PUBLIC HEALTH ASSESSMENT
LITTLE VALLEY, CATTARAUGUS COUNTY, NEW YORK
NEW YORK STATE DEPARTMENT OF HEALTH
PROCEDURE FOR EVALUATING POTENTIAL HEALTH RISKS
FOR CONTAMINANTS OF CONCERN
To evaluate the potential health risks from contaminants of concern associated with the Little Valley 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 in a million||very low|
|greater than one in a million to less than one in ten thousand||low|
|one in ten thousand to less than one in a thousand||moderate|
|one in a thousand to less than one in ten||high|
|equal to or greater than one in 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 million or less is generally considered an insignificant increase in cancer risk.
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 reference dose or minimal risk level||minimal|
|greater than one to five times the reference dose or minimal risk level||low|
|greater than five to ten times the reference dose or minimal risk level||moderate|
|greater than ten times the reference dose or minimal risk level||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. 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. A ratio equal to or less than one is generally considered an insignificant (minimal) increase in risk.
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|
Summary of Public Comments and Responses
This summary was prepared to address comments and questions on the public comment draft of the Little Valley Site Public Health Assessment. The public was invited to review the draft during the public comment period, which ran from July 13, 2000 -- August 15, 2000. We received two responses: one from a public agency and one from a local resident. Minor clarifying changes were made in the text in response to the agency's comments. The comment from the resident involved a family health issue. A physician from the NYS DOH Center for Environmental Health contacted the resident for follow-up. 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.
ATSDR Plain Language Glossary of Environmental Health Terms
- 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.
- 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.
- Used in public health, things that humans would eat - including animals, fish and plants.
- See Community Assistance Panel.
- A group of diseases which occur when cells in the body become abnormal and grow, or multiply, out of control
- Any substance shown to cause tumors or cancer in experimental studies.
- 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.
- A belief or worry that chemicals in the environment might cause harm to people.
- How much or the amount of a substance present in a certain amount of soil, water, air, or food.
- 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).
- 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.
- 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.
- The study of the different factors that determine how often, in how many people, and in which people will disease occur.
- 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.
- 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.
- Swallowing something, as in eating or drinking. It is a way a chemical can enter your body (See Route of Exposure).
- Breathing. It is a way a chemical can enter your body (See Route of Exposure).
- 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.
- See Cancer.
- 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.
- 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.
- 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.
- 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.
- 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.
- A group of people living in a certain area; or the number of people in a certain area.
- 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
- 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
- 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.
- 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.
- 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.
- A branch of the math process of collecting, looking at, and summarizing data or information.
- Superfund Site:
- See NPL.
- 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.
- 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.
- The study of the harmful effects of chemicals on humans or animals.
- 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.