ENVS 4113 Midterm Flashcards
What is the primary purpose of FIFRA?
The primary purpose of FIFRA is to establish a regulatory framework for the sale and use of pesticides to protect applicators, consumers, and the environment.
Who is responsible for administering and regulating FIFRA?
FIFRA is administered and regulated by the U.S. Environmental Protection Agency (EPA) and state environmental agencies.
What significant change occurred in 1972 regarding FIFRA?
In 1972, the Federal Environmental Pesticide Control Act (FEPCA) significantly revised FIFRA, expanding the EPA’s authority and emphasizing the protection of human health and the environment.
What was the first pesticide legislation in the United States?
The Federal Insecticide Act of 1910 was the first pesticide legislation, focusing on protecting consumers from fraudulent and adulterated products.
How did pesticide use change after World War II?
After World War II, pesticide use increased from 100 million pounds in 1945 to over 300 million pounds by 1950 due to newly discovered insecticidal properties of chemicals.
What are the main goals of the Endangered Species Act in relation to pesticides?
The main goals are to ensure that the registration and use of pesticides do not harm endangered and threatened animals and their habitats.
What is required for a pesticide to be registered under FIFRA?
A pesticide must undergo over 120 tests to assess its safety and effectiveness, and only about 1 in 139,000 test compounds make it through to registration.
What is a “restricted-use” pesticide?
A restricted-use pesticide is one that is deemed too hazardous for general use and is available only to certified applicators.
What significant revision did the 1972 FEPCA amendment contribute to FIFRA?
The 1972 FEPCA amendment shifted the regulatory responsibility from the USDA to the EPA and required the EPA to assess pesticides’ risks against their benefits.
How are the risks and benefits of pesticides evaluated under FIFRA?
The EPA must weigh the potential risks posed by pesticides to humans, the environment, and wildlife against their agricultural and economic benefits.
What does the term “pesticide” include according to FIFRA?
According to FIFRA, the term “pesticide” includes any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, as well as substances intended for use as a plant regulator, defoliant, or desiccant.
What is the significance of the 1988 amendments to FIFRA?
The 1988 amendments to FIFRA required the re-registration of pesticides registered before 1984 to ensure they meet current health and safety standards.
What does the Food Quality Protection Act (FQPA) of 1996 require?
The FQPA of 1996 requires that all pesticides cause no harm to infants, children, and sensitive individuals within “reasonable certainty” and mandates a 15-year cycle for pesticide review.
How does the EPA handle special reviews of pesticides under FIFRA?
If new information suggests adverse side effects, the EPA may conduct a special review to assess the risks and benefits of continued use of the pesticide and may amend or cancel the registration.
What is the role of the Federal Food, Drug, and Cosmetic Act (FFDCA) in pesticide regulation?
Under FFDCA, the EPA regulates the amount of pesticide residues on or in food, establishing “tolerance levels” to ensure they are safe for consumption.
What does the Pesticide Registration Improvement Act (PRIA) aim to achieve?
PRIA aims to ensure a smooth implementation of pesticide rules and regulations, including the process of approving pesticide registrations and collecting maintenance fees.
How does FIFRA define a “new animal drug” in relation to pesticides?
FIFRA excludes “new animal drugs” as defined in section 321(w) of title 21 from the term “pesticide,” focusing on substances intended for pest control rather than veterinary medicine.
What is the goal of the Endangered Species Act regarding pesticides?
The goal is to protect endangered and threatened species from potential dangers posed by pesticides, requiring the EPA to consider these risks during the pesticide registration process.
What is the significance of pesticide labels under FIFRA?
Pesticide labels, created upon registration, instruct users on proper usage to maximize effectiveness and minimize risks to humans and the environment. Misuse can lead to liability for negative consequences.
How does FIFRA address the distribution and use of “restricted-use” pesticides?
FIFRA establishes a certification system for applicators wishing to purchase and use restricted-use pesticides, ensuring they are properly trained to handle these more hazardous substances.
What is the definition of “Risk” in the context of chemical risk assessment?
Risk = Hazard x Exposure.
What does “Hazard” refer to in chemical safety?
The built-in property of a chemical’s potential to cause adverse effects to an organism, system or population when exposed to it.
What are the three main steps of chemical risk assessment?
Hazard characterization, Exposure assessment, Risk characterization.
Define “Exposure” in terms of chemical risk.
The amount of chemical present and the degree of contact with a system or organism.
What is hazard characterization?
Determining the relationship between the magnitude of exposure to a hazard and the probability and severity of adverse effects.
What is involved in exposure assessment?
Identifying and quantifying how much exposure to a chemical actually occurs.
What is risk characterization?
Combining the information from the hazard characterization and the exposure assessment in order to form a conclusion about the nature and magnitude of risk, and, if indicated, implement additional risk management measures. (Combining hazard and exposure information to conclude the nature and magnitude of risk).
What is LD50?
The dose of a chemical that is lethal to 50% of the test population.
What is the Risk Characterization Ratio (RCR)?
A ratio of the exposure estimate to the Derived No-Effect Level (DNEL), used to assess risk acceptability.
Define NOAEL.
No Observed Adverse Effect Level - the highest exposure level at which there are no significant increases in frequency or severity of adverse effects in the exposed population compared to control.
What is acute toxicity?
The adverse effects of a substance that result from a single exposure or multiple exposures in a short period of time.
Define carcinogenicity in toxicology.
The ability of a substance to cause cancer.
What is the goal of ecotoxicology?
To study the effects of toxic chemicals on biological organisms, especially at the population, community, ecosystem, and biosphere levels.
Define NOEC in ecotoxicology.
No Observed Effect Concentration - the concentration below which an unacceptable effect is unlikely to be observed.
GHS Classification Criteria
Globally Harmonized System of Classification and Labeling Chemicals - criteria used to determine the nature and the relative severity of the hazard of a chemical substance or mixture
What is Toxicology?
Defined as the study of the adverse effects of chemicals or physical agents on living organisms.
What is Simpson’s Rule used for?
Numerical integration, specifically for approximating definite integrals.
What is truncation error?
Truncation error is the difference between an actual and a truncated, or cut-off value. A truncated quantity is represented by a numeral with a fixed number of allowed digits, with any excess digits chopped off.
Define “round-off error”.
The difference between an approximation of a number used in computation and its exact value.
What is the purpose of REACH regulation?
To improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances.
What does GHS stand for and what is its purpose?
Globally Harmonized System of Classification and Labeling of Chemicals, aimed at harmonizing hazard classification and communication.
Types of Toxicology Studies?
Acute Toxicity, Skin and Eye Irritation, Sensitization, Repeated Dose Toxicity, Mutagenicity and genotoxicity, Reproductive and developmental toxicity, carcinogenicity, toxicokinetics.
Types of Acute Toxicity?
Oral, Inhalation, Dermal
Type of Sensitization studies?
Skin, Respiratory
Type of Repeated Dose Toxicity Studies?
28d, 90d, Chronic
How is DNEL used in risk assessment?
To assess the risk to human health by comparing the level of exposure to the DNEL.
What determines a chemical’s persistence in the environment?
The chemical’s half-life (DT50), indicating the time it takes for half of the substance to degrade.
What does DNEL stand for in chemical risk assessment?
Derived No-Effect Level.
What is the significance of LD50 in toxicology?
LD50 is the lethal dose that kills 50% of the test population, indicating acute toxicity.
What does NOAEL represent?
No Observed Adverse Effect Level - the highest exposure level at which no significant adverse effects are observed.
Define Exposure in chemical risk assessment.
The degree of contact with a chemical substance.
What is the goal of ecotoxicology?
To study the effects of chemicals on ecosystems and organisms at various biological levels.
Define Hazard in the context of chemical safety.
The inherent property of a chemical to cause adverse effects.
What is REACH, and what is its purpose?
Registration, Evaluation, Authorisation, and Restriction of Chemicals; aims to protect human health and the environment from hazardous chemicals.
What does LC50 measure in toxicology?
The lethal concentration that kills 50% of the test population, used for assessing inhalation toxicity.
What does GHS stand for, and why is it important?
Globally Harmonized System of Classification and Labelling of Chemicals; important for harmonizing hazard communication.
Describe the concept of “Risk Characterization”.
The process combining hazard and exposure assessment to estimate the risk. Combining the information from the hazard characterization and the exposure assessment in order to form a conclusion about the nature and magnitude of risk, and, if indicated, implement additional risk management measures.
What is the purpose of the NOEC value in ecotoxicology?
No Observed Effect Concentration; the highest concentration that does not result in observable adverse effects on the environment.
Explain the term “Round-off Error” in numerical analysis.
The error resulting from the approximation of a number due to limited precision in its representation.
What is a Risk Quotient (RQ), and how is it calculated?
RQ = Estimated Environmental Concentration (EEC) / Ecotoxicity Effect Endpoint; used to assess ecological risk.
Describe the term “Acute Toxicity”.
The adverse effects of a substance that result from a single exposure or multiple exposures in a short period.
What does the term “Carcinogenicity” mean in toxicology?
The ability of a substance to cause cancer.
Explain the purpose of a Margin of Exposure (MOE) calculation.
To assess the safety of a substance by comparing the no-observed-adverse-effect level to the estimated exposure level.