CUMULATIVE RISK PROJECT. Michael D. Larrañaga, PhD, PE, FAIHA Principal Consultant Dallas, TX

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1 CUMULATIVE RISK PROJECT Michael D. Larrañaga, PhD, PE, FAIHA Principal Consultant Dallas, TX 1

2 CUMULATIVE RISK 1964 Civil Rights Act Population-based approach for multiple environmental contaminants. Executive Order (1994) Address Environmental Justice (minorities/low-income/at risk). Food Quality Protection Act (1996) Required that EPA move past single chemical assessments and focus on the cumulative effects of multiple exposures occurring simultaneously, including pesticides/herbicides. EPA Risk Assessment Forum (1999) Development of EPA-wide Cumulative Risk Assessment Guidance EPA Cumulative Risk Assessment Framework (2003) NIOSH Mixed Exposures Report (2004) Consumer Product Safety Improvement Act (2008) CRA of Pthalate Mixtures in children s products 2

3 EARLY EPA CUMULATIVE RISK ASSESSMENT ACTIVITIES (CIRCA ) Superfund Cumulative risk considered for ecological risk assessments Office of Water Multiple stressors considered in ecological risk Cumulative Hazards, Exposures and Effects Multiple toxic contaminants in Urban Environments GIS approach for planning/scoping cumulative risks Office of Pesticide Programs Preliminary CRA for organophosphorous pesticides Total Risk Integrated Methodology (TRIM) Multi-media/multi-pathway human health and ecological assessment tool for human health and ecological risk assessments at neighborhood/city scale 3

4 EPA CRA Multiple Stressors Synergism/Addition/Antagonism Population focus Multiple durations, pathways, sources, routes of exposure Multiple effects/outcomes Quantification of risks 4

5 CUMULATIVE RISK WHAT IS IT (EPA)? Cumulative risk is the combined risks from aggregate exposures to multiple agents or stressors, which may include chemicals, biological or physical agents Cumulative risk assessment is an analysis, characterization, and possible quantification of the combined risks to human health or the environment from multiple agents or stressors CRA is population-based with stakeholder emphasis and consideration of Vulnerability Factors: Susceptibility/sensitivity (e.g., genetics, lifestages, disease states) Differential exposure (e.g., homes close to pollutant sources, diet of locally caught fish or game) Differential preparedness (e.g., lack of access to health care) Differential ability to recover (e.g., poor nutrition) 5

6 CRA EPA DEFINITION An analysis, characterization, and possible quantification of the combined risks to human health or the environment from multiple agents or stressors. 6

7 CRA - NAS DEFINITION The combination of risks posed by aggregate exposure to multiple agents or stressors in which aggregate exposure is exposure by all routes and pathways and from all sources of each given agent or stressor. 7

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9 CDC CUMULATIVE RISK ASSESSMENT PROJECT 9

10 CRA PROJECT 10

11 CURRENT CRA Current CRA approaches focus primarily on: Aggregate exposures to chemical classes with common toxic mechanisms Foods mercury (neurotoxicity) Pesticides - Neurotoxicity Environmental, community and residential issues Environmental justice EPA and academics CRA Project Proposes a Modified CRA Method 11

12 CRA PROJECT - MODIFIED CRA METHOD 12

13 OCCUPATIONAL ORF Health and Well-Being Non-ORF influence Knowledge of Exposome leads to enhanced exposure management and reduced incidence of disease [Schulte et al. (2011). Am J Public Health 102 (3): ]. 13

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15 THE CHALLENGE OF DELINEATING THE EXPOSOME External Exposures Socio-economic factors Environmental exposures Occupational risks Infection Dietary influences Social networks Behavioral norms/cues Other Internal Exposures Genetic factors Epigenetic factors Physiologic influences Immunity Habits/repetitive behaviors Retained, cumulative changes from prior exposures Other

16 CHALLENGES How do we integrate different forms of traditional stressors (i.e., hazards)? Ex: noise plus ototoxicants contributing to hearing loss Ex: history of hepatitis B and occupational exposures to vinyl chloride increasing the risk of liver cancer How do we integrate non-traditional stressors? Ex: psychological stressors

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20 JOB STRAIN - CARDIOVASCULAR HEALTH Risks of hypertension and high blood pressure associated with: Low promotion potential, little participation in decision-making, communication difficulties, unsupportive co-workers and foremen, and overall job dissatisfaction. Biological and psychological pathways: chronic stress, irritation, suppression of anger and problems, and selection by personality type. Job strain may produce cumulative wear (allostatic load), potentially suppressing immune function over time, increasing susceptibility, reducing systemic regulation, and increasing broad disease risk Source: Clougherty, J. E., Souza, K. and Cullen, M. R. (2010), Work and its role in shaping the social gradient in health. Annals of the New York Academy of Sciences, 1186: doi: /j x

21 BETTER JOBS = BETTER HEALTH Annals of the New York Academy of Sciences Volume 1186, Issue 1, pages , 16 FEB 2010 DOI: /j x

22 CRA PROJECT: PHASE 1 Large Team Recruitment Subject matter experts (SMEs) in the fields of toxicology, epidemiology, risk assessment/management, exposure science, behavioral science/psychology, statistics, and health policy SMEs from US federal agencies (NIOSH, ATSDR, NIEHS, NTP EPA, DOE), academia and private industry Small group to focus on specific topics Based on National Academies of Science Risk Assessment paradigm Hazard characterization/dose-response assessment Exposure assessment Risk characterization Risk management 22

23 PRIMARY QUESTIONS What are the issues that need to be addressed to advance the practice of CRA? What are the issues that need to be addressed to integrate CRA into the practice of occupational risk analysis? What are the data gaps and limitations that must be overcome to integrate PRF and ORF-based models in CRA? 23

24 PHASE 2: TERMINOLOGY 24

25 PHASE 3: FRAMEWORKS

26 PHASE 4: TOOLS AND METHODS Tools and approaches from community and environmental public health can be adapted for application in related risk assessment fields. Use of these tools and risk assessment approaches can also inform better risk management and control strategies. Tools may be developed further to integrate all CRA factors. 26

27 CONCLUSIONS Societal implications Challenges Opportunities Modern Risk Assessment is quickly evolving Risk is a concept in the eye of the beholder Technology Advancements in biology 27

28 THANK YOU L. Casey Chosewood, M.D., MPH (NIOSH/Total Worker Health) G. Scott Dotson, Ph.D. (NIOSH/Education and Information Division) Thomas J. Lentz, Ph.D. (NIOSH/Education and Information Division) Thomas Cunningham, Ph.D. (NIOSH/Education and Information Division) Glenn Rice, Sc.D. (USEPA/National Center for Environmental Assessment) 28

29 Michael Larrañaga