This document discusses the relationship between science and law in environmental issues. It provides context on Natural England, the statutory advisor to the UK government on nature conservation. It then examines how environmental law deals with scientific uncertainty, outlining the precautionary principle which allows preventative action in situations of scientific uncertainty regarding serious environmental risks. The precautionary principle balances scientific evidence with non-scientific factors in political and regulatory decision making about environmental protection.
This document discusses recent Supreme Court cases addressing patent eligibility of claims involving abstract ideas or laws of nature in biotechnology. It summarizes the tests developed in Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank for determining whether a claim is directed to a judicial exception like an abstract idea. The analysis involves determining whether the claim wholly preempts a fundamental principle and if additional elements together provide an inventive concept. The presentation provides takeaways on applying this analysis in emerging technologies while avoiding overly broad interpretations that could undermine patent law.
IAQM AGM 2015 - Nick Molden - Insights from Real World Emissions Testing in c...IES / IAQM
This document discusses insights from real-world emissions testing of over 1000 vehicles conducted by Emissions Analytics. It finds that while NOx emissions from diesel vehicles have decreased significantly in recent years, they still exceed regulatory limits in real-world driving. NOx and NO2 emissions from gasoline vehicles also exceed limits for some larger engines. The gap between official and real-world fuel economy is growing, potentially creating a CO2 problem. Upcoming regulations may not be strict enough to achieve required NOx reductions in real-world driving.
This document provides an overview of the precautionary principle, including its origins, key elements, and approaches to implementation. It discusses the principle in the context of environmental health problems caused by human activities that have led to issues like climate change, fishery collapses, and chemical contamination. The precautionary principle aims to take anticipatory action to prevent harm when threats exist, even in cases of scientific uncertainty, by shifting the burden of proof to those introducing potentially hazardous activities or technologies. The document examines uncertainties in science, different types of errors, and limits to proof when assessing environmental health issues. It also outlines values underlying the principle and ways to apply it in policy through setting goals, using science carefully, enhancing information sharing,
This document provides an overview of the precautionary principle, including its origins, key elements, and approaches to implementation. It discusses the principle in the context of environmental health problems caused by human activities that have led to issues like climate change, fishery collapses, and chemical contamination. The precautionary principle aims to take anticipatory action to prevent harm when threats exist, even in cases of scientific uncertainty, and places the burden of proof on those introducing potentially hazardous activities. The document examines uncertainties in science, different types of errors, and limits to proof when assessing environmental health issues. It also outlines values like respect, humility and responsibility that underlie the precautionary principle.
Innovation: managing risk, not avoiding itbis_foresight
The document discusses managing risks associated with innovation. It argues that innovation is essential for economic growth and well-being but always carries risks. It advocates for framing risks rigorously to make decisions more robust, and acknowledges that context matters as science is not the only lens for assessing risks. Well-informed regulation and decision-making requires considering these factors and sustaining strong institutions for scientific advice.
The document provides an overview of the Declaration of Helsinki, which establishes ethical principles for medical research involving human subjects. It discusses the history and development of the Declaration since 1964. The key principles covered include prioritizing subject well-being and autonomy, minimizing risks and maximizing benefits, obtaining informed consent, ensuring equitable subject selection, and independent review of research protocols.
This document discusses ethics and risk management in relation to chemicals. It provides definitions of risk as the probability of an adverse outcome and uncertainty of events and outcomes. It discusses utilitarianism which focuses on achieving the greatest good for the greatest number. The precautionary principle is explained as taking regulatory action when there are reasonable concerns about potential harm, even if there is not full scientific certainty of causal links or harm. The document examines cases where the precautionary principle has been applied, such as to flame retardants, insecticides, and bisphenol A, and criticisms of the precautionary principle. It stresses that risk management must still consider if prohibitions are necessary and proportional.
The webinar presentation summarizes the LEARN Toolkit project which developed best practices for research data management. It includes 23 case studies organized into 8 sections covering topics like policies, advocacy, costs, roles and responsibilities. The project produced a model research data management policy and guidance document to help institutions develop their own policies. It engaged stakeholders through workshops around Europe and Latin America to align policies and terminology. The materials from the project, including the model policy, are published in the LEARN Toolkit which aims to support research organizations in improving their research data management.
This document discusses recent Supreme Court cases addressing patent eligibility of claims involving abstract ideas or laws of nature in biotechnology. It summarizes the tests developed in Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank for determining whether a claim is directed to a judicial exception like an abstract idea. The analysis involves determining whether the claim wholly preempts a fundamental principle and if additional elements together provide an inventive concept. The presentation provides takeaways on applying this analysis in emerging technologies while avoiding overly broad interpretations that could undermine patent law.
IAQM AGM 2015 - Nick Molden - Insights from Real World Emissions Testing in c...IES / IAQM
This document discusses insights from real-world emissions testing of over 1000 vehicles conducted by Emissions Analytics. It finds that while NOx emissions from diesel vehicles have decreased significantly in recent years, they still exceed regulatory limits in real-world driving. NOx and NO2 emissions from gasoline vehicles also exceed limits for some larger engines. The gap between official and real-world fuel economy is growing, potentially creating a CO2 problem. Upcoming regulations may not be strict enough to achieve required NOx reductions in real-world driving.
This document provides an overview of the precautionary principle, including its origins, key elements, and approaches to implementation. It discusses the principle in the context of environmental health problems caused by human activities that have led to issues like climate change, fishery collapses, and chemical contamination. The precautionary principle aims to take anticipatory action to prevent harm when threats exist, even in cases of scientific uncertainty, by shifting the burden of proof to those introducing potentially hazardous activities or technologies. The document examines uncertainties in science, different types of errors, and limits to proof when assessing environmental health issues. It also outlines values underlying the principle and ways to apply it in policy through setting goals, using science carefully, enhancing information sharing,
This document provides an overview of the precautionary principle, including its origins, key elements, and approaches to implementation. It discusses the principle in the context of environmental health problems caused by human activities that have led to issues like climate change, fishery collapses, and chemical contamination. The precautionary principle aims to take anticipatory action to prevent harm when threats exist, even in cases of scientific uncertainty, and places the burden of proof on those introducing potentially hazardous activities. The document examines uncertainties in science, different types of errors, and limits to proof when assessing environmental health issues. It also outlines values like respect, humility and responsibility that underlie the precautionary principle.
Innovation: managing risk, not avoiding itbis_foresight
The document discusses managing risks associated with innovation. It argues that innovation is essential for economic growth and well-being but always carries risks. It advocates for framing risks rigorously to make decisions more robust, and acknowledges that context matters as science is not the only lens for assessing risks. Well-informed regulation and decision-making requires considering these factors and sustaining strong institutions for scientific advice.
The document provides an overview of the Declaration of Helsinki, which establishes ethical principles for medical research involving human subjects. It discusses the history and development of the Declaration since 1964. The key principles covered include prioritizing subject well-being and autonomy, minimizing risks and maximizing benefits, obtaining informed consent, ensuring equitable subject selection, and independent review of research protocols.
This document discusses ethics and risk management in relation to chemicals. It provides definitions of risk as the probability of an adverse outcome and uncertainty of events and outcomes. It discusses utilitarianism which focuses on achieving the greatest good for the greatest number. The precautionary principle is explained as taking regulatory action when there are reasonable concerns about potential harm, even if there is not full scientific certainty of causal links or harm. The document examines cases where the precautionary principle has been applied, such as to flame retardants, insecticides, and bisphenol A, and criticisms of the precautionary principle. It stresses that risk management must still consider if prohibitions are necessary and proportional.
The webinar presentation summarizes the LEARN Toolkit project which developed best practices for research data management. It includes 23 case studies organized into 8 sections covering topics like policies, advocacy, costs, roles and responsibilities. The project produced a model research data management policy and guidance document to help institutions develop their own policies. It engaged stakeholders through workshops around Europe and Latin America to align policies and terminology. The materials from the project, including the model policy, are published in the LEARN Toolkit which aims to support research organizations in improving their research data management.
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
Precautionary principle / Precautionary principle in environmental law.nehatiwari116
Precautionary principle is a moral and political principle which states that if an action or policy might cause severe or irreversible harm to the public, in the absence of a scientific consensus that harm would not ensue, then the action should be stopped The principle implies that there is a social responsibility to protect the public from exposure to harm, when scientific investigation has found a plausible risk. These protections can be relaxed only if further scientific findings emerge that provide sound evidence that no harm will result.
the slide tells about precautionary principle . it's meaning , origin , definition , international agreement and declaration . also explains the relation of environment and health , and criticism .
Developing core common outcomes for tropical peatland research and managementMark Reed
Presentation by Prof Mark Reed at CIFOR Indonesian to open UN Global Peatland Initiative workshop to identify key variables that should be measured in tropical peatland research and monitoring. Workshop co-facilitated by Mark Reed and Dylan Young, with slides adapted from a presentation by Gav Stewart, Newcastle University.
This document discusses several topics related to research ethics including guidelines, codes, and organizations. It provides 10 guidelines for ethical research including honesty, objectivity, integrity, and social responsibility. It summarizes the Nuremberg Code which consists of 10 principles for ethical human experimentation such as voluntary consent and avoiding unnecessary suffering. It also discusses the Belmont Report which established three ethical principles for research involving human subjects: beneficence, justice, and respect for persons. It provides an overview of the roles of WHO, UNESCO, and UNESCO in establishing standards and guidance for ethical research practices globally. It identifies several types of research misconduct and issues that can arise from collaboration, peer review, and conflicts of interest. It
Unit 2,ethical consideration in researchChanda Jabeen
This document discusses ethical considerations in research. It covers objectives like defining ethics terms, discussing historical events that shaped research ethics, and describing informed consent. Key topics include the Nuremberg Code, Declaration of Helsinki, principles of beneficence and respecting human dignity. Research ethics aim to protect participants and ensure their voluntary consent, privacy, and fair distribution of risks and benefits.
The document discusses different epidemiological study designs. It distinguishes between observational and experimental studies. Observational studies include descriptive designs like case reports, case series, cross-sectional studies and analytical designs like cohort and case-control studies. Experimental designs involve assigning subjects to intervention and control groups. The key factors in choosing a study design are the research question, current knowledge on the problem, and practical considerations. Each design has strengths and limitations for establishing causality that must be considered.
The document provides an overview of research ethics and guidelines for master's and doctoral students. It defines ethics and research, discusses the key differences between clinical and social science research. It also summarizes the international evolution of research ethics codes and regulations, including the Nuremberg Code, Declaration of Helsinki, Belmont Report, CIOMS Guidelines, and ICH Guidelines. The document outlines ethical principles of respect, beneficence, and justice in research and considerations at different stages of the research process.
This document discusses ethics in research and provides guidelines for ethical research practices. It outlines key ethical principles like respect for persons, beneficence, and justice. It describes past unethical research studies and the responses that established standards like the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The Belmont Report identifies basic ethical principles and how they should be applied. It also discusses the role of institutional review boards in ensuring research follows ethical standards by minimizing risks and requiring informed consent.
This document discusses some of the ethical issues related to genetically modified (GM) crops. It examines concepts like moral luck, distributive justice, and food sovereignty in the context of GM crop development and adoption. It also analyzes approaches like libertarianism and utilitarianism that are relevant to these issues. A major topic is the precautionary principle and how it relates to assessing and managing risks from GM crops given uncertainties. Variations in how the precautionary principle is formulated and some criticisms of it are outlined.
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 15, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
This document discusses various ethical issues related to research involving human subjects. It addresses the need for informed consent, minimizing risks and assessing participant understanding. Key points covered include obtaining consent, withdrawal procedures, deception/concealment, assessing risks, and maintaining participant confidentiality and autonomy. Overall, the document emphasizes that research ethics are important to consider for any study involving human participants.
This document discusses research ethics and academic honesty. It begins by defining key terms related to research integrity and misconduct. The outline then discusses concepts of ethics, good and ethical research practices, ethical theories, data collection and presentation standards, authorship guidelines, and the process of obtaining funding. The document emphasizes principles of research ethics like autonomy, beneficence, non-maleficence, confidentiality, and integrity. It also defines and discusses research misconduct, including fabrication, falsification and plagiarism.
Communicating science and quality for understanding climate change-TalkDr. Pamposh Kumar
This document discusses communicating science and quality for climate change. It addresses that while uncertainty is inherent in scientific research, it is sometimes used as an excuse for not taking action. The document outlines levels of confidence used in climate change reports and notes the precautionary principle that lack of full certainty should not delay cost-effective preventative measures. It emphasizes the role of transparent science communication in conveying gaps, hypotheses, and consequences of inaction. The document concludes by advocating for developing best solutions and practices through collaborative processes between scientists, policymakers, and other stakeholders.
Trust and transparency plus in chemicals regulation: Annamaria Carusi from In...OECD Environment
On 16 March 2021, the OECD co-organised a webinar with the Joint Research Centre (JRC) of the European Commission to discuss the recently published report on Addressing evidence needs in chemicals policy and regulation by the JRC.
There are deep divisions between key stakeholders in chemical regulation regarding the best methods for obtaining data and evidence for informing policy in general and decisions on particular substances. This report summarises the key insights of a study on stakeholder perceptions of the main challenges facing chemicals regulation, and of alternative approaches to conducting toxicological studies. The report offers a proposal for overcoming mistrust between stakeholders, building on the AOP Framework to more fully support ‘transparency plus’, which supplements access to data and evidence with shared understanding.
The webinar was an opportunity to hear the main findings of the report and a set of actionable recommendations, including how knowledge management systems can be designed in a user-centric fashion to address current challenges, with the Adverse Outcome Pathway (AOP) framework being a prominent example.
Programme and speakers:
- Introduction: Magda Sachana from the OECD Environment Directorate
- Trust and Transparency Plus in chemicals regulation: Annamaria Carusi from Interchange Research
- Building trust through improved tools and practice in the life cycle of mechanistic data: Antonio Franco from the EC Joint Research Centre
- The role of the AOP Framework in knowledge management and trust building: Jason O’Brien from the National Wildlife Research Centre, Canada
- Q&A session moderated by Magda Sachana from the OECD Environment Directorate and Clemens Wittwehr from the EC Joint Research Centre.
Here are the answers to the quiz:
1. Research is a systematic process of collecting and analyzing information to increase our understanding of a topic or issue. It involves the discovery of new facts or testing new ideas.
2. Two reasons why we need to conduct research are:
- To gain new knowledge and understanding. Research allows us to discover new facts and relationships that were previously unknown. This expands our body of knowledge.
- To solve problems. Research helps us identify solutions to problems by testing new ideas and approaches through a systematic process. This allows us to improve practices, products, policies and theories.
3. Two general and specific purposes of research are:
- Description - Research describes a phenomenon. For example,
The Thalidomide tragedy is one of the most devastating events in the history of medicine and drug regulation. Thalidomide was a medication that was introduced in the late 1950s and early 1960s as a sedative and treatment for nausea during pregnancy. However, its use led to a widespread public health crisis with severe and tragic consequences.
Here's an overview of the Thalidomide tragedy:
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
Precautionary principle / Precautionary principle in environmental law.nehatiwari116
Precautionary principle is a moral and political principle which states that if an action or policy might cause severe or irreversible harm to the public, in the absence of a scientific consensus that harm would not ensue, then the action should be stopped The principle implies that there is a social responsibility to protect the public from exposure to harm, when scientific investigation has found a plausible risk. These protections can be relaxed only if further scientific findings emerge that provide sound evidence that no harm will result.
the slide tells about precautionary principle . it's meaning , origin , definition , international agreement and declaration . also explains the relation of environment and health , and criticism .
Developing core common outcomes for tropical peatland research and managementMark Reed
Presentation by Prof Mark Reed at CIFOR Indonesian to open UN Global Peatland Initiative workshop to identify key variables that should be measured in tropical peatland research and monitoring. Workshop co-facilitated by Mark Reed and Dylan Young, with slides adapted from a presentation by Gav Stewart, Newcastle University.
This document discusses several topics related to research ethics including guidelines, codes, and organizations. It provides 10 guidelines for ethical research including honesty, objectivity, integrity, and social responsibility. It summarizes the Nuremberg Code which consists of 10 principles for ethical human experimentation such as voluntary consent and avoiding unnecessary suffering. It also discusses the Belmont Report which established three ethical principles for research involving human subjects: beneficence, justice, and respect for persons. It provides an overview of the roles of WHO, UNESCO, and UNESCO in establishing standards and guidance for ethical research practices globally. It identifies several types of research misconduct and issues that can arise from collaboration, peer review, and conflicts of interest. It
Unit 2,ethical consideration in researchChanda Jabeen
This document discusses ethical considerations in research. It covers objectives like defining ethics terms, discussing historical events that shaped research ethics, and describing informed consent. Key topics include the Nuremberg Code, Declaration of Helsinki, principles of beneficence and respecting human dignity. Research ethics aim to protect participants and ensure their voluntary consent, privacy, and fair distribution of risks and benefits.
The document discusses different epidemiological study designs. It distinguishes between observational and experimental studies. Observational studies include descriptive designs like case reports, case series, cross-sectional studies and analytical designs like cohort and case-control studies. Experimental designs involve assigning subjects to intervention and control groups. The key factors in choosing a study design are the research question, current knowledge on the problem, and practical considerations. Each design has strengths and limitations for establishing causality that must be considered.
The document provides an overview of research ethics and guidelines for master's and doctoral students. It defines ethics and research, discusses the key differences between clinical and social science research. It also summarizes the international evolution of research ethics codes and regulations, including the Nuremberg Code, Declaration of Helsinki, Belmont Report, CIOMS Guidelines, and ICH Guidelines. The document outlines ethical principles of respect, beneficence, and justice in research and considerations at different stages of the research process.
This document discusses ethics in research and provides guidelines for ethical research practices. It outlines key ethical principles like respect for persons, beneficence, and justice. It describes past unethical research studies and the responses that established standards like the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The Belmont Report identifies basic ethical principles and how they should be applied. It also discusses the role of institutional review boards in ensuring research follows ethical standards by minimizing risks and requiring informed consent.
This document discusses some of the ethical issues related to genetically modified (GM) crops. It examines concepts like moral luck, distributive justice, and food sovereignty in the context of GM crop development and adoption. It also analyzes approaches like libertarianism and utilitarianism that are relevant to these issues. A major topic is the precautionary principle and how it relates to assessing and managing risks from GM crops given uncertainties. Variations in how the precautionary principle is formulated and some criticisms of it are outlined.
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 15, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
This document discusses various ethical issues related to research involving human subjects. It addresses the need for informed consent, minimizing risks and assessing participant understanding. Key points covered include obtaining consent, withdrawal procedures, deception/concealment, assessing risks, and maintaining participant confidentiality and autonomy. Overall, the document emphasizes that research ethics are important to consider for any study involving human participants.
This document discusses research ethics and academic honesty. It begins by defining key terms related to research integrity and misconduct. The outline then discusses concepts of ethics, good and ethical research practices, ethical theories, data collection and presentation standards, authorship guidelines, and the process of obtaining funding. The document emphasizes principles of research ethics like autonomy, beneficence, non-maleficence, confidentiality, and integrity. It also defines and discusses research misconduct, including fabrication, falsification and plagiarism.
Communicating science and quality for understanding climate change-TalkDr. Pamposh Kumar
This document discusses communicating science and quality for climate change. It addresses that while uncertainty is inherent in scientific research, it is sometimes used as an excuse for not taking action. The document outlines levels of confidence used in climate change reports and notes the precautionary principle that lack of full certainty should not delay cost-effective preventative measures. It emphasizes the role of transparent science communication in conveying gaps, hypotheses, and consequences of inaction. The document concludes by advocating for developing best solutions and practices through collaborative processes between scientists, policymakers, and other stakeholders.
Trust and transparency plus in chemicals regulation: Annamaria Carusi from In...OECD Environment
On 16 March 2021, the OECD co-organised a webinar with the Joint Research Centre (JRC) of the European Commission to discuss the recently published report on Addressing evidence needs in chemicals policy and regulation by the JRC.
There are deep divisions between key stakeholders in chemical regulation regarding the best methods for obtaining data and evidence for informing policy in general and decisions on particular substances. This report summarises the key insights of a study on stakeholder perceptions of the main challenges facing chemicals regulation, and of alternative approaches to conducting toxicological studies. The report offers a proposal for overcoming mistrust between stakeholders, building on the AOP Framework to more fully support ‘transparency plus’, which supplements access to data and evidence with shared understanding.
The webinar was an opportunity to hear the main findings of the report and a set of actionable recommendations, including how knowledge management systems can be designed in a user-centric fashion to address current challenges, with the Adverse Outcome Pathway (AOP) framework being a prominent example.
Programme and speakers:
- Introduction: Magda Sachana from the OECD Environment Directorate
- Trust and Transparency Plus in chemicals regulation: Annamaria Carusi from Interchange Research
- Building trust through improved tools and practice in the life cycle of mechanistic data: Antonio Franco from the EC Joint Research Centre
- The role of the AOP Framework in knowledge management and trust building: Jason O’Brien from the National Wildlife Research Centre, Canada
- Q&A session moderated by Magda Sachana from the OECD Environment Directorate and Clemens Wittwehr from the EC Joint Research Centre.
Here are the answers to the quiz:
1. Research is a systematic process of collecting and analyzing information to increase our understanding of a topic or issue. It involves the discovery of new facts or testing new ideas.
2. Two reasons why we need to conduct research are:
- To gain new knowledge and understanding. Research allows us to discover new facts and relationships that were previously unknown. This expands our body of knowledge.
- To solve problems. Research helps us identify solutions to problems by testing new ideas and approaches through a systematic process. This allows us to improve practices, products, policies and theories.
3. Two general and specific purposes of research are:
- Description - Research describes a phenomenon. For example,
The Thalidomide tragedy is one of the most devastating events in the history of medicine and drug regulation. Thalidomide was a medication that was introduced in the late 1950s and early 1960s as a sedative and treatment for nausea during pregnancy. However, its use led to a widespread public health crisis with severe and tragic consequences.
Here's an overview of the Thalidomide tragedy:
Land remediation and conservation - the interaction of regulatory regimesIES / IAQM
This document discusses biodiversity and land remediation. It begins by defining biodiversity and listing various protected species. It then discusses policies and frameworks related to enhancing biodiversity and remediating contaminated land from documents like the NPPF, Environment Act 2021, and reports from the House of Lords. Key points addressed include biodiversity net gain, habitat assessments, balancing development with environmental protection, and ensuring adequate resources for regulatory bodies.
A Contractor’s Perspective on Redeveloping Historical LandfillsIES / IAQM
Andy O'Dea, Technical Director of Cognition Land and Water, discusses challenges with redeveloping historical landfills. Key challenges include overly complex waste regulation, the unsuitability of using the Definition of Waste Code of Practice (DoWCoP) for landfill restoration projects, and lack of clear guidance. Through project examples, O'Dea illustrates how using DoWCoP previously allowed sustainable reuse of soils but the revised agency position now prohibits this for landfilled materials. He calls for pragmatic solutions like a new recovery permit to better facilitate sustainable management and reuse of surplus soils from construction projects.
Sharing is Caring – Can cross industry collaboration be achieved on key envir...IES / IAQM
Sharing is Caring – Can cross industry collaboration be achieved on key environmental topics?
Rebecca Hearn, Director, Midland Lands Events: MidLE
mental topics?
The document outlines the evolution of the three pillars of sustainable development - society, economy, and environment - through different eras from hunter-gathering to modern times. It shows how societies and economies developed based on agriculture, then industry, and now a global digital economy, and how each transition impacted the environment. The conclusion suggests that for the future, we need an integrated economy, society, and consideration for the global environment.
16.00 Updates to CURED and CREAM Emissions Models.pdfIES / IAQM
- The document describes updates made to the CURED and CREAM emissions models, which predict emissions of NOx, PM, and NH3 from road vehicles.
- For CURED, the updates include incorporating projections of electric vehicle uptake from the Transport Analysis Guidance, and a new approach for calculating non-exhaust PM emissions. Comparisons show CURED estimates of NOx and PM emissions are slightly lower than the Emissions Factors Toolkit.
- For CREAM, updates include incorporating the same electric vehicle projections as CURED and updated ammonia emission factors. Comparisons show higher estimated ammonia emissions than the previous version, especially with inclusion of cold starts.
15.30 Reducing Construction Emissions.pdfIES / IAQM
This document discusses reducing construction emissions through partnerships and tools. It introduces a partnership with Impact on Urban Health to identify exemplar construction sites and develop an emissions tool. The tool calculates emissions from non-road mobile machinery and compares scenarios to benchmarks. The tool was updated to include carbon calculations and additional fuels. Next steps include sharing the tool widely and updating it with real-world emissions data. The tool helps plan equipment use and evaluate policies but has limitations in fully capturing alternative fuel emissions.
15.30 Ethical considerations when determining air quality policies.pdfIES / IAQM
This document discusses the ethical considerations of using air quality standards as the principal policy lever for determining air quality policies. It notes that while standards were effective when acute health impacts were thought to occur above thresholds, evidence now suggests pollution affects health down to low concentrations with no clear threshold. Standards also focus only on areas in exceedance, leaving large inequalities. Overall, directly targeting emissions through reductions may be a more ethical approach as it affects the population equally and aims to maximize health benefits. The document advocates that policies should be clearly articulated to allow the public to judge costs and impacts, and that national emission policies are likely to result in greater health benefits and equity across the population.
14.50 The Impact of the Clean Air Zone on Air Quality in Birmingham.pdfIES / IAQM
The document analyzes the impact of Birmingham's Clean Air Zone (CAZ) on air quality in the city. It shows that nitrogen dioxide (NO2) levels decreased by over 30% after the CAZ was implemented at several roadside monitoring sites, providing evidence that the CAZ successfully improved air quality in Birmingham.
14.40 The role of clean air zones in achieving the UK’s net-zero emissions ta...IES / IAQM
Clean air zones (CAZs) are areas that charge vehicles for not meeting emission standards. While originally intended to reduce nitrogen dioxide, CAZs can help the UK achieve its 2050 net-zero emissions target by restricting polluting vehicles and encouraging cleaner options. The document discusses how CAZs have been implemented in many UK cities and are most effective at reducing air pollution near schools. However, there is also controversy over their potential economic impacts and unfair effects on some groups.
14.30 The discord between limit value compliance and the LAQM objective regim...IES / IAQM
The document discusses the discord between air quality limit value compliance and the local air quality management objective regime in England. It outlines different timelines for particulate matter standards under Part IV Environment Act, Air Quality Standards Regulations, Environment Bill, and the Environmental Targets (Fine Particulate Matter) Regulations. This matters as the inconsistent standards can lead to incompatible mitigation efforts, inconsistent planning decisions, differences in pollutant concentration reporting, and funding issues.
14.00 Developments in occupational hygiene and air quality.pdfIES / IAQM
The British Occupational Hygiene Society (BOHS) is a UK-based scientific body celebrating 70 years of protecting worker health. It has over 1,400 members in 45 countries. BOHS' mission is to safeguard health through effective workplace environment management. It aims to eliminate harmful exposures, promote substitutes for hazards, and ensure workers have proper protection. BOHS conducts research, publishes information, advises regulators, and runs awareness campaigns on occupational hygiene topics like chemicals, dusts, and ventilation.
12.15 Insights from the Clean Air Networks Conference.pdfIES / IAQM
The document summarizes insights from the Clean Air Networks Conference. It discusses two waves of funding from the Strategic Priorities Fund (SPF) Clean Air totalling over £40 million to support air quality research. This includes developing solutions to air pollution and addressing indoor and outdoor air quality challenges. It outlines the Clean Air Champions network and priorities for advancing air quality science, including overcoming barriers through multidisciplinary research, stakeholder engagement, funding, data sharing, and better communication to enable behaviour change.
12.00 Applied Source Apportionment using Low Cost Sensors.pdfIES / IAQM
This document describes a new low-cost method for particulate matter source apportionment using particle number size distribution analysis. It has been tested on two sites: a construction site for the HS2 rail project in Birmingham, and a granite quarry in Leicestershire. The method was able to identify unique particle profiles associated with different pollution sources at each site, such as construction activities or quarry works. It shows potential to automate source apportionment using machine learning and a growing database of particle profiles from known sources. Future work includes applying this technique to establish better emission factors and expand its use in environmental impact assessments.
11.15 Addressing emissions from NRMM.pdfIES / IAQM
The document discusses London's Non-Road Mobile Machinery (NRMM) Low Emission Zone, which aims to reduce emissions from construction machinery. It has led to measured reductions of 48% for PM10 and PM2.5, and 42% for NOx, compared to baseline levels. The zone requires machinery above 37kW to meet certain emission standards, and sites must register their machinery online. Compliance is enforced through on-site inspections. The standards have tightened over time and will require newer Stage V machines by 2023. The program has seen little industry pushback and provides a model that could be applied in other cities.
09.45 Dispersion modelling considerations for Net Zero and air quality.pdfIES / IAQM
Catheryn Price will give a talk at the "Routes to Clean Air, 2023" conference on modeling fugitive methane emissions and controlled carbon dioxide venting from carbon capture facilities. Some of the projects discussed will include modeling fugitive methane from landfills and other sites using inverse dispersion modeling, verifying a carbon dioxide emissions inventory in Glasgow using ambient measurements, and assessing potential degradation products from amine emissions from carbon capture. The talk will emphasize that while new challenges arise in modeling emissions related to achieving net zero goals, established approaches like validation, sensitivity testing, transparency, and knowledge sharing can help address uncertainties.
09.15Measuring air pollutant emissions using novel techniques.pdfIES / IAQM
This document discusses using novel techniques like remote sensing, telematics data, and sensor data to measure vehicular pollutant concentrations and emissions at high spatial and temporal resolution. Combining data streams from different devices allows the generation of detailed maps of air pollution sources, levels, and how they change over time and location. While this offers potential benefits, integrating diverse data also raises privacy and ethical concerns that need addressing.
The debris of the ‘last major merger’ is dynamically youngSérgio Sacani
The Milky Way’s (MW) inner stellar halo contains an [Fe/H]-rich component with highly eccentric orbits, often referred to as the
‘last major merger.’ Hypotheses for the origin of this component include Gaia-Sausage/Enceladus (GSE), where the progenitor
collided with the MW proto-disc 8–11 Gyr ago, and the Virgo Radial Merger (VRM), where the progenitor collided with the
MW disc within the last 3 Gyr. These two scenarios make different predictions about observable structure in local phase space,
because the morphology of debris depends on how long it has had to phase mix. The recently identified phase-space folds in Gaia
DR3 have positive caustic velocities, making them fundamentally different than the phase-mixed chevrons found in simulations
at late times. Roughly 20 per cent of the stars in the prograde local stellar halo are associated with the observed caustics. Based
on a simple phase-mixing model, the observed number of caustics are consistent with a merger that occurred 1–2 Gyr ago.
We also compare the observed phase-space distribution to FIRE-2 Latte simulations of GSE-like mergers, using a quantitative
measurement of phase mixing (2D causticality). The observed local phase-space distribution best matches the simulated data
1–2 Gyr after collision, and certainly not later than 3 Gyr. This is further evidence that the progenitor of the ‘last major merger’
did not collide with the MW proto-disc at early times, as is thought for the GSE, but instead collided with the MW disc within
the last few Gyr, consistent with the body of work surrounding the VRM.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
Phenomics assisted breeding in crop improvementIshaGoswami9
As the population is increasing and will reach about 9 billion upto 2050. Also due to climate change, it is difficult to meet the food requirement of such a large population. Facing the challenges presented by resource shortages, climate
change, and increasing global population, crop yield and quality need to be improved in a sustainable way over the coming decades. Genetic improvement by breeding is the best way to increase crop productivity. With the rapid progression of functional
genomics, an increasing number of crop genomes have been sequenced and dozens of genes influencing key agronomic traits have been identified. However, current genome sequence information has not been adequately exploited for understanding
the complex characteristics of multiple gene, owing to a lack of crop phenotypic data. Efficient, automatic, and accurate technologies and platforms that can capture phenotypic data that can
be linked to genomics information for crop improvement at all growth stages have become as important as genotyping. Thus,
high-throughput phenotyping has become the major bottleneck restricting crop breeding. Plant phenomics has been defined as the high-throughput, accurate acquisition and analysis of multi-dimensional phenotypes
during crop growing stages at the organism level, including the cell, tissue, organ, individual plant, plot, and field levels. With the rapid development of novel sensors, imaging technology,
and analysis methods, numerous infrastructure platforms have been developed for phenotyping.
Travis Hills' Endeavors in Minnesota: Fostering Environmental and Economic Pr...Travis Hills MN
Travis Hills of Minnesota developed a method to convert waste into high-value dry fertilizer, significantly enriching soil quality. By providing farmers with a valuable resource derived from waste, Travis Hills helps enhance farm profitability while promoting environmental stewardship. Travis Hills' sustainable practices lead to cost savings and increased revenue for farmers by improving resource efficiency and reducing waste.
Comparing Evolved Extractive Text Summary Scores of Bidirectional Encoder Rep...University of Maribor
Slides from:
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Track: Artificial Intelligence
https://www.etran.rs/2024/en/home-english/
Deep Behavioral Phenotyping in Systems Neuroscience for Functional Atlasing a...Ana Luísa Pinho
Functional Magnetic Resonance Imaging (fMRI) provides means to characterize brain activations in response to behavior. However, cognitive neuroscience has been limited to group-level effects referring to the performance of specific tasks. To obtain the functional profile of elementary cognitive mechanisms, the combination of brain responses to many tasks is required. Yet, to date, both structural atlases and parcellation-based activations do not fully account for cognitive function and still present several limitations. Further, they do not adapt overall to individual characteristics. In this talk, I will give an account of deep-behavioral phenotyping strategies, namely data-driven methods in large task-fMRI datasets, to optimize functional brain-data collection and improve inference of effects-of-interest related to mental processes. Key to this approach is the employment of fast multi-functional paradigms rich on features that can be well parametrized and, consequently, facilitate the creation of psycho-physiological constructs to be modelled with imaging data. Particular emphasis will be given to music stimuli when studying high-order cognitive mechanisms, due to their ecological nature and quality to enable complex behavior compounded by discrete entities. I will also discuss how deep-behavioral phenotyping and individualized models applied to neuroimaging data can better account for the subject-specific organization of domain-general cognitive systems in the human brain. Finally, the accumulation of functional brain signatures brings the possibility to clarify relationships among tasks and create a univocal link between brain systems and mental functions through: (1) the development of ontologies proposing an organization of cognitive processes; and (2) brain-network taxonomies describing functional specialization. To this end, tools to improve commensurability in cognitive science are necessary, such as public repositories, ontology-based platforms and automated meta-analysis tools. I will thus discuss some brain-atlasing resources currently under development, and their applicability in cognitive as well as clinical neuroscience.
hematic appreciation test is a psychological assessment tool used to measure an individual's appreciation and understanding of specific themes or topics. This test helps to evaluate an individual's ability to connect different ideas and concepts within a given theme, as well as their overall comprehension and interpretation skills. The results of the test can provide valuable insights into an individual's cognitive abilities, creativity, and critical thinking skills
ESR spectroscopy in liquid food and beverages.pptxPRIYANKA PATEL
With increasing population, people need to rely on packaged food stuffs. Packaging of food materials requires the preservation of food. There are various methods for the treatment of food to preserve them and irradiation treatment of food is one of them. It is the most common and the most harmless method for the food preservation as it does not alter the necessary micronutrients of food materials. Although irradiated food doesn’t cause any harm to the human health but still the quality assessment of food is required to provide consumers with necessary information about the food. ESR spectroscopy is the most sophisticated way to investigate the quality of the food and the free radicals induced during the processing of the food. ESR spin trapping technique is useful for the detection of highly unstable radicals in the food. The antioxidant capability of liquid food and beverages in mainly performed by spin trapping technique.
Remote Sensing and Computational, Evolutionary, Supercomputing, and Intellige...University of Maribor
Slides from talk:
Aleš Zamuda: Remote Sensing and Computational, Evolutionary, Supercomputing, and Intelligent Systems.
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Inter-Society Networking Panel GRSS/MTT-S/CIS Panel Session: Promoting Connection and Cooperation
https://www.etran.rs/2024/en/home-english/
The ability to recreate computational results with minimal effort and actionable metrics provides a solid foundation for scientific research and software development. When people can replicate an analysis at the touch of a button using open-source software, open data, and methods to assess and compare proposals, it significantly eases verification of results, engagement with a diverse range of contributors, and progress. However, we have yet to fully achieve this; there are still many sociotechnical frictions.
Inspired by David Donoho's vision, this talk aims to revisit the three crucial pillars of frictionless reproducibility (data sharing, code sharing, and competitive challenges) with the perspective of deep software variability.
Our observation is that multiple layers — hardware, operating systems, third-party libraries, software versions, input data, compile-time options, and parameters — are subject to variability that exacerbates frictions but is also essential for achieving robust, generalizable results and fostering innovation. I will first review the literature, providing evidence of how the complex variability interactions across these layers affect qualitative and quantitative software properties, thereby complicating the reproduction and replication of scientific studies in various fields.
I will then present some software engineering and AI techniques that can support the strategic exploration of variability spaces. These include the use of abstractions and models (e.g., feature models), sampling strategies (e.g., uniform, random), cost-effective measurements (e.g., incremental build of software configurations), and dimensionality reduction methods (e.g., transfer learning, feature selection, software debloating).
I will finally argue that deep variability is both the problem and solution of frictionless reproducibility, calling the software science community to develop new methods and tools to manage variability and foster reproducibility in software systems.
Exposé invité Journées Nationales du GDR GPL 2024
The use of Nauplii and metanauplii artemia in aquaculture (brine shrimp).pptxMAGOTI ERNEST
Although Artemia has been known to man for centuries, its use as a food for the culture of larval organisms apparently began only in the 1930s, when several investigators found that it made an excellent food for newly hatched fish larvae (Litvinenko et al., 2023). As aquaculture developed in the 1960s and ‘70s, the use of Artemia also became more widespread, due both to its convenience and to its nutritional value for larval organisms (Arenas-Pardo et al., 2024). The fact that Artemia dormant cysts can be stored for long periods in cans, and then used as an off-the-shelf food requiring only 24 h of incubation makes them the most convenient, least labor-intensive, live food available for aquaculture (Sorgeloos & Roubach, 2021). The nutritional value of Artemia, especially for marine organisms, is not constant, but varies both geographically and temporally. During the last decade, however, both the causes of Artemia nutritional variability and methods to improve poorquality Artemia have been identified (Loufi et al., 2024).
Brine shrimp (Artemia spp.) are used in marine aquaculture worldwide. Annually, more than 2,000 metric tons of dry cysts are used for cultivation of fish, crustacean, and shellfish larva. Brine shrimp are important to aquaculture because newly hatched brine shrimp nauplii (larvae) provide a food source for many fish fry (Mozanzadeh et al., 2021). Culture and harvesting of brine shrimp eggs represents another aspect of the aquaculture industry. Nauplii and metanauplii of Artemia, commonly known as brine shrimp, play a crucial role in aquaculture due to their nutritional value and suitability as live feed for many aquatic species, particularly in larval stages (Sorgeloos & Roubach, 2021).
3. What is Natural England?
Our remit
• Natural England is here to conserve and enhance the natural
environment for its intrinsic value, the wellbeing and enjoyment of
people and the economic prosperity that it brings
• Natural England's general purpose - to ensure that the natural
environment is conserved, enhanced and managed for the benefit of
present and future generations, thereby contributing to sustainable
development
4. What is Natural England?
• Natural England is the statutory advisor to the Government on nature
conservation in England and promotes the conservation of England’s wildlife
and natural features
• It is financed by Defra, but it forms its own views based on the best scientific
evidence available
Natural England is a statutory consultee in respect of (amongst other
things):
proposals falling under the Environmental Impact Assessment
Regulations in England
proposals likely to damage a Site of Special Scientific Interest
plans or projects likely to have a significant effect on any European site.
European sites include Special Protection Areas and Special Areas of
Conservation or sites listed under the 1971 Convention on Wetlands of
International Importance (Ramsar sites)
5.
6. The Problem – environmental law as ‘hot law’
E. Fisher, Environmental Law as ‘Hot’ Law, Journal of Environmental
Law 25:3 (2013), 347-358
The p o ly c e ntric , inte rd is c ip lina ry , no rm a tive a nd s c ie ntific a lly
unc e rta in na ture o f e nviro nm e nta l p ro ble m s le a d s to a bo d y o f
e nviro nm e nta l law in which it c a n be d iffic ult to s e ttle o n a
s ing le fram e fo r und e rs ta nd ing a p ro ble m a nd thus to id e ntify
re le va nt p a rtie s , the re la tio nship s be twe e n the m , a nd the
c o urs e s o f a c tio n tha t c a n be ta ke n.
6
7. Hot situations’ leading to ‘hot law’
Environmental law is
thus a subject in
which ‘reassured
certainties
give way to
tormented
complexities’.
7
‘…struck by the contrast
between the relative simplicity
of the basic objectives, and
the complexity of machinery
by which we try to give them
effect’.
‘…many environmental
law issues are not just
‘controversial’, but that
the controversies are
structural and
foundational’.
9. The scientific method
9
The game of science is, in
principle, without end. He who
decides one day that scientific
statements do not call for any
further test, and that they can be
regarded as finally verified, retires
from the game.
Karl Popper
10. What is science?
10
Hunts for
error.
No simple
definitive
answers.
Knowledge
is tentative
(e.g. 95%
confident)
Falsifiable,
corrigible,
progressive.
Reflexive. An interconnected series of
concepts and conceptual schemes
that have developed as a result of
experimentation and observation
and are fruitful of further
experimentation and observation.
11. The scientific method
• Deductive and inductive forms of reasoning
• Where knowledge is uncertain or incomplete we can rely on
inductive reasoning to help us make sense of it
• I.e. the conclusion follows with high probability from the information
in the premise (or the premises) of the argument
– P1: Most As are B
– P2: C is an A
– C: Therefore, C is likely to be B
11
P1: Most little dogs are
yappy.
P2: Fido is a little dog.
C: Therefore, Fido is likely
to be yappy.
12. Inductive reasoning
• Inductive reasoning is:
– Based on samples
– Relies on analogies or comparisons to reach a conclusion
• Either strong or weak based on whether the conclusion follows
with a high degree of probability from the premises
Therefore it is:
1. Inherently uncertain
2. Predictive in nature
3. Not always easy to determine whether an outcome is or is not
highly likely based on the available information
12
13. The role of scientists
• Scientists are duty bound to demonstrate where there are
uncertainties
• Uncertainties can be lost when we over simplify
• Cannot give us absolute certainty. Rather it gives us degrees of
confidence (high, moderate, or low) based on probability – i.e. a
strong argument or a weak argument
“We believe it is essential that environmental policies should have a sound scientific
basis … There is, however, a widely held view, even an expectation, that scientists
can provide the answer to whatever issues are under consideration. Science is not a
matter of certainties but of hypothesis and experiments. It advances by examining
alternative explanations for phenomena, and by abandoning superseded views. It has
provided very powerful tools for gaining understanding of complex environmental
processes and systems. At the same time there are many cases … in which damage
has been caused to health or the natural environment because of gaps in
understanding. Such incompleteness is inherent in the nature of science, especially
environmental science, which deals with ‘the world outside the laboratory’.
RCEP 21st Report: Setting Environmental Standards (1998), para 2.66 13
14. Scientific confidence and uncertainty
• Common forms of uncertainty:
– Value uncertainty
– Structural uncertainty
– Unpredictability
• European Commission examples of what causes uncertainty:
– The variable chosen
– The measurement made
– The sample drawn
– The models used
– The causal relationships employed
– Controversy on existing data or lack of some relevant data
• Scientific confidence is undermined by uncertainty (uncertainties
which the (good) scientist must point out)
14
16. Reconciling scientific uncertainty in a legal
framework: The Precautionary Principle
Principle 15 of the Rio Declaration, 1992
•“In order to protect the environment, the precautionary approach shall
be widely applied by States according to their capabilities. Where
there are threats of serious or irreversible damage, lack of
full scientific certainty shall not be used as a reason for
postponing cost-effective measures to prevent
environmental degradation” (weak version because measures
whose benefits are outweighed by the costs would not need to be
taken under this formulation)
Article 191(2) of the Treaty on the Functioning of the European Union
•Union policy on the environment shall be “based on the precautionary
principle”
16
17. European Commission Communication on the
Precautionary Principle 02.02.2000
The precautionary principle should be considered within a
structured approach to the analysis of risk:
•risk assessment
•risk management
•risk communication
Not confuse the principle with the element of caution that scientists
apply in their assessment of scientific data
It applies where potentially dangerous effects deriving from a
phenomenon, product or process have been identified, and that
scientific evaluation does not allow the risk to be determined with
sufficient certainty
17
18. European Commission Communication on the
Precautionary Principle (continued)
• Start with a scientific evaluation, as complete as possible, and
where possible, identifying at each stage the degree of scientific
uncertainty
• Decision-makers need to be aware of the degree of uncertainty
attached to the results
• Judging what is an "acceptable" level of risk for society is an
eminently political responsibility
• The scope of the precautionary principle in part depends on trends
in case law, which to some degree are influenced by prevailing
social and political values
• An analysis of the precautionary principle reveals two quite distinct
aspects: (i) the political decision to act or not to act as such, which is
linked to the factors triggering recourse to the precautionary
principle; (ii) in the affirmative, how to act, i.e. the measures
resulting from application of the precautionary principle
18
19. Principles which should underpin the application
of the precautionary principle
• Proportional – tailoring measures to the chosen level of protection
• Non-discriminatory – comparable situations should not be treated
differently, and that different situations should not be treated in the
same way
• Consistent – measures should be of comparable scope and nature
to those already taken in equivalent areas in which all scientific data
are available
• Based on a comparison of the risks and benefits associated with
various possible alternatives, both in the short and long term.
• Subject to review – in the light of new scientific data
• Capable of assigning responsibility for producing the scientific
evidence necessary for more comprehensive risk assessment
• Transparent – important given uncertainty and provisional solutions.
• Burden of proof with the applicant
19
20. Pfizer Animal Health SA v. Council of the
European Union [2002] ECR II-3305
• Applies in a situation of scientific uncertainty, when a risk
assessment cannot provide the decision-maker with conclusive
scientific evidence of the reality of the risk or the seriousness of the
potential adverse effects were that risk to become a reality
• Can take preventative action without having to wait
• Cannot be based on a purely hypothetical approach to the risk …
founded on a mere conjecture which has not been scientifically
verified – must be backed up by the scientific data available at the
time – therefore must be a scientific assessment
• No to “zero-risk” – i.e. not have to establish positive proof of
absolute safety
20
21. Reflections on the Precautionary Principle
• Complex
• Primarily procedural
• Facts alone not justify a decision. Creates space for non-scientific
arguments to inform the debate and form a basis for decision
making
• Therefore interpretation and application raises questions about the
values of decision makers – part of a political process, involving
democratic deliberation
• Reflects EU’s approach to environmental law which is to separate
out facts from values in decisions and create space for both in
environmental law and policy – separation between provision of
expertise and the political responsibility for decisions
• But – are the two fields kept separate? Tensions between two types
of reasoning – technical expertise and politics
21
22. Landelijke Vereniging tot Behoud van de
Waddenzee v Staatssecretaris van Lanbouw,
Natuurbeheer en Visserij, C-127/02
Likely Significant Effect (Article 6(3))
•There must be an appropriate assessment unless, on the basis of
objective information, it can be excluded that the plan or project will
have a significant effect on the site, either individually or in combination
with other plans or projects [Waddenzee, para 45].
Appropriate Assessment
•In undertaking an appropriate assessment, all the aspects of the plan
or project must be identified in the light of the best scientific knowledge
in the field [Waddenzee, paras 54, 61].
Adverse Effect on Integrity
•Competent authority must be convinced /certain/made sure that
the scheme will not adversely affect the integrity of the site. No
reasonable scientific doubt remaining [Waddenzee, para 56, 59, 61].
No alternatives/IROPI (Article 6(4))
22
24. Overview of themes in environmental policy
Command and
Control
Procedural/
flexible/
’experimental’/
Governance
Reflexive
Approaches –
voluntary
mechanisms
Economic
Instruments
Definition Top down
Regulation/Standards
Governance
Approaches -
deregulatory
Self -regulation Market incentives
Characteristics/
Elements
Uniformity/quantative
Licenses
Standards
Flexible
More tolerant of risk
Problem
identification
Bottom up
Internalisation of
externalities
Market failure
Examples Drinking Water Directive Water Framework
Directive/IPPC/EIA
EMAS Eco
Labelling
Emissions Trading
Regime
Rule of
Law/Policy
Require licence, standards
Provides sanction
Provide information
Framework for
debate. Create
values.
Embedding values.
Information
provision
Regulatory paradox –
need regulation to start,
but relies on free
market.
Rationale Scientific/expert led best
technique
Efficiency lessens
‘implementation gap’
– input legitimacy
Environmental
citizenship.
Green awareness
CSR
Internalise externalities
Efficiency
Incentive for R&D
Participative
Nature
Government led In theory lightly
participatory – but
opaque.
Consumerism Not very transparent/
participatory.
24
25. The Water Framework Directive
25
Response
to the
Sandoz
spill
Good
(ecological)
status
Intercalibration
Scope for
public
participation
Reflexive,
iterative
River Basin
Plans
Just a
talking
shop?
26. Public Participation: The Aarhus Convention 1998
Although regional in scope, the significance of the Aarhus Convention
is global. It is by far the most impressive elaboration of principle 10 of
the Rio Declaration, which stresses the need for citizens' participation
in environmental issues and for access to information on the
environment held by public authorities. As such it is the most ambitious
venture in the area of "environmental democracy" so far undertaken
under the auspices of the United Nations.
26
27. Other examples…
• Environmental Impact Assessment/Strategic Environmental
Assessment – aim to generate information in order to encourage
public participation and transparency in environmental decision
making
• Environmental Information Regulations – give people access to
environmental information in order to encourage public participation
and transparency in environmental decision making
• Marine Strategy Framework Directive – builds of WFD principles but
in the marine environment. Tries to incorporate an ecosystem
approach and sustainable use of marine resources as well as
greater cooperation at EU and regional levels and greater levels of
public participation
27
28. Personal reflections
Lee & Holder (2005)
“Science has a central role in legitimating environmental law and
policy: an appeal to ‘facts’, as established by science, is used to pre-empt
and undermine criticism. Although …there are inherent difficulties
with relying on science in this area, the apparent objectivity and
testability of science, seemingly above the fray of divided interest and
political advantage, can be extremely attractive to politicians and to
lawyers”
“Notwithstanding acknowledgement of public values, the temptation for
final decision makers is to seek refuge (rather than enlightenment) in
scientific or technical discourse such as risk assessment or cost benefit
analysis is great. The challenge is to ensure that technical information
is used in a way that informs, rather than usurps, political decision
making” 28
29. Thank you
Please feel free to provide feedback
Richard.broadbent@naturalengland.org.uk
29
Editor's Notes
“The history of science, like the history of all human ideas, is a history of irresponsible dreams, of obstinacy, and of error. But science is one of the very few human activities — perhaps the only one — in which errors are systematically criticized and fairly often, in time, corrected. This is why we can say that, in science, we often learn from our mistakes, and why we can speak clearly and sensibly about making progress there.” ― Karl Popper, Conjectures and Refutations: The Growth of Scientific Knowledge
However this means that it is difficult to deliver absolute certainty to decision makers.
So how does environmental law and policy respond to this?