The document provides background on EFSA's efforts to develop guidance on pesticide exposure assessment. It summarizes EFSA's process of gathering input, conducting public consultations, and drafting the guidance document and related scientific opinion between 2006-2010. The main contents of the scientific opinion are outlined, including defining the scope, reviewing legal requirements, current risk assessment methods, and proposed new approaches for assessing acute risk and accounting for statistical variability.
In vitro data and in silico models for predictive toxicologyEFSA EU
The SEURAT project is a 7-year, 50 million Euro collaboration between the European Commission and Cosmetics Europe to develop non-animal approaches for repeated dose systemic toxicity testing. It involves over 70 research partners across 16 countries. The project aims to adopt a toxicological mode-of-action framework and use this knowledge to develop complementary in vitro and computational models that can predict toxicity endpoints needed for safety assessment. Key activities include developing genetically engineered cell lines, multi-scale models of organ toxicity, and an adverse outcome pathway knowledgebase to structure toxicity information. The models and data generated will be stored in online repositories to support regulatory safety evaluation.
Regulation of toxic substances requires determining risk levels amid scientific uncertainty. Regulators use risk assessment involving hazard identification, dose-response analysis, exposure assessment, and risk characterization. The precautionary principle also guides assuming risk until safety is proven, though the U.S. historically opposed this due to impact on business. The Toxic Substances Control Act of 1976 regulates chemicals, requiring pre-approval of new substances but grandfathering many existing ones.
Biological Monitoring of Workers Exposed to Pesticides - Guidelines for appli...PiLNAfrica
This guideline was produced for those persons responsible for the maintenance of health and safety measures at agricultural workplaces handling potentially hazardous organophosphate and carbarnate chemicals. It is primarily aimed at professional nursing and other medical staff charged with monitoring workers for pesticide exposure, but will be useful to all personnel involved in workplace health and safety wishing to understand the principles behind monitoring workers for pesticide exposure.
The guidelines concentrate on monitoring for organophosphate and carabarnate insecticides because the technology is reasonably readily available, and the methodology well described. These chemicals are widely used, and are the most common cause of acute poisoning by pesticides. The guidelines have also been written bearing in mind the Hazardous Chemical Regulations (Regulation 556 of 25 August 1995 in terms of the Occupational Health and Safety Act) that include agricultural workplaces in addition to industry.
The document discusses regulatory requirements for manufacturing high potent drugs globally. It covers definitions of high potent and hazardous drugs, classification systems like GHS, and key considerations like determining Acceptable Daily Exposures to manage risk of cross-contamination when producing multiple high potent drugs in one facility. The talk provides an overview of complex global regulations and approaches like Risk-MaPP to establish controls that ensure regulatory compliance and personnel safety for potent pharmaceuticals.
Occupational exposure limits (OEL) to chemical agents APIs - Quantitative Ris...Azierta
The Occupational Exposure Limit (OEL) is defined as the airborne concentration of a substance (expressed as a weighted average in time for a working day of 8 hours/day and 40 hours/working week) under which it is believed that nearly all workers may be repeatedly exposed (day after day, over a working lifetime) without adverse health effects (ACGIH, 2006; DFG, 2005).
Occupational exposure limits (OELs) are a useful tool to prevent adverse effects on health when managing chemical substances.
On a European scale…
• Employers are legally obliged to provide a work environment that does not threaten the health of the workers (Chemical Agent Directive 98/24/EC and Framework Directive 89/391/EEC).
• Under Directive 89/391/EEC, OELs can be developed nationally, Indicative Occupational Exposure Limit Values (IOELVs).
1) The document provides industry's view on EFSA's contributions to pesticide regulation, including their processes for active substance peer reviews, establishing maximum residue levels (MRLs), and scientific guidance.
2) While timelines are generally respected, industry finds some EFSA comments on active substance evaluations arrive too late and there are limitations on submitting new information.
3) Guidelines for MRL reasoned opinions are followed predictably but outcomes are sometimes viewed as conservative.
4) The annual MRL report is considered very useful but guidance documents are seen as sometimes disconnected from use contexts and imposing unnecessarily complex or conservative standards.
EFSA provides independent scientific advice on food safety and nutrition issues to the European Commission, European Parliament, and EU member states. In 2013, EFSA predicted 676 scientific outputs to meet the continuing high demand for scientific advice. Key priorities included boosting risk assessment capacity, enhancing dialogue with risk managers, and improving efficiency. Major science highlights included providing scientific opinions on meat inspection modernization, dietary reference values, and assessments of genetically modified organisms, pesticides, and food contact materials.
This document discusses the EU Commission's request for EFSA to provide a scientific opinion and guidance on risk assessment of plant protection products (pesticides) on bees. It outlines the composition of the working group, terms of reference, and proposed chapters to cover introduction, protection goals, exposure assessment, chronic toxicity from low doses, test methods, cumulative/synergistic effects, and risk assessment methodology for honeybees, bumblebees and solitary bees. It provides details on the key sections including identifying the most exposed bee categories and life stages, major exposure routes, and proposing a new method to assess cumulative toxicity from long-term low exposures.
In vitro data and in silico models for predictive toxicologyEFSA EU
The SEURAT project is a 7-year, 50 million Euro collaboration between the European Commission and Cosmetics Europe to develop non-animal approaches for repeated dose systemic toxicity testing. It involves over 70 research partners across 16 countries. The project aims to adopt a toxicological mode-of-action framework and use this knowledge to develop complementary in vitro and computational models that can predict toxicity endpoints needed for safety assessment. Key activities include developing genetically engineered cell lines, multi-scale models of organ toxicity, and an adverse outcome pathway knowledgebase to structure toxicity information. The models and data generated will be stored in online repositories to support regulatory safety evaluation.
Regulation of toxic substances requires determining risk levels amid scientific uncertainty. Regulators use risk assessment involving hazard identification, dose-response analysis, exposure assessment, and risk characterization. The precautionary principle also guides assuming risk until safety is proven, though the U.S. historically opposed this due to impact on business. The Toxic Substances Control Act of 1976 regulates chemicals, requiring pre-approval of new substances but grandfathering many existing ones.
Biological Monitoring of Workers Exposed to Pesticides - Guidelines for appli...PiLNAfrica
This guideline was produced for those persons responsible for the maintenance of health and safety measures at agricultural workplaces handling potentially hazardous organophosphate and carbarnate chemicals. It is primarily aimed at professional nursing and other medical staff charged with monitoring workers for pesticide exposure, but will be useful to all personnel involved in workplace health and safety wishing to understand the principles behind monitoring workers for pesticide exposure.
The guidelines concentrate on monitoring for organophosphate and carabarnate insecticides because the technology is reasonably readily available, and the methodology well described. These chemicals are widely used, and are the most common cause of acute poisoning by pesticides. The guidelines have also been written bearing in mind the Hazardous Chemical Regulations (Regulation 556 of 25 August 1995 in terms of the Occupational Health and Safety Act) that include agricultural workplaces in addition to industry.
The document discusses regulatory requirements for manufacturing high potent drugs globally. It covers definitions of high potent and hazardous drugs, classification systems like GHS, and key considerations like determining Acceptable Daily Exposures to manage risk of cross-contamination when producing multiple high potent drugs in one facility. The talk provides an overview of complex global regulations and approaches like Risk-MaPP to establish controls that ensure regulatory compliance and personnel safety for potent pharmaceuticals.
Occupational exposure limits (OEL) to chemical agents APIs - Quantitative Ris...Azierta
The Occupational Exposure Limit (OEL) is defined as the airborne concentration of a substance (expressed as a weighted average in time for a working day of 8 hours/day and 40 hours/working week) under which it is believed that nearly all workers may be repeatedly exposed (day after day, over a working lifetime) without adverse health effects (ACGIH, 2006; DFG, 2005).
Occupational exposure limits (OELs) are a useful tool to prevent adverse effects on health when managing chemical substances.
On a European scale…
• Employers are legally obliged to provide a work environment that does not threaten the health of the workers (Chemical Agent Directive 98/24/EC and Framework Directive 89/391/EEC).
• Under Directive 89/391/EEC, OELs can be developed nationally, Indicative Occupational Exposure Limit Values (IOELVs).
1) The document provides industry's view on EFSA's contributions to pesticide regulation, including their processes for active substance peer reviews, establishing maximum residue levels (MRLs), and scientific guidance.
2) While timelines are generally respected, industry finds some EFSA comments on active substance evaluations arrive too late and there are limitations on submitting new information.
3) Guidelines for MRL reasoned opinions are followed predictably but outcomes are sometimes viewed as conservative.
4) The annual MRL report is considered very useful but guidance documents are seen as sometimes disconnected from use contexts and imposing unnecessarily complex or conservative standards.
EFSA provides independent scientific advice on food safety and nutrition issues to the European Commission, European Parliament, and EU member states. In 2013, EFSA predicted 676 scientific outputs to meet the continuing high demand for scientific advice. Key priorities included boosting risk assessment capacity, enhancing dialogue with risk managers, and improving efficiency. Major science highlights included providing scientific opinions on meat inspection modernization, dietary reference values, and assessments of genetically modified organisms, pesticides, and food contact materials.
This document discusses the EU Commission's request for EFSA to provide a scientific opinion and guidance on risk assessment of plant protection products (pesticides) on bees. It outlines the composition of the working group, terms of reference, and proposed chapters to cover introduction, protection goals, exposure assessment, chronic toxicity from low doses, test methods, cumulative/synergistic effects, and risk assessment methodology for honeybees, bumblebees and solitary bees. It provides details on the key sections including identifying the most exposed bee categories and life stages, major exposure routes, and proposing a new method to assess cumulative toxicity from long-term low exposures.
The presentation was an overview of the GMP regulations specific to cleaning validation for medicine manufacturers. New guidelines for Health Based Exposure Limits were discussed along with common GMP deficiencies observed during TGA inspections.
This document discusses cleaning validation requirements from a regulatory perspective. It provides an overview of key concepts in cleaning validation including establishing health-based exposure limits and determining maximum allowable carryover levels. A risk-based approach using bracketing and worst-case determination is recommended. Common deficiencies observed include inadequate hazard assessment, lack of justification for cleaning approaches, and failure to revalidate cleaning when processes change. International GMPs are incorporating guidelines for setting health-based exposure limits to ensure contamination risks are properly managed.
Setac asia pacific 2014 - pharmaceutical era [gm2]David Taylor
The document discusses the environmental risk assessment process for pharmaceuticals in Europe. It outlines the two phase process used, with phase 1 involving an exposure assessment and phase 2 involving either further risk assessment or additional testing. It identifies several problems with the current process including inconsistencies between member states, duplication of data and testing efforts, and flaws in the risk assessment methodology. It also discusses challenges around prioritizing pharmaceuticals for environmental risk assessment due to limited data availability. Recommendations are made around harmonizing approaches between member states, enabling data sharing, revising risk assessment methodology, and further research to improve prioritization.
CLE Contribution on the Assessment of Innovative Biochemicals in the EU Statu...OECD 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.
The European perspective on regulatory aspects and experiences with dsRNA-bas...OECD Environment
10-12 April 2019: The OECD Conference on RNAi based pesticides provided an overview on the current status and future possibilities for the regulation of externally applied dsRNA-based products that are proposed for use as pesticides. The event facilitated exchanges between policy makers, academia, industry on their implications in health, environment, and regulation.
This document summarizes Jürg Oliver Straub's presentation on assessing and managing medicines in the environment at Roche, a global pharmaceutical company. Some key points:
- Roche is a large Swiss pharmaceutical company with production sites worldwide and many well-known drugs.
- Most pharmaceuticals enter the environment through human use from improper disposal down sinks/toilets and excretion. Roche works to reduce this through take-back programs and increasing awareness.
- Roche incorporates environmental risk assessments into drug development and production to minimize release of pharmaceuticals into wastewater. They audit their own and third-party production sites.
- Beyond development, Roche conducts environmental risk assessments, supports industry stewardship programs,
Franz Streissl - The revision of the GD on terrestrial ecotoxicologycropprotection
The document discusses the revision of the EFSA Guidance Document on terrestrial ecotoxicology. It provides background on EFSA taking over responsibility from the European Commission to revise existing guidance documents. It outlines the topics identified through a public consultation and Member State survey to be priority areas for updating the terrestrial guidance documents, including non-target organism risk assessment, effects of multiple exposures, and linking exposure to effects. The mandate for revision includes developing guidance on risk assessment for non-target arthropods, in-soil organisms, non-target plants, and amphibians/reptiles. Overarching issues for harmonization between guidance documents are also identified.
Case Study: Peptides-based Plant Protection Product (harpin proteins*) by Ros...OECD 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.
Regulators from the US EPA, European Commission, and OECD discuss the role of science in informing nanotechnology decisions. Science helps identify hazards, exposures, and risks to inform whether nanomaterials can be used safely. Testing requires characterization of nanomaterials and consideration of potential exposures and transformations throughout their lifecycles. Regulators worldwide are working to generate data on nanomaterials through voluntary and mandatory programs to make responsible decisions about their development and use.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...MilliporeSigma
The draft EU GMP Annex 1 provides additional guidance on sterile filtration and single-use systems. It emphasizes minimizing contamination risks through engineering controls like preassembled equipment. It recommends considering a second sterile filter immediately before filling due to filtration risks. It also provides more specific recommendations around filter selection, validation, and system design to ensure sterility and product quality.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...Merck Life Sciences
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
This document describes the development and optimization of a method for rapidly analyzing bisphenols A, B, and E in baby food and infant formula using LC/MS/MS. It provides background on bisphenols and potential health issues. An optimized sample preparation method was developed using protein precipitation, DisQUE, and OASIS HLB solid phase extraction to reduce matrix effects and extract the target compounds. The method showed good linearity, repeatability, and robustness for quantifying bisphenols in food matrices. Tools like RADAR, matrix calculator, TargetLynx, and TrendPlot helped improve the method and monitor long-term system performance.
This document provides guidelines for setting health-based exposure limits to be used for risk identification when manufacturing different medicinal products in shared facilities. It recommends calculating a Permitted Daily Exposure (PDE) based on a substance's no-observed-adverse-effect level and adjustment factors accounting for uncertainties. The PDE represents a dose unlikely to cause adverse effects with lifetime exposure. It should consider all relevant pharmacological and toxicological data from non-clinical and clinical studies. Deviations from this approach require adequate justification. The guidelines aim to enable a standardized, scientifically-based approach to derive threshold values for identifying risks from cross-contamination between medicinal products manufactured in shared facilities.
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
Problem formulation for environmental risk assessment in the context of EC Re...OECD 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.
A better understanding of the OECD Test Guidelines Programme and the validati...OECD Environment
The two presentations in the video offer clear explanations of how the OECD Test Guidelines Programme operates, the key actors and partners. The second presentation illustrates how a validation body has been actively contributing to the Programme. A number of challenges are also identified moving forward with new approach methods.
Presentation by Des Corrigan (School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin) on the occasion of the EESC hearing on New Psychoactive Substances (Brussels, 27 November 2013)
New PDA/IPEC Technical Report on Excipient Risk Assessment - insights for dru...MilliporeSigma
Access the interactive recording: https://bit.ly/37HqbTK
Abstract:
Since March 2016 the EU Guideline to ascertain the appropriate GMP for pharmaceutical excipients is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging. In January 2018 PDA and IPEC formed a joint Task Force with the objective to develop a joint Technical Report to share best practices with industry. This Technical Report was published in December 2019. In this webinar you will be introduced to the new Technical Report, its objective, proposed approaches and examples shared by PDA/IPEC member companies.
Chris Lythgo - Semiochemicals: Current review programme - initial comments an...cropprotection
The document discusses some key issues with semiochemical active substance dossiers submitted for evaluation including:
1) A lack of detailed specifications and supporting analytical data for both active substances and impurities.
2) Sources of active substances are not always defined with specific plant locations.
3) Methods of manufacture are sometimes missing or lack detail.
4) Guidance on straight chain lepidopteran pheromones could be accepted except the trigger dose appears to be based on a personal communication rather than peer reviewed literature.
5) For other semiochemicals, comparisons to natural background levels need to be supported by measurable data from peer reviewed scientific literature.
Csaba Szentes - Micro-organisms: Part II: E-fate and ecotoxcropprotection
This document discusses the data requirements and potential data gaps for assessing the environmental fate and ecotoxicity of micro-organisms. It notes that experimental data are normally required unless an assessment can be made based on available information. Weak dossiers lacking data or sufficient justification from literature are identified as an issue. The key data requirements include information on persistence, mobility, effects on birds, aquatic organisms, bees, and other non-target organisms. Potential data gaps include a lack of data on natural background concentrations, persistence in water, and impacts of repeated applications over time.
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The presentation was an overview of the GMP regulations specific to cleaning validation for medicine manufacturers. New guidelines for Health Based Exposure Limits were discussed along with common GMP deficiencies observed during TGA inspections.
This document discusses cleaning validation requirements from a regulatory perspective. It provides an overview of key concepts in cleaning validation including establishing health-based exposure limits and determining maximum allowable carryover levels. A risk-based approach using bracketing and worst-case determination is recommended. Common deficiencies observed include inadequate hazard assessment, lack of justification for cleaning approaches, and failure to revalidate cleaning when processes change. International GMPs are incorporating guidelines for setting health-based exposure limits to ensure contamination risks are properly managed.
Setac asia pacific 2014 - pharmaceutical era [gm2]David Taylor
The document discusses the environmental risk assessment process for pharmaceuticals in Europe. It outlines the two phase process used, with phase 1 involving an exposure assessment and phase 2 involving either further risk assessment or additional testing. It identifies several problems with the current process including inconsistencies between member states, duplication of data and testing efforts, and flaws in the risk assessment methodology. It also discusses challenges around prioritizing pharmaceuticals for environmental risk assessment due to limited data availability. Recommendations are made around harmonizing approaches between member states, enabling data sharing, revising risk assessment methodology, and further research to improve prioritization.
CLE Contribution on the Assessment of Innovative Biochemicals in the EU Statu...OECD 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.
The European perspective on regulatory aspects and experiences with dsRNA-bas...OECD Environment
10-12 April 2019: The OECD Conference on RNAi based pesticides provided an overview on the current status and future possibilities for the regulation of externally applied dsRNA-based products that are proposed for use as pesticides. The event facilitated exchanges between policy makers, academia, industry on their implications in health, environment, and regulation.
This document summarizes Jürg Oliver Straub's presentation on assessing and managing medicines in the environment at Roche, a global pharmaceutical company. Some key points:
- Roche is a large Swiss pharmaceutical company with production sites worldwide and many well-known drugs.
- Most pharmaceuticals enter the environment through human use from improper disposal down sinks/toilets and excretion. Roche works to reduce this through take-back programs and increasing awareness.
- Roche incorporates environmental risk assessments into drug development and production to minimize release of pharmaceuticals into wastewater. They audit their own and third-party production sites.
- Beyond development, Roche conducts environmental risk assessments, supports industry stewardship programs,
Franz Streissl - The revision of the GD on terrestrial ecotoxicologycropprotection
The document discusses the revision of the EFSA Guidance Document on terrestrial ecotoxicology. It provides background on EFSA taking over responsibility from the European Commission to revise existing guidance documents. It outlines the topics identified through a public consultation and Member State survey to be priority areas for updating the terrestrial guidance documents, including non-target organism risk assessment, effects of multiple exposures, and linking exposure to effects. The mandate for revision includes developing guidance on risk assessment for non-target arthropods, in-soil organisms, non-target plants, and amphibians/reptiles. Overarching issues for harmonization between guidance documents are also identified.
Case Study: Peptides-based Plant Protection Product (harpin proteins*) by Ros...OECD 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.
Regulators from the US EPA, European Commission, and OECD discuss the role of science in informing nanotechnology decisions. Science helps identify hazards, exposures, and risks to inform whether nanomaterials can be used safely. Testing requires characterization of nanomaterials and consideration of potential exposures and transformations throughout their lifecycles. Regulators worldwide are working to generate data on nanomaterials through voluntary and mandatory programs to make responsible decisions about their development and use.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...MilliporeSigma
The draft EU GMP Annex 1 provides additional guidance on sterile filtration and single-use systems. It emphasizes minimizing contamination risks through engineering controls like preassembled equipment. It recommends considering a second sterile filter immediately before filling due to filtration risks. It also provides more specific recommendations around filter selection, validation, and system design to ensure sterility and product quality.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...Merck Life Sciences
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
This document describes the development and optimization of a method for rapidly analyzing bisphenols A, B, and E in baby food and infant formula using LC/MS/MS. It provides background on bisphenols and potential health issues. An optimized sample preparation method was developed using protein precipitation, DisQUE, and OASIS HLB solid phase extraction to reduce matrix effects and extract the target compounds. The method showed good linearity, repeatability, and robustness for quantifying bisphenols in food matrices. Tools like RADAR, matrix calculator, TargetLynx, and TrendPlot helped improve the method and monitor long-term system performance.
This document provides guidelines for setting health-based exposure limits to be used for risk identification when manufacturing different medicinal products in shared facilities. It recommends calculating a Permitted Daily Exposure (PDE) based on a substance's no-observed-adverse-effect level and adjustment factors accounting for uncertainties. The PDE represents a dose unlikely to cause adverse effects with lifetime exposure. It should consider all relevant pharmacological and toxicological data from non-clinical and clinical studies. Deviations from this approach require adequate justification. The guidelines aim to enable a standardized, scientifically-based approach to derive threshold values for identifying risks from cross-contamination between medicinal products manufactured in shared facilities.
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
Problem formulation for environmental risk assessment in the context of EC Re...OECD 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.
A better understanding of the OECD Test Guidelines Programme and the validati...OECD Environment
The two presentations in the video offer clear explanations of how the OECD Test Guidelines Programme operates, the key actors and partners. The second presentation illustrates how a validation body has been actively contributing to the Programme. A number of challenges are also identified moving forward with new approach methods.
Presentation by Des Corrigan (School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin) on the occasion of the EESC hearing on New Psychoactive Substances (Brussels, 27 November 2013)
New PDA/IPEC Technical Report on Excipient Risk Assessment - insights for dru...MilliporeSigma
Access the interactive recording: https://bit.ly/37HqbTK
Abstract:
Since March 2016 the EU Guideline to ascertain the appropriate GMP for pharmaceutical excipients is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging. In January 2018 PDA and IPEC formed a joint Task Force with the objective to develop a joint Technical Report to share best practices with industry. This Technical Report was published in December 2019. In this webinar you will be introduced to the new Technical Report, its objective, proposed approaches and examples shared by PDA/IPEC member companies.
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The document discusses some key issues with semiochemical active substance dossiers submitted for evaluation including:
1) A lack of detailed specifications and supporting analytical data for both active substances and impurities.
2) Sources of active substances are not always defined with specific plant locations.
3) Methods of manufacture are sometimes missing or lack detail.
4) Guidance on straight chain lepidopteran pheromones could be accepted except the trigger dose appears to be based on a personal communication rather than peer reviewed literature.
5) For other semiochemicals, comparisons to natural background levels need to be supported by measurable data from peer reviewed scientific literature.
Csaba Szentes - Micro-organisms: Part II: E-fate and ecotoxcropprotection
This document discusses the data requirements and potential data gaps for assessing the environmental fate and ecotoxicity of micro-organisms. It notes that experimental data are normally required unless an assessment can be made based on available information. Weak dossiers lacking data or sufficient justification from literature are identified as an issue. The key data requirements include information on persistence, mobility, effects on birds, aquatic organisms, bees, and other non-target organisms. Potential data gaps include a lack of data on natural background concentrations, persistence in water, and impacts of repeated applications over time.
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Stephanie Bopp - GD on aquatic ecotoxicologycropprotection
This document outlines the background and plans for revising the Guidance Document on Aquatic Ecotoxicology. It discusses the need to update the current guidance to align with new regulations and data requirements. The revision will take a modular approach, beginning with practical guidance on topics where "building blocks" already exist. The first module will focus on a tiered risk assessment for aquatic organisms in edge-of-field surface waters. Further modules will address topics like combined exposure/effect modelling, sediment organisms, and multiple stress assessment. The working group is currently drafting the first module and plans to seek public comment on the draft guidance in October 2012.
1) The document outlines EFSA's work on developing guidance documents for estimating soil degradation rates, soil exposure concentrations, emissions from protected crop systems, and groundwater exposure assessments.
2) EFSA has published opinions and supporting documents on estimating soil degradation rates and soil exposure and is developing guidance documents on these topics for 2013-2014.
3) EFSA is also developing a new guidance document on estimating emissions from protected crop systems based on published opinions and reports, with the guidance foreseen for 2013.
4) EFSA received mandates from the European Commission for two opinions on the FOCUS groundwater report to evaluate lower and higher tier assessment recommendations, with opinions planned for adoption in 2013.
The document discusses the PPR Panel guidance on using probabilistic methodology to model dietary exposure to pesticide residues. It will provide guidance on how cumulative exposure varies across populations for acute and chronic exposure scenarios. It details basic and refined probabilistic modeling approaches and notes the guidance will be adopted in June 2012 after two public consultations. Next steps include EFSA developing more detailed guidance documents on specific scenarios in cooperation with the Commission and Member States.
This document discusses the Panel on Plant Protection Products' (PPR Panel) work on cumulative risk assessment of pesticides. It outlines the legislative background requiring consideration of cumulative and synergistic effects of pesticides. It describes the PPR Panel's past scientific opinions developing methodologies for cumulative assessment of pesticides with similar and dissimilar modes of action. It also lists current and planned activities, including developing guidance on probabilistic exposure modeling and identifying cumulative assessment groups of pesticides. Finally, it discusses emerging work on assessing cumulative exposure from non-dietary routes.
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Istvan Sebestyen - Workers operators bystanders and residents
1. Committed since 2002
to ensuring that Europe’s food is safe
Draft Guidance Document on Pesticide Exposure Assessment
for Workers, Operators, Bystanders and Residents
ECPA – IBMA- EFSA Workshop
1
Parma, 26th April 2012
2. Background
• In 2006 EFSA ran an
investigation among MSs to
ask the priorities of Guidance
Documents
• One of the claims was the
development of a new GD on
operator exposure assessment
• Prioritised by EFSA
2
3. Background
• 2007: Call to outsource the information gathering and
evaluation of the existing models/activities (Art. 36. of
Regulation 178/2002)
• 2008: Report from outsourced work carried out jointly by the
UK Pesticides Safety Directorate (PSD) and the University of
Ghent (UG).
3
4. Scientific Opinion
• 2009: Public consultation on the draft scientific opinion on
Preparation of a Guidance Document on Pesticide Exposure
Assessment for Workers, Operators, Bystanders and Residents,
containing the draft GD (as an annex).
• In response to the comments received, various clarifications
and amendments were made.
4
5. Public Consultation
Table 2: Comments received on the draft opinion and GD per organizations and countries
Organization Country Number
ECPA BEL 20
IPH BEL 8
Health Canada - Pest Management Regulatory Agency CAN 14
National Institute of Public Health CZE 1
Federal Environmental Agency DEU 1
Federal Institute of Risk Assessment Berlin DEU 17
Danish EPA DNK 1
INSHT/MTIN ESP 2
Finnish Institute of Occupational Health FIN 14
AFSSA (Agence Française de Sécurité Sanitaire des
FRA 22
Aliments)
BCPC GBR 1
Nufarm UK Ltd GBR 11
Health and Safety Executive GBR 1
Silsoe Spray Application Unit, The Arable Group GBR 10
JSC International Limited GBR 6
Toxicology Unit, PCS, Department of Agriculture,
IRL 9
Fisheries & Food
The Netherlands NLD 37
Swedish Chemicals Agency (KemI) SWE 9
US Environmental Protection Agency, Office of
USA 2
Pesticide Programs
Total number of comments 186
5
6. Scientific Opinion
• 2010: Scientific Opinion on Preparation of a Guidance
Document on Pesticide Exposure Assessment for Workers,
Operators, Bystanders and Residents, containing the draft GD
(as an annex), adopted by the PPR Panel on 27 January 2010.
Available online:
www.efsa.europa.eu/en/efsajournal/pub/1501.htm
• 2010: Outcome of the Public Consultation on the Draft
Scientific Opinion on Preparation of a Guidance Document on
Pesticide Exposure Assessment for Workers, Operators,
Bystanders and Residents
Available online:
www.efsa.europa.eu/en/efsajournal/pub/1517.htm
6
7. Introduction
• The starting point for this opinion was an outsourced project
carried out jointly by the UK Pesticides Safety Directorate
(PSD) and the University of Ghent (UG).
• Relevant new data could be expected from several sources
over the next five years. The PPR Panel concluded that it
would be worth developing the Guidance Document for
immediate use.
• This could then be revised, as and when new data emerged.
• During drafting, the Panel aimed for a level of precaution
similar to, or somewhat higher than, that which is currently
applied, but changing the level of precaution if necessary, can
be performed without major restructuring of the text.
7
8. Main contents
• The opinion starts by defining the scope of the Guidance
Document (Section 2).
• It then reviews the legal requirements that underpin the
relevant components of risk assessment for plant protection
products (Section 3).
• It describes the methods of risk assessment that are currently
used (Section 4), and considers their adequacy and limitations
(Sections 5 and 6).
• Next it proposes a revised approach to exposure and risk
assessment for operators, workers, residents and bystanders,
and gives the underlying rationale (Section 7).
8
9. Main contents
• Section 8 then builds on the PSD/UG review, setting out
proposals for standard models and data sets that should be
used as a default when estimating exposures for different
scenarios, and giving reasons for choices where more than one
option is available.
• Section 9 provides a link to the draft Guidance Document,
which is set out in Appendix 1. Finally, there is a brief
summary of conclusions and recommendations.
9
10. Scope
• The Guidance Document is intended for use in relation to
chemical PPPs
• It does not apply to biocides, which are the subject of separate
legislation (Directive 98/8/EC), or to biological pesticides.
10
11. Scope
• Definitions of exposed groups
Compatible with the draft Guidance Document on AOELs
that is currently in use.
• The main focus of the opinion is risk assessment for systemic
toxicity
it does not cover all the aspects of exposure that could be
relevant to localised toxicity such as respiratory irritation,
and
it does not provide guidance on the quantification of dermal
absorption.
11
12. New approaches
Proposed percentiles
• A particular challenge in exposure estimation is the wide
variability (often over several orders of magnitude), between
individual measurements of exposure associated with the same
exposure scenario.
• One implication of the substantial variability of pesticide
exposures for a given scenario is that the 50th or 75th centile
from a set of measured exposures might importantly
underestimate some individual exposures on a single day.
12
13. New approaches
Acute risk assessment
• In the current practice operator and other non-dietary pesticide
exposure assessments consider repeated exposure
often geometric/arithmetic mean, 75th centile, 90/95th
centile exposure values
occasional higher exposures not assessed
• The underestimation of exposure could be more important
where toxic effects could result from acute exposure on a
single day.
13
14. New approaches
Acute risk assessment
• For PPPs which might cause toxicity through exposures on a
single day, a separate acute risk assessment should be carried
out
• The acute risk assessment for operators, workers and
bystanders will require the specification of a separate
toxicological reference value, an “acute AOEL∗” (“AAOEL”),
derived from a relevant study or studies.
• This should not require any additional use of experimental
animals.
• The AAOEL should be used as a reference for realistic upper
estimates of exposure in a single day for operators, workers
and bystanders.
14
15. New approaches
Statistical variability
• Estimates of exposure derived from empirical data sets are
subject to statistical uncertainty.
• This could lead to substantial underestimation of potential
exposures
• To address this problem, in addition to the relevant centile of
the empirical data set, a parametric estimate should be made of
the corresponding centile in the theoretical population from
which this sample of measurements was derived with the
assumption that the population has a log-normal distribution.
( )
exp x + t n −1,a * S * 1 + 1
n
15
16. New approaches
Proposed percentiles
• For risk assessments in relation to acute exposures (i.e. those
that could occur in a single day), exposure estimates should as
a default be derived as the higher of:
a) the 95th centile of the distribution of measurements in the
sample; and
b) a statistical estimate of the 95th centile for the theoretical
population of measurements from which the sample was
derived, under the assumption that this population has a
log-normal distribution.
16
17. New approaches
Proposed percentiles
• For risk assessments in relation to longer term exposures,
exposures should as a default be derived as the higher of:
a) the 75th centile of the distribution of measurements in the
sample; and
b) a statistical estimate of the 75th centile for the theoretical
population of measurements from which the sample was
derived, under the assumption that this population has a
log-normal distribution.
17
18. Harmonisation
Proposed methods and standard data sets
OPERATOR EXPOSURE
• In current practice multiple models are used
Pooling data?
Data quality issues (EUROPOEM)
Professional judgement to select most “robust” individual
data sets
• Typical (main) scenarios identified
• Scenario exposure data sets taken from EUROPOEM, German
model, PHED and interpreted according to GD
• Several scenarios without data, and protective surrogates
proposed
18
19. Harmonisation
Proposed methods and standard data sets
Choices of standard models and underpinning data sets for first tier estimation of exposures in
operators when mixing and loading
Scenario Formulation Sources of data
Dermal exposure Inhalation exposure
SOLIDS
1 a (i) Large scale (e.g. tractor- WP, SP German model (PDE) PHED
mounted) equipment
[German model has most robust dataset] [PHED has larger and more robust data
set than EUROPOEM and German
model]
(ii) GR, FG PHED (ADE) PHED
[PHED has larger and more robust data set than [PHED has larger and more robust data
EUROPOEM] set than EUROPOEM]
[Data for exposure to body not log-normal, use [Data not log-normal, use parametric
parametric estimate for 95th centile] estimate for 95th centile]
19
20. Harmonisation
Proposed methods and standard data sets
Specific exposures during mixing/loading (potential exposures except where indicated otherwise)
Scenario Formulation Standard 75th and 95th Specific Exposure Centiles
(mg exposure/kg a.s. mixed/loaded, excepted where stated otherwise)
Dermal exposure Inhalation exposure
SOLIDS 75th Centile 95th Centile 75th 95th Centile
Centile
1 a (i) Large scale (e.g. Tractor WP, SP Hands 13.5 Hands 48.0 0.248 0.973
mounted) equipment
(ii) GR, FG Hands under Hands under 0.0146 0.0784
protective gloves protective glove
0.00145 0.00688
Body under coverall Body under coverall
0.00198 0.036
(iii) WG, SG Hands 3.52 Hands 9.20 0.0332 0.140
1 b (i) Medium scale (e.g. WP, SP Hands under Hands under 1.53 4.06
Professional hand-held) protective gloves 10.7 protective gloves 39.4
equipment mg in-use mg in-use
preparation/min preparation/min
20
21. Harmonisation
Proposed methods and standard data sets
WORKER EXPOSURE
• EUROPOEM DFR & TC approach
Potential dermal exposure (PDE) µg/day = DFR µg/cm2 x TC cm2/h x T h/day
DFR dissipation no data default t/2 = 30 days
TC values
i) Total potential exposures
ii) Arms, body and legs covered
• Inhalation exposure in greenhouses
Potential inhalation exposure (mg a.s./hr inhaled) = Application rate (kg/a.s./ha) x
Task Specific Factor (ha/hr x 10-3)
• Residues in soil/compost
21
22. Harmonisation
Proposed methods and standard data sets
RESIDENTS (i)
• Spray drift
Arable crop single pass 8m distant, dermal data 10x
adjustment
Commission: level of precaution?
Orchard crop whole orchard 8m distant, no adjustment
• Vapour drift using the method that has been developed in the
UK (CRD, 2008) and Germany (Martin et al., 2008)
24 h TWA
22
23. Harmonisation
Proposed methods and standard data sets
RESIDENTS (ii)
• Exposure to surface deposits (fallout in garden)
sum of dermal transfer, plus young children hand- and
object- to mouth
• Entry into treated crops
only dermal exposure, DFR as for workers, 15 minutes
exposure/day
on treated lawn drift percentage 100%
• Residues in crops grown adjacent to treated areas - future?
23
24. Harmonisation
Proposed methods and standard data sets
BYSTANDERS
• Same 4 pathways as residents
Spray drift pathway
95th centile exposure spray values
Surface residues
Higher TCs
Higher hand-to-mouth frequency (20 events /hour)
Vapour drift and entry into treated crops same values as
residents
24
25. Harmonisation
Proposed methods and standard data sets
• The Panel has also made proposals for default assumptions
Body weights
Adults & children
Breathing rates
Latest EPA approach
Scale of use (work rates)
Reflecting equipment used in data
PPE and level of protection
TNO Review, similar to biocides
25
26. Draft Guidance Document
• Designed to assist risk assessors and notifiers when
quantifying potential non-dietary, systemic exposures as part
of regulatory risk assessment for plant protection products
(PPPs).
• Risk assessments must be carried out for all scenarios of
exposure to operators, workers, residents and bystanders that
can be expected to occur as a consequence of the proposed
uses of a PPP.
• Most exposure scenarios will fall into a category for which a
standardised first tier exposure assessment can be applied as
described in this document.
26
27. Draft Guidance Document
Overall approach
Step one: Identification of risk assessments that are required
Risk assessments that may be required(a)
PPPs with no significant potential PPPs with significant potential for
Exposure group for toxicity from exposure in a toxicity from exposure in a single
single day day
Operators L AL
Workers L AL
Residents L L
Bystanders A
(a): A = acute, L = longer term
International Fresenius Conference for the Agrochemical Industry
Operator and Resident Exposure and Risk Assessment 27
Mainz, 13-14 December 2010
28. Draft Guidance Document
Overall approach
• Step two: Use standardised first tier methods of exposure
assessment where available.
Where available, a single, relevant, standard dataset of
adequate quality was identified and proposed by the PPR
Panel for each exposure scenario. This should then be used to
derive the exposure values that will be applied in the risk
assessment.
• Step three: Use appropriate ad hoc methods where
standardised first tier methods of exposure assessment are not
available.
28
29. Recommendations
• The PPR Panel recommends that a new guidance document
on exposure assessment for operators, workers, residents and
bystanders should be adopted along the lines of that set out in
Appendix A.
• Risk managers in the European Commission wish to vary the
level of precaution that is applied, the guidance should be
modified accordingly.
29
30. Recommendations
• Once the exact format of the guidance document has been
agreed by risk managers, it should be published with a
supporting spreadsheet to enable easy application by notifiers
and regulatory authorities, and also a separate document
detailing the derivation of specified exposure values from
underlying datasets.
• The Guidance Document should thereafter be reviewed
periodically, as and when relevant new data become available,
and if appropriate, be revised.
30
31. Current Mandate of EFSA
• Consultation of risk managers in the European
Commission took place in May 2011- Risk management
options (e.g. percentiles, default values) included in the draft
guidance document were discussed and agreed.
• The outcome of these discussions was communicated to
the Standing Committee on the Food Chain and Animal
Health and to EFSA in 2011.
• As a consequence EFSA received an external mandate
from the Commission, with the preparation of the EFSA
Guidance Document on Pesticide Exposure Assessment
for Workers, Operators, Bystanders and Residents.
31
32. Current Mandate of EFSA
• Preparation of an EXCEL calculator sheet facilitating the
use of the methodologies presented in the EFSA Guidance
• An EFSA working group is being established to prepare
this Guidance Document under the lead of the Pesticide
unit.
• Circulating the draft EXCEL calculator to the
Commission and stakeholders for a trial phase foreseen at
the end of July 2012.
• Expected deadline for finalization of the EFSA Guidance:
End of 2012.
32