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Dr. Manfred Wentz Director, Hohenstein Institutes (USA) Head, Oeko-Tex Certification Body (USA) AAFA – Environmental Committee Meeting November 10, 2008 - Washington, D.C. Methodology of Human Risk Assesment 11/10/2008 1 M. Wentz, Oeko-Tex (USA) - AAFA/RSL

Methodology of Human Risk Assesment

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Methodology of Human Risk Assesment. Dr. Manfred Wentz Director, Hohenstein Institutes (USA) Head, Oeko-Tex Certification Body (USA) AAFA – Environmental Committee Meeting November 10, 2008 - Washington, D.C. Sustainability of Global Textile Market Triple Bottom Line (TBL) – Willard (2002). - PowerPoint PPT Presentation

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Page 1: Methodology of  Human Risk Assesment

Dr. Manfred WentzDirector, Hohenstein Institutes (USA)

Head, Oeko-Tex Certification Body (USA)

AAFA – Environmental Committee Meeting

November 10, 2008 - Washington, D.C.

Methodology of

Human Risk Assesment

11/10/20081 M. Wentz, Oeko-Tex (USA) - AAFA/RSL

Page 2: Methodology of  Human Risk Assesment

Sustainability of Global Textile MarketTriple Bottom Line (TBL) – Willard (2002)

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL2

Page 3: Methodology of  Human Risk Assesment

Environmental Sustainability

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL3

Page 4: Methodology of  Human Risk Assesment

M. Wentz, Oeko-Tex (USA) - AAFA/RSL4 11/10/20084

Concept of Textile Ecology

Page 5: Methodology of  Human Risk Assesment

M. Wentz, Oeko-Tex (USA) - AAFA/RSL5

Human Health Risk Assessment

Human Ecology Challenges (EPA)

Life stage

Low Dose

Acute

Cumulative

Characterizing uncertainty

(weight of evidence)

Estimating risk from diverse exposure

scenarios:

Applying novel biological data:

Improving human exposure assessment

Toxic genomic

11/10/2008

Page 6: Methodology of  Human Risk Assesment

What is a “Poison” ?“Dose makes the Poison”

“All things are poison, and nothing is without poison. It is the dose only that

makes a thing not a poison.”

Paracelsus (1494-1541)

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL6

Page 7: Methodology of  Human Risk Assesment

Toxics - Basic Definitions

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL7

Page 8: Methodology of  Human Risk Assesment

Risk - Basic Definitions

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL8

Page 9: Methodology of  Human Risk Assesment

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL9

Exposure and Toxicity

Page 10: Methodology of  Human Risk Assesment

Types of Toxic Effects on Humans

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL10

Page 11: Methodology of  Human Risk Assesment

M. Wentz, Oeko-Tex (USA) - AAFA/RSL11

Risk Assessment and ManagementNational Research Council (1983, 1996)

11/10/200811

Page 12: Methodology of  Human Risk Assesment

Typical Assays for Human Risk Assessment

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL12

Assay Subjects EndpointDose

CriterionExtrapolati

on

Ames BacteriaGenetic Damage

In Vitro Screening

Acute Rodents Death50%

Lethality(LD50)

None

Subacute Rodents MultipleSafe Level

(NOAEL, MTD)

Safety Factor

Cancer -chronic

Rodents CancerAcceptableRisk Level

Mathematical

Epidemiology

-chronicHumans Multiple Variable None

Page 13: Methodology of  Human Risk Assesment

General Risk Assessment Process

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL13

Page 14: Methodology of  Human Risk Assesment

EPA- Design for the Environment (DfE)Voluntary Stakeholder Program

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL14

Page 15: Methodology of  Human Risk Assesment

Chemical and Pesticides Results Measures (CAPRM) 145 Environmental Indicators (EPA/OPPTS-FSU Project)

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL15

Human Health

Ecological Health

Chemical and Pesticides

Food Safety

Product Safety

Transboundary Movement

Product Steward ship

Pollution Prevention

Page 16: Methodology of  Human Risk Assesment

CAPRM /EPA Hierarchy of Indicators

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL16

Page 17: Methodology of  Human Risk Assesment

Complex Process of Regulatory DecisionsSource: EPA

11/10/2008M. Wentz, Oeko-Tex (USA) - AAFA/RSL17

Page 18: Methodology of  Human Risk Assesment

M. Wentz, Oeko-Tex (USA) - AAFA/RSL18

Factors Affecting Risk Perception“Perception is Reality”

Increased Public Concern Decreased Public Concern

11/10/200818