Presented at Gowlings Toronto office on September 24, 2014.
With the ongoing evolution of chemical substance regulation in Canada and abroad, manufacturers and importers face significant and highly technical compliance challenges. Failure to adequately navigate the complex chemicals management regimes can result in costly disruptions to business, customer relation issues, and potential regulatory liability.
Erica Canzler - Advances and Lessons Learned in DecontaminationMatthew Kirkby
Advances in decontamination technologies and strategies were tested to help improve response to biological incidents. The Biological Operational Test and Evaluation Project tested three decontamination methods - vaporized hydrogen peroxide, bleach, and chlorine dioxide fumigation. Chlorine dioxide was most effective at reducing spore levels, while bleach produced the most waste. Overall costs were dominated by waste management. The methyl bromide fumigation study demonstrated the feasibility of using this technology for decontamination of structures. Efforts are also underway to develop strategies to safely restore contaminated underground transportation systems like subways following an incident.
Screening and extraction of heavy metals from anaerobically digested sewage s...IRJET Journal
This document summarizes a study that investigated screening and extracting heavy metals from anaerobically digested sewage sludge using citric acid. The study characterized the sewage sludge and found heavy metal concentrations of copper, lead, nickel and zinc to be above regulatory standards. It then used a full factorial experimental design to study the effects of pH, hydrogen peroxide dosage, and extraction time on removing the heavy metals. Lead removal was highest at 99.9%, followed by nickel, copper and zinc. Statistical analysis found extraction time and hydrogen peroxide dosage to most significantly impact heavy metal removal efficiency.
Toxicological Risk Assessment For Medical Devices - ISO 10993-1Russell Sloboda
Russell Sloboda presented on toxicological risk assessment for medical devices. He discussed how risk assessment plays an increasing role in preclinical safety evaluation under ISO 10993-1. Key points included how chemical characterization data forms the basis for risk assessment, and how tools like threshold of toxicological concern, quantitative structure-activity relationship analysis, and permissible exposure thresholds can be applied to evaluate risks. The goal of risk assessment is to identify hazards, evaluate exposure levels, and characterize overall risks to determine if biological testing is needed.
Item 4. Report from the Asian Soil Laboratory Network (SEALNET)Soils FAO-GSP
The 4th meeting of the Asian Soil Laboratory Network (SEALNET) was held virtually from June 30 to July 2, 2020 with 255 participants from 17 Asian countries. The meeting aimed to inform soil laboratories about progress in the Global Soil Laboratory Network (GLOSOLAN), provide training on quality control and health and safety, and define SEALNET's role in GLOSOLAN. Sessions included updates from SEALNET members, quality control trainings, and determining regional leaders for harmonizing soil analysis methods. The meeting highlighted needs for member laboratories around quality control implementation, staff training, and technical assistance to improve capacities.
This document is the Lead Management Plan for Pueblo Chemical Depot. It outlines goals and regulatory drivers for lead management, including OSHA, EPA, and Army regulations. It describes the lead management team roles, including the Lead Program Manager, Environmental Management Office, Safety Office, and others. Notification and labeling requirements for lead are also covered. The work permit system for projects involving lead is explained.
Este documento describe las funciones básicas de Excel como MAX, MIN, SUMA, PROMEDIO, CONTAR y CONTARA. Explica que estas funciones permiten realizar operaciones matemáticas de forma sencilla introduciendo el nombre de la función y los datos requeridos en una celda. También recomienda conocer cada función para obtener mejores resultados al trabajar con cálculos matemáticos en Excel.
Business English Workshop Highlights:
• Enhance Small Business Talk phrases.
• Enrich your diction with business phrases and words.
• Boost up your Receptive and Expressive language communication.
• Explicit effective professional writing expressions.
The Global CCS Institute hosted a workshop on 6 June 2013 in Calgary, Alberta, on the role of new bi-national storage standards in the deployment of CCS in Canada and the United States.
Erica Canzler - Advances and Lessons Learned in DecontaminationMatthew Kirkby
Advances in decontamination technologies and strategies were tested to help improve response to biological incidents. The Biological Operational Test and Evaluation Project tested three decontamination methods - vaporized hydrogen peroxide, bleach, and chlorine dioxide fumigation. Chlorine dioxide was most effective at reducing spore levels, while bleach produced the most waste. Overall costs were dominated by waste management. The methyl bromide fumigation study demonstrated the feasibility of using this technology for decontamination of structures. Efforts are also underway to develop strategies to safely restore contaminated underground transportation systems like subways following an incident.
Screening and extraction of heavy metals from anaerobically digested sewage s...IRJET Journal
This document summarizes a study that investigated screening and extracting heavy metals from anaerobically digested sewage sludge using citric acid. The study characterized the sewage sludge and found heavy metal concentrations of copper, lead, nickel and zinc to be above regulatory standards. It then used a full factorial experimental design to study the effects of pH, hydrogen peroxide dosage, and extraction time on removing the heavy metals. Lead removal was highest at 99.9%, followed by nickel, copper and zinc. Statistical analysis found extraction time and hydrogen peroxide dosage to most significantly impact heavy metal removal efficiency.
Toxicological Risk Assessment For Medical Devices - ISO 10993-1Russell Sloboda
Russell Sloboda presented on toxicological risk assessment for medical devices. He discussed how risk assessment plays an increasing role in preclinical safety evaluation under ISO 10993-1. Key points included how chemical characterization data forms the basis for risk assessment, and how tools like threshold of toxicological concern, quantitative structure-activity relationship analysis, and permissible exposure thresholds can be applied to evaluate risks. The goal of risk assessment is to identify hazards, evaluate exposure levels, and characterize overall risks to determine if biological testing is needed.
Item 4. Report from the Asian Soil Laboratory Network (SEALNET)Soils FAO-GSP
The 4th meeting of the Asian Soil Laboratory Network (SEALNET) was held virtually from June 30 to July 2, 2020 with 255 participants from 17 Asian countries. The meeting aimed to inform soil laboratories about progress in the Global Soil Laboratory Network (GLOSOLAN), provide training on quality control and health and safety, and define SEALNET's role in GLOSOLAN. Sessions included updates from SEALNET members, quality control trainings, and determining regional leaders for harmonizing soil analysis methods. The meeting highlighted needs for member laboratories around quality control implementation, staff training, and technical assistance to improve capacities.
This document is the Lead Management Plan for Pueblo Chemical Depot. It outlines goals and regulatory drivers for lead management, including OSHA, EPA, and Army regulations. It describes the lead management team roles, including the Lead Program Manager, Environmental Management Office, Safety Office, and others. Notification and labeling requirements for lead are also covered. The work permit system for projects involving lead is explained.
Este documento describe las funciones básicas de Excel como MAX, MIN, SUMA, PROMEDIO, CONTAR y CONTARA. Explica que estas funciones permiten realizar operaciones matemáticas de forma sencilla introduciendo el nombre de la función y los datos requeridos en una celda. También recomienda conocer cada función para obtener mejores resultados al trabajar con cálculos matemáticos en Excel.
Business English Workshop Highlights:
• Enhance Small Business Talk phrases.
• Enrich your diction with business phrases and words.
• Boost up your Receptive and Expressive language communication.
• Explicit effective professional writing expressions.
The Global CCS Institute hosted a workshop on 6 June 2013 in Calgary, Alberta, on the role of new bi-national storage standards in the deployment of CCS in Canada and the United States.
This document provides an update on Phase 2 of the C4SL Project, which aims to derive Contaminated Land: Soil Guideline Values (C4SLs) for approximately 20 additional contaminants. It outlines the project organization, including steering committee members and roles of the project management team, exposure modellers, and Tier 1 and Tier 2 toxicologists in deriving C4SL values. The document describes the methodology that will be used, including evaluating toxicological data to derive Lowest Levels of Toxicological Concern (LLTCs), conducting probabilistic modeling using CLEA exposure parameters, and accounting for uncertainties. Priority contaminants were selected for evaluation based on a 2015 consultation. The project aims
Session 1 role and importance of dsp in biotechnologyKAKARADIVYA
This document discusses downstream processing (DSP) in bioproduct manufacturing. It defines DSP as a series of isolation and purification steps to separate biological molecules from complex mixtures. DSP is challenging due to the similar properties of products, impurities, and contaminants. The document outlines various unit operations used in low, medium, and high resolution separation. It emphasizes that DSP is a major cost in bioproduct production and recovery method selection impacts overall economics. Proper method choice requires understanding the product properties, quality needs, and ability to scale the process.
The TCE Revolution and Its Permanent Impact on Environmental Due DiligenceEDR
EDR INSIGHT WEBINAR: THE TCE REVOLUTION AND ITS PERMANENT IMPACT ON ENVIRONMENTAL DUE DILIGENCE
June 24, 2015
Presented by:
-David Gillay, Partner and Chair of Brownfields & Environmental Transactional Diligence Practice Areas, Barnes & Thornburg LLP
-Dr. Michael Dourson, Ph.D., Alliance for Risk Assessment
Following decades of studies, scrutiny and debate, the U.S. EPA updated its TCE’s toxicity profile in the IRIS database, dramatically lowering the toxicity value. For transactional due diligence, this more stringent limit has important implications, including markedly more extensive and expensive cleanup processes. Given the focus on vapor migration in the new ASTM Phase I ESA standard, environmental professionals need to be increasingly cautious when making REC determinations and recommendations to clients.
Adding to the confusion is the significant variability in how regulators are using the updated TCE toxicity profile when making closure decisions at contaminated properties. For instance, U.S. EPA Regions 9, 10 and states like Minnesota, Indiana and Massachusetts (among others) have implemented profoundly different approaches to address TCE risk at contaminated sites. Thus, it is critical for environmental professionals to stay abreast of the how TCE guidance is being interpreted and applied across the country. In the latest development, the Agency for Toxic Substances & Disease Registry is proposing a dramatic change to its TCE toxicity profile for the first time in 18 years. The comment period ended on March 16, 2015, and if the update is finalized in its current form, there will be more intense scrutiny on exposure risks which will further complicate transactional due diligence.
This timely webinar will bring together an attorney and a national subject matter expert to address the various impacts of TCE’s toxicity update on transactional due diligence. This panel will help EPs answer the following questions:
-Does TCE in groundwater constitute a VEC and/or a REC?
-How should an EP manage variability in TCE standards in multi-state transactions?
-How can an EP take steps to minimize exposure to potential liability?
-How can an EP make sense of the science and available guidance?
-How should an EP communicate potential risks associated with TCE to clients?
This document summarizes the state of policy development in the EU to manage contaminants of emerging concern (CECs). It discusses the EU's chemicals legislation and monitoring efforts for CECs in surface water and groundwater. The EU is developing watch lists of substances of concern for surface and groundwater. It is also exploring effect-based monitoring methods and using grouping approaches to assess chemical risks. The document notes efforts to increase data access and sharing, as well as increasing focus on persistent and mobile substances with potential for groundwater contamination. It concludes by mentioning the upcoming EU strategic approach on pharmaceuticals in the environment.
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.
Brokerage session: project idea
Title: Real Time Monitoring for Effective and Sustainable Industrial wastewater Treatment and Compliance
Presented by Stephen Moore, MANTECH
Clean Air Act Compliance, Risk Management Plans, and Preparing for the July 1...Triumvirate Environmental
The document discusses regulatory requirements under the Clean Air Act for risk management plans and toxic release inventory reporting, including an overview of the Risk Management Plan rule requirements under the Clean Air Act, what facilities must submit risk management plans, and details on toxic release inventory reporting requirements including what chemicals must be reported and the annual July 1st deadline.
This document summarizes a presentation on aseptic processing of biological products and common regulatory issues. The presentation covers quality microbiology content required in BLA submissions, including guidance documents and regulations. It discusses common deficiencies seen in sterilizing filtration, post-reconstitution and post-dilution storage, and container closure integrity testing. It provides an overview of laws and regulations for biological products and concludes with recommendations for including appropriate microbiological data in BLA submissions.
This document discusses the main air pollutants - carbon monoxide, lead, ozone, nitrogen dioxide, particulate matter, and sulfur dioxide. It describes their sources, health effects, and regulations. It also outlines the history of air pollution control acts and standards in the United States, current issues regarding inadequate control and understanding health impacts, and recommendations for reducing air pollution exposure.
This document provides an overview of extractables and leachables (E&Ls) studies. It discusses that E&Ls studies are needed in industries like biomedical devices, food packaging, and pharmaceutical packaging to identify substances that can migrate from materials into products. Jordi Labs is introduced as a leader in E&Ls analysis with state-of-the-art facilities and over 80% of staff being chemists. The document outlines the basic process of an E&L study including sample selection, extractions, identification of E&Ls using techniques like mass spectrometry, quantitative analysis, and determining acceptable levels. Regulations for E&Ls from organizations like USP, FDA and ISO are also summarized.
8minSlideDeck National Green Theatres Programme (002).pptxalifiachakera1
The document discusses the National Green Theatres Programme in Scotland, which aims to reduce carbon emissions from healthcare, particularly in surgical theatres and anaesthetics. It notes that NHS Scotland emissions are 577,700 tonnes of CO2e annually, with theatres and anaesthetics being high contributors. It outlines over 40 proposed sustainability actions and an approach using quality improvement methods to implement emission mitigation efforts across structures, equipment, practices and culture. Examples provided show significant emission reductions achieved from switching anaesthetic agents and capturing waste gases. The programme aims to establish sustainable procurement, evaluate impacts, and develop a framework allowing for circular economy practices in healthcare.
Presentation at the ESPP stakeholder meeting concerning the use on farmland of sewage biosolids (04/12/2018) organised by the European Sustainable Phosphorus Platform (ESPP, www.phosphorusplatform.eu)
All outcomes of the meeting can be found here https://www.phosphorusplatform.eu/activities/conference/meeting-archive/1788-espp-meeting-sludge-2018
1) The document discusses contaminants of emerging concern (CECs) in surface waters, which challenge traditional water protection policy approaches based on establishing environmental quality norms for individual compounds.
2) It proposes that the precautionary principle is an appropriate strategy to deal with the uncertainties surrounding CECs given their diversity, unknown impacts, and constant introduction of new substances.
3) An international survey of decision-makers found support for precautionary, source-directed policies to reduce CECs rather than relying solely on the scientific testing and regulation paradigm currently used.
Passive Samplers for Vapor Intrusion Monitoring: Update of EPA’s Technical S...Chris Lutes
Lutes, C., R. Truesdale, H. Hayes, T. McAlary, H. Dawson, B. Cosky , D. Grossee, B. Schumacher and J. Zimmerman Passive Samplers for Vapor Intrusion Monitoring: Update of EPA’s Technical Support Document and Research Results, Presented at Third International Symposium on Bioremediation and Sustainable Environmental Technologies (Battelle Symposium); Miami Florida 2015
EPC introduction.pptx it is a environment pollution and controlSakiShaikh
This document outlines the objectives, outcomes, and units of a course on environmental pollution and control. The key points are:
- The course aims to teach students about water and wastewater treatment systems, air pollution control, and environmental management and policies.
- After completing the course, students will understand water quality, pollution sources, air pollution assessment, and solid waste management techniques.
- The course covers topics like environmental pollutants, natural water and air purification processes, water and air pollution control methods, and pollution control in industries.
This document provides an introduction and overview of the European Union's REACH chemical regulation program and California's new Green Chemicals Initiative. It summarizes the key elements of REACH including registration requirements, data sharing obligations, evaluation processes, and restrictions on chemicals of concern. It also outlines California's new legislative efforts to adopt aspects of the REACH model and prioritize safer chemical alternatives. Contact information is provided for further discussion.
This document discusses brands, trademarks, and advertising. It begins by defining what a brand is, noting that a brand comprises a product or service, packaging, name/logo, promotion, and appeals to customers physically, aesthetically, rationally, and emotionally. It then defines what a trademark is, explaining that it distinguishes one company's goods/services from another's. The document recommends conducting trademark searches to identify potential issues and minimize risks. It also explains why trademarks should be registered, providing exclusive rights and prima facie evidence of ownership. The document concludes by discussing proper trademark use and marking.
Le gestion de crise : considérations juridiques et pratiques pour traverser l...This account is closed
Au cours de ce programme de formation préparé spécifiquement pour les conseillers juridiques en entreprise, nous vous présenterons une série d’outils visant à vous équiper pour affronter la tempête, peu importe quand et comment elle se présente.
More Related Content
Similar to Gowlings - Environmental Law for Business Seminar: Chemical & Substances Management
This document provides an update on Phase 2 of the C4SL Project, which aims to derive Contaminated Land: Soil Guideline Values (C4SLs) for approximately 20 additional contaminants. It outlines the project organization, including steering committee members and roles of the project management team, exposure modellers, and Tier 1 and Tier 2 toxicologists in deriving C4SL values. The document describes the methodology that will be used, including evaluating toxicological data to derive Lowest Levels of Toxicological Concern (LLTCs), conducting probabilistic modeling using CLEA exposure parameters, and accounting for uncertainties. Priority contaminants were selected for evaluation based on a 2015 consultation. The project aims
Session 1 role and importance of dsp in biotechnologyKAKARADIVYA
This document discusses downstream processing (DSP) in bioproduct manufacturing. It defines DSP as a series of isolation and purification steps to separate biological molecules from complex mixtures. DSP is challenging due to the similar properties of products, impurities, and contaminants. The document outlines various unit operations used in low, medium, and high resolution separation. It emphasizes that DSP is a major cost in bioproduct production and recovery method selection impacts overall economics. Proper method choice requires understanding the product properties, quality needs, and ability to scale the process.
The TCE Revolution and Its Permanent Impact on Environmental Due DiligenceEDR
EDR INSIGHT WEBINAR: THE TCE REVOLUTION AND ITS PERMANENT IMPACT ON ENVIRONMENTAL DUE DILIGENCE
June 24, 2015
Presented by:
-David Gillay, Partner and Chair of Brownfields & Environmental Transactional Diligence Practice Areas, Barnes & Thornburg LLP
-Dr. Michael Dourson, Ph.D., Alliance for Risk Assessment
Following decades of studies, scrutiny and debate, the U.S. EPA updated its TCE’s toxicity profile in the IRIS database, dramatically lowering the toxicity value. For transactional due diligence, this more stringent limit has important implications, including markedly more extensive and expensive cleanup processes. Given the focus on vapor migration in the new ASTM Phase I ESA standard, environmental professionals need to be increasingly cautious when making REC determinations and recommendations to clients.
Adding to the confusion is the significant variability in how regulators are using the updated TCE toxicity profile when making closure decisions at contaminated properties. For instance, U.S. EPA Regions 9, 10 and states like Minnesota, Indiana and Massachusetts (among others) have implemented profoundly different approaches to address TCE risk at contaminated sites. Thus, it is critical for environmental professionals to stay abreast of the how TCE guidance is being interpreted and applied across the country. In the latest development, the Agency for Toxic Substances & Disease Registry is proposing a dramatic change to its TCE toxicity profile for the first time in 18 years. The comment period ended on March 16, 2015, and if the update is finalized in its current form, there will be more intense scrutiny on exposure risks which will further complicate transactional due diligence.
This timely webinar will bring together an attorney and a national subject matter expert to address the various impacts of TCE’s toxicity update on transactional due diligence. This panel will help EPs answer the following questions:
-Does TCE in groundwater constitute a VEC and/or a REC?
-How should an EP manage variability in TCE standards in multi-state transactions?
-How can an EP take steps to minimize exposure to potential liability?
-How can an EP make sense of the science and available guidance?
-How should an EP communicate potential risks associated with TCE to clients?
This document summarizes the state of policy development in the EU to manage contaminants of emerging concern (CECs). It discusses the EU's chemicals legislation and monitoring efforts for CECs in surface water and groundwater. The EU is developing watch lists of substances of concern for surface and groundwater. It is also exploring effect-based monitoring methods and using grouping approaches to assess chemical risks. The document notes efforts to increase data access and sharing, as well as increasing focus on persistent and mobile substances with potential for groundwater contamination. It concludes by mentioning the upcoming EU strategic approach on pharmaceuticals in the environment.
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.
Brokerage session: project idea
Title: Real Time Monitoring for Effective and Sustainable Industrial wastewater Treatment and Compliance
Presented by Stephen Moore, MANTECH
Clean Air Act Compliance, Risk Management Plans, and Preparing for the July 1...Triumvirate Environmental
The document discusses regulatory requirements under the Clean Air Act for risk management plans and toxic release inventory reporting, including an overview of the Risk Management Plan rule requirements under the Clean Air Act, what facilities must submit risk management plans, and details on toxic release inventory reporting requirements including what chemicals must be reported and the annual July 1st deadline.
This document summarizes a presentation on aseptic processing of biological products and common regulatory issues. The presentation covers quality microbiology content required in BLA submissions, including guidance documents and regulations. It discusses common deficiencies seen in sterilizing filtration, post-reconstitution and post-dilution storage, and container closure integrity testing. It provides an overview of laws and regulations for biological products and concludes with recommendations for including appropriate microbiological data in BLA submissions.
This document discusses the main air pollutants - carbon monoxide, lead, ozone, nitrogen dioxide, particulate matter, and sulfur dioxide. It describes their sources, health effects, and regulations. It also outlines the history of air pollution control acts and standards in the United States, current issues regarding inadequate control and understanding health impacts, and recommendations for reducing air pollution exposure.
This document provides an overview of extractables and leachables (E&Ls) studies. It discusses that E&Ls studies are needed in industries like biomedical devices, food packaging, and pharmaceutical packaging to identify substances that can migrate from materials into products. Jordi Labs is introduced as a leader in E&Ls analysis with state-of-the-art facilities and over 80% of staff being chemists. The document outlines the basic process of an E&L study including sample selection, extractions, identification of E&Ls using techniques like mass spectrometry, quantitative analysis, and determining acceptable levels. Regulations for E&Ls from organizations like USP, FDA and ISO are also summarized.
8minSlideDeck National Green Theatres Programme (002).pptxalifiachakera1
The document discusses the National Green Theatres Programme in Scotland, which aims to reduce carbon emissions from healthcare, particularly in surgical theatres and anaesthetics. It notes that NHS Scotland emissions are 577,700 tonnes of CO2e annually, with theatres and anaesthetics being high contributors. It outlines over 40 proposed sustainability actions and an approach using quality improvement methods to implement emission mitigation efforts across structures, equipment, practices and culture. Examples provided show significant emission reductions achieved from switching anaesthetic agents and capturing waste gases. The programme aims to establish sustainable procurement, evaluate impacts, and develop a framework allowing for circular economy practices in healthcare.
Presentation at the ESPP stakeholder meeting concerning the use on farmland of sewage biosolids (04/12/2018) organised by the European Sustainable Phosphorus Platform (ESPP, www.phosphorusplatform.eu)
All outcomes of the meeting can be found here https://www.phosphorusplatform.eu/activities/conference/meeting-archive/1788-espp-meeting-sludge-2018
1) The document discusses contaminants of emerging concern (CECs) in surface waters, which challenge traditional water protection policy approaches based on establishing environmental quality norms for individual compounds.
2) It proposes that the precautionary principle is an appropriate strategy to deal with the uncertainties surrounding CECs given their diversity, unknown impacts, and constant introduction of new substances.
3) An international survey of decision-makers found support for precautionary, source-directed policies to reduce CECs rather than relying solely on the scientific testing and regulation paradigm currently used.
Passive Samplers for Vapor Intrusion Monitoring: Update of EPA’s Technical S...Chris Lutes
Lutes, C., R. Truesdale, H. Hayes, T. McAlary, H. Dawson, B. Cosky , D. Grossee, B. Schumacher and J. Zimmerman Passive Samplers for Vapor Intrusion Monitoring: Update of EPA’s Technical Support Document and Research Results, Presented at Third International Symposium on Bioremediation and Sustainable Environmental Technologies (Battelle Symposium); Miami Florida 2015
EPC introduction.pptx it is a environment pollution and controlSakiShaikh
This document outlines the objectives, outcomes, and units of a course on environmental pollution and control. The key points are:
- The course aims to teach students about water and wastewater treatment systems, air pollution control, and environmental management and policies.
- After completing the course, students will understand water quality, pollution sources, air pollution assessment, and solid waste management techniques.
- The course covers topics like environmental pollutants, natural water and air purification processes, water and air pollution control methods, and pollution control in industries.
This document provides an introduction and overview of the European Union's REACH chemical regulation program and California's new Green Chemicals Initiative. It summarizes the key elements of REACH including registration requirements, data sharing obligations, evaluation processes, and restrictions on chemicals of concern. It also outlines California's new legislative efforts to adopt aspects of the REACH model and prioritize safer chemical alternatives. Contact information is provided for further discussion.
Similar to Gowlings - Environmental Law for Business Seminar: Chemical & Substances Management (20)
This document discusses brands, trademarks, and advertising. It begins by defining what a brand is, noting that a brand comprises a product or service, packaging, name/logo, promotion, and appeals to customers physically, aesthetically, rationally, and emotionally. It then defines what a trademark is, explaining that it distinguishes one company's goods/services from another's. The document recommends conducting trademark searches to identify potential issues and minimize risks. It also explains why trademarks should be registered, providing exclusive rights and prima facie evidence of ownership. The document concludes by discussing proper trademark use and marking.
Le gestion de crise : considérations juridiques et pratiques pour traverser l...This account is closed
Au cours de ce programme de formation préparé spécifiquement pour les conseillers juridiques en entreprise, nous vous présenterons une série d’outils visant à vous équiper pour affronter la tempête, peu importe quand et comment elle se présente.
This presentation includes information about legal project management fundamentals, creating a framework for legal project management (define, plan, monitor and manage, review and improve), ethics and the law, conflicts from outside counsel and the general counsel.
This document discusses financing models for nuclear power projects and the risks involved. It describes three models for government engagement: complete engagement where governments own projects and absorb risks; complete disengagement where private actors must take on risks; and a middle road where governments hedge some risks. Two US projects using the middle road of rate increases are proceeding, while others failed. The UK uses contracts that hedge electricity prices but not completion risks, requiring massive contingent equity funds. For new projects, sponsors may need to pass completion risks down the supply chain.
Canadian Procurement/Construction Delivery Methods
Various procurement/construction delivery methods exist to provide alternatives as to how risks and responsibilities are allocated for a project and how key factors such as time and price are addressed.
Traditional Delivery Method:
Design-Bid-Build
- Stipulated Price
- Cost Plus
- Unit Price
Contemporary Delivery Methods:
- Construction Management (not-at-risk / at-risk)
- Design-Build
- P3’s
This document summarizes the key intellectual property rights affected by the Trans-Pacific Partnership (TPP) agreement, including patents, trademarks, copyright, industrial designs, and geographical indications. It outlines the TPP provisions relating to patentable subject matter, patent term extensions, data protection, biologics, trademark registration requirements, well-known marks, copyright duration, and industrial design harmonization. The TPP signatories recognize different approaches to geographical indication protection and enforcement measures include criminal sanctions for IP infringement and border measures.
In this presentation, Gowlings partner Parul Armitage will look at current trends in life sciences licensing and collaborations.
Topics to be explored include:
Financial terms
Valuations
The continuing saga of the patent cliff
“More payer pressure, more commercialization risk”
Licensing as a commercialization strategy
Academic to industry licensing
The Cloud Computing Contract Playbook - Contracting for Cloud Services, Sept. 30This account is closed
The document discusses key considerations for contracting cloud services. It notes that cloud contracts replace on-premises infrastructure agreements and outlines important clauses like data security, service level agreements, auditing rights, and ensuring access to data if the provider exits. The document also recommends due diligence on provider security practices and insurance to cover risks from outages or breaches at third-party providers. Overall it provides guidance on structuring contracts to maintain control over data and set clear performance standards when transitioning IT services to cloud models.
It’s widely known that foreign companies looking to acquire strong targets are drawn to Canada’s vast resource sector. But there’s also plenty of M&A activity — and opportunity — across many other Canadian industries, such as technology, life sciences, media and communications, manufacturing and retail.
In this one-hour webinar, experts from Gowlings will share their insights on the Canadian M&A legal regime, and offer tips on how to navigate the complexities of the market and successfully acquire a Canadian company. Topics include:
- Building your acquisition model and determining the most appropriate structure for a Canadian company acquisition
- Determining the applicable tax rules and assessing the potential tax advantages
- An overview of competition law and the Investment Canada Act — due diligence, thresholds and the review process
PLSAs, SEPs and PAEs: The Antitrust/IP Acronyms You Should Know and UnderstandThis account is closed
In this presentation from June 2015, Davit Akman and a panel of other antitrust experts provide an overview of recent regulatory and jurisprudential developments in the U.S., Europe and Canada, and their impact on antitrust counselling and risk assessment.
Key topics discussed include:
• Patent litigation settlement agreements (PLSAs)
• Standard setting and conduct involving standard essential patents (SEPs)
• Conduct involving patent assertion entities (PAEs)
Your company’s people, products, profits and politics have a direct impact on its bottom line.
In this seminar presentation aimed at in-house counsel, HR and other business leaders, you’ll learn from legal and industry insiders on how to master these four key pillars ― and succeed in today’s competitive manufacturing market.
This document summarizes a presentation on navigating social media in the workplace. It discusses how social media has become integrated into daily life and work. While it provides opportunities as a business tool, it also poses risks if not properly managed, such as lost productivity, privacy issues, and legal liabilities. The presentation provides guidance for developing social media policies and educating employees on appropriate social media use and their obligations regarding loyalty, confidentiality and off-duty conduct. It also reviews case law establishing that employers can discipline employees for inappropriate social media use that damages the employer or violates policies.
This document summarizes five key employment law cases from 2015:
1. McConaghie v. Systemgroup Consulting Inc. found an employer discriminated against a female employee by holding a "Men's Day" event that excluded her. The employer was ordered to pay damages.
2. Wilson v. Atomic Energy established that without cause dismissals under the Canada Labour Code are not automatically unjust, allowing some flexibility for employers.
3. Thompson v. Cardel Homes was found to be a constructive dismissal when the employer asked an employee not to return to work before the end of their fixed term contract.
4. Paquette v. Quadraspec Inc. determined that termination pay must include
John, an employee of Talk2Me Inc., began experiencing migraines in 2014 that caused frequent absences and reduced productivity. After various attempts to accommodate John through modified duties and arrangements, it was discovered that John had a brain tumor requiring surgery and lengthy rehabilitation. John was provided disability benefits but was eventually told he may no longer qualify. Talk2Me must now determine how to reasonably accommodate John upon his return to work or termination of benefits, considering its legal obligations and undue hardship factors.
This document discusses enforceable termination provisions in employment agreements. It emphasizes that termination language must comply with employment standards legislation and outlines key cases that highlight the importance of carefully drafting provisions. Specifically, provisions must refer to benefits during notice periods and not potentially provide less than legally required compensation. Overall, the document recommends using employment agreements with saving clauses and reviewing them regularly to balance protecting business interests with employees' legal rights.
Climate Change All over the World .pptxsairaanwer024
Climate change refers to significant and lasting changes in the average weather patterns over periods ranging from decades to millions of years. It encompasses both global warming driven by human emissions of greenhouse gases and the resulting large-scale shifts in weather patterns. While climate change is a natural phenomenon, human activities, particularly since the Industrial Revolution, have accelerated its pace and intensity
Epcon is One of the World's leading Manufacturing Companies.EpconLP
Epcon is One of the World's leading Manufacturing Companies. With over 4000 installations worldwide, EPCON has been pioneering new techniques since 1977 that have become industry standards now. Founded in 1977, Epcon has grown from a one-man operation to a global leader in developing and manufacturing innovative air pollution control technology and industrial heating equipment.
Optimizing Post Remediation Groundwater Performance with Enhanced Microbiolog...Joshua Orris
Results of geophysics and pneumatic injection pilot tests during 2003 – 2007 yielded significant positive results for injection delivery design and contaminant mass treatment, resulting in permanent shut-down of an existing groundwater Pump & Treat system.
Accessible source areas were subsequently removed (2011) by soil excavation and treated with the placement of Emulsified Vegetable Oil EVO and zero-valent iron ZVI to accelerate treatment of impacted groundwater in overburden and weathered fractured bedrock. Post pilot test and post remediation groundwater monitoring has included analyses of CVOCs, organic fatty acids, dissolved gases and QuantArray® -Chlor to quantify key microorganisms (e.g., Dehalococcoides, Dehalobacter, etc.) and functional genes (e.g., vinyl chloride reductase, methane monooxygenase, etc.) to assess potential for reductive dechlorination and aerobic cometabolism of CVOCs.
In 2022, the first commercial application of MetaArray™ was performed at the site. MetaArray™ utilizes statistical analysis, such as principal component analysis and multivariate analysis to provide evidence that reductive dechlorination is active or even that it is slowing. This creates actionable data allowing users to save money by making important site management decisions earlier.
The results of the MetaArray™ analysis’ support vector machine (SVM) identified groundwater monitoring wells with a 80% confidence that were characterized as either Limited for Reductive Decholorination or had a High Reductive Reduction Dechlorination potential. The results of MetaArray™ will be used to further optimize the site’s post remediation monitoring program for monitored natural attenuation.
Kinetic studies on malachite green dye adsorption from aqueous solutions by A...Open Access Research Paper
Water polluted by dyestuffs compounds is a global threat to health and the environment; accordingly, we prepared a green novel sorbent chemical and Physical system from an algae, chitosan and chitosan nanoparticle and impregnated with algae with chitosan nanocomposite for the sorption of Malachite green dye from water. The algae with chitosan nanocomposite by a simple method and used as a recyclable and effective adsorbent for the removal of malachite green dye from aqueous solutions. Algae, chitosan, chitosan nanoparticle and algae with chitosan nanocomposite were characterized using different physicochemical methods. The functional groups and chemical compounds found in algae, chitosan, chitosan algae, chitosan nanoparticle, and chitosan nanoparticle with algae were identified using FTIR, SEM, and TGADTA/DTG techniques. The optimal adsorption conditions, different dosages, pH and Temperature the amount of algae with chitosan nanocomposite were determined. At optimized conditions and the batch equilibrium studies more than 99% of the dye was removed. The adsorption process data matched well kinetics showed that the reaction order for dye varied with pseudo-first order and pseudo-second order. Furthermore, the maximum adsorption capacity of the algae with chitosan nanocomposite toward malachite green dye reached as high as 15.5mg/g, respectively. Finally, multiple times reusing of algae with chitosan nanocomposite and removing dye from a real wastewater has made it a promising and attractive option for further practical applications.
ENVIRONMENT~ Renewable Energy Sources and their future prospects.tiwarimanvi3129
This presentation is for us to know that how our Environment need Attention for protection of our natural resources which are depleted day by day that's why we need to take time and shift our attention to renewable energy sources instead of non-renewable sources which are better and Eco-friendly for our environment. these renewable energy sources are so helpful for our planet and for every living organism which depends on environment.
Microbial characterisation and identification, and potability of River Kuywa ...Open Access Research Paper
Water contamination is one of the major causes of water borne diseases worldwide. In Kenya, approximately 43% of people lack access to potable water due to human contamination. River Kuywa water is currently experiencing contamination due to human activities. Its water is widely used for domestic, agricultural, industrial and recreational purposes. This study aimed at characterizing bacteria and fungi in river Kuywa water. Water samples were randomly collected from four sites of the river: site A (Matisi), site B (Ngwelo), site C (Nzoia water pump) and site D (Chalicha), during the dry season (January-March 2018) and wet season (April-July 2018) and were transported to Maseno University Microbiology and plant pathology laboratory for analysis. The characterization and identification of bacteria and fungi were carried out using standard microbiological techniques. Nine bacterial genera and three fungi were identified from Kuywa river water. Clostridium spp., Staphylococcus spp., Enterobacter spp., Streptococcus spp., E. coli, Klebsiella spp., Shigella spp., Proteus spp. and Salmonella spp. Fungi were Fusarium oxysporum, Aspergillus flavus complex and Penicillium species. Wet season recorded highest bacterial and fungal counts (6.61-7.66 and 3.83-6.75cfu/ml) respectively. The results indicated that the river Kuywa water is polluted and therefore unsafe for human consumption before treatment. It is therefore recommended that the communities to ensure that they boil water especially for drinking.
Presented by The Global Peatlands Assessment: Mapping, Policy, and Action at GLF Peatlands 2024 - The Global Peatlands Assessment: Mapping, Policy, and Action
Improving the viability of probiotics by encapsulation methods for developmen...Open Access Research Paper
The popularity of functional foods among scientists and common people has been increasing day by day. Awareness and modernization make the consumer think better regarding food and nutrition. Now a day’s individual knows very well about the relation between food consumption and disease prevalence. Humans have a diversity of microbes in the gut that together form the gut microflora. Probiotics are the health-promoting live microbial cells improve host health through gut and brain connection and fighting against harmful bacteria. Bifidobacterium and Lactobacillus are the two bacterial genera which are considered to be probiotic. These good bacteria are facing challenges of viability. There are so many factors such as sensitivity to heat, pH, acidity, osmotic effect, mechanical shear, chemical components, freezing and storage time as well which affects the viability of probiotics in the dairy food matrix as well as in the gut. Multiple efforts have been done in the past and ongoing in present for these beneficial microbial population stability until their destination in the gut. One of a useful technique known as microencapsulation makes the probiotic effective in the diversified conditions and maintain these microbe’s community to the optimum level for achieving targeted benefits. Dairy products are found to be an ideal vehicle for probiotic incorporation. It has been seen that the encapsulated microbial cells show higher viability than the free cells in different processing and storage conditions as well as against bile salts in the gut. They make the food functional when incorporated, without affecting the product sensory characteristics.
Evolving Lifecycles with High Resolution Site Characterization (HRSC) and 3-D...Joshua Orris
The incorporation of a 3DCSM and completion of HRSC provided a tool for enhanced, data-driven, decisions to support a change in remediation closure strategies. Currently, an approved pilot study has been obtained to shut-down the remediation systems (ISCO, P&T) and conduct a hydraulic study under non-pumping conditions. A separate micro-biological bench scale treatability study was competed that yielded positive results for an emerging innovative technology. As a result, a field pilot study has commenced with results expected in nine-twelve months. With the results of the hydraulic study, field pilot studies and an updated risk assessment leading site monitoring optimization cost lifecycle savings upwards of $15MM towards an alternatively evolved best available technology remediation closure strategy.
Evolving Lifecycles with High Resolution Site Characterization (HRSC) and 3-D...
Gowlings - Environmental Law for Business Seminar: Chemical & Substances Management
1. Environmental Law for
Business: Chemicals &
Substances Management
Wednesday, September 24, 2014
2. Board of Review for Siloxane D5
Presented by: Harry Dahme
Certified Specialist (Environmental Law)
3. Introduction
• Board of Review, established by Minister of the
Environment under ss. 333(1) of CEPA, 1999
• Siloxane D5
• Odourless, colourless liquid
• Used in personal care products and industrial cleaning
• In use for more than 30 years
3
4. Legislative Background
• CEPA, 1999
• S. 73 required Ministers of Environment and Health to
categorize the substances on the Domestic Substances
List (DSL) within seven years in order to identify
substances that may:
- present greatest potential for exposure
- are persistent or bioaccumulative (in accordance with the
regulations), and may be inherently toxic
• December 2006
• Completion of categorization of 23,000 substances on DSL
• Identification of approximately 200 substances as high priority
for action
4
5. Legislative Background
• Industry Challenge
• Substances released in 12 Batches with dates for submission of
information, publication of draft Screening Assessment Reports and
final Screening Assessment Reports)
• S. 64 “toxic” means immediate or long-term harmful effect on
the environment, danger to the environment, danger to
human health
• S. 68 Minister may collect information on whether a
substance is toxic
• S. 71: Notice requiring submission of information for purpose
of assessing whether substance is toxic or capable of
becoming toxic
• S. 74 Screening Assessment
5
6. Legislative Background
• Options upon completion of screening assessment
• No further action
• Addition to the Priority Substances List
• Addition to the Toxic Substances List if a substance is “toxic”
(mandatory where substance is toxic, has long-term harmful
effect on the environment, persistent and bioaccumulative,
inherently toxic and present due to human activity)
• Virtual elimination (persistent and bioaccumulative, inherently
toxic and present due to human activity, not naturally
occurring)
6
7. Legislative Background
• Decision made based on the application of:
• Weight of evidence approach
• Precautionary principle
• Persistence and Bioaccumulation Regulations
apply
• Numeric half-life values for different media
• Numeric values to BAF, BCF, Kow
7
8. Screening Assessment and Notice of Objection
• Screening Assessment concluded D5:
• Met the criteria for persistence and bioaccumulation and
• Was entering the environment in a quantity or concentration or under
conditions that had the immediate or long-term harmful effects on the
environment or its biological diversity
• Notice of objection by SEHSC provided new studies and
requested a Board of Review
• Section 333 – Ministers may establish a Board of Review to
inquire into the nature and extent of the danger posed by the
substance in respect of which the decision is made
• Board of Review granted based on new scientific information
regarding D5 having been made available since conduct and
publication of the final Screening Assessment
8
9. Board of Review
• 3 internationally recognized toxicologists
• Scope of the hearing
• Nature and extent of the danger posed by D5 to the
environment (not health)
• Not whether substance is “toxic” pursuant to section 64
• De novo risk assessment
9
10. Issues
• Characteristics of D5
• Chemical characteristics of D5 are well understood
• Chemical characteristics are unusual compared to other
PBT substances (for example very large vapour pressure
for such a high molecular weight, very low water
solubility…)
• There was general agreement on its physical properties
with the exception of sediment half-life
10
11. Issues
• Is D5 persistent and bioaccumulative?
• Environment Canada – if D5 was persistent and
bioaccumulative and used in substantial quantities, then D5 is
“toxic” notwithstanding that there may be no harmful effects
caused by D5 in the concentrations at which it was entering the
environment
• Persistence and Bioaccumulation Regulations
• Persistence in different media determined by half-life
• Whether a substance is bioaccumulative depends on:
- whether bioaccumulation factor (BaF) equal to or greater than 5000
- where the BaF cannot be determined, one of the bioconcentration
factor (BcF) equal to or greater than 5000; and
- if neither BaF or BcF can be determined, then where the octanol-water
partition coefficient (Kow) is greater than 5
11
12. Issues
• Subsection 5
• Determination to be made based on generally recognized
methods “taking into account the intrinsic properties of the
substance, the ecosystem under consideration and the
conditions in the environment”
• Bioaccumulation (BcF)
• One out of four studies showed a BcF of greater than 5000
• Biomagnification
• D5 does not bio magnify (confirmed by depuration and
biotransformation)
• Biota-sediment accumulation factors (BSAF)
• Express the distribution of a substance between organism
and sediment
• Comparative studies between D5 and PCBs (which do
bioaccumulate)
12
13. Issues
• Trophic Magnification Studies
• Trophic dilution occurs as D5 moves up the food chain
• The use of UK or EU studies
• “Weight of evidence approach”
• Not defined
• It must be readily evident or possible to recreate the
conclusion based upon the information which was
reviewed
13
14. Issues
• Releases to the environment
• Need to consider “real world emission characteristics” (9.5%
the sanitary sewers, 90.5% being released to air)
• Clear evidence that D5 is entered into a steady state in the
environment
• Partitioning to different media
• 94.5% to air
• 0.8% to water
• 4.7% to soil
14
15. Issues
• Atmospheric fate, ozone destruction, snow scavenging
• Soil exposure (including application of bio solids)
• Not persistent in soil
• Water and sediment exposure
• Rleases to surface water and use of “Mega Flush”
• Sewage treatment plant removal efficiency
• Long Range Transport
• Air
• Water (inappropriate use of model)
15
16. Issues
• Conclusion
• All predicted and measured concentration of D5 are less
than the matrix solubility
• No matter how much D5 is released into the environment,
the maximum concentration cannot exceed solubility in the
media
• Primary medium of concern is sediment (and then only
close to sewage treatment plant outfall)
16
17. Issues
• Toxicity
• Not toxic up to its solubility limit in various media (water, soil,
sediment, air)
• Toxicity measured by narcosis (therefore no need for a broad
range of species being analyzed)
• Risk
• The No Observable Effect Concentrations far exceed the D5
concentrations in media - therefore no risk
• Weight of evidence (see the next slide)
17
19. Conclusion, Comments and Recommendations
• Comprehensive and extensive record of studies
relating to D5
• D5 exceeded regulatory threshold for persistence
• D5 did not exceed regulatory threshold for
bioaccumulation
• D5 does not biomagnify (but can accumulate in an
organism)
• D5 not toxic up to solubility limits
• Will not accumulate in concentrations sufficient to
cause adverse effects
• Does not pose a danger to the environment
19
20. Conclusion, Comments and Recommendations
• Environment Canada suggested the review should not
be based on “average or standard use of chemicals”
but if a pure product poses a danger then it must form
part of the Board’s assessment
• Periodic review of the Persistence and
Bioaccumulation Regulations
• Making models available and make the use of the
models transparent
20
21. Thank You
Harry Dahme
Certified Specialist (Environmental Law)
Tel: (416) 862-4300
Email: harry.dahme@gowlings.com
montréal ottawa toronto hamilton waterloo region calgary vancouver moscow london
23. Overview: New Substance Notification (NSN)
• NSN Regulatory Framework
• Notifiable Substances
• Key Exemptions
• Volume Splitting
• Compliance Tips
Is it a “new substance”?
Is there any applicable exception?
We’ve reached the import limit,
what can we do?
24. NSN Overview
• Purpose is control of new substances
• New = Post 1984
• Program designed to put burden of assessing potential
health/environmental impact on industry
• Level of assessment increases with quantity put into
commerce
• Program administered by Environment Canada
and Health Canada
• Places restrictions on import and manufacture
• Applies to:
• Chemical substances
• Polymers/Biopolymers
• Organisms
25. DSL / NDSL
• Domestic Substances List (DSL)
• Non-Domestic Substances List (NDSL)
• Polymers and Biopolymers
• Reduced Regulatory Requirement Polymers
26. NSN Regulatory Framework
Domestic Substances List (DSL)
CEPA Prohibition
Substance not on DSL = Importation & Manufacture Prohibited
CEPA Exception
Notification Provided = Importation & Manufacture Permitted
NSN Regulations – Notification Requirements
Quantity Level 1 Data Level 1
Quantity Level 2 Data Level 2
Quantity Level 3 Data Level 3
27. Notifiable Substances
If not on the DSL, must notify in respect of:
• Any chemical with a unique CAS#
• Unknown or variable composition, complex reaction products
and biological materials (UVCBs)
• substances that have no definite molecular formula representation and
either partial structural diagrams or no structural diagrams
• Nanomaterial form of substance
(1) having one or more dimensions (or internal or surface structure) at the
nanoscale (1-100 nanometers inclusive);
(2) exhibiting nanoscale-related phenomena above or below the nanoscale.
28. Key Exemption – Impurities and Contaminants
For exemption to apply substance must:
• Be found in minimal concentration in the starting
materials; or
• Be a result of secondary reactions that occur during the
manufacturing process.
and must NOT:
• Be necessary to the end use of product;
• Have been intentionally added to the product; or
• Enhance the value of the product.
29. Key Exemption – Incidental Reaction Products
Exemption applies to:
1. Substances produced when a product
undergoes a chemical reaction that is incidental
to its use; or
2. Substances resulting from storage or from
environmental factors.
30. Other Exemptions
• 2 % Rule Polymers and Proteins
• Transient Reaction Intermediates
• Substances Occurring in Nature
• Manufactured Items
• Wastes
• Low Volume
31. Volume Splitting
Environment Canada Advisory Note:
…any regulatee who has reached the maximum manufacture or import quantity
to obtain additional quantities of the new substance from another
regulatee who has already manufactured or imported the new
substance into Canada for his own use and has not reached its
maximum quantity.
However, a regulatee may not obtain additional quantities of the new
substance from another regulatee by contracting the person to
manufacture or import the new substance on his behalf…
32. Compliance Tips
• Tracking program is key
• 90% of issue arise due to late identification of issue
• Can cause issues with commercial supply arrangements
• Inquiries to suppliers re: regulatory status of
product components
• Disclosure to customers re: regulatory status of
product components
• Do not assume REACH or TSCA registration is
sufficient
33. Thank You
Gatlin Smeijers
Toronto office
Tel: 416-862-3511
Email: gatlin.smeijers@gowlings.com
montréal ottawa toronto hamilton waterloo region calgary vancouver beijing moscow london
34. The International Trend Toward
Hazard-Based Regulation:
Navigating the New Reality
Robert P. DeMott, PhD, DABT
Principal Toxicologist
Presented for:
Gowling Lafleur Henderson LLP Toronto
September 24, 2014
35. 35
Outline
• Overview of hazards and risks
• Toxicology Primer – dose and exposure
• International landscape of hazard and risk-based
regulations for products
• Implications, Responses, Realities
36. 36
Risk Analysis Basics
• Risk Analysis 101 – in three bullets
– Hazard – inherent characteristic
– Risk – requires exposure to a hazard
– Pathway – connecting hazards to exposed people
Example: Migration of chemical from packaging onto exterior
surface of toy handled by child who puts hands in mouth
• Starts with Assessing Hazards
– New hazards necessitate new evaluation
– Should we stop there?
37. 37
Risk-Based Decision Making
• Guiding concept is making environmental cleanup
decisions based on:
– Potential health risks to humans or other species
• Sounds obvious and desirable, what else would we use
– Specified concentration limits (“Standards”)
– Technological feasibilty
– Background
– Hazard Avoidance
38. 38
We Have an Intuitive Grasp of Hazard vs.
Healthful…
Which scene above do you
associate with the following?
39. 39
“Good Chemicals” and Hazardous
Chemicals
List A
Arsenic
Lead
Trichloroethylene
Mercury
Warfarin (D-con rat
bait)
List B
Oxygen
Water
Chromium (piccolinate)
Vitamin A
Digoxin
40. 40
Toxicological Reality
• List A are all “medicines”
Arsenic – Fowlers solution (1809-1950s)
and other formulations
• treat asthma, diabetes, malaria, syphilis
Lead – various historical uses, folk
remedies continue in use
• for colic, menstrual disorders
TCE
• general anesthetic; orally, as treatment for worms
41. 41
A Modern Example: Rat Poison or Heart
Medication?
Source: www.coumadin.com
42. 42
Mercury – Historically
Significant, and …
• Used to treat
– Syphilis
– Various GI upsets, skin conditions
– historical experimentation lead to Paracelsus’ recognition:
There are no substances which are not
poisons, it is the dose that makes the poison
43. 43
The “Good Chemicals” are Toxic too
• Everything in List B is also
associated with toxicity List B
Oxygen
Water
Chromium (picolinate)
Vitamin A
Digoxin
44. 44
Dose-Response Characteristics
• How changes in dose cause changes in response
• Generally have flat region and region where responses
increase with dose
• Steepness of
increasing segment
corresponds to
potency of chemical
Response
Dose
Threshold
45. 45
Critical Concept # 1
• No matter how “good” or “bad” the
associations
with a given chemical:
The relevant or potential
dose determines the risk of
undesired outcomes
46. 46
Risk-Based Regulation
• Risk analysis incorporates:
– Toxicity assessment (dose-response) AND
– Exposure assessment (describe pathways) TO
– Characterize risks
• Product uses, ingredients, environmental conditions
prioritized based on estimated risk and controls – Botox
Paradox
• Exposure and toxicity assumptions intentionally biased
to be protective
47. 47
Hazard-Based Regulation
• Toxicity assessment (dose-response) – all we need
• Benchmarks used to prioritize chemicals
– Potency
– Type of effect
– Associations and perceptions
• Use lists/scorecards as basis for
– Notification/disclosure
– Reformulation/substitution
– Restriction
48. 48
The Lure of Regulating Hazards
• Fast and easy
– Find it with your iPhone
– Explain it to non-specialists
• Pre-determined list
– Controlled by interested parties
– Use the threat of being listed
• Eliminate discussion/debate about risk complexities
49. 49
International Trend to Toward Hazard-
Based Decisions
• Initial voices were primarily advocacy groups (90’s)
– Adopted “precautionary principal” concept
– Highlighted supposedly limited evaluations
• In the US, dismissed by regulatory bureaucracy and
professionals
• Gained traction mid ‘00’s
– REACH
– Greener product initiatives.
50. 50
EU – REACH
• Registration, Evaluation, Authorisation and Restriction–
– Registration – gatekeeping process, incentivizes hazard-based
management, substitution
– Hazard alone documented initially – presumed risky
“Substances of Very High Concern”
– Authorisation step – provides for risk assessment, but you are
way into 6-digit costs to get there, plus “prove it’s safe to our
satisfaction” burden
– Intended to impose chemical specific restrictions
Risk-Hazard Continuum – leaning hazard
51. 51
Korea– K-REACH
• Modeled on REACH
– Registration timelines still in future (comes in force Jan, 2015)
Risk-Hazard Continuum – promoting hazard
52. 52
US – Federal
• Current programs (TSCA, FIFRA, RCRA/CERCLA, FDA
– Strong risk-based framework
– Criticized for demonstration of risk, not demonstration of safety
paradigm
– Not significantly changed in decades
• Updates in the offing
– Advocates pushing REACH-like approach (with a mission)
– National Academy of Sciences reiterating value of risk-based
decision-making
Risk-Hazard Continuum – pendulum swinging from risk
53. 53
US – State of Washington
• Children’s Safe Products Act
– Notification, not prohibition framework
– Hazard-based listing – “Chemicals of High Concern”
• Scarlet-letter problem incentivizing substitution
• Draft Guidance on Alternatives Analysis (July 2014)
“The safest alternative and, by definition, the alternative with
the lowest risk has both the lowest hazard and exposure
potential.”
Risk-Hazard Continuum – pushing hazard
54. 54
US – State of California
• Safer Consumer Products Regulations
– Directly focused on substitution
– Hazard-based lists developed by agency and reviewed to
require further action
– If you make the finals – “Alternatives Analysis” with risk
assessment options
– If not, stuck in limbo with the label
• Open statements and pressure to re-formulate of risk
incurring effort of engaging on AA and subsequent
restrictions
Risk-Hazard Continuum – pushing hazard
55. 55
Canada – Pragmatic authority, no chemical-directed
prohibitions
• New Substances Notification Regulations –
– 2005 concept, lists revised routinely
– Domestic Substance List – no need to join a consortium like
REACH
– NDSL – requires information submittal, specifies toxicity AND
exposure information
• Consumer Product Safety Act (2011)
– general prohibition against “unreasonable danger”
– Focus on monitoring, notification and recalls, no pre-approval of
products
Risk-Hazard Continuum – leaning risk
56. 56
Implications for Safer Products
• “More study needed”
• Prudence in the face of uncertainty
• Non-traditional, quick-cycle information release will exert
more pressure – internet science
• “Prove it’s safe” paradigm will have room to keep
moving the finish tape in face of uncertainty
57. 57
Responses to Hazard-Based Issues
• For naturally occurring and ubiquitous constituents
– Background in the environment
– Routine dietary exposure
• For readily substituted ingredients
– Cost/risk/benefit evaluation
– Protection of the brand image as priority
• For products/ingredients not readily de-selected – force
the conversation to risk
58. 58
Realities of Business in a Hazard-Based
Landscape
• Years to decades for positioning and planning will no
longer be the norm in the blogosphere age
• Understanding vulnerabilities and options can provide:
– Easier, cheaper, better compliance
– Competitive advantage – BPA-free bottles
– Plans to respond to internet/social media inititiatives
• Careful analysis required to avoid unfortunate
substitutions – down side of acting rapidly
59. 59
Take-Away Messages
• Hazard-based regulations and pressures are here and
increasing
• Perception is reality – If you’re fighting over the risk
science, you’re in a battle you lose one way or the other
• Look for strategies to adapt and turn competitive
advantages, e.g., first to adopt safer, greener alternative
• Risk-based concepts will not be completely supplanted
in complicated situations
60. 60
Thank You
Robert P. DeMott
rdemott@environcorp.com