Presentation by Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University, at the Workshop on Risk Assessment in Regulatory Policy Analysis (RIA), Session 9, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
Presentation by Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University, at the Workshop on Risk Assessment in Regulatory Policy Analysis (RIA), Session 5, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
Risk-based Regulation: OECD Best Practice Principles, Nick MalyshevOECD Governance
Presentation by Nick Malyshev, Head of the OECD Regulatory Policy Divison, Directorate for Public Governance and Terrritorial Development, at the Workshop on Risk Assessment in Regulatory Policy Analysis (RIA), Session 3, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
Presentation by Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University, at the Workshop on Risk Assessment in Regulatory Policy Analysis (RIA), Session 5, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
Risk-based Regulation: OECD Best Practice Principles, Nick MalyshevOECD Governance
Presentation by Nick Malyshev, Head of the OECD Regulatory Policy Divison, Directorate for Public Governance and Terrritorial Development, at the Workshop on Risk Assessment in Regulatory Policy Analysis (RIA), Session 3, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
INTRODUCTION TO WATER POLLUTION PARAMETERS -CONCEPT, OBJECTIVES AND NEED OF W...Arvind Kumar
INTRODUCTION TO WATER POLLUTION PARAMETERS
-CONCEPT, OBJECTIVES AND NEED OF WATER QUALITY MONITORING, SAMPLING AND ANALYSIS
by DR. I.D. MALLDepartment of Chemical Engg.Indian Institute of Technology, RoorkeeRoorkee- 247667
Modeling Dose Response for Risk Assessment, George GrayOECD Governance
Presentation by Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University, at the Workshop on Risk Assessment in Regulatory Policy Analysis (RIA), Session 11, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
Training slides of Environmental Risk Management addressing issues on the importance of preserving the nature while doing business. Some important highlights:
- Environmental Risk Assessment
- Environmental Degradation
- Disaster Risk Management
- Environment & Sustainability
- Environmental Management Plan
Contact us for further information regarding the training course: info@asia-masters.com
This presentation was delivered as part of ICEM and PACT training course on Strategic Environmental Assessments in the context of energy development in the Greater Mekong Subregion in May 2016.
Risk Management Process Steps Powerpoint Presentation SlidesSlideTeam
“You can download this product from SlideTeam.net”
Download Risk Management Process Steps PowerPoint Presentation Slides to identify and manage potential business risk. This risk analysis and management PowerPoint complete deck includes content ready slides such as risk management lifecycle, types of risks, risk categories, stakeholder’s management and engagement, risk appetite and tolerance, procedure, risk management plan, risk identification, risk register, risk assessment, risk analysis, risk response plan, risk response matrix, risk control matrix, risk items tracking, tools and practices, risk impact & profitability analysis, risk mitigations strategies, plans, qualitative and quantitative risk analysis, etc. The content given in this Presentation has been researched by our team of experts. All slides are easy to customize. Users can edit these templates as per their requirements. Showcase risk evaluation and analysis techniques with risk response plan PPT Slides. Demonstrate the risk aspect involved in the project using the risk management approach and plan presentation graphics. Our Risk Management Process Steps Powerpoint Presentation Slides come in a fantastic array. They offer a broad canvas of exclusive craftsmanship. https://bit.ly/30Cg1VG
Risk Analysis is a process that helps identify and assess potential threats that could affect the success of a business or project. It allows to examine the risks and includes means to measure, mitigate and control them effectively.
the occupational exposure limit (OEL) represents the maximum airborne concentration of a toxic substance to which a worker can be exposed over a period of time without suffering any harmful consequences.
In this webinar, we talk about the risks associated with colorectal cancer – including everything from diet, lifestyle, age, family history and more. We review the risks of recurrence for colorectal cancer survivors. Join us to learn how to reduce your risk of colorectal cancer!
Presented by Harvey Murff, M.D, M.P.H. is an Associate Professor of Medicine in the Division of General Internal Medicine and Public Health at Vanderbilt University
INTRODUCTION TO WATER POLLUTION PARAMETERS -CONCEPT, OBJECTIVES AND NEED OF W...Arvind Kumar
INTRODUCTION TO WATER POLLUTION PARAMETERS
-CONCEPT, OBJECTIVES AND NEED OF WATER QUALITY MONITORING, SAMPLING AND ANALYSIS
by DR. I.D. MALLDepartment of Chemical Engg.Indian Institute of Technology, RoorkeeRoorkee- 247667
Modeling Dose Response for Risk Assessment, George GrayOECD Governance
Presentation by Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University, at the Workshop on Risk Assessment in Regulatory Policy Analysis (RIA), Session 11, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
Training slides of Environmental Risk Management addressing issues on the importance of preserving the nature while doing business. Some important highlights:
- Environmental Risk Assessment
- Environmental Degradation
- Disaster Risk Management
- Environment & Sustainability
- Environmental Management Plan
Contact us for further information regarding the training course: info@asia-masters.com
This presentation was delivered as part of ICEM and PACT training course on Strategic Environmental Assessments in the context of energy development in the Greater Mekong Subregion in May 2016.
Risk Management Process Steps Powerpoint Presentation SlidesSlideTeam
“You can download this product from SlideTeam.net”
Download Risk Management Process Steps PowerPoint Presentation Slides to identify and manage potential business risk. This risk analysis and management PowerPoint complete deck includes content ready slides such as risk management lifecycle, types of risks, risk categories, stakeholder’s management and engagement, risk appetite and tolerance, procedure, risk management plan, risk identification, risk register, risk assessment, risk analysis, risk response plan, risk response matrix, risk control matrix, risk items tracking, tools and practices, risk impact & profitability analysis, risk mitigations strategies, plans, qualitative and quantitative risk analysis, etc. The content given in this Presentation has been researched by our team of experts. All slides are easy to customize. Users can edit these templates as per their requirements. Showcase risk evaluation and analysis techniques with risk response plan PPT Slides. Demonstrate the risk aspect involved in the project using the risk management approach and plan presentation graphics. Our Risk Management Process Steps Powerpoint Presentation Slides come in a fantastic array. They offer a broad canvas of exclusive craftsmanship. https://bit.ly/30Cg1VG
Risk Analysis is a process that helps identify and assess potential threats that could affect the success of a business or project. It allows to examine the risks and includes means to measure, mitigate and control them effectively.
the occupational exposure limit (OEL) represents the maximum airborne concentration of a toxic substance to which a worker can be exposed over a period of time without suffering any harmful consequences.
In this webinar, we talk about the risks associated with colorectal cancer – including everything from diet, lifestyle, age, family history and more. We review the risks of recurrence for colorectal cancer survivors. Join us to learn how to reduce your risk of colorectal cancer!
Presented by Harvey Murff, M.D, M.P.H. is an Associate Professor of Medicine in the Division of General Internal Medicine and Public Health at Vanderbilt University
What are the five critical elements ensuring the program planning success?
1) Mobilizing the community
2) Collecting and organizing data
3) Choosing health priorities
4) Developing a comprehensive intervention plan
5) Evaluating PATCH
The four Multiple Determinants of Chronic Disease?
1) Behavioral determinants
2) Healthcare determinants
3) Environmental determinants
4) Social determinants.
What is Epidemiology?
distribution and determinants of health-related states in specified populations, and the application of this study to the control of health problems
compare between person analyzes and Time analyses?
Person: distribution of a disease or condition varies in the population according to personal characteristics, such as age, race, or gender
Time: surveillance systems monitor the trends in occurrence of chronic disease rates through utilizing the epidemic curve to detect outbreaks
4 elements for Health Believe Model
1) Perceived suscssibility
2) Perceived severity
3) Perceived benefits
4) Perceived barrier
5) Cuss action
6) Self-efficacy
cause of tobacco use?
1) Societal and individual factors
2) Advertising and promotion (tobacco” Safer)
3) Access
4) Social norms
5) Individual psychosocial factors
6) Continued tobacco use
7) Inadequate understanding
8) Lower price
elements of a chronic disease surveillance system:
1) Notifiable Disease Systems
2) statistics vital
3) Sentinel Surveillance
4) Chronic Disease Registries
5) Health Surveys
6) Administrative Data Collection Systems
7) Census Data
Cohort, case control & survival studies-2014Ramnath Takiar
The presentation discusses about Cohort, Case-control and Survival studies. The concept of Cohort and Case-control studies is explained with the help of diagrams as perceived by me. Some discussion is also there about survival and relative survival. Appropriate data is also provided to explain about survival and relative survival.
Case-control studies are observational studies, where two groups determine the level of exposure to a risk or a disease, by identifying a group of individuals with disease and for purpose of comparison, a group of people without the disease.
Mey Akashah, "Risk Assessment and Improved Decision-Making," Harvard School of Public Health, Harvard Medical School, and Harvard Extension School, April 5 2012.
Course: Human Health and Global Environmental Change
Introduction to Epidemiology
History of Epidemiology.
Definition of Epidemiology and its components.
Epidemiological Basic concepts.
Aims of Epidemiology.
Ten Uses of Epidemiology.
Scope or The Areas of Application .
Types of Epidemiological Studies.
Summary of the OECD expert meeting: Construction Risk Management in Infrastru...OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
Using AI led assurance to deliver projects on time and on budget - D. Amratia...OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
ECI in Sweden - A. Kadefors, KTH Royal Institute of Technology, Stockholm (SE)OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
Building Client Capability to Deliver Megaprojects - J. Denicol, professor at...OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
Procurement strategy in major infrastructure: The AS-IS and STEPS - D. Makovš...OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
Procurement of major infrastructure projects 2017-22 - B. Hasselgren, Senior ...OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
ECI Dutch Experience - A. Chao, Partner, Bird&Bird & J. de Koning, Head of Co...OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
ECI in Sweden - A. Kadefors, KTH Royal Institute of Technology, StockholmOECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
EPEC's perception of market developments - E. Farquharson, Principal Adviser,...OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
Geographical scope of the lines in Design and Build - B.Dupuis, Executive Dir...OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
Executive Agency of the Dutch Ministry of Infrastructure and Water Management...OECD Governance
Presented at the OECD expert meeting "Construction Risk Management in Infrastructure Procurement: The Loss of Appetite for Fixed-Price Contracts", held on 17 May 2023 at the OECD, Paris and online.
Presentation of OECD Government at a Glance 2023OECD Governance
Paris, 30 June, 2023
Presentation by Elsa Pilichowski, Director for Public Governance, OECD.
The 2023 edition of Government at a Glance provides a comprehensive overview of public governance and public administration practices in OECD Member and partner countries. It includes indicators on trust in public institutions and satisfaction with public services, as well as evidence on good governance practices in areas such as the policy cycle, budgeting, procurement, infrastructure planning and delivery, regulatory governance, digital government and open government data. Finally, it provides information on what resources public institutions use and how they are managed, including public finances, public employment, and human resources management. Government at a Glance allows for cross-country comparisons and helps identify trends, best practices, and areas for improvement in the public sector.
See: https://www.oecd.org/publication/government-at-a-glance/2023/
The Protection and Promotion of Civic Space: Strengthening Alignment with Int...OECD Governance
Infographics from the OECD report "The Protection and Promotion of Civic Space Strengthening Alignment with International Standards and Guidance".
See: https://www.oecd.org/gov/the-protection-and-promotion-of-civic-space-d234e975-en.htm
OECD Publication "Building Financial Resilience
to Climate Impacts. A Framework for Governments to manage the risks of Losses and Damages.
Governments are facing significant climate-related risks from the expected increase in frequency and intensity of cyclones, floods, fires, and other climate-related extreme events. The report Building Financial Resilience to Climate Impacts: A Framework for Governments to Manage the Risks of Losses and Damages provides a strategic framework to help governments, particularly those in emerging market and developing economies, strengthen their capacity to manage the financial implications of climate-related risks. Published in December 2022.
OECD presentation "Strengthening climate and environmental considerations in infrastructure and budget appraisal tools"
by Margaux Lelong and Ana Maria Ruiz during the 9th Meeting of the OECD Paris Collaborative on Green Budgeting held on 17 and 18 of April 2023 in Paris.
OECD presentation "Building Financial Resilience to Climate Impacts. A Framework to Manage the Risks of Losses and Damages" by Andrew Blazey, Stéphane Jacobzone and Titouan Chassagne. Presented during the 9th Meeting of the OECD Paris Collaborative on Green Budgeting held on 17 and 18 of April 2023 in Paris
OECD Presentation "Financial reporting, sustainability information and assurance" by Peter Welch during the 5th Session during the 9th Meeting of the OECD Paris Collaborative on Green Budgeting held on 17 and 18 of April 2023 in Paris
Presentation "Developments in sovereign green bond markets" by Ms. Fatos Koc during the 4th Session of 9th Meeting of the OECD Paris Collaborative on Green Budgeting held on 17 and 18 of April 2023 in Paris.
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
Monitoring Health for the SDGs - Global Health Statistics 2024 - WHOChristina Parmionova
The 2024 World Health Statistics edition reviews more than 50 health-related indicators from the Sustainable Development Goals and WHO’s Thirteenth General Programme of Work. It also highlights the findings from the Global health estimates 2021, notably the impact of the COVID-19 pandemic on life expectancy and healthy life expectancy.
Donate to charity during this holiday seasonSERUDS INDIA
For people who have money and are philanthropic, there are infinite opportunities to gift a needy person or child a Merry Christmas. Even if you are living on a shoestring budget, you will be surprised at how much you can do.
Donate Us
https://serudsindia.org/how-to-donate-to-charity-during-this-holiday-season/
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ZGB - The Role of Generative AI in Government transformation.pdfSaeed Al Dhaheri
This keynote was presented during the the 7th edition of the UAE Hackathon 2024. It highlights the role of AI and Generative AI in addressing government transformation to achieve zero government bureaucracy
Understanding the Challenges of Street ChildrenSERUDS INDIA
By raising awareness, providing support, advocating for change, and offering assistance to children in need, individuals can play a crucial role in improving the lives of street children and helping them realize their full potential
Donate Us
https://serudsindia.org/how-individuals-can-support-street-children-in-india/
#donatefororphan, #donateforhomelesschildren, #childeducation, #ngochildeducation, #donateforeducation, #donationforchildeducation, #sponsorforpoorchild, #sponsororphanage #sponsororphanchild, #donation, #education, #charity, #educationforchild, #seruds, #kurnool, #joyhome
This session provides a comprehensive overview of the latest updates to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (commonly known as the Uniform Guidance) outlined in the 2 CFR 200.
With a focus on the 2024 revisions issued by the Office of Management and Budget (OMB), participants will gain insight into the key changes affecting federal grant recipients. The session will delve into critical regulatory updates, providing attendees with the knowledge and tools necessary to navigate and comply with the evolving landscape of federal grant management.
Learning Objectives:
- Understand the rationale behind the 2024 updates to the Uniform Guidance outlined in 2 CFR 200, and their implications for federal grant recipients.
- Identify the key changes and revisions introduced by the Office of Management and Budget (OMB) in the 2024 edition of 2 CFR 200.
- Gain proficiency in applying the updated regulations to ensure compliance with federal grant requirements and avoid potential audit findings.
- Develop strategies for effectively implementing the new guidelines within the grant management processes of their respective organizations, fostering efficiency and accountability in federal grant administration.
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
Presentation by Jared Jageler, David Adler, Noelia Duchovny, and Evan Herrnstadt, analysts in CBO’s Microeconomic Studies and Health Analysis Divisions, at the Association of Environmental and Resource Economists Summer Conference.
2017 Omnibus Rules on Appointments and Other Human Resource Actions, As Amended
Hazard Identification
1. Center for Risk Science and Public Health
Hazard Identification
George Gray
Center for Risk Science and Public Health
Department of Environmental and Occupational Health
Milken Institute School of Public Health
2. Center for Risk Science and Public Health
Actuarial vs Modeled Risks
• Actuarial Risks
• based on previous experience with the same risk
• predictions can be made with a great deal of
precision
• examples include diseases, auto accidents, etc.
• Modeled Risks
• based on data and theory not direct observation of
the risk
• predictions subject to considerable uncertainty
• examples include cancer risk from chemicals , global
warming, etc.
3. Center for Risk Science and Public Health
How is Risk Assessment
Done?
• Hazard Identification
• Dose-Response Evaluation
• Exposure Assessment
• Risk Characterization
4. Center for Risk Science and Public Health
Hazard Identification Asks the
Questions:
• What harmful effects is the agent capable of
causing?
• At what doses are the effects seen?
• Is there additional information which can help us
understand the hazard posed by the agent?
5. Center for Risk Science and Public Health
Hazard Identification and
Causality
• Hazard identification is really about judging the
weight of evidence for a causal relationship between
an agent and an outcome
• All of our sources of information have uncertainty
• Epidemiology – bias, confounding, conflicting data
• Toxicology – relevance of animal models,
relevance of high doses, what is adverse
response?
6. Center for Risk Science and Public Health
Some Definitions
• “The purpose of hazard assessment is to review and
evaluate data pertinent to two questions: (1) whether
an agent may pose a carcinogenic hazard to human
beings and (2) under what circumstances an
identified hazard may be expressed.
US EPA - Proposed Guidelines for Carcinogen Risk Assessment EPA/600/
P-92/003C
• “Hazard Identification is the identification of the
adverse effects which a substance has the inherent
capacity to cause”
Commission Directive 93/67/EEC, Article 2
7. Center for Risk Science and Public Health
Types of Adverse Effects
• Acute toxicity
• Irritation
• Corrosivity
• Sensitization
• Repeated dose toxicity
• Mutagenicity
• Carcinogenicity
• Toxicity for reproduction
Source: Commission Directive 93/67/EEC, Annex I
8. Center for Risk Science and Public Health
Determining Hazard
• Epidemiology
• Study of disease rates in human populations with, and without
exposure to chemical under study
• Can discover a statistical association between exposure and disease
• Rarely can establish causal relationship or mechanism of disease
causation
• Toxicology
• Tests in animals
• Measure many potential types of toxicity
• Well controlled experiments
• Have to generalize results across species and to different exposures
9. Center for Risk Science and Public Health
Key Questions in
Epidemiology
• Is an association different than would be expected by
random chance?
• Have relevant confounders been ruled out?
• Is the association biologically-plausible?
10. Center for Risk Science and Public Health
Random Chance?
• Usually accounted for through tests of statistical
significance
• Beware multiple comparisons
• Hypothesis testing or hypothesis generating study?
11. Center for Risk Science and Public Health
Coffee Drinking
Smoking
Pancreatic Cancer
Confounding
• One of the most tricky and contentious issues in
interpretation of epidemiological studies
• Often “controlled” through statistical methods - questions
about adequacy
12. Center for Risk Science and Public Health
Biologically Plausible?
• Is plausibility argument post hoc or part of hypothesis
testing?
• Plausible doesn’t mean right
• Important factor in weight of evidence for causality
based on epidemiology
13. Center for Risk Science and Public Health
Toxicity Testing
• Tests conducted on animals (usually rodents) to
assess and study adverse effects
• Rodents chosen for short life, small size and
relatively easy care
• Tests can address acute (1-7 days), subchronic (3-6
months), or chronic (1-2 years) toxicity
• Other tests look at isolated tissues, cells or
biomolecules
14. Center for Risk Science and Public Health
Key Questions for Toxicology
• Are animals like humans? (and vice versa)
• Can effects be extrapolated from different exposure
levels?
• What is an adverse response?
15. Center for Risk Science and Public Health
Animals to Humans: Cancer
Bioassays
Question 1 - Animal to Human Extrapolation of Effect
• How well does carcinogenesis translate across species?
• all known human carcinogens are carcinogenic to some
animal species under some conditions
• concordance between rats and mice is 71% - very rarely
same type of cancer
• concordance between mice and rats is 75%
• male rat to female rat concordance is 87%
• male mouse to female mouse concordance is 89%
• Is there reason to believe that there may be species
specific carcinogenic responses?
• d-limonene
• human specific responses?
16. Center for Risk Science and Public Health
• To maximize sensitivity, rodents are exposed to chemicals at
levels 1000 to 10,000 times higher than environmental
exposures
• Question 2: Are Carcinogenic effects observed at high doses in
animal tests relevant to human responses at low doses?
• Yes
• Mutational theory of carcinogenesis
• Assumption of no threshold for carcinogenic effects
• No
• All toxicological effects have thresholds
• Mechanisms of high dose carcinogenesis will not apply to
low dose exposure
Dose Extrapolation: Cancer
Bioassays
17. Center for Risk Science and Public Health
What is an Adverse Response?
Rodent Cancer Bioassays
Question 3 - What is a carcinogenic response in an animal
bioassay?
• Response in any tested animals?
• In National Toxicology Program bioassays, of all positive
studies
• 28 % of tests are positive in all 4 sex/species
• 16 % are positive in 3 out of 4
• 35 % are positive in 2 out of 4 (usually same species)
• 21 % are positive in 1 out of 4
• What about tumors in rodent organs with no human
equivalent?
• Focus on specific tumor types or overall cancer rate?
18. Center for Risk Science and Public Health
Individual Tumor Rates Can
Increase
Dose
ProportionResponding
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
100.0
0 1 10 100
liver tumors
pulmonary
tumors
19. Center for Risk Science and Public Health
Individual Tumor Rates Can
Decrease
Dose
ProportionResponding
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
100.0
0 1 10 100
mammary gland tumors uterus tumors
20. Center for Risk Science and Public Health
What if We Look at Total
Tumor Rate?
Dose
0.0
50.0
100.0
150.0
200.0
250.0
300.0
0 1 10 100
total tumors
21. Center for Risk Science and Public Health
Judging Hazard - Risk
Assessment
• Risk assessment
• Arose for use in setting standards and limits
• Needs to operate in the face of scientific uncertainty
• “as an Agency policy, risk assessment procedures,
including default options that are used in the absence of
scientific data to the contrary, should be health protective.”
“Use of health protective risk assessment procedures as
described in these cancer guidelines means that estimates,
while uncertain, are more likely to overstate than
understate hazard and/or risk.”
U.S. EPA Risk Assessment Forum (2005) Guidelines for Carcinogen Risk Assessment. EPA/630/P-03/001F
22. Center for Risk Science and Public Health
Choices in Hazard
Identification
Question
• Which species best predicts
human response?
• Which sex best predicts
human response?
• Are carcinogenic effects in
animals exposed to levels of
chemical 10,000 time higher
than human exposure
relevant?
Regulatory Risk
Assessment Choice
⇒ The most sensitive
⇒ The most sensitive
⇒ Yes
23. Center for Risk Science and Public Health
Potential Cancer Hazards
Identified by Animal Bioassays
Several hundred compounds have been found to increase some type of tumor in
rodents in a standard 2 year bioassay
Agent Animal Evidence Human Evidence
Acrylamide sufficient inadequate
Chloroform sufficient inadequate
Carbon Tetrachloride sufficient inadequate
1,4-Dioxane sufficient inadequate
Naphthalene sufficient no adequate data
Ochratoxin A sufficient inadequate
Phenytoin sufficient no adequate data
PCBs sufficient inadequate/conflicting
Source: U.S. DHHS 12th Report on Carcinogens
24. Center for Risk Science and Public Health
Using Hazard Data
• U.S. EPA or IARC Carcinogen Classification
• EU “List of Dangerous Substances”
• FDA “Bad Bug Book”
• May trigger labeling requirements - e.g.,
• Directive 67/548/EEC and amendments
• US EPA Pesticide labels
25. Center for Risk Science and Public Health
IARC Carcinogen
Classification
Category* Description Human Evidence Animal Evidence
1 carcinogenic sufficient none, inadequate,
to humans limited or sufficient
2A probably limited sufficient
2B possibly none or inadequate sufficient
3 not classifiable none or inadequate inadequate or limited
4 probably not suggests not suggests not
carcinogenic carcinogenic carcinogenic
*All categories can be modified with sufficient supporting mechanistic information
26. Center for Risk Science and Public Health
EPA Hazard Descriptors
• Carcinogenic to Humans
• Likely to Be Carcinogenic to Humans
• Suggestive Evidence of Carcinogenic Potential
• Inadequate Information to Assess Carcinogenic Potential
• Not Likely to Be Carcinogenic to Humans
• Multiple descriptors allowed for single compound (i.e.,
route specific or dose-dependent carcinogenicity)
• Accompanied by 1-2 page Hazard Characterization
27. Center for Risk Science and Public Health
Uncertainty Does Exist
28. Center for Risk Science and Public Health
FDA
• Although research is ongoing, the
Food and Drug Administration (FDA)
says that available scientific evidence
—including World Health Organization
(WHO) findings released May 17,
2010—shows no increased health risk
due to radio- frequency (RF) energy, a
form of electromagnetic radiation that
is emitted by cell phones.
• Despite the dramatic increase in cell
phone use, occurrences of brain
cancer did not increase between 1987
and 2005.
29. Center for Risk Science and Public Health
International Agency for
Research on Cancer
• "After reviewing all the evidence available,
the IARC working group classified
radiofrequency electromagnetic fields as
possibly carcinogenic to humans," panel
chairman Jonathan Samet, MD, chair of
preventive medicine at the USC Keck
School of Medicine, said at a news
teleconference. "We reached this
conclusion based on a review of human
evidence showing increased risk of
glioma, a malignant type of brain cancer,
in association with wireless phone use."
30. Center for Risk Science and Public Health
National Cancer Institute
• Studies thus far have not shown a
consistent link between cell phone use
and cancers of the brain, nerves, or
other tissues of the head or neck.
More research is needed because cell
phone technology and how people use
cell phones have been changing
rapidly.
• Although there have been some
concerns that radiofrequency energy
from cell phones held closely to the
head may affect the brain and other
tissues, to date there is no evidence
from studies of cells, animals, or
humans that radiofrequency energy
can cause cancer.
31. Center for Risk Science and Public Health
What is Going On?
• Different questions
• Could there be a relationship?
• Is the evidence sufficient to say cell phones
causally related to cancer?
• Scientific uncertainty
• Conflicting studies
• Hard for science to prove a negative
32. Center for Risk Science and Public Health
Take Away Messages
• The hazards posed by an agent are identified through
physical/chemical properties, epidemiology or
toxicologic studies
• All sources of information have inherent uncertainty in
the ability to determine a causal relationship between
exposure and outcome
• Many risk assessment processes use “conservative”
assumptions in the face of this uncertainty
• Uncertainty may be important when estimating
benefits in RIA