Risk Assessment and Regulatory Science

These flashcards cover key concepts and definitions related to risk assessment and regulatory science, including the phases of assessment, components of risks, and principles guiding risk management.

What is risk in the context of risk assessment?

Risk is the possibility or probability of suffering harm from a hazard.

What do possibility and probability mean in risk assessment?

Possibility refers to whether harm can occur, while probability refers to how likely it is that the harm will actually occur.

What are the three components necessary for a risk of harm to exist in drinking water contamination?

Contaminants, receptors, and exposure pathways.

What is the purpose of risk assessment in regulatory science?

To take action without full scientific understanding of a hazard and to set procedures to bridge gaps in understanding.

What are the phases of Environmental Sites Assessment?

Phase 1: Identify potential contamination, Phase 2: Investigate and confirm contamination, Phase 3: Deal with contamination, Phase 4: Confirm the site is safe.

What are some benefits of conducting a risk assessment?

Identifying diseases caused by agents, testing new chemicals, ranking contributions to overall risk, and clarifying known vs. unknown risks.

What is Problem Definition in the context of risk assessment?

Clearly defining the purpose of the assessment and management goals.

What questions should be answered during the identification of contaminants phase?

Is the contaminant a single compound or a mixture? What environmental medium is affected?

What does receptor analysis involve in risk assessment?

Identifying organisms or populations at risk, such as humans and wildlife, exposed to the contaminant.

What are exposure scenarios and why are they important?

They define who is exposed and help characterize risk based on specific human populations.

What is meant by 'pathways analyses' in risk assessment?

Analyzing how contaminants move through the environment and lead to exposure.

How is exposure quantified in the exposure assessment process?

By measuring or estimating the dose based on various exposure routes like air, water, and diet.

What is the formula to calculate exposure from ingestion?

Exposure from ingestion = Concentration (Cf) x Intake Rate (IRf) for food.

What is the Estimated Daily Intake (EDI)?

It's the estimated dose a person is exposed to for each exposure medium.

What is a key assumption in chemical risk assessment regarding non-cancer effects?

Non-cancer effects are assumed to have thresholds below which no adverse effects are expected.

How are cancer risk assessments different from non-cancer risk assessments?

Cancer risks are assumed to have no safe level, while non-cancer risks focus on identifying safe exposure levels.

What does NOAEL stand for in toxicity assessment?

No Observed Adverse Effect Level.

What does RfD stand for in risk assessment?

Reference Dose.

What is the Hazard Quotient (HQ) used to determine?

Whether there is a potential for harm based on daily intake compared to a reference dose.

What are the weight-of-the-evidence categories for carcinogenicity defined by IARC?

Group 1: Carcinogenic to humans, Group 2A: Probably carcinogenic, Group 2B: Possibly carcinogenic, Group 3: Not classifiable, Group 4: Probably not carcinogenic.

What does RMOS stand for and what is its significance?

Relative Margin of Safety; it's used to assess acceptable risk levels.

What is the Precautionary Principle in risk assessment?

Taking precautionary measures when there are threats of harm to health or the environment, even if scientific cause-and-effect relationships are not fully established.

What are some examples of precautionary approaches?

Kyoto Protocol, Montreal Protocol, and the US Toxic Substances Control Act.

What are some historical instances where precaution was not taken?

Widespread use of asbestos, large-scale use of synthetic organic chemicals like DDT, and practices leading to mad cow disease.

What does 'uncertainties' refer to in the context of risk assessment?

Variability and limitations in data, measurement errors, and assumptions made in assessments.

Why is risk communication important in risk analyses?

It informs decision makers and the public about risks and the rationale behind management decisions.

What is the role of risk management in relation to risk assessment?

Making decisions and options about reducing or eliminating identified risks.