Programme: Health Risk Assessment-Principles and Applications

March 20 – 24, 2017

IMM Institute of Environmental Medicine, KarolinskaInstitutet, Nobelsväg 13, Stockholm, Floor 2, Bergendorff room

Course leader: Anna Beronius

Monday March 20 / Tuesday March 21 / Wednesday March 22 / Thursday March 23 / Friday March 24
9.00-9.30
Welcome and introduction to the course(AB) / 9.00-9.45
In vitro studies used for risk assessment (AF) / 9.00-9.45
Derivation of health-based guidance values including exercise (AH) / 9.00-9.45
Case study: Risk assessment of air pollution (TB) / 9.00-9.45
Presentation and discussion of group work/Examination (AH, AB, IS, LW)
9.30-10.30
Concepts in risk assessment (AB) / 9.45-10.15
Coffee break / 9.45-10.15
Coffee break / 9.45-10.15
Coffee break / 9.45-10.15
Coffee break
10.30-11.00
Coffee break / 10.15-11.00
Epidemiology in risk assessment (GP) / 10.15-10.45
Derivation of health-based guidance values including exercise, cont. (AH) / 10.15-11.00
Case study: Risk assessment of bisphenol A (AB) / 10.15-12.30
Presentation and discussion of group work/Examination(AH, AB, IS, LW)
11.00-12.00
Web-based information sources for risk assessment (LW) / 11.15-12.00
Assessment of data (AB) / 11.00-12.00
Exposure assessment (MB) / 11.15-12.00
Discussion on how research can contribute to risk assessment (AB)
12.00-13.00
Lunch / 12.00-13.00
Lunch / 12.00-13.00
Lunch / 12.00-13.00
Lunch / 12.30-13.00
Course ending
13.00-14.00
Web-based information sources – exercise (LW) / 13.00-14.00
Risk assessment for the REACH legislation (BOL) / 13.00-14.00
Case studies: Risk assessment of cadmium, lead and methylmercury(AÅ, MK) / 13.00-14.00
Group work (AB, IS, LW)
14.00-14.30
Coffee break / 14.00-14.30
Coffee break / 14.00-14.30
Coffee break / 14.00-14.30
Coffee break
14.30-16.00
Toxicity testing and test guidelines (LW) / 14.30-17.00
Group work (AB, IS, LW) / 14.30-17.00
Group work (AB, IS, LW) / 14.30-17.00
Group work (AB, IS, LW)
16.00-17.00
Presentation of participants
17.00Get-together

Teachers:

AB – Anna Beronius, IMM, KI

AF – Anna Forsby, Stockholm university/Swetox

AH – Annika Hanberg, IMM, KI

AÅ – Agneta Åkesson, IMM, KI

BOL – Bert-Ove Lund, Swedish Chemicals Agency

GP – Göran Pershagen, IMM, KI

IS – Ilona Silins, IMM, KI

JZ – Johanna Zilliacus, IMM, KI

LW – Lars Wiklund, RegSafe

MB–Marika Berglund, IMM, KI

MK – Maria Kippler, IMM, KI

TB – Tom Bellander, IMM, KI

Course information

Learning outcomes:

Upon completion of the course, the student should be able to:

  • describe the basic concepts and principles of health risk assessment of chemical substances
  • explain how different types of data from in vivo/animal, epidemiological and in vitro studies as well as exposure data are used in risk assessment
  • assess the relevance and reliability of data used in risk assessment
  • derive health based guidance values such as Acceptable Daily Intake (ADI) based on the data
  • reflect on the role of health risk assessment in regulatory decision making

Content of the course:

Health risk assessment of chemicals is the scientific method to assess the risk to humans of exposure to different types of chemical substances, such as pharmaceuticals, environmental pollutants, chemicals in cosmetics, clothing or other everyday products and pesticide residues, food additives and other substances in food.

The course starts off with introducing the concepts in risk assessment, e.g. aims of risk assessment, role of risk assessment in risk analysis (risk assessment, risk management, risk communication), different steps in risk assessment (hazard identification, hazard characterisation, exposure assessment, risk characterisation). It moves on to the different types of data from in vivo/animal, epidemiological and in vitro studies as well as exposure data that are used in risk assessment. Thereafter it is discussed how the relevance and reliability of the data is assessed, and how different kind of evidence is integrated (for example from animal and epidemiological studies). The principles on how to derive health-based guidance values such as Acceptable Daily Intake (ADI) and to derive Margins of Safety values based on the data are exercised. The course then moves on to provide examples of the role of risk assessment in regulatory decision making. Case studies of different types of risk assessments exemplify how research connects to risk assessment activities. The participants will also discuss how their own research can contribute to risk assessments.

Content of individual teaching and learning activities:

Concepts in risk assessment (lecture)

Introduction to the main concepts in risk assessment that will be dealt with in more depth in the rest of the course. Including e.g. aims of risk assessment, role of risk assessment in risk analysis (risk assessment, risk management, risk communication), different steps in risk assessment (hazard identification, hazard characterisation, exposure assessment, risk characterisation), introduction to different kind of data used in risk assessment (animal data, epidemiological data, in vitro data).

Web-based information sources in risk assessment (lecture and exercise)

Identification and assessment of web-based data sources to be used in risk assessment, including exercise to familiarize the participants with the information sources.

Toxicity testing and test guidelines(lecture)

Overview of in vivo animal studies used for risk assessment, including test guidelines.

In vitro studies usedfor risk assessment (lecture)

Development of in vitro methods and the use of in vitro data in risk assessment.

Epidemiology in risk assessment (lecture)

Principles for epidemiological studies, use of epidemiological data in risk assessment, challenges in evaluation of epidemiological data. Example from own experience.

Assessment of data (lecture)

Assessment of different types of data (animal studies, epidemiological studies, in vitro studies) for risk assessment. How can the data be used, reliability and relevance of the data, criteria for use of data, integration of different types of data, weight of evidence.

Risk assessment for the REACH legislation (lecture)

REACH legislation and risk assessment procedures including example from own experience.

Derivation of health-based guidance values (lecture and exercise)

Principles on how to identify point-of departure and derive health-based guidance values. Calculation of different health-based guidance values (ADI, TDI, DNEL, RfD) and Margin of Safety/Exposure.

Exposure assessment (lecture)

Principles of exposure assessment for use in risk assessment.

Case studies of risk assessments (lectures)

Examples of risk assessments performed by IMM researchers. Examples are chosen to show a variety of risk assessments, where different types of data have been guiding the conclusions of the risk assessment. Bisphenol A (animal data), air pollution(epidemiological data), as well as cadmium, lead and methylmercury(epidemiological data). Discussion on how research can contribute to risk assessment.

Group work

Group work to apply the knowledge in the course on a real example. The groups analyse critically a risk assessment of a compound and present their results orally. The presentations are discussed by the other participants.

Examination

The examination is based on the presentations and the discussions of the group work.