Lecture 7 Flashcards
What is regulatory toxicology?
-a subfield of toxicology that focuses on the application of toxicology principles to establish and enforce regulations aimed at protecting human health and the environment from hazardous substances.
-Intersection between science and regulation
-Identify, evaluate, and manage risks
What do regulatory toxicologists do?
- Risk Assessment
- Compliance & Regulations
- Data Review & Interpretation
- Policy Development
- Communication
Typically work for government agencies, pharmaceutical
companies, food and chemical industries, or consulting firms.
What are their job titles?
-Product safety toxicologist
- Toxicology Exposure/Risk assessor
- Risk assessment scientist
-Regulatory affairs toxicologist
Problems between science and policy interface:
Science:
* Data-driven, objective and
analytical.
* Can continue to study problem
for indefinitely.
* To identify and understand the
toxicity of the substances.
Policy:
* Value-driven, incorporates
societal, economic and ethical
factors.
* Time-bound. Need to adopt set
or adopt regulations on time.
* To protect public health and
environment through
regulation
Key aspects of regulator’s dilemma:
- Act based on incomplete evidence or wait for more conclusive
data. - Must weigh in economic impact and other society impact.
- Short-term vs long-term risk management.
- Must balance political, public demand of action.
What are the different regulatory agencies?
-OECD, ISO, ICH
-FDA, EPA
-ISDT, TCEQ
Difference between regulation, policy, and guideline:
Regulation: It is a rule or order issued by a governmental authority
that has the force of law. Eg: Food Quality Protection Law
Policy: Set of principles adopted by the agency.
Guidelines/Guidance: Interpretation of the Regulations.
Policy and Guidance do not carry the force of law but provide
important direction
Global regulatory toxicology
Multiple regulatory agencies come together and bring
harmonization.
-Pictograms and codes that help with transporting and using the chemicals
An example: Globally Harmonized System (GHS). The goal is to
harmonize the criteria by which chemicals are classified in terms of
their hazards.
ICH guidelines:
-International council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
-Established to standardize pharmaceutical regulations across different regions
REACH Regulation: Global/Regional
Regulatory Toxicology
Enforced by European Chemicals Agency (ECHA)
-Aims to protect human health and the environment from
hazardous chemicals
The US has Four main agencies:
-Food and Drug Administration
* Food, Drug, Medical Devices and Cosmetics
-Environmental Protection Agency
* Pesticides, Industrial Chemicals, Hazardous Wastes, Pollutants, Drinking
Water
-Occupational Safety and Health Administration
* Occupational exposure limits for hazardous chemicals
-Consumer Product Safety Commission
* Regulate products that may pose unreasonable
Origin of FDA
-1906 Pure Food and Drug Act
-1902 Harvey Wiley and the Poison squad
-1904 and 1906 Meat inspection Act and Pure Food and Drug Act
Harvey Wiley
-Faculty position at Purdue (opened in 1874)
-studied sorghum culture and sugar chemistry
-Became indiana state chemist and later chief chemist in the US department of Agriculture
-poison squad experiment
Risk assessment methods (evolution)
Phase 1: Enhanced problem formulation
Phase 2: Planning and assessment
Phase 3: Risk management
Step 1 of Risk assessment: Hazard assessment
-Identify the potential sources of harm
-Types of Hazards: Physical, Chemical, Biological
Step 2: Dose-Response Assessment
-Evaluating the relationship between the amount of exposure (dose) to a hazard and the severity of the effect (response)
Threshold Level
The lowest dose at which an effect is observed
No-Observed-Adverse-Effect-Level (NOAEL)
Highest dose with no adverse effects
Lowest-Observed-Adverse-Effect (LOAEL)
Lowest dose where effects are seen
Dose-Response Curve
Graph showing how response changes with increasing dose
Hazard vs Risk
-Hazard: Something you see or observe that could cause harm but you have not been exposed yet. Exposure is zero (See a shark in the water from the beach)
-Risk: If in the presence or in contact with the hazard, your exposure increases and this is a risk (raises the probability of risk) (in the water with the shark)
The US focuses more on what? Hazard or risk based assessment?
Risk based assessment
-Considers both hazard and exposure
-Evaluates Dose-Response curve
-Agencies based Dose-Response Assessment
Step 3: Exposure Assessment
Evaluating the extent, frequency, and duration of human or
environmental exposure to a hazard.
Key factors of Exposure Assessment:
- Source of Exposure – Air, water, food, soil, workplace.
- Exposure Pathways – Inhalation, ingestion, skin contact.
- Exposure Duration – Acute (short-term) vs. Chronic (long-term).
- Population at Risk – Workers, general public, vulnerable groups.
