A key aspect of fit for purpose

It is important that risk assessments not be manipulated to support a predetermined policy or management choice.

Initial steps prior to conducting a risk assessment: Planning & Scoping

Gathering lots of information with all the right people regarding the risk assessment tasks to be completed

Initial steps prior to conducting a risk assessment: Problem Formulation

Taking all the information from the planning & scoping phase to create a conceptual model and an analysis plan

The EPA “Framework” reading discussed 6 categories of information that should be considered in this initial phase:

1. Context, purpose & scope 2. Overarching considerations 3. Responsibilities, resources & timeline 4. Scientific peer review & other reviews 5. Public, stakeholder & community involvement 6. Past experiences and assessments

The decision-making situation, including regulatory or statutory requirements

The decision to be informed. • Identify the goals, objectives and broad elements of the assessment.

The boundaries of the assessment (e.g. which chemicals and exposure pathways will be addressed)

Overarching considerations are:

Children’s environmental health protection, Cumulative risk assessment, Environmental Justice, Sustainability

Responsibilities, resources & timeline require:

Require a team approach. Identify the team during Planning & Scoping.

Scientific peer review & other reviews

Qualified individuals not involved in the risk assessment critically evaluate the scientific or technical work products to ensure they are competently performed, properly documented and consistent with established quality criteria

Problem Formulation: Conceptual Model

• A written description and a visual representation • Can be simple or complex depending on the situation • Can identify factors that won’t be included in the risk assessment

Problem Formulation: Analysis Plan

• Final stage of problem formulation • Describes intentions for the assessment, as discussed during planning & scoping • Provides details on the planned technical aspects of the assessment

While the conceptual model may identify a larger set of relationships, the analysis plan focuses on:

The relationships that will be studied in the risk assessment

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Risk Assessment P1

Risk Assessment Phase 1 Planning & Scoping & Problem Formulation

Question	Answer
A key aspect of fit for purpose	It is important that risk assessments not be manipulated to support a predetermined policy or management choice.
The assessment is “fit” ____________ the pre-identified and explicitly stated purpose of the assessment	= designed to match up with
Initial steps prior to conducting a risk assessment: Planning & Scoping	Gathering lots of information with all the right people regarding the risk assessment tasks to be completed
Initial steps prior to conducting a risk assessment: Problem Formulation	Taking all the information from the planning & scoping phase to create a conceptual model and an analysis plan
The EPA “Framework” reading discussed 6 categories of information that should be considered in this initial phase:	1. Context, purpose & scope 2. Overarching considerations 3. Responsibilities, resources & timeline 4. Scientific peer review & other reviews 5. Public, stakeholder & community involvement 6. Past experiences and assessments
Context	The decision-making situation, including regulatory or statutory requirements
Purpose	The decision to be informed. • Identify the goals, objectives and broad elements of the assessment.
Scope	The boundaries of the assessment (e.g. which chemicals and exposure pathways will be addressed)
Overarching considerations are:	Children’s environmental health protection, Cumulative risk assessment, Environmental Justice, Sustainability
Responsibilities, resources & timeline require:	Require a team approach. Identify the team during Planning & Scoping.
Scientific peer review & other reviews	Qualified individuals not involved in the risk assessment critically evaluate the scientific or technical work products to ensure they are competently performed, properly documented and consistent with established quality criteria
Problem Formulation: Conceptual Model	• A written description and a visual representation • Can be simple or complex depending on the situation • Can identify factors that won’t be included in the risk assessment
Problem Formulation: Analysis Plan	• Final stage of problem formulation • Describes intentions for the assessment, as discussed during planning & scoping • Provides details on the planned technical aspects of the assessment
While the conceptual model may identify a larger set of relationships, the analysis plan focuses on:	The relationships that will be studied in the risk assessment

Created by: cheche.stoddard

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