmful. Any substance or chemical can be toxic at a certain dose (amount).
The dose is what determines the potential harm of a chemical and whether it
would cause someone to get sick.
Toxicology:
The study of the harmful effects of chemicals on humans or animals.
Tumor:
Abnormal growth of tissue or cells that have formed a lump or mass.
Uncertainty Factor:
See Safety Factor.
Urgent Public Health Hazard:
This category is used in ATSDR's Public Health Assessment documents for
sites that have certain physical features or evidence of short-term (less
than 1 year), site-related chemical exposure that could result in adverse
health effects and require quick intervention to stop people from being exposed.
