PANEL 3: Priority setting of chemicals – potential for harmonisation and synergies
Presentation: Tala R. Henry, Director, Risk Assessment Division, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency
PANEL 3: Priority setting of chemicals – potential for harmonisation and synergies
Presentation: Michael Walls, Vice President – Regulatory and Technical Affairs, American Chemistry Council, US
Canada's Chemicals Management Plan aims to reduce risks from chemicals to Canadians and the environment. Substances are assessed for harm and actions are taken to control risks. The government committed to developing a long-term strategy to systematically assess the effectiveness of actions controlling toxic substances. Measuring performance establishes indicators, collects data on substance levels, evaluates current conditions against baselines, and identifies needed monitoring and follow up actions. Challenges include inconsistent data, appropriate population representation, timing of data availability, and resource requirements. Performance measurement can improve public health and the environment while minimizing future costs through earlier recognition of concerns.
Measuring the performance of chemical management systems is important to assess impact with limited resources and ensure efficiency. There are several types of indicators to measure performance, including impact indicators related to chemicals-related diseases and environmental impacts, result indicators on chemical levels in human and environmental samples, and output indicators like restricted substances. However, accurately measuring impact indicators is challenging due to complex attribution of health effects and lack of data, and result indicators are limited to known chemicals with inconsistent monitoring. Harmonization of research, monitoring, and testing is needed to strengthen performance measurement of chemical management systems.
The document discusses OECD's Mutual Acceptance of Data (MAD) system, which aims to avoid duplicative testing of chemicals by industry and reduce non-tariff trade barriers. Under MAD, toxicological and ecotoxicological data generated in OECD countries in accordance with OECD Test Guidelines and Good Laboratory Practice principles must be accepted by other OECD members for regulatory purposes. Approximately 160 Test Guidelines cover various endpoints. Guidelines are regularly updated to meet regulatory needs. MAD is estimated to result in over 300 million euros in annual net savings through eliminating redundant testing.
This document summarizes an annual report card that benchmarks retailers on their policies addressing toxic chemicals. It evaluates forty retailers across twelve sectors on fourteen criteria related to chemical safety. The criteria examine elements like eliminating chemicals of high concern and increasing transparency. The report found that since 2016, eleven retailers improved their grade from a D+ to a C+ by strengthening existing policies or adopting new ones. It also notes recent policy developments from retailers like Lowe's, Whole Foods, Trader Joe's, Amazon, Target, Walmart, and Dollar Tree aimed at restricting additional toxic chemicals.
This document discusses the grouping of chemical substances for regulatory purposes and how to avoid unintended consequences when substituting chemicals. It addresses how chemicals are grouped for restrictions, classifications, and authorizations under REACH. The challenges of grouping chemicals when there is uncertainty about their properties is discussed. Read-across, which is using data from one chemical to predict the properties of another, is examined, including the criteria used to evaluate it. Ensuring there is sufficient data and scientific justification for groupings and read-across is important to support informed substitution of chemicals.
This document compares the comparative effectiveness research (CER) and relative effectiveness (RE) evidence environments in the US and Europe. It identifies critical factors and likely scenarios for each region by 2020. Both regions will see increasing demands for CER/RE evidence from payers to demonstrate value. The US will make greater progress in data and analytics capabilities while Europe increases harmonization between regulators and health technology assessors. Adaptive licensing will be implemented in Europe but not the US.
This document discusses scenario-building methods to define the future of clinical evidence requirements in the US drug development and healthcare systems. It identifies key factors like integration of health systems, use of big data, and patient roles that could impact clinical evidence requirements. Three potential scenarios are described ranging from a status quo system to a fully integrated system. The "moderate integration" scenario is deemed most likely, featuring some increased system integration, standardized electronic health records, growing big data opportunities, and more organized patient groups. Accountable care organizations are also examined, finding they may evaluate drug effectiveness and cost-effectiveness as risk-based payments increase and care pathways are established.
PANEL 3: Priority setting of chemicals – potential for harmonisation and synergies
Presentation: Michael Walls, Vice President – Regulatory and Technical Affairs, American Chemistry Council, US
Canada's Chemicals Management Plan aims to reduce risks from chemicals to Canadians and the environment. Substances are assessed for harm and actions are taken to control risks. The government committed to developing a long-term strategy to systematically assess the effectiveness of actions controlling toxic substances. Measuring performance establishes indicators, collects data on substance levels, evaluates current conditions against baselines, and identifies needed monitoring and follow up actions. Challenges include inconsistent data, appropriate population representation, timing of data availability, and resource requirements. Performance measurement can improve public health and the environment while minimizing future costs through earlier recognition of concerns.
Measuring the performance of chemical management systems is important to assess impact with limited resources and ensure efficiency. There are several types of indicators to measure performance, including impact indicators related to chemicals-related diseases and environmental impacts, result indicators on chemical levels in human and environmental samples, and output indicators like restricted substances. However, accurately measuring impact indicators is challenging due to complex attribution of health effects and lack of data, and result indicators are limited to known chemicals with inconsistent monitoring. Harmonization of research, monitoring, and testing is needed to strengthen performance measurement of chemical management systems.
The document discusses OECD's Mutual Acceptance of Data (MAD) system, which aims to avoid duplicative testing of chemicals by industry and reduce non-tariff trade barriers. Under MAD, toxicological and ecotoxicological data generated in OECD countries in accordance with OECD Test Guidelines and Good Laboratory Practice principles must be accepted by other OECD members for regulatory purposes. Approximately 160 Test Guidelines cover various endpoints. Guidelines are regularly updated to meet regulatory needs. MAD is estimated to result in over 300 million euros in annual net savings through eliminating redundant testing.
This document summarizes an annual report card that benchmarks retailers on their policies addressing toxic chemicals. It evaluates forty retailers across twelve sectors on fourteen criteria related to chemical safety. The criteria examine elements like eliminating chemicals of high concern and increasing transparency. The report found that since 2016, eleven retailers improved their grade from a D+ to a C+ by strengthening existing policies or adopting new ones. It also notes recent policy developments from retailers like Lowe's, Whole Foods, Trader Joe's, Amazon, Target, Walmart, and Dollar Tree aimed at restricting additional toxic chemicals.
This document discusses the grouping of chemical substances for regulatory purposes and how to avoid unintended consequences when substituting chemicals. It addresses how chemicals are grouped for restrictions, classifications, and authorizations under REACH. The challenges of grouping chemicals when there is uncertainty about their properties is discussed. Read-across, which is using data from one chemical to predict the properties of another, is examined, including the criteria used to evaluate it. Ensuring there is sufficient data and scientific justification for groupings and read-across is important to support informed substitution of chemicals.
This document compares the comparative effectiveness research (CER) and relative effectiveness (RE) evidence environments in the US and Europe. It identifies critical factors and likely scenarios for each region by 2020. Both regions will see increasing demands for CER/RE evidence from payers to demonstrate value. The US will make greater progress in data and analytics capabilities while Europe increases harmonization between regulators and health technology assessors. Adaptive licensing will be implemented in Europe but not the US.
This document discusses scenario-building methods to define the future of clinical evidence requirements in the US drug development and healthcare systems. It identifies key factors like integration of health systems, use of big data, and patient roles that could impact clinical evidence requirements. Three potential scenarios are described ranging from a status quo system to a fully integrated system. The "moderate integration" scenario is deemed most likely, featuring some increased system integration, standardized electronic health records, growing big data opportunities, and more organized patient groups. Accountable care organizations are also examined, finding they may evaluate drug effectiveness and cost-effectiveness as risk-based payments increase and care pathways are established.
The document discusses how the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) groups substances for assessment and avoids regrettable substitution. It notes that NICNAS assessed over 4,000 chemicals at tier 2, grouping over 3,600 into 333 groups based on toxicophore similarity, common toxic species, mode of action, and physicochemical properties. It describes how the confidence in grouping predictions increases with more evidence and can range from priority setting to severe restrictions, depending on the consequence and justification. The new Australian Industrial Chemicals Introduction Scheme (AICIS) will take over from NICNAS from July 2020 with a more risk-proportionate and post-market focused approach.
This document summarizes progress made and remaining challenges in developing new approach methods for regulatory toxicology assessments. It outlines several new approach methods developed including high-throughput in vitro screening databases and models. However, it notes remaining scientific challenges including limited metabolic and biological complexity of current in vitro assays and gaps in exposure and dosimetry data. The document also discusses philosophical challenges in validating new approach methods, defining adversity at the molecular level, and gaining acceptance for qualitative and quantitative uncertainties compared to traditional animal studies.
This document discusses a feasibility study examining whether decisions by the UK's National Institute for Health and Care Excellence (NICE) influence decisions by health technology assessment bodies in other countries. The study analyzed 29 drug-indication pairs assessed by NICE and other countries' HTAs. The results suggest NICE decisions are related to subsequent HTAs in other countries. Drugs without positive NICE recommendations had a higher probability of being not recommended by other HTAs. Additionally, the number of fully reimbursed drugs was higher before versus after NICE assessment. The consideration of NICE decisions may increase the likelihood of other HTAs issuing negative decisions. However, the small sample size means results must be interpreted cautiously and more research is needed.
This document discusses a new drug development paradigm (NDDP) that aims to improve the efficiency and effectiveness of clinical drug development. It outlines several proposals that call for reforming the current drug development model, including using more modeling, adaptive trial designs, and integrating clinical trials into healthcare delivery systems. The NDDP proposes a more flexible framework with early patient/payer engagement, exploratory and confirmatory research phases using modern trial designs, and post-approval studies to establish relative value. Challenges for industry include conducting large simple trials, partnering to support more efficient trials, and having a clear evidentiary strategy tailored to different drug archetypes.
Strengthening data sharing for public health: ethical, legal and political is...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
Strengthening data sharing for public health: ethical, legal and political issues. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
Future Health Challenges: Developing Global Norms for Data and Results Sharin...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
Future Health Challenges: Developing Global Norms for Data and Results Sharing during Public Health Emergencies. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
Jim Jones, US EPA Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, delivered the keynote presentation at the Commission for Environmental Cooperation's (CEC) Chemicals Management Forum held in San Antonio, Texas, on May 15, 2012
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...OECD Environment
Humans and the environment are exposed every day to chemicals. How do we make sure that these chemicals are safe?
Industry is required to test these chemicals to understand how they may affect people and the environment. In the past, these tests were most commonly carried out on animals. As scientific methods and tools progress, the use of animals to test a product designed for humans are becoming obsolete, in addition to being unethical. With new methods being developed, it is possible to perform these tests on human and animal cell cultures with equally rigorous and robust results. Because the OECD is committed to chemical safety and animal welfare, a new ground-breaking Guideline on Defined Approaches for Skin Sensitisation (OECD GL 497: https://doi.org/10.1787/b92879a4-en) was released on 14 June 2021. It is the first ever Guideline that uses non-animal methods to predict whether a chemical can cause skin allergies. The OECD organised a webinar on 18 October 2021 at 14:00 to discuss the implementation of the Defined Approaches on Skin Sensitisation for chemical safety in member countries. This webinar paved the way for companies and authorities to determine the environmental toxicity of chemicals without having to resort to animal testing.
Speakers:
- Nicole Kleinestreuer: NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) - Silvia Casati: European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
- Anna Lowit: U.S. Environmental Protection's Office of Pesticide Programs (US EPA OPP)
- Paul Brown: U.S. Food and Drug Administration (US FDA)
- Laura Rossi: European Chemicals Agency (ECHA)
- Andre Muller: National Institute for Public Health and the Environment (RIVM)
Access the video replay and more information about our work at: https://oe.cd/testing-assessment-webinars
This presentation was hosted by Gerry Jeffcott from 3Sixty Public Affairs, who was joined by two pharmaceutical policy researchers who have conducted analyses of Canada’s access performance over time and in comparison with other countries.
The session began with an overview of each of the elements of the Canadian review and approval process by our moderator. After that, the session explored each agency’s performances in terms of supporting efficient access to needed new medicines. We will also compare Canada with other similar countries to determine how we fare internationally in terms of gaining access.
The presentation includes an interactive question and answer session.
Data Governance for Real-World Evidence: Cross-country differences and recomm...Office of Health Economics
This document analyzes data governance frameworks for using real-world data (RWD) to generate real-world evidence (RWE) in eight countries. It identifies 29 elements of an ideal governance framework and assesses each country's framework against these criteria. Recommendations include having clear data protection laws that allow secondary uses of health data to benefit patients, using opt-out consent for large cohort data collection, and transparent data linkage mechanisms with national interoperability standards. Current country frameworks show varying adherence to these recommendations.
The CRO-Sponsor Interaction: Regulatory AffairsMedpace
The document discusses the evolution of relationships between clinical research organizations (CROs) and sponsors from primarily transactional to preferred partnerships and strategic integration. It outlines keys to productive alliances such as sharing objectives and expertise. The document emphasizes that early engagement between CROs and sponsors is critical for regulatory success and positive relationships. Regulatory affairs experiences a seamless transition across regions and development cycles through CRO support.
Data Governance for Real-World Evidence: Cross-country differences and recommendations for a governance framework
Cole, A., Garrison, L., Mestre-Ferrandiz, J. & Towse A.
MCDA can help address some challenges in health technology assessment by systematically considering multiple criteria, such as health impacts, costs, equity and other value dimensions. Some countries have piloted the use of MCDA in HTA processes, but there are still open questions around which criteria and weights to use, how to incorporate opportunity costs and deal with uncertainty. While MCDA shows promise for improving transparency and decision-making in HTA, further work is needed to balance its benefits and costs for different healthcare systems.
How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...Office of Health Economics
This document summarizes a panel discussion on how health technology assessments (HTAs) in Asia can respond to increased clinical uncertainty through the potential use of outcomes-based risk sharing agreements (PBRSAs). The panel focused on implementing risk sharing in the region, examining case studies from other areas, and identifying barriers and opportunities. It provided an overview of PBRSAs in the US and Europe, discussed feasibility challenges, and outlined alternatives to outcomes-based risk sharing that payers could consider at drug launch.
25 January 2022: Webinar on Adverse Outcome Pathway co-operative activities b...OECD Environment
On 25 January 2022, the OECD held a webinar on Adverse Outcome Pathway (AOP) co-operative activities between Scientific journals and the OECD.
This webinar was organised primarily for Scientific Journal editors or publishers who are interested in reviewing/publishing AOPs and collaborating with the OECD in this activity.
The objective of the webinar was to present the basis for cooperation between scientific journals and the OECD and discuss the lessons learnt so far.
Dan Villeneuve (US EPA) presented the AOP framework and challenges being encountered.
Access the webinar replay at: https://oe.cd/testing-assessment-webinars
The document discusses how the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) groups substances for assessment and avoids regrettable substitution. It notes that NICNAS assessed over 4,000 chemicals at tier 2, grouping over 3,600 into 333 groups based on toxicophore similarity, common toxic species, mode of action, and physicochemical properties. It describes how the confidence in grouping predictions increases with more evidence and can range from priority setting to severe restrictions, depending on the consequence and justification. The new Australian Industrial Chemicals Introduction Scheme (AICIS) will take over from NICNAS from July 2020 with a more risk-proportionate and post-market focused approach.
This document summarizes progress made and remaining challenges in developing new approach methods for regulatory toxicology assessments. It outlines several new approach methods developed including high-throughput in vitro screening databases and models. However, it notes remaining scientific challenges including limited metabolic and biological complexity of current in vitro assays and gaps in exposure and dosimetry data. The document also discusses philosophical challenges in validating new approach methods, defining adversity at the molecular level, and gaining acceptance for qualitative and quantitative uncertainties compared to traditional animal studies.
This document discusses a feasibility study examining whether decisions by the UK's National Institute for Health and Care Excellence (NICE) influence decisions by health technology assessment bodies in other countries. The study analyzed 29 drug-indication pairs assessed by NICE and other countries' HTAs. The results suggest NICE decisions are related to subsequent HTAs in other countries. Drugs without positive NICE recommendations had a higher probability of being not recommended by other HTAs. Additionally, the number of fully reimbursed drugs was higher before versus after NICE assessment. The consideration of NICE decisions may increase the likelihood of other HTAs issuing negative decisions. However, the small sample size means results must be interpreted cautiously and more research is needed.
This document discusses a new drug development paradigm (NDDP) that aims to improve the efficiency and effectiveness of clinical drug development. It outlines several proposals that call for reforming the current drug development model, including using more modeling, adaptive trial designs, and integrating clinical trials into healthcare delivery systems. The NDDP proposes a more flexible framework with early patient/payer engagement, exploratory and confirmatory research phases using modern trial designs, and post-approval studies to establish relative value. Challenges for industry include conducting large simple trials, partnering to support more efficient trials, and having a clear evidentiary strategy tailored to different drug archetypes.
Strengthening data sharing for public health: ethical, legal and political is...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
Strengthening data sharing for public health: ethical, legal and political issues. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
Future Health Challenges: Developing Global Norms for Data and Results Sharin...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
Future Health Challenges: Developing Global Norms for Data and Results Sharing during Public Health Emergencies. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
Jim Jones, US EPA Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, delivered the keynote presentation at the Commission for Environmental Cooperation's (CEC) Chemicals Management Forum held in San Antonio, Texas, on May 15, 2012
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...OECD Environment
Humans and the environment are exposed every day to chemicals. How do we make sure that these chemicals are safe?
Industry is required to test these chemicals to understand how they may affect people and the environment. In the past, these tests were most commonly carried out on animals. As scientific methods and tools progress, the use of animals to test a product designed for humans are becoming obsolete, in addition to being unethical. With new methods being developed, it is possible to perform these tests on human and animal cell cultures with equally rigorous and robust results. Because the OECD is committed to chemical safety and animal welfare, a new ground-breaking Guideline on Defined Approaches for Skin Sensitisation (OECD GL 497: https://doi.org/10.1787/b92879a4-en) was released on 14 June 2021. It is the first ever Guideline that uses non-animal methods to predict whether a chemical can cause skin allergies. The OECD organised a webinar on 18 October 2021 at 14:00 to discuss the implementation of the Defined Approaches on Skin Sensitisation for chemical safety in member countries. This webinar paved the way for companies and authorities to determine the environmental toxicity of chemicals without having to resort to animal testing.
Speakers:
- Nicole Kleinestreuer: NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) - Silvia Casati: European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
- Anna Lowit: U.S. Environmental Protection's Office of Pesticide Programs (US EPA OPP)
- Paul Brown: U.S. Food and Drug Administration (US FDA)
- Laura Rossi: European Chemicals Agency (ECHA)
- Andre Muller: National Institute for Public Health and the Environment (RIVM)
Access the video replay and more information about our work at: https://oe.cd/testing-assessment-webinars
This presentation was hosted by Gerry Jeffcott from 3Sixty Public Affairs, who was joined by two pharmaceutical policy researchers who have conducted analyses of Canada’s access performance over time and in comparison with other countries.
The session began with an overview of each of the elements of the Canadian review and approval process by our moderator. After that, the session explored each agency’s performances in terms of supporting efficient access to needed new medicines. We will also compare Canada with other similar countries to determine how we fare internationally in terms of gaining access.
The presentation includes an interactive question and answer session.
Data Governance for Real-World Evidence: Cross-country differences and recomm...Office of Health Economics
This document analyzes data governance frameworks for using real-world data (RWD) to generate real-world evidence (RWE) in eight countries. It identifies 29 elements of an ideal governance framework and assesses each country's framework against these criteria. Recommendations include having clear data protection laws that allow secondary uses of health data to benefit patients, using opt-out consent for large cohort data collection, and transparent data linkage mechanisms with national interoperability standards. Current country frameworks show varying adherence to these recommendations.
The CRO-Sponsor Interaction: Regulatory AffairsMedpace
The document discusses the evolution of relationships between clinical research organizations (CROs) and sponsors from primarily transactional to preferred partnerships and strategic integration. It outlines keys to productive alliances such as sharing objectives and expertise. The document emphasizes that early engagement between CROs and sponsors is critical for regulatory success and positive relationships. Regulatory affairs experiences a seamless transition across regions and development cycles through CRO support.
Data Governance for Real-World Evidence: Cross-country differences and recommendations for a governance framework
Cole, A., Garrison, L., Mestre-Ferrandiz, J. & Towse A.
MCDA can help address some challenges in health technology assessment by systematically considering multiple criteria, such as health impacts, costs, equity and other value dimensions. Some countries have piloted the use of MCDA in HTA processes, but there are still open questions around which criteria and weights to use, how to incorporate opportunity costs and deal with uncertainty. While MCDA shows promise for improving transparency and decision-making in HTA, further work is needed to balance its benefits and costs for different healthcare systems.
How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...Office of Health Economics
This document summarizes a panel discussion on how health technology assessments (HTAs) in Asia can respond to increased clinical uncertainty through the potential use of outcomes-based risk sharing agreements (PBRSAs). The panel focused on implementing risk sharing in the region, examining case studies from other areas, and identifying barriers and opportunities. It provided an overview of PBRSAs in the US and Europe, discussed feasibility challenges, and outlined alternatives to outcomes-based risk sharing that payers could consider at drug launch.
25 January 2022: Webinar on Adverse Outcome Pathway co-operative activities b...OECD Environment
On 25 January 2022, the OECD held a webinar on Adverse Outcome Pathway (AOP) co-operative activities between Scientific journals and the OECD.
This webinar was organised primarily for Scientific Journal editors or publishers who are interested in reviewing/publishing AOPs and collaborating with the OECD in this activity.
The objective of the webinar was to present the basis for cooperation between scientific journals and the OECD and discuss the lessons learnt so far.
Dan Villeneuve (US EPA) presented the AOP framework and challenges being encountered.
Access the webinar replay at: https://oe.cd/testing-assessment-webinars
Canada's Chemicals Management Plan has a closing timeline of 2020 and although it seem far away the question is how will it help or hinder your business in the use of chemicals and what changes MUST you apply in your business?
Toxic Substances Control Act (TSCA) Reform: What's New & How It May Affect YouTriumvirate Environmental
This presentation provides an overview of recent amendments to the federal Toxic Substances Control Act (TSCA). On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law, substantially amending TSCA. The new law, which received bipartisan support in both the U.S. House of Representatives and the Senate, includes much needed improvements such as requirements that EPA evaluate existing chemicals, a new risk-based safety standard, and increased public transparency of chemical information.
Barbara Cunningham, Deputy Director, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency (U.S. EPA) and Chair of the SMOC Working Group of the Commission for Environmental Cooperation speaks at the Chemicals Management Forum in San Antonio, Texas, on May 15, 2012. More information at http://www.cec.org/chemicals2012
The document discusses environmental risk assessment and management. It defines key terms like risk, environmental risk assessment, and risk characterization. It outlines the steps in risk assessment as hazard identification, dose-response assessment, exposure assessment, and risk characterization. It also discusses grading of risk from low to high. The steps in risk management are identified as risk assessment, technological feasibility assessment, economic impact analysis, consideration of public concerns and legal requirements, decision making, implementation, monitoring and evaluation, and review. Risk management aims to prevent adverse effects on human health and ecological systems.
This document discusses risk assessment and management of the domestic water supply system in Pleiku City, Vietnam. It identifies hazards at each stage of the water supply system from the source to the distribution system. Hazards are assessed based on likelihood and severity to determine raw risk scores. Existing control measures are considered to assess residual risk. Key risks identified include agricultural and livestock activities polluting the water source, power failures at water treatment plants affecting disinfection, and degraded piping in the distribution system allowing recontamination of treated water. The study aims to propose improvements to better manage risks and ensure a safe domestic water supply.
This document provides a summary of the key steps to implement ICH Q3D Guideline for Elemental Impurities:
1. Collect baseline information on potential elemental impurity sources from suppliers.
2. Define the risk assessment strategy to use, such as the component-based Options 1, 2A, 2B or finished-product Option 3.
3. Develop an analytical plan using techniques like ICP-MS to test for elemental impurities.
4. Establish a control strategy where impurities below 30% of the PDE are acceptable.
5. Manage the implementation as a continuous process, reassessing for product or supplier changes.
The document provides an overview of an integrated assessment being conducted on hydraulic fracturing in Michigan. It includes an agenda, background on the Graham Institute conducting the assessment, key points from technical reports produced, the guiding question and goals of the integrated assessment, participants in the assessment, potential policy topics to be examined, and the timeline for the assessment. The integrated assessment aims to analyze policy options for managing hydraulic fracturing through stakeholder engagement and by building on technical reports addressing topics like technology, environment, health and economics.
Canadian Perspective on Problem Formulation for Biopesticides: Emma BabijOECD Environment
The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
Margaret Kenny, Director General, Chemicals Sector, Environment Canada and Member of the SMOC Working Group of the Commission for Environmental Cooperation spoke about Canada's Chemicals Management Plan at the Chemicals Management Forum in San Antonio, Texas, May 15, 2012. More info. at: http://www.cec.org/chemicals2012
This document discusses environmental impact assessments (EIAs) and environmental monitoring. It explains that an EIA assesses potential positive and negative environmental, social, and economic impacts of proposed projects. EIAs are required for certain Schedule 1 and 2 projects based on their potential significance. Monitoring is a key part of EIAs and involves collecting baseline data, measuring impacts during construction and operation, and checking compliance with standards to facilitate impact management. The goals, methods, analysis, and use of monitoring data are described.
1) The document provides an overview of food defense training covering incidents of intentional food contamination, government policy and preparedness response, and the CARVER+Shock risk assessment tool.
2) It describes incidents where food products were intentionally contaminated for economic gain or to influence elections, causing illnesses and some deaths.
3) The Food Safety Modernization Act aims to improve food protection through rules focused on mitigation strategies, foreign supplier verification, and preventative controls for human and animal food.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
01.Elemental Impurities and Nitrosamine contamination regulatory trend.pdfrdaguardianp
The document discusses strategies for controlling elemental impurities and nitrosamine contamination in biomanufacturing. It begins with an introduction to elemental impurity regulations from various organizations like ICH, USP and EMA. The document then provides an overview of Merck's approach to providing elemental impurity information and risk assessment support to drug product manufacturers. This includes dossiers on over 400 products with details on intentionally added elements, impurity profiles and test results. The document also discusses recent ICH Q3D guideline revisions regarding new PDE limits and additional guidance for cutaneous routes of administration. It then shifts to discussing incidents of nitrosamine contamination in certain API classes like sartans since 2018.
The guidelines are intended to help countries identify priorities, objectives and the desired goal of disease control programmes. Disease control programmes are often established with the aim of eventual eradication of agents at a country, zone or compartment level. While this approach is desirable, the needs of stakeholders may require a broader range of outcomes. For some diseases, eradication may not be economically or practically feasible and options for sustained mitigation of disease impacts may be needed. It is important to clearly describe the programme goals and these may range from simple mitigation of disease impacts to progressive control or eradication of the disease. These guidelines highlight the importance of economic assessment of disease intervention options in the design of programmes taking into consideration effectiveness, feasibility of implementation, as well as costs and benefits. The purpose is to provide a conceptual framework that can be adapted to a particular national and epidemiological context.
High-level inter-ministerial workshop held in Hanoi June 6-7, 2017 hosted by the Ministry of Agricultural Development (MARD) of Viet Nam and supported under the Integrating Agriculture in National Adaptation Plans (NAP-Ag) Programme. The meeting was attended by over 75 national and provincial level government officials, including MONRE, MARD, MPI and the Ministry of Finance (MOF), UN and development partners, private sector representatives including insurance companies, as well as non-governmental organisations.
The document summarizes meetings of a Minnesota Chemical Regulation and Policy Project work group regarding green chemistry, science and risk assessment, and policy and risk management. It discusses the work group's draft recommendations to: 1) create a Minnesota Green Chemistry Innovation Council, 2) implement a project to evaluate emerging risk assessment methodologies, and 3) create a Chemical Science Advisory Panel. The recommendations aim to promote green chemistry, improve risk assessment, and provide independent scientific advice on chemical issues.
The document summarizes discussions from the Helsinki Chemicals Forum 2019 on various topics related to chemicals safety. The forum brought together 191 delegates from 31 countries to discuss five main themes: 1) Choosing the best options to manage risks from substances of very high concern, 2) Approaches to plastic circularity, 3) The struggle between data access and protection of intellectual property, 4) Grouping of chemical substances to avoid regrettable substitution, and 5) Measuring the performance of different chemical management systems. Panel discussions covered issues such as predictability and transparency in risk management, promoting substitution of hazardous chemicals, ensuring recycled goods do not reintroduce hazardous substances, and challenges in measuring the impacts of chemicals regulations.
The document summarizes the European Union's efforts towards establishing a circular economy for chemicals. Some key points:
- The EU has implemented 54 actions through its Circular Economy Action Plan to close material cycles and reduce waste. This is estimated to create jobs and reduce CO2 emissions by up to 4%.
- Specific achievements include the EU Plastics Strategy, revisions to waste legislation, and analysis of the interface between chemicals, product, and waste policies.
- The chemical sector is seen as key to enabling circular economy innovations like better design for recycling and chemical recycling technologies.
- REACH legislation has created a large database of chemical information, promoted alternatives to animal testing, and ensured a functioning single market while
The document summarizes the mission and goals of the End Plastic Waste organization, which aims to minimize plastic waste ending up in the environment through developing and scaling solutions for reuse, recovery, and recycling of plastic. It outlines the challenges of increasing plastic waste production and leakage into oceans. The organization takes a collaborative approach across the plastic value chain and promotes complementary solutions like increasing recycling infrastructure/rates, engaging stakeholders, advancing technologies, and cleaning up concentrated plastic waste areas. Its strategy involves innovation, education, infrastructure development, and funding of $1.5 billion over 5 years from member companies for waste management programs and investments.
The document summarizes the European Chemicals Agency's proposal to restrict intentionally added microplastics in professional and consumer uses. The proposed restriction would prohibit the placing on the market of products containing microplastics, with some derogated uses allowed. It would also mandate improved instructions for proper use and disposal to avoid releases into the environment, as well as reporting. A public consultation on the proposal is open until September 2019.
The document discusses grouping of chemical substances and the issue of regrettable substitution. It notes that grouping enables extrapolation of hazard properties from data-rich to data-poor substances and can help address the data deficit problem. However, there is a risk of regrettable substitution, where an unsafe substance is replaced by another unsafe substance. The document then provides an example of an expert committee recommending grouping to some extent for the assessment of organohalogen flame retardants into 16 groups, as individual assessments of each chemical would be unrealistic. It raises questions about ensuring consistent global approaches to grouping while addressing legislative and chemical diversity, and how risk assessors should define groups.
Cefic represents the chemical industry in Europe, with over 500 company members. It interacts daily with EU and international institutions on behalf of its members. The chemical industry invests 700 billion euros annually in R&D to develop new chemicals that improve performance, meet regulations, and anticipate customer needs. Substitution of chemicals is an innovation opportunity that requires a holistic assessment of technical performance, safety, and environmental properties to avoid regrettable substitution. Grouping chemicals can be useful for regulatory assessments if based on robust scientific criteria, but a one-size-fits-all approach should not be used, as substances within a group can have different hazard properties. The only way forward is through dialogue and cooperation between regulators and industry.
The document discusses challenges with accessing chemical data for regulatory purposes and proposes potential solutions. It notes that generating data is costly but necessary to gain market access, and that data sharing is difficult due to regional restrictions and ownership issues. It proposes creating a centralized global database where studies could be purchased via subscription. This would facilitate consistent data access and interpretation across regulatory agencies. Ensuring high quality, compliant data remains challenging due to subjectivity, but the goal of safety and a viable industry requires improved data sharing and alternative assessment methods.
Mike Rasenberg discussed the quality and access to chemical data collected under REACH and CLP regulations. Over 22,000 substances and 148,000 notifications have provided 4.5 million webpages of substance information. IUCLID format standardizes the data and maximizes sharing. While lack of compliance is an issue, other challenges include the data volume, requirement complexity, and balancing data protection and access. ECHA focuses on basic data access through their website and search tools, and plans to further streamline access through pilots with other agencies and transforming data to develop alternatives to animal testing. Global data sharing is expected to increase through IUCLID harmonization, though quality remains a challenge as well as fully accessing the knowledge potential in
Karel De Schamphelaere, a professor at Ghent University and president of SETAC Europe, argues that all raw ecotoxicity data should be fully accessible and reusable in data repositories regardless of origin. This would increase transparency and credibility, allow for evidence-based risk assessment including data quality assessment, and maximize reusability and opportunities for innovation in risk assessment. Currently, important information like full concentration-response data and control performance is often lost when published, limiting reusability and quality assessment. Making all underlying data openly available would help address this "information loss issue."
The document discusses Argentina's Directorate of Chemicals and its approach to chemicals management. It engages stakeholders from government, private sector, civil society, and academia. It uses tools from the OECD and studies the EU regulatory system to develop Argentina's legal framework. Key activities include cleaner production, risk management of substances, contaminated site remediation, and reporting. Challenges include availability of initial information, prioritizing differences, flexibility of tools, and inability to exactly replicate other systems.
1. Guy Thiran gave a speech about metals and the challenges facing their safe use and demand over time. He outlined 4 pillars needed to properly manage risks: having robust data, understanding use and value chains, exposure levels, and considering costs and benefits.
2. Metals demand is forecast to greatly increase due to renewable technologies, while Europe relies on imports as mining makes up less than 2% of production. Recycling rates vary but are improving, though data and access to resources is still challenging.
3. Trade-offs are needed between decarbonization, circularity, toxicity reduction, and sourcing to balance goals over the next 30 years, requiring integration across policies and materials. Exposure management
This document discusses plastics and circularity from a panel at the Helsinki Chemicals Forum. It emphasizes that plastic pollution begins before plastics enter the oceans and promotes preventing plastic waste by prioritizing reduced plastic production and consumption through eco-design within a circular economy approach for non-packaging plastics. The document provides contact information for Justine Maillot from Zero Waste Europe to learn more.
The document discusses marine litter and microplastics from the Norwegian Ministry of Climate and Environment. It was presented at the Helsinki Chemicals Forum on May 24, 2019 by Ingeborg Mork-Knutsen. Photos were provided by Bo Eide.
This document discusses a company that produces products made from recycled or renewable fibers that are recyclable or biodegradable, aiming to reach 100% circular products by 2022. It takes a holistic perspective in designing its value chain to take full responsibility socially, ethically, and environmentally. The company sees regenerative technologies that work in partnership with nature as an opportunity to shift from exploitation to regeneration as the standard.
The document discusses measuring the performance of the EU chemicals acquis. It assessed effectiveness, efficiency, coherence, relevance, and EU added value. The assessment involved scientific evidence, citizens, stakeholders, and experts from several EU commission services and agencies. Challenges included assessing a broad framework with no baseline, data gaps, attribution issues, and diverging views. Next steps include collecting more data, evidence, and stakeholder input to conduct additional research and develop better indicators for assessing specific legislation.
Grouping substances based on their similar structure and effects could help avoid regrettable substitution and play catch up regulation. Regulatory controls are needed for substance groups to improve data quality for registrations and restrict chemicals of concern from the market. Companies would bear the burden of proving a substance does not share hazardous properties with its group. Approaching regulation by groups could more efficiently lead to safer chemicals and uses.
Gamify it until you make it Improving Agile Development and Operations with ...Ben Linders
So many challenges, so little time. While we’re busy developing software and keeping it operational, we also need to sharpen the saw, but how? Gamification can be a way to look at how you’re doing and find out where to improve. It’s a great way to have everyone involved and get the best out of people.
In this presentation, Ben Linders will show how playing games with the DevOps coaching cards can help to explore your current development and deployment (DevOps) practices and decide as a team what to improve or experiment with.
The games that we play are based on an engagement model. Instead of imposing change, the games enable people to pull in ideas for change and apply those in a way that best suits their collective needs.
By playing games, you can learn from each other. Teams can use games, exercises, and coaching cards to discuss values, principles, and practices, and share their experiences and learnings.
Different game formats can be used to share experiences on DevOps principles and practices and explore how they can be applied effectively. This presentation provides an overview of playing formats and will inspire you to come up with your own formats.
This presentation by Tim Capel, Director of the UK Information Commissioner’s Office Legal Service, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
This presentation by Professor Giuseppe Colangelo, Jean Monnet Professor of European Innovation Policy, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
1.) Introduction
Our Movement is not new; it is the same as it was for Freedom, Justice, and Equality since we were labeled as slaves. However, this movement at its core must entail economics.
2.) Historical Context
This is the same movement because none of the previous movements, such as boycotts, were ever completed. For some, maybe, but for the most part, it’s just a place to keep your stable until you’re ready to assimilate them into your system. The rest of the crabs are left in the world’s worst parts, begging for scraps.
3.) Economic Empowerment
Our Movement aims to show that it is indeed possible for the less fortunate to establish their economic system. Everyone else – Caucasian, Asian, Mexican, Israeli, Jews, etc. – has their systems, and they all set up and usurp money from the less fortunate. So, the less fortunate buy from every one of them, yet none of them buy from the less fortunate. Moreover, the less fortunate really don’t have anything to sell.
4.) Collaboration with Organizations
Our Movement will demonstrate how organizations such as the National Association for the Advancement of Colored People, National Urban League, Black Lives Matter, and others can assist in creating a much more indestructible Black Wall Street.
5.) Vision for the Future
Our Movement will not settle for less than those who came before us and stopped before the rights were equal. The economy, jobs, healthcare, education, housing, incarceration – everything is unfair, and what isn’t is rigged for the less fortunate to fail, as evidenced in society.
6.) Call to Action
Our movement has started and implemented everything needed for the advancement of the economic system. There are positions for only those who understand the importance of this movement, as failure to address it will continue the degradation of the people deemed less fortunate.
No, this isn’t Noah’s Ark, nor am I a Prophet. I’m just a man who wrote a couple of books, created a magnificent website: http://www.thearkproject.llc, and who truly hopes to try and initiate a truly sustainable economic system for deprived people. We may not all have the same beliefs, but if our methods are tried, tested, and proven, we can come together and help others. My website: http://www.thearkproject.llc is very informative and considerably controversial. Please check it out, and if you are afraid, leave immediately; it’s no place for cowards. The last Prophet said: “Whoever among you sees an evil action, then let him change it with his hand [by taking action]; if he cannot, then with his tongue [by speaking out]; and if he cannot, then, with his heart – and that is the weakest of faith.” [Sahih Muslim] If we all, or even some of us, did this, there would be significant change. We are able to witness it on small and grand scales, for example, from climate control to business partnerships. I encourage, invite, and challenge you all to support me by visiting my website.
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11June 2024. An online pre-engagement session was organized on Tuesday June 11 to introduce the Science Policy Lab approach and the main components of the conceptual framework.
About 40 experts from around the globe gathered online for a pre-engagement session, paving the way for the first SASi-SPi Science Policy Lab event scheduled for June 18-19, 2024 in Malmö. The session presented the objectives for the upcoming Science Policy Lab (S-PoL), which featured a role-playing game designed to simulate stakeholder interactions and policy interventions for food systems transitions. Participants called for the sharing of meeting materials and continued collaboration, reflecting a strong commitment to advancing towards sustainable agrifood systems.
This presentation by OECD, OECD Secretariat, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
This presentation by Katharine Kemp, Associate Professor at the Faculty of Law & Justice at UNSW Sydney, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
1. PRIORITIZATION UNDER THE TOXIC
SUBSTANCES CONTROL ACT
Tala Henry
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
June 2018
henry.tala@ epa.gov
2. 2
Prioritization
Statutory Requirements
• EPA must establish a risk-based screening process, including criteria, for
designating a chemical substance as either:
– High-priority substance for risk evaluations
• may present an unreasonable risk of injury to health or the environment
because of a potential hazard and a potential route of exposure under the
conditions of use, including an unreasonable risk to a “potentially exposed or
susceptible subpopulation”, without consideration of costs or other non-risk
factors
– Low-priority substance for which risk evaluations are not warranted at the time
• based on information sufficient to establish that the chemical does not meet
the standard for high-priority
• By December 2019: 20 high-priority under evaluation + 20 low-priority designations
3. 3
• The process to designate the priority must include consideration of:
– hazard and exposure potential
– persistence and bioaccumulation
– potentially exposed or susceptible subpopulations
– storage near significant sources of drinking water
– the conditions of use or significant changes in the conditions of use
– the volume or significant changes in the volume
• Preference in designating priority substances:
– 2014 TSCA Work Plan chemicals (50% until complete) with persistence and
bioaccumulation scores of 3 (high) and that are know human carcinogens and
have high acute and chronic toxicity.
Prioritization
Statutory Requirements
On June 22, 2016, “The Frank R. Lautenberg Chemical Safety for the 21st Century Act” amended the Toxic Substances Control Act (TSCA).
A key new provision in the amendments was a MANDATE to conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluations by the Administrator, under the conditions of use. [section 6(b)(4)]
Identification of Priorities for Risk Evaluation is a precursor requirement to the mandate to evaluate risks [section 6(b)(1)].
Under TSCA, Prioritization is a risk-based screening process, that includes criteria for designating chemical substances as:
high-priority for risk evaluation or
low priority for which risk evaluation is not warranted at the time.
The process to designate the priority must include consideration of:
Hazard potential and Exposure potential, including consideration of:
persistence and bioaccumulation
potentially exposed or susceptible subpopulations
storage near significant sources of drinking water
the conditions of use or significant changes in the conditions of use
the volume or significant changes in the volume
Under TSCA, Prioritization is a risk-based screening process, that includes criteria for designating chemical substances as:
high-priority for risk evaluation or
low priority for which risk evaluation is not warranted at the time.
The process to designate the priority must include consideration of:
Hazard potential and Exposure potential, including consideration of:
persistence and bioaccumulation
potentially exposed or susceptible subpopulations
storage near significant sources of drinking water
the conditions of use or significant changes in the conditions of use
the volume or significant changes in the volume
In addition to definitions and considerations, the statue also requires:
Specific steps and timeframes in the process
Preferences for certain TSCA Work Plan chemicals