Questions Flashcards
What is a pesticide?
- A pesticide is something that prevents, destroys, or controls a harmful organism (‘pest’) or disease
- Protects plants or plant products during production, storage and transport.
What is an active substance?
- Any chemical, plant extract, pheromone or microorganism (including viruses), that has action against pests or on plants, parts of plants or plant products.
- Before an active substance can be used within a plant protection product in the EU, it must be approved by the European Commission.
What is a plant protection product?
- Plant protection products are ‘pesticides’ that protect crops or desirable or useful plants.
- They are primarily used in the agricultural sector but also in forestry, horticulture, amenity areas and in home gardens.
- They contain at least one active substance and have one of the following functions:
- protect plants or plant products against pests/diseases before or after harvest
- influence the life processes of plants (such as substances influencing their growth, excluding nutrients)
- preserve plant products
- destroy or prevent growth of undesired plants or parts of plants.
What is a plant protection product formulation?
- A homogeneous and stable mixture of active and inert ingredients which make the final product simpler, safer, and more efficacious to apply to a target pest.
The inert ingredients may involve:
- The carrier (e.g. organic solvent or mineral clay)
- Surface active ingredients (e.g. stickers or spreaders)
- Other ingredients, such as stabilizers, dyes and chemicals that improve or enhance the activity of the plant protection product
Remember the directive 91/414/EEC- Why was this directive important?
- Initiated the harmonization of the registration procedures
- Each active substance had to be proofed safe before market entrance (comprehensive risk assessment and authorization procedure)
What´s the difference between regulation and a directive?
Regulation:
- A regulation is a binding legislative act. It must be applied in its entirety across the EU.
Directive:
- A directive is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals.
Directive 2009/128 EC Sustainable use directive- What is so particular about this one?
- It is the first directive focusing on the use phase
- encourages a low input agriculture (PPP should only be used as a last instance)
- Sustainable use, IPM
Who is responsible for the approving of active substances? Of PPP?
- Active substances EU level
- PPP member state level
Who is responsible to provide all the documentation about risk characteristics?
- The industry has to provide all the studies and data
What do the required studies focus on?
- Human health,
- Environmental risk,
- Residue levels,
- Efficacy data (does it work?)
Who makes the final decisions for approval?
- EFSA and the EU commission
For what period does an approval normally last?
- 10 years provided that no new data comes out that makes an other investigation necessary
- Know: Authorization is given only for particular crop/use
What are illegal PPP?
- Expired
- No label
- Counterfeited products
- Damaged products
- Forbidden products etc.
What could be reason for a emergency approval for PPPs?
- Emergency approval of plant protection products is foreseen by Article 53 of Regulation (EC) 1107/2009
- Under special circumstances for a period not exceeding 120 days
- In the case of new alien pests
Define risk assessment?
- a comprehensive evaluation process following scientific principles carried out in cooperation with experts
What is risk?
Risk= f(x) hazard (toxicity) x exposure
- Risk: The potential for injury to take place
- Hazard (toxicity): The capacity of a pesticide to cause injury
- Exposure: The amount of pesticide entering or contacting the body
What is the difference between acute and chronic effects?
- Toxicological testing evaluates whether short-term exposure to a plant protection product will produce:
1. acute effects (e.g., eye and skin irritation, death)
and whether long-term, continual exposure will cause
2.chronic effects (e.g., impaired liver function, reproductive abnormalities, cancer)
Define duration and magnitude of exposure?
- The duration and magnitude of exposure determine the severity of the adverse effect
Duration: increment of time during which exposure to the dose occurs
Magnitude of exposure: size and number of doses received
Know the concept of dose and response? Draw the dose response curve? What does the slope of the curve tell us? Interpretation of dose response relationships? Explain the different values like LD50 etc. – Will be a question!!
- The toxicity of a chemical substance is determined by quantifying the response of laboratory animals to a series of increasing doses
- The relationship between the administered dose and animal response is graphically depicted as the dose- response curve
- The higher the LD50 dose, the less acutely toxic the chemical substance
- The threshold level is the lowest dose that produces a measurable response in the most sensitive animals (Between NOEL and LOEL)
- The slope of the dose-response curve is of critical importance: a steep curve indicates only a slight difference between a nontoxic dose and a toxic dose

Human risk assessment- Risk assessment is a multi step process. What are the steps?
- Toxicity assessment: evaluation of intrinsic toxicity or hazard potential of the chemical
- Exposure assessment: estimation of potential human exposure to the chemical
- Risk characterization: evaluation of potential risk to humans
Human risk assessment- Risk assessment is a multi step process. What are the steps?
- Toxicity assessment: evaluation of intrinsic toxicity or hazard potential of the chemical
- Exposure assessment: estimation of potential human exposure to the chemical
- Risk characterization: evaluation of potential risk to humans
Routes of exposure- and which route plays are more important role for the consumers and which one for the operators? Question!!!
Plant protection products may enter the human body through:
- the skin (dermal exposure)
- the mouth (oral exposure)
- the lungs (respiratory exposure)
The site of exposure to the plant protection products impacts the rate of absorption into the bloodstream, as well as its distribution pattern
- General public exposure regards mainly residues in food and water (dietary exposure), but also residential exposure
- Occupational exposure occurs during manufacture, transport or use of plant protection products
Skin, Oral, Lungs (respiratory) –> Operator rather skin
Which are the factors that influence the dermal exposure? Question!!!
- Different anatomical sites
- Warm and moist areas with increased blood vessels
- Skin condition such as cuts, abrasions and rashes
- Type of plant protection product formulation
How does the dietary exposure estimation work?
- Main source of exposure for the general public
- Dietary exposure is a function of the type and amount of food consumed and the residues of the plant protection product in or on that food
- Two types of dietary exposure are generally considered: chronic and acute