Standards of Proof, Presumptions and Defaults: Tools for Thinking about Environmental Health Protections
|
|
- Ruth Tucker
- 5 years ago
- Views:
Transcription
1 Standards of Proof, Presumptions and Defaults: Tools for Thinking about Environmental Health Protections Carl F. Cranor Distinguished Professor of Philosophy Faculty Member, Environmental Toxicology Graduate Program, University of California, Riverside
2 Standards of Proof Standards of proof, presumptions, and defaults provide models for different approaches to scientific evidence in environmental health decisions. Abstract structural similarities: A body of similarities, e.g., empirical evidence, Social, legal or scientific values as part of a rationale, then Specified (or vague) standards of evidence for departing from the background views.
3 Standards of Proof: Examples A criminal defendant must be found guilty beyond a reasonable doubt. [A non-rebuttable enforceable norm]. A defendant s interests of transcending value avoiding loss of liberty, isolation, and social condemnation may not be changed without overwhelming evidence in order to limit mistakes. (Speiser v. Randall, 1958)
4 Standards of Proof: Examples A tort or personal injury law defendant, alleged to have injured another, may not have his/her legal status changed to pay compensation without the balance of evidence favoring liability. [A non-rebuttable enforceable norm].
5 Standards of Proof: Examples Unusually a civil defendant may be held accountable when harm results from disfavored behavior (short of criminal conduct), e.g., fraud, deception, or undue influence. This must be supported by clear and convincing (or highly probable) evidence. [A non-rebuttable enforceable norm].
6 Legal Presumptions Legal presumptions are rules for [determining]/inferring further facts from previously established facts. (Prosser, 1984, 240; McCormick,1984, 966) Examples: A child under the age of 7 is non-rebuttably presumed to be unable to commit a felony. (McCormick, 966) Goods damaged in transit conveyed by several carriers are presumed to have been damaged by the last carrier [rebuttable]. (Prosser, 240)
7 Legal Presumptions: Rationales Fairness: to correct an imbalance from one party s superior access to evidence. (McCormick,968) Legal/social policy inclines courts to benefit one party or handicap another. (McCormick, 969) Commonly, presumptions favor probabilities of an inference. A letter properly addressed, stamped, and mailed is presumed to have been delivered. (McCormick, 969) When violent death has occurred and suicide or other cause is not clear, the presumption is against suicide. (McCormick, )
8 Legal Presumptions Legal or scientific presumptions and default approaches in regulatory science are rebuttable norms. Typically they are Based on empirical evidence and/or important scientific or social values, they identify some favored position or status quo e.g., protection of children, linear extrapolations at low doses or disfavored view e.g., toxicants having related features should be treated similarly. There are provisions for departing from the status quo.
9 Defaults in Regulatory Science: NAS Recommendations Should be consistent with evolving science. (NRC, 2008, 184) Have a clear standard to justify the plausibility of the default for a wide array of circumstances. (NRC, 2008, 184, 186) Have clear scientific standards for identifying when a departure is appropriate. (NRC, 2008, 184, 191) Determine when evidence supporting an alternative assumption is robust enough to depart from the default. (NRC, 2008, 184, 186)
10 NAS: Defaults Are Efficient They make explicit the existing assumptions or develop new assumptions to address missing defaults. (NRC, 2008,186) They avoid full ad hoc examination of data and the spectrum of inferences they may support without being selective or contrasting them with the default to reflect on their plausibility. (NRC, 2008, 176) They [provide important starting places, help to clarify discussions], avoid ad hoc choices, provide predictable and consistent risk assessment structures and a basis for the public assessment of its actions. (NRC, 2008, 176, 184)
11 Some EPA Defaults The 1996 Food Quality Protection Act (FQPA) mandates the use of a safety factor of 10 unless EPA has sufficient evidence to determine that a different value is more appropriate [Sec. 408(b)(2)(c)].; NRC, 2008, 187)
12 Some EPA Defaults When cancer effects in humans are attributed to to an agent, the default is that data are predictive of cancer in other exposed human population[s]. (EPA 2005a, A-2); NRC,2008, 179) When cancer effects are not found in an exposed human population, this is not generally sufficient to conclude that the agent poses no carcinogenic hazard to this or other populations of potentially exposed humans, including susceptible subpopulations or life stages. (EPA 2005a, p. A-2; NRC, 2008, 179)
13 Some EPA Defaults Extrapolation from animals to humans Positive effects in animal cancer studies indicate that the agent under study can have carcinogenic potential in humans. (EPA 2005a, p. A-3; NRC, 2008, 179) When cancer effects are not found in [two or more appropriate] well-conducted animal cancer studies and other information does not support the carcinogenic potential of the agent, the agent is not likely to possess human carcinogenic potential, in the absence of [countervailing] human data (EPA 2005a, p A-4; NRC, 2008, 179).
14 Some EPA Defaults Extrapolation of metabolic pathways There is a similarity of the basic pathways of metabolism and the occurrence of metabolites in tissues in regard to the species-to-species extrapolation of cancer hazard and risk. (EPA 2005a, p. A-6); NRC, 2009, 179) For oral exposure, a human equivalent dose for adults is estimated from data on another species by a scaling factor [of] body weight to the 3/4 power. [This] is [also] slightly more protective than using children s body weight (EPA 2005a, p. A-7; NRC, 2008, 179).
15 Some EPA Defaults When the weight of evidence evaluation of all available data are insufficient to establish the mode of action for a tumor site and when scientifically plausible based on the available data, linear extrapolation is used as a [health-protective] default approach. (EPA 2005a, p. 3-21; NRC, 2008, 179) Nonlinear approaches generally should not be used in cases where the mode of action has not been ascertained. (EPA 2005a, p. 3-21; NRC, 2008, 179)
16 One Generic Idea Identify some disfavored toxicity status based on accumulated evidence with a presumption for finding similar toxic effects (that may vary in potency) to identify other toxicants in a relevant class. Anchor substances that exhibit toxicity with certain mechanistic properties. (Zeise, 2017) Apply to other compounds exhibiting similar mechanistic properties to estimate their toxicity and avoid human harm.
17 Example of a Toxicological Presumption Scrutinize all epoxides or epoxide-forming chemicals for toxicity. Aim: to prevent such exposures or to reduce existing exposures, unless there is evidence to contrary that there are no unreasonable risks to human health.
18 Example of a a Toxicological Presumption 12 high volume epoxide-forming chemicals are alkylating agents that react with nucleophilic sites on DNA, damage them, producing mutagens and likely causing cancer. [T]he three-membered ring structure [makes] epoxides reactive molecules. (Melnick, 2002) Reducing occupational and environmental exposures to these chemicals will certainly reduce human cancer risks. (Melnick, 2002)
19 Create a Default for Epoxides and Epoxide-forming Substances Substantial, but not complete, data on epoxides. Many are carcinogenic in animals. Numerous DNA adducts produced by this class of substances have been identified. The types of mutations detected in epoxide-induced tumors are consistent with the types of DNA adducts formed by these agents. (Melnick, 2002) Plausible default: Products that are epoxides or epoxideforming substances are presumed to cause cancer in humans and people should not be exposed unless there is strong countervailing evidence.
20 Role of Mechanistic Evidence in Upgrading Epoxides 2002 Known Human Carcinogens benzene ethylene oxide vinyl chloride Probable HCs: glycidol [RAHC] styrene oxide [RAHC] Possible HCs or lower: acrylonitrile chloroprene Isoprene styrene vinyl bromide, vinyl fluoride, ethylene (not classified) Post-Melnick article (2002) Known Human Carcinogens benzene ethylene oxide vinyl chloride Probable HCs: glycidol styrene oxide, vinyl bromide, vinyl fluoride, Possible HCs or lower: acrylonitrile [RAHC] chloroprene [RAHC] Isoprene [RAHC] styrene [RAHC] ethylene (not classified)
21 Second Scientific Presumption: Toxicity Equivalent Factors Toxicity equivalent factors (TEFs) facilitate the estimated toxicity of related chemicals that induce the aryl-hydrocarbon (Ah) receptor. Example substances: 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD), Related chlorinated and brominated dibenzo-pdioxins, dibenzofurans, and planar biphenyls. There is a TEF formula for generalizing between substances. (Faustman, Omen, 2001)
22 Cautionary Notes for New Science: Identifying Genotoxic Carcinogens Some substances are non-mutagenic in numerous cell culture assays, but positive in animal studies: 2-nitrotoluene (2NL) a probable human carcinogen (IARC) and mutagenic (EU Commission) Metabolism seems quite important in activating 2NL. (Eastmond, 2012) Clororprene an IARC possible carcinogen; an NTP RAHC. It is positive for mutagenicity in some studies; negative in many, yet is an epoxide-forming substance that is structurally similar to 1-3 butadiene and isoprene (should be part of Melnick s list). (Eastmond, 2012)
23 Cautionary notes for New Science: Identifying Genotoxic Carcinogens Some substances are mutagenic in numerous cell culture assays, but negative for mutagenicity in animal studies: Captan was once classified as a probable human carcinogen (EPA) and mutagenic. Despite positive mutagenicity results, captan was determined to act through a non-genotoxic mechanism based on... high reactivity and anticipated short lifetime of captan and thiophosgene under physiological conditions, combined with lack of observed genotoxic effects in vivo both systemically and in the target organ (Eastmond, 2012)
24 For Premarket Review Find toxicity triggers for the earliest evidence of hazards and provide extra scrutiny before the public is exposed: Good structure-activity protein and DNA alerts, e.g., PBDEs, epoxides. Substances that are strongly mutagenic according to certain quick test batteries (must be done carefully). Binding to certain cellular receptors (e.g., Ah receptor). (Cranor, 2001, 2003)
25 Congress Passed the Old Toxic Substances Control Act (1976) The Council on Environmental Quality found (1971) that toxic substances were entering the environment, they could have severe effects, existing legal authorities were inadequate to address toxicity at the point of manufacture, and new legal authority was needed to address these issues (PCBs a major concern) (CEQ, Toxic Substances, 1971).
26 Under Old TSCA(1976) We lived in a Postmarket World Substances entered commerce with little or no careful review for toxicity. They remained in commerce until an overwhelming scientific case established their toxicity to reduce risks. The focus usually was how to make postmarket risk assessment faster while retaining accuracy.
27 Partial Postmarket Risk Assessments were Glacial Substances in EPA s Integrated Risk Information System: Trichloroethylene (TCE) known human carcinogen, also causes Parkinson s disease (20+ years). Dioxin known human carcinogen (20+). Perchloroethylene probable human carcinogen; neurotoxicant (13+). Formaldehyde known human carcinogen, including leukemia (11+). Naphthalene probable human carcinogen (9+) (GAO, 2005).
28 Sluggish Postmarket Protections Are Unjust: Hairdresser Sandy Guest s Death She used Brazilian Blowout loaded with formaldehyde and died of leukemia (55). (Morris, 2015) : 17 studies revealed formaldehyde caused various cancers nasopharyngeal, sinonasal, and myeloid but still there are few or no EPA protections. Industry resistance and slow EPA review likely led to Guest s death. Oxford University Press, 2017
29 The Council on Environmental Quality s Hopes Have Been Dashed We should no longer be limited to repairing the damage after it has been done [Torts]; nor should we continue to allow the entire population or the entire environment to be used as a laboratory [postmarket]. (CEQ Toxic Substances, 1971) This is precisely where we remain 46 years later.
30 New TSCA Promises Better Protection of the Public The EPA must make an affirmative finding on the safety of a new chemical or significant new use of an existing chemical before it is allowed into the marketplace. (EPA, 2016) It formally seeks to protect children, highly exposed workers, pregnant women, and the elderly from toxicants, both premarket and postmarket. It also has rigorous postmarket review deadlines.
31 Developing Children Are Especially Vulnerable to Toxicants Have greater exposures per body weight. Are more susceptible to toxicants. Have lesser defenses. Have a longer lifespan for diseases to develop. Some adverse effects are irreversible.
32 Twenty-First Century Science Holds Hope for Faster Protection of the Public Twenty-first Century Science points to evidence that might accurately protect susceptible subpopulations before exposures and more quickly remove existing toxicants from commerce. What scientific defaults, modeled on the above examples, might lead to better and more efficient use of scientific studies to provide the protections?
33 Will New TSCA and 21 st Century Science Better Protect the Public? Will the evidentiary bar for new substances be too low? The EPA s approval of 600 new substances in a few months is not reassuring. Will the evidentiary bar for existing substances be too high? EPA s failure to ban chlorpyrifos with an overwhelming body of data and without support of its scientists also does not bode well for protecting susceptible subpopulations.
34 Will New TSCA and 21 st Century Science Better Protect the Public? Public health protections in premarket and postmarket assessments depends upon how they are administered.
35 Thank you
Addendum to the 12th Report on Carcinogens
Addendum to the 12th Report on Carcinogens Published by the U.S. Department of Health and Human Services, National Toxicology Program The twelfth edition of the National Toxicology Program (NTP) Report
More informationEnvironmental Exposures and Cancer Hazards
Environmental Exposures and Cancer Hazards Ruth Lunn, DrPH Director, Office of the Report on Carcinogens Division of the National Toxicology Program National Institute of Environmental Health Sciences
More informationA review of human carcinogens -Part F: Chemical agents and related occupations
A review of human carcinogens -Part F: Chemical agents and related occupations In October 2009, 23 scientists from 6 countries met at the International Agency for Research on Cancer (IARC) to re-assess
More informationRethinking Approaches To Low Dose Extrapolation for Environmental Health Risk Assessment
Rethinking Approaches To Low Dose Extrapolation for Environmental Health Risk Assessment Introduction Over the past half-century, methods for quantitatively assessing the human health risks from exposures
More informationQuantitative Risk Assessment: An Overview and Discussion of Emerging Issues. Anne-Marie Nicol, PhD
Quantitative Risk Assessment: An Overview and Discussion of Emerging Issues Anne-Marie Nicol, PhD Today s talk Broader overview of Risk Assessment process (at the US EPA) Explanation of the 4 step formal
More informationThe IARC Monographs, Vol 100: A review and update on occupational carcinogens
The IARC Monographs, Vol 100: A review and update on occupational carcinogens Kurt Straif, MD MPH PhD International Agency for Research on Cancer Lyon, France Carpi, 23 Oct 2010 IARC Monographs, Volume
More informationPart 2. Chemical and physical aspects
Part 2. Chemical and physical aspects 12. Chemical and physical aspects: introduction 12.1 Background information used The assessment of the toxicity of drinking-water contaminants has been made on the
More informationApplications of Genomics to Toxic Torts
Applications of Genomics to Toxic Torts Gary Marchant & Andrew Askland Arizona State University College of Law Center for the Study of Law, Science, & Technology Potential Uses of Toxicogenomics Medical
More informationMethodologies for development of human health criteria and values for the lake Erie drainage basin.
3745-1-42 Methodologies for development of human health criteria and values for the lake Erie drainage basin. [Comment: For dates of non-regulatory government publications, publications of recognized organizations
More informationAssessing and Managing Health Risks from Chemical Constituents and Contaminants of Food
16 17 September 2013 Assessing and Managing Health Risks from Chemical Constituents and Contaminants of Food Workshop on A Framework for Assessing the Health, Environmental and Social Effects of the Food
More informationThe Application of Genomic Technologies to Benzene Litigation
The Application of Genomic Technologies to Benzene Litigation An ArrayXpress White Paper. 4 Dec 2014 Benzene is an aromatic solvent and a major component in the manufacturing of numerous chemicals. It
More informationRegulation of Genotoxic and Carcinogenic Impurities in
Regulation of Genotoxic and Carcinogenic Impurities in Pharmaceuticals Impurities in Drugs: Monitoring, Safety and Regulation The Israel Chapter of PDA July, 15 16, 2008 David Jacobson-Kram, Ph.D. DABT
More informationThe Normative Nature of Risk Assessment: Features and Possibilities
RISK: Health, Safety & Environment (1990-2002) Volume 8 Number 2 Article 5 March 1997 The Normative Nature of Risk Assessment: Features and Possibilities Carl F. Cranor Follow this and additional works
More informationDioxins and dioxin-like compounds (DLCs) are released into the environment from
July 2006 Public Summary Health Risks from Dioxin and Related Compounds Evaluation of the EPA Reassessment Dioxins and dioxin-like compounds (DLCs) are released into the environment from several sources,
More informationEnvironmental Law and Policy Salzman & Thompson
Environmental Law and Policy Salzman & Thompson Ch.6/7: Regulating Toxic Substances HWR415/515 The University of Arizona 2013 1 Summary I. The Difficulties of Regulating Toxic Substances A. Is Tolerable
More informationGlyphosate and Cancer Risk. Jeffrey Jenkins, Ph.D. Department of Environmental and Molecular Toxicology Oregon State University
Glyphosate and Cancer Risk Jeffrey Jenkins, Ph.D. Department of Environmental and Molecular Toxicology Oregon State University Cancer and Human Health Cancer is considered the most severe health condition
More informationJanuary 2, Overview
American Statistical Association Position on Statistical Statements for Forensic Evidence Presented under the guidance of the ASA Forensic Science Advisory Committee * January 2, 2019 Overview The American
More informationSubject: Assessing the Potential Risk of Human Exposure to Tetrachloroethylene (Perchloroethylene) and Formaldehyde
Memo Date: June 20, 2006 To: From: Shelly Burman, Minnesota Pollution Control Agency Hillary Carpenter, Health Risk Assessment Unit Subject: Assessing the Potential Risk of Human Exposure to Tetrachloroethylene
More informationDISCUSSION GROUP 3. Mechanism of carcinogenicity. EFSA Scientific Colloquium on Acrylamide carcinogenicity, 22/23 May
DISCUSSION GROUP 3 Mechanism of carcinogenicity EFSA Scientific Colloquium on Acrylamide carcinogenicity, 22/23 May 2008 1 1. Review the recent evidence for the mutagenicity and genotoxicity of acrylamide
More informationInformation Generation and Use Under Proposition 65: Model Provisions for Other Postmarket Laws?
Information Generation and Use Under Proposition 65: Model Provisions for Other Postmarket Laws? CARL CRANOR * INTRODUCTION California s Proposition 65, The Safe Drinking Water Act of 1986, 1 a voter-passed
More informationStatute: Liability for Failure to Vaccinate
Statute: Liability for Failure to Vaccinate Proposal: Create a statute that would hold a parent who decides, without a valid medical reason, to not vaccinate his or her child according to the State s school
More informationDistinguishing between Mode and Mechanism of Action
Distinguishing between Mode and Mechanism of Action Michael Dourson Toxicology Excellence for Risk Assessment Center University of Cincinnati College of Medicine Conflict of Interest Statement The research
More informationAre tumor incidence rates from chronic bioassays telling us what we need to know about carcinogens?
Regulatory Toxicology and Pharmacology 41 (2005) 128 133 Regulatory Toxicology and Pharmacology www.elsevier.com/locate/yrtph Are tumor incidence rates from chronic bioassays telling us what we need to
More information10 facts you should know about occupational carcinogens
10 facts you should know about occupational carcinogens Carcinogens are the time bombs of hazardous substances in the workplace. But many substances do not develop their deadly effect until years after
More informationPremarket Review. FFDCA Section 201(s) FFDCA Section 201(s) (cont.)
FFDCA Section 201(s) intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food Mitchell
More informationTexas Commission on Environmental Quality
Roberta L. Grant, Susan L. Santos, Mike L. Dourson, Stephanie Shirley, Neeraja K. Erraguntla, R. Jeffrey Lewis, and Nancy B. Beck Society of Toxicology, March 22-26, 2015 San Diego, CA Texas Commission
More information10 facts you should know about occupational carcinogens
10 facts you should know about occupational carcinogens Carcinogens are the time bombs of hazardous substances in the workplace. But many substances do not develop their deadly effect until years after
More informationThe Director General Maisons-Alfort, 30 July 2018 OPINION. of the French Agency for Food, Environmental and Occupational Health & Safety
The Director General Maisons-Alfort, 30 July 2018 OPINION of the French Agency for Food, Environmental and Occupational Health & Safety on the development of chronic TRVs for the oral and respiratory routes
More informationUNIVERSITY FOOD SERVICES, INC. POLICIES AND PROCEDURES REGARDING THE SALE AND SERVICE OF ALCOHOLIC BEVERAGES
UNIVERSITY FOOD SERVICES, INC. POLICIES AND PROCEDURES REGARDING THE SALE AND SERVICE OF ALCOHOLIC BEVERAGES SERVER POLICIES AND PROCEDURES The following policies are the alcoholic beverage server policies
More informationReview of Danish EPA List of EDCs
Review of Danish EPA List of EDCs February 2017 For many years, Denmark has been very active on the endocrine issue. In 2011 the Danish EPA proposed a set of criteria for the EU Commission to use to identify
More informationNext-Generation Sequencing in Toxic Tort Litigation
Next-Generation Sequencing in Toxic Tort Litigation An ArrayXpress White Paper. 4 Dec 2014 A Primer Presented by ArrayXpress, Inc. ArrayXpress (AX) has produced a series of white papers on specific applications
More informationEXECUTIVE SUMMARY INTERPRETING FUND SCOPING PROJECT LAW INSTITUTE OF VICTORIA
i EXECUTIVE SUMMARY INTERPRETING FUND SCOPING PROJECT LAW INSTITUTE OF VICTORIA 2 Introduction In Victoria, civil law matters range from small consumer disputes to large contractual claims between businesses.
More informationGlyphosate Hazard and Risk Assessment: A Comparison of the Approaches of Two International Agencies
Glyphosate Hazard and Risk Assessment: A Comparison of the Approaches of Two International Agencies David A. Eastmond Environmental Toxicology Graduate Program University of California, Riverside Glyphosate
More informationECPA position paper on the criteria for the determination of endocrine disrupting properties under Regulation
POSITION PAPER 09/06/2016 PP/14/PD/23734 ECPA position paper on the criteria for the determination of endocrine disrupting properties under Regulation The European Commission is currently developing new
More informationIARC Monographs on the Evaluation of Carcinogenic Risks to Humans IARC Monograph Evaluations
IARC Monographs on the Evaluation of Carcinogenic Risks to Humans IARC Monograph Evaluations Subgroup work humans Sufficient evidence Limited evidence Inadequate evidence Evidence suggesting lack of carcinogenicity
More informationProposition 65 Update: Proposed Warnings, Website and other Woes
Proposition 65 Update: Proposed Warnings, Website and other Woes ACC Environmental & Sustainability Legal Quick Hit Laura Duncan, Principal September 10, 2015 This presentation is not intended as, nor
More informationNew Notation for Carcinogens with Threshold
New Notation for Carcinogens with Threshold Michael Koller, MD, PhD Division of Occupational Medicine SUVA, Switzerland MEDICHEM 2016, Basel Seite 1 Program 1. Introduction 2. Thresholds in carcinogenesis
More informationICH Topic S1B Carcinogenicity: Testing for Carcinogenicity of Pharmaceuticals. Step 5
European Medicines Agency March 1998 CPMP/ICH/299/95 ICH Topic S1B Carcinogenicity: Testing for Carcinogenicity of Pharmaceuticals Step 5 NOTE FOR GUIDANCE ON CARCINOGENICITY: TESTING FOR CARCINOGENICITY
More informationMr. Bruce Allen. Dr. Harvey Clewell.
Mr. Bruce Allen. Mr. Allen has 27 years of experience related to human and environmental health and safety. He has expertise as a biomathematician involved in risk assessment, modeling, statistical analysis,
More information10 facts you should know about carcinogens in the workplace
10 facts you should know about carcinogens in the workplace Carcinogens are the time bombs of hazardous substances in the workplace. That s because many substances do not develop their deadly effect until
More informationSafe Drinking Water and Toxic Enforcement Act
International Coffee Organization Private Sector Consultative Board March 2012 Under the Microscope: California s Proposition 65 Robert F. Nelson President & Chief Executive Officer National Coffee Association
More informationIARC Monographs, Vol 98, 2007 Occupational Exposure as a Firefighter. Kurt Straif, MD MPH PhD
IARC Monographs, Vol 98, 2007 Occupational Exposure as a Firefighter Kurt Straif, MD MPH PhD DGUV, St. Augustin, 3 November 2015 The encyclopaedia of The IARC Monographs evaluate Chemicals Complex mixtures
More informationINITIAL STATEMENT OF REASONS TITLE 27, CALIFORNIA CODE OF REGULATIONS
INITIAL STATEMENT OF REASONS TITLE 27, CALIFORNIA CODE OF REGULATIONS PROPOSED AMENDMENT TO: SECTION 25705(b) SPECIFIC REGULATORY LEVELS POSING NO SIGNIFICANT RISK GLYPHOSATE SAFE DRINKING WATER AND TOXIC
More informationThe Chinese University of Hong Kong. Survey and Behavioural Research Ethics
The Chinese University of Hong Kong Survey and Behavioural Research Ethics GUIDELINES FOR SURVEY AND BEHAVIOURAL RESEARCH ETHICS A. Scope Survey and behavioural research covers surveys as well as observation
More informationStatutory Basis. Since Eden and Counting 1/28/2009. Chapter 8. Sexual Harassment
Chapter 8 Sexual Harassment Employment Law for BUSINESS sixth edition Dawn D. BENNETT-ALEXANDER and Laura P. HARTMAN McGraw-Hill/Irwin Copyright 2009 by The McGraw-Hill Companies, Inc. All rights reserved.
More informationOCCUPATIONAL CANCER: an Australian problem? Deborah Vallance AMWU
OCCUPATIONAL CANCER: an Australian problem? Deborah Vallance AMWU Acknowledgement Ngunnawal people on whose land we stand today Summary of presentations know cancer in the workplace Cancer Council Australia
More informationFAQs on bisphenol A in consumer products
FAQs on bisphenol A in consumer products Updated BfR FAQ, 19 February 2015 The substance bisphenol A is contained in polycarbonate products such as food and drink containers and bottles. Bisphenol A is
More informationDescriptive vs Quantitative Risk Assessment: Is there a Best practice? Hermann M. Bolt
ICNIRP/WHO International Workshop on Risk Assessment and Terminology Salzburg, Nov 23/24, 2009 Descriptive vs Quantitative Risk Assessment: Is there a Best practice? Hermann M. Bolt Member of the Scientific
More informationRulemaking1CEm Resource
Rulemaking1CEm Resource From: RulemakingComments Resource Sent: Wednesday, October 28, 2015 2:42 PM To: Rulemaking1CEm Resource Subject: Comment on PRM-20-28, 20-29 & 20-30 Attachments: EPA comments.pdf
More informationpresents Introduction to Toxicology and its Role in Green Chemistry
presents Introduction to Toxicology and its Role in Green Chemistry August 6, 2013 12:00 PM 1:00 PM ET Disclaimer: The Michigan Green Chemistry Clearinghouse (MGCC) is committed to providing webinars that
More information(Text with EEA relevance) Having regard to the opinion of the European Economic and Social Committee ( 1 ),
27.12.2017 Official Journal of the European Union L 345/87 DIRECTIVE (EU) 2017/2398 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2017 amending Directive 2004/37/EC on the protection of
More informationChlorinated Solvents
Chlorinated Solvents What is a chlorinated solvent? Also known as chlorinated hydrocarbons. Organic compounds that contain at least one covalently-bonded chlorine atom. Examples and Uses Methylene Chloride
More informationDRAFT COMMISSION DELEGATED REGULATION (EU) /... of XXX
EUROPEAN COMMISSION Brussels, XXX C(2016) 3752 projet DRAFT COMMISSION DELEGATED REGULATION (EU) /... of XXX setting out scientific criteria for the determination of endocrine-disrupting properties pursuant
More informationUncertainty Characterization: The Role of Hypothesis-Based Weight of Evidence"
Uncertainty Characterization: The Role of Hypothesis-Based Weight of Evidence" Lorenz Rhomberg, PhD Gradient Corporation lrhomberg@gradientcorp.com 617-395-5552 LSRO / CHRA -- 23 May 2007 -- Washington
More informationRisk Assessment Report on styrene. Human Health Part
Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on styrene Human Health Part CAS No.: 100-42-6 EINECS no.: 202-851-5 SCHER adopted this opinion at its 23 rd plenary
More informationETHYLENE OXIDE: AN UPDATE
May 23, 2012 ETHYLENE OXIDE: AN UPDATE BILL GULLEDGE ACC s Ethylene Oxide Panel EO Panel Overview ACGIH TLV Review of EO EPA Development of EO IRIS Assessment Other Activities- EO Mode of Action Ethylene
More informationWorking Through The Haze: What Legal Marijuana Means For Nevada Employers
Working Through The Haze: What Legal Marijuana Means For Nevada Employers Publication 12/14/2016 Dora Lane Partner 775.327.3045 Reno, Las Vegas dlane@hollandhart.com Anthony Hall Partner 775.327.3000 Reno,
More informationINSTRUCTION NO. which renders him/her incapable of safely operating a motor vehicle. Under the law, a person
INSTRUCTION NO. The mere consumption of alcohol combined with the driving of a vehicle is not unlawful. It is only unlawful for someone to drive a vehicle while under the influence of alcohol to a degree
More informationRegulatory Impact Statement. The International Convention on Standards of Training, Certification and Watchkeeping 1978
Regulatory Impact Statement Introducing a Blood Alcohol Limit for On-duty Seafarers The International Convention on Standards of Training, Certification and Watchkeeping 1978 Agency disclosure statement
More informationAn Experimental Investigation of Self-Serving Biases in an Auditing Trust Game: The Effect of Group Affiliation: Discussion
1 An Experimental Investigation of Self-Serving Biases in an Auditing Trust Game: The Effect of Group Affiliation: Discussion Shyam Sunder, Yale School of Management P rofessor King has written an interesting
More informationApproaches to Integrating Evidence From Animal and Human Studies in Chemical Assessments
Approaches to Integrating Evidence From Animal and Human Studies in Chemical Assessments Kris Thayer, National Center for Environmental Assessment (NCEA) Integrated Risk Information System (IRIS) Division
More informationC H A M B E R O F COMME R C E O F T H E U N ITED STATES OF AME R ICA. November 19, 2015
C H A M B E R O F COMME R C E O F T H E U N ITED STATES OF AME R ICA W I L L I A M L. K O V A C S S E N I O R V I C E P R E S I D E N T E N V I R O N M E N T, T E C H N O L O G Y & R E G U L A T O R Y
More informationArkansas Department of Health
Mr. Jim Wise Ecologist Coordinator, Office of Water Arkansas Department of Environmental Quality 5301 Northshore Drive North Little Rock, AR 72118-5317 Dear Mr. Wise: Arkansas Department of Health 4815
More informationCRIJ 1301: INTRODUCTION TO CRIMINAL JUSTICE COURSE SYLLABUS
CRIJ 1301.01-1 Revised Summer 2010 CRIJ 1301: INTRODUCTION TO CRIMINAL JUSTICE COURSE SYLLABUS CRIJ 1301. Introduction to Criminal Justice. (3-3-0) A study of the history and philosophy of criminal justice.
More informationWorld Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects
Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 29th WMA General Assembly, Tokyo, Japan, October
More informationHAZARDOUS AND TOXIC SUBSTANCES
HAZARDOUS AND TOXIC SUBSTANCES The most successful toxic tort cases are generally found to involve asbestos (mesothelioma), benzene (acute myelogenous leukemia ( AML ), multiple myeloma, and non- Hodgkin
More informationMortality Studies Summary of Summaries
Mortality Studies Summary of Summaries Dow has posted a number of mortality studies on its Dioxin Data website. Due to the difficulty of understanding epidemiology studies, it s reasonable to assume that
More informationNational Chemical Contaminants Programme
National Chemical Contaminants Programme Dairy Products and Raw Milk Dioxin, Dioxin-like PCB, and Indicator PCB Results (2014, 2015, and 2016) MPI Technical Paper No: 2017/25 By MPI Regulation and Assurance
More informationG O L D E N S E A L R O O T P O W D E R
T H E A M E R I C A N H E R B A L P R O D U C T S A S S O C I A T I O N S GUIDANCE CA PROPOSITION 65: G O L D E N S E A L R O O T P O W D E R AUGUST 2016 This document is the property of the American Herbal
More informationOpinion on the Green Paper of the Commission Ágnes Bruszt Generáció 2020 Egyesület
Opinion on the Green Paper of the Commission Ágnes Bruszt Generáció 2020 Egyesület www.generacio2020.hu generacio2020@generacio2020.hu Tel/Fax: (+36) 1 555-5432 Károly krt 5/A 1075 Budapest Hungary (Anti-smoking
More informationInterpretation of Epidemiologic Studies
Interpretation of Epidemiologic Studies Paolo Boffetta Mount Sinai School of Medicine, New York, USA International Prevention Research Institute, Lyon, France Outline Introduction to epidemiology Issues
More information12883/16 PR/mk 1 DG B 1C
Council of the European Union Brussels, 5 October 2016 12883/16 Interinstitutional File: 2016/0130 (COD) SOC 590 EMPL 392 SAN 346 IA 81 CODEC 1381 REPORT from: Permanent Representatives Committee (Part
More informationpharmaceuticals volume 100 A A review of human carcinogens iarc monographs on the evaluation of carcinogenic risks to humans
pharmaceuticals volume 100 A A review of human carcinogens This publication represents the views and expert opinions of an IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, which met
More informationDEVELOPMENT OF THE CHROMIUM PUBLIC HEALTH GOAL
DEVELOPMENT OF THE CHROMIUM PUBLIC HEALTH GOAL Robert A. Howd, Ph.D. Chief, Water Toxicology Unit Office of Environmental Health Hazard Assessment, California Environmental Protection Agency Oakland and
More informationScientific Conventions, Ethics and Legal Institutions
RISK: Health, Safety & Environment (1990-2002) Volume 1 Number 2 RISK: Issues in Health & Safety Article 7 March 1990 Scientific Conventions, Ethics and Legal Institutions Carl F. Cranor Follow this and
More information4/2/2012. IARC Monograph Evaluations. Scrotal Cancer among Chimney Sweeps. What do we Know about Occupational Carcinogens?
Scrotal Cancer among Chimney Sweeps Occupational Cancer Research: Current State of Knowledge and Data Gaps Paul A. Demers, PhD ICOH Congress Cancun 2012 Percival Pott (1775) linked scrotal cancer in chimney
More informationMay 7, Dear Minister Rock: Draft Marijuana Medical Access Regulations
Minister of Health 16 th Floor, Brooke Claxton Building Headquarters Tunney's Pasture Postal Locator: 0916-B Ottawa, ON KlA 0K9 Dear Minister Rock: Subject: Draft Marijuana Medical Access Regulations I
More informationOverhauling The 510(k) Process
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Overhauling The 510(k) Process Law360, New York (August
More informationEvidence review. 1. Supporting research evidence. guide 2.1. The review of the evidence should include:
Evidence review There are considerable volumes of evidence, both research studies from a number of countries and statistical evidence from Australia, which demonstrates plain packaging is a policy that
More informationMedia centre. Dioxins and their effects on human health. Key Facts. 1 of 7 1/7/11 1:31 PM
Media centre Dioxins and their effects on human health Fact sheet N 225 May 2010 Key Facts Dioxins are a group of chemically-related compounds that are persistent environmental pollutants. Dioxins are
More informationFramework for Causation Analysis of Toxic Exposure Claims. CLCW SME Training August, 2017
Framework for Causation Analysis of Toxic Exposure Claims CLCW SME Training August, 2017 Purpose Examiners are frequently asked: is the condition attributable to a specific event? It is incumbent on SME
More informationIN THE SUPREME COURT OF BRITISH COLUMBIA KENNETH KNIGHT IMPERIAL TOBACCO CANADA LIMITED STATEMENT OF CLAIM
No. Vancouver Registry IN THE SUPREME COURT OF BRITISH COLUMBIA Between: KENNETH KNIGHT Plaintiff AND: IMPERIAL TOBACCO CANADA LIMITED Defendant Brought under the Class Proceedings Act, R.S.B.C. 1996,
More informationEnvironmental Risk Assessment Toxicity Assessment
Environmental Risk Assessment Toxicity Assessment UT Evening School Course Spring Semester 2000 Class #07 on February 29, 2000 Environmental Engineering EV595 Martin Clauberg, Ph.D. 1 Outline of discussion
More informationOPINION of the French Agency for Environmental and Occupational Health Safety
The Director General Maisons-Alfort, France, 15 June 2009 OPINION of the French Agency for Environmental and Occupational Health Safety Relating to establishing carcinogenic HTVs by inhalation for carbon
More informationAlliance of Nuclear Worker Advocacy Groups
Alliance of Nuclear Worker Advocacy Groups Presentation to National Academy of Sciences Institute of Medicine January 23, 2012 Excerpts from July 29, 2005 letters to Secretary Chao from the U.S. Senate
More informationCHARACTERIZING THE IMPACTS OF UNCERTAINTY AND SCIENTIFIC JUDGMENT IN EXPOSURE LIMIT DEVELOPMENT
CHARACTERIZING THE IMPACTS OF UNCERTAINTY AND SCIENTIFIC JUDGMENT IN EXPOSURE LIMIT DEVELOPMENT Andrew Maier, Ph.D., CIH, DABT TERA Robert Sussman, Ph.D., DABT SafeBridge Consultants, Inc. Bruce Naumann,
More informationConsultation Response
Consultation Response CHEM Trust response to EFSA consultation on a draft scientific opinion on: Recent developments in the risk assessment of chemicals in food and their potential impact on the safety
More informationJunkScience.com. June 16, Mr. Ray Wassel National Academy of Sciences 500 Fifth St., N.W. Washington, D.C
JunkScience.com June 16, 2016 Mr. Ray Wassel National Academy of Sciences 500 Fifth St., N.W. Washington, D.C. 20001 Re: Comment on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure
More informationconsistent with the industry documents we note in our September letter.
February 18, 2010 Division of Dockets Management (HFA-305) Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Docket Number FDA-2010-N-0020
More informationHybrid Coating Technologies Newsletter
Hybrid Coating Technologies Newsletter 2nd Qtr 2017 Issue No. 1 Photos below of the team at HCT and our recent attendance at the highly productive European Coatings Show. Letter from the CEO "Due to the
More informationRobert G. Sussman, Ph.D., DABT Managing Principal, Eastern Operations. SafeBridge Consultants, Inc. Mountain View, CA New York, NY Liverpool, UK
Robert G. Sussman, Ph.D., DABT Managing Principal, Eastern Operations SafeBridge Consultants, Inc. Mountain View, CA New York, NY Liverpool, UK Paracelsus (1493 1541) All substances are poisons; there
More informationSTATEMENT OF THE AMERICAN DENTAL ASSOCIATION ON REGULATION BY STATE BOARDS OF DENTISTRY OF MISLEADING DENTAL SPECIALTY CLAIMS.
STATEMENT OF THE AMERICAN DENTAL ASSOCIATION ON REGULATION BY STATE BOARDS OF DENTISTRY OF MISLEADING DENTAL SPECIALTY CLAIMS August 10, 2018 From time to time, general dentists who are not adequately
More informationConsumer Warning Labels Aren t Working
Page 1 of 7 RISK MANAGEMENT Consumer Warning Labels Aren t Working by Lisa A. Robinson, W. Kip Viscusi, and Richard Zeckhauser NOVEMBER 30, 2016 Warning labels are everywhere. They alert us to the risks
More informationCoversheet: Medicinal cannabis: 100 day action
Coversheet: Medicinal cannabis: 100 day action Advising agencies Decision sought Proposing Ministers Ministry of Health Introduction of Misuse of Drugs Amendment Bill Hon Dr David Clark, Minister of Health
More informationEnvironmental Law/Science Case Studies. Environmental Toxicology
Environmental Law/Science Case Studies Environmental Toxicology What is the fundamental disagreement between these two authors? How to best direct research efforts and funding The potential human risks
More informationOccupational Exposure Limits
Formaldehyde Science Conference, Madrid 19-20 Apr 2012 Occupational Exposure Limits Hermann M. Bolt Leibniz-Institut für Arbeitsforschung an der TU Dortmund Leibniz Research Centre for Working Environment
More informationF L O R I D A H O U S E O F R E P R E S E N T A T I V E S HJR
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 House Joint Resolution A joint resolution proposing the creation of Section 28 of Article X and the creation of Section 32 of
More informationAN ACT. The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:
Pennsylvania General Assembly http://www.legis.state.pa.us/cfdocs/legis/li/uconscheck.cfm?txttype=htm&yr=2014&sessind=0&smthlwind=0&act=89 07/17/2014 12:54 PM Home / Statutes of Pennsylvania / Unconsolidated
More informationII. The Federal Government s Current Approach to Compensation. The issue of compensation for vaccine related injuries has been brought to
13 II. The Federal Government s Current Approach to Compensation The issue of compensation for vaccine related injuries has been brought to congressional and wider public attention most dramatically in
More informationA compensable claim for psychological injury can arise as an injury by itself with no physical injury or as a result of a physical injury.
Section Policy 40 44.05.30 Section Title: Subject: Effective Date: Benefits Administration Adjudication and Compensation Adjudication of Psychological Injuries November 1, 2012, for all claims regardless
More information