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Dr. Manfred Wentz Director, Hohenstein Institutes (USA) Head, Oeko-Tex Certification Body (USA) AAFA – Environmental Committee Meeting November 10, 2008.

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Presentation on theme: "Dr. Manfred Wentz Director, Hohenstein Institutes (USA) Head, Oeko-Tex Certification Body (USA) AAFA – Environmental Committee Meeting November 10, 2008."— Presentation transcript:

1 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

2 Sustainability of Global Textile Market Triple Bottom Line (TBL) – Willard (2002) Economic Factors Social Responsibilities Environmental Issues 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 2

3 Environmental Sustainability AtmosphereAirWaterSoil 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 3

4 4 11/10/2008 4 Concept of Textile Ecology Production Ecology: Effects of production processes on people and environment (Oeko-Tex 1000). Human Ecology: Effects of textiles on people’s health and comfort (Oeko-Tex 100; AAFA/ETF/RSL) Performance Ecology: Textile care and effect on people and environment Disposal Ecology: Reuse, recycling and disposal

5 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 5 Human Health Risk Assessment Human Ecology Challenges (EPA) Life stageLow 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

6 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) 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 6

7 Toxics - Basic Definitions Chemical that is acutely highly toxic Poison: Harmful effects of poison Toxicity Study of adverse effects of chemicals on living organism Toxicology Evaluation of toxicity of a chemical based on human and animal data. Toxicity Assessment 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 7

8 Risk - Basic Definitions Risk Probability that a substance will cause harm Risk Assessment Determination of potential toxic effects due to chemical exposure Risk Management Actions to reduce or eliminate risk Risk Perception Risk perceived by individual or population 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 8

9 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 9 Exposure Dermal ContactInhalationIngestionOther Toxicity AcuteChronicCarcinogenicOther Exposure and Toxicity

10 Types of Toxic Effects on Humans Organ Toxicity Lung, Kidney, Liver, Multiple Receptors Human Carcinogenesis Carcinogenic, Likely, Suggestive, Inadequate Information, Not Likely (EPA 2005) Reproductive Toxicity Birth Defects Mutagenesis Genetic Changes 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 10

11 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 11 Risk Assessment and Management National Research Council (1983, 1996) Research: Laboratory and Field Observations of adverse Health Effects Experimental Assumptions (Extrapolations, Metabolism) Field Measurements (Exposures, Populations, Epidemiology) Risk Assessment Hazard Identification Dose-Response Assessment Exposure Assessment Risk Management: Voluntary Actions Regulatory Options 11/10/2008 11

12 Typical Assays for Human Risk Assessment 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 12 AssaySubjectsEndpointDose CriterionExtrapolation AmesBacteria Genetic Damage In VitroScreening AcuteRodentsDeath 50% Lethality (LD 50 ) None SubacuteRodentsMultiple Safe Level (NOAEL, MTD) Safety Factor Cancer -chronic RodentsCancer Acceptable Risk Level Mathematical Epidemiology -chronic HumansMultipleVariableNone

13 General Risk Assessment Process 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 13

14 EPA- Design for the Environment (DfE) Voluntary Stakeholder Program 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 14

15 Chemical and Pesticides Results Measures (CAPRM) 145 Environmental Indicators (EPA/OPPTS-FSU Project) 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 15 Human Health Ecological Health Chemical and Pesticides Food Safety Product Safety Transboundary Movement Product Steward ship Pollution Prevention

16 CAPRM /EPA Hierarchy of Indicators Pressure Indicators Measure of pressure on environment caused by human activities State Indicators Measures quality of environment and natural resources Effects Indicators Measures impact on environment Societal Response Regulatory and Community actions Data Characteristics and Limitations Methodology and strength or weakness of data 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 16

17 Complex Process of Regulatory Decisions Source: EPA Decision PoliticalLegalSocialRiskTechnologyEconomics 11/10/2008 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 17

18 M. Wentz, Oeko-Tex (USA) - AAFA/RSL 18 Factors Affecting Risk Perception “ Perception is Reality” Increased Public ConcernDecreased Public Concern Unfamiliar, not understood UncontrollableInvoluntaryChildren at riskNo trust in institutionMajor media attentionCaused by humans Familiar, understoodControllableVoluntaryChildren not at riskTrust in institutionLittle media attentionCaused by nature 11/10/2008 18


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