Module 4 - Home USES AND LIMITATIONS OF RISK ASSESSMENT Modular Learning Outcomes Upon successful completion of this module, the student will be able to satisfy the following outcomes: Case o Examine the limitations of using models (validated and unvalidated) to assess exposure as it applies to risk assessment. SLP o Identify and analyze risk-management options for a project based on a risk assessment. Discussion o Explore factors that determine the need for a risk assessment. Module Overview Explain the problems associated with assessing risk from exposure to trace chemicals. (TD) Uses and Limitations of Risk Assessment In this module we will discuss some of the limitations of risk assessments based on toxicity assessments, exposure assessments, and ecological risk assessments. Toxicity assessments -- Any risk management decision based on toxicity assessments must be very carefully considered for the following reasons. Most human toxicity and exposure studies are usually extrapolated from a few studies of a population's exposure to a contaminated source. The studies are usually not controlled and exposure data is commonly collected after exposure has occurred. In other cases, exposure measures and effects are based on workers in the workplace who have been exposed accidentally to very high levels of a specific chemical. The most common source of data used in toxicity assessments, however, is derived from toxicity test with laboratory animals. These results then are extrapolated to humans. Rarely is there an opportunity to accurately measure the chemical exposure on a sufficiently large population to make a reliable toxicity assessment. Exposure assessments -- Exposure assessments are based on measurements in the field and/or are calculated from models. Assumptions are associated with both sources. The more complex the exposure assessment and the greater the number of assumptions, the less value should be placed on it by risk management decision makers. The Risk Characterization, which is the final step of the risk assessment, should discuss uncertainty in the risk assessment to include that associated with assumption. Simple exposure methods should be considered before the more complex exposure methods. In addition, due to statutory requirements many risk assessments have estimated risks for a hypothetical, nonexistent "maximally exposed individual" (MEI) and have failed to obtain information about the frequency, duration, and magnitude of actual population exposures. The challenge for those conducting exposure assessments is to develop an acceptable and credible exposure assessment for a population that by definition is exposed to a multitude of chemicals and other environmental stressors that may be more significant than the problem exposure. This is why it is so important that the problem is defined within the proper context. Ecological risk assessments -- One problem with ecological risk assessments is that they have no commonly accepted starting point. In addition, many ecological risk assessments are actually ecological risk case studies. Ecological risk assessments usually consist of two different parts of the study. The first part is a characterization of exposure followed by, the second part, which is a characterization of ecological effects. Another problem with ecological risk assessments is that there is very little standardization among them. As you review the background material for this module try to focus on the strengths and weaknesses of each method of assessment. Examining Options There are many options to consider that have the potential to reduce risk associated with a problem. Their outcome can range from accepting all risk (i.e., doing nothing) to mitigating risk to some acceptable level to completely eliminating risk. Some of these options are as follows: Limiting pollutant emissions Taxing industry Reducing or eliminating the use of hazardous chemicals Recycling Using recycled materials Establishing market incentives Removing or eliminating the source of the risk There are other options that may be considered; however, the process of identifying all viable options and assessing each options' cost and benefits will be strengthened by assuring that all stakeholders are involved in the process. Another aspect of analyzing options is the process of or the manner in which the feasibility of the various options are considered. This is where the technological, legal, political, and economic considerations play an important role. Module 4 - Background USES AND LIMITATIONS OF RISK ASSESSMENT Required Readings Centers for Disease Control, National Institutes for Occupational Safety and Health (2002). Exposure Assessment Methods: Research Needs and Priorities. DHHS (NIOSH) Publication number 2002-126. Retrieved on September 12, 2011 at http://www.cdc.gov/niosh/docs/2002-126/pdfs/2002-126.pdf Environmental Protection Agency (2008). Watershed Ecological Risk Assessment. Retrieved on February 21, 2011 at http://cfpub.epa.gov/watertrain/moduleFrame.cfm? module_id=5&parent_object_id=5&object_id=5 Tannenbaum, L.. (2007). And So We Model: The Ineffective Use of Mathematical Models in Ecological Risk Assessments. Integrated Environmental Assessment and Management, 3(4), 473-475. Retrieved May 3, 2012, from ProQuest Science Journals. (Document ID: 1381829541). Jim Wharfe, William Adams, Sabine E Apitz, Ricardo Barra, & et al. (2007). In Situ Methods of Measurement-An Important Line of Evidence in the Environmental Risk Framework. Integrated Environmental Assessment and Management, 3(2), 268-274. Retrieved May 3, 2012, from ProQuest Science Journals. (Document ID: 1258266991). Optional Readings Kenny S Crump. (2003). Quantitative risk assessment since the Red Book: Where have we come and where should we be going? Human and Ecological Risk Assessment, 9(5), 1105-1112. Retrieved May 3, 2012, from Research Library. (Document ID: 489624801). Adam Finkel. (2007, August). RISK ASSESSMENT AND PRECAUTION: COMMON STRENGTHS AND FLAWS. Rachel's Democracy & Health News,(920), ***[insert pages]***. Retrieved May 3, 2012, from ProQuest Central. (Document ID: 1331975081). Environmental Protection Agency (1992). Guidelines for Exposure Assessment. Retrieved on February 21, 2011 at http://oaspub.epa.gov/eims/eimscomm.getfile? p_download_id=429103 Olin SS, Neumann DA, Foran JA, and Scarano GJ. 1997. Topics in Cancer Risk Assessment. Environmental Health Perspectives 105 (Supplement) in the Trident Online Library. Stenzel, M. (2010). An Overview of Exposure Assessment Techniques Retrieved on February 21, 2011 at: http://www.geosociety.org/meetings/08geoHealthI/presentations/Ste nzel.pdf Vlaanderen J, Vermeulen R, Heederik D, and Kromhout H. 2008. Guidelines to Evaluate Human Observational Studies for Quantitative Risk Assessment. Environ Health Perspect 116:1700- 1705 at: http://ehp03.niehs.nih.gov/article/fetchArticle.action? articleURI=info%3Adoi%2F10.1289%2Fehp.11530#abstract0 Module 4 - Case USES AND LIMITATIONS OF RISK ASSESSMENT Case Assignment Understanding the Limitations in Risk Assessment A prominent group of citizens approach you to discuss the new uses and limitations of risk assessments for risk management decision making. They expressed to you their concern that the State's decision makers (State Senate and Assembly) were overly impressed with scientific studies and refused to see its limitations. Specifically, they were concerned that exposure assessments were based on invalidated mathematical models which used too many assumptions about population's exposure. Write a 3-5+ page paper in which you respond to the following questions: 1. How would you respond to the citizens concerns? 2. Should all exposure assessments be based only on validated models? (Support your response with appropriate references.) 3. How would you determine if the assumptions made about the population's exposure are valid? Be sure to justify your opinions with evidence from the literature. Your answer should be supported by references and the references should be cited in the body of your discussion as well as in a reference list. Assignment Expectations Length: Case Assignment Module assignments should be at least 35+ pages (600-1200 words) in length. References: At least three references should be included from academic sources (e.g. peer-reviewed journal articles). Required readings are included. Quoted material should not exceed 10% of the total paper (since the focus of these assignments is critical thinking). Use your own words and build on the ideas of others. When material is copied verbatim from external sources, it MUST be enclosed in quotes. The references should be cited within the text and also listed at the end of the assignment in the References section (preferably in APA format). Organization: Subheadings should be used to organize your paper according to question Format: APA format is recommended (but not required) for this assignment. See Syllabus page for more information on APA format. Grammar and Spelling: While no points are deducted, assignments are expected to adhere to standards guidelines of grammar, spelling, punctuation, and sentence syntax. Points may be deducted if grammar and spelling impact clarity. The following items will be assessed in particular: Relevance (e.g. all content is connected to the question) Precision (e.g. specific question is addressed. Statements, facts, and statistics are specific and accurate). Depth of discussion (e.g. present and integrate points that lead to deeper issues) Breadth (e.g. multiple perspectives and references, multiple issues/factors considered) Evidence (e.g. points are well-supported with facts, statistics and references) Logic (e.g. presented discussion makes sense, conclusions are logically supported by premises, statements, or factual information) Clarity (e.g. writing is concise, understandable, and contains sufficient detail or examples) Objectivity (e.g. avoid use of first person and subjective bias) Module 4 - SLP USES AND LIMITATIONS OF RISK ASSESSMENT For your session-long project, you were to develop an environmental health risk management plan for a project type of your choice. The plan will be divided into five parts. The framework for the risk management plan is as follows: 1. Identifying the project and defining the problem. This step includes identifying the specific chemical and the situation that may cause an adverse impact on human health or the ecosystem. (Module 1) 2. Identifying the Stakeholders. (Module 2) 3. Placing the problem in the proper context. (Module 3) 4. Examining options for addressing the risks. (Module 4) 5. Making a decision about which option to implement. (Module 5) Module 4 Assignment For this SLP, write a 3-5+ page paper in which you: 1. Identify and examine risk management options for the project, and 2. Describe how project impacts are controlled. Examples of options include regulatory and non-regulatory approaches to reducing risk such as recycling, taxing industries on the basis of pollution, limiting pollutant emissions, and eliminating the use of hazardous materials. Try to consider all reasonable alternatives including the alternative of no project. Be sure to justify your opinions with evidence from the literature. Your answer should be supported by references and the references should be cited in the body of your discussion as well as in a reference list. SLP Assignment Expectations Length: The completed SLP should be approximately 25 pages, double spaced. (Plus/minus 3 pages). Each module SLP should be approximately 3-5 pages or appr oximately 600 to 1200 words. References: At least three references should be included from academic sources (e.g. peer-reviewed journal articles). Required readings are included. Quoted material should not exceed 10% of the total paper (since the focus of these assignments is critical thinking). Use your own words and build on the ideas of others. When material is copied verbatim from external sources, it MUST be enclosed in quotes. The references should be cited within the text and also listed at the end of the assignment in the References section (preferably in APA format). Organization: Subheadings should be used to organize your paper according to question Format: APA format is recommended (but not required) for this assignment. See Syllabus page for more information on APA format. Grammar and Spelling: While no points are deducted, assignments are expected to adhere to standards guidelines of grammar, spelling, punctuation, and sentence syntax. Points may be deducted if grammar and spelling impact clarity. The following items will be assessed in particular: Relevance (e.g. all content is connected to the question) Precision (e.g. specific question is addressed. Statements, facts, and statistics are specific and accurate). Depth of discussion (e.g. present and integrate points that lead to deeper issues) Breadth (e.g. multiple perspectives and references, multiple issues/factors considered) Evidence (e.g. points are well-supported with facts, statistics and references) Logic (e.g. presented discussion makes sense, conclusions are logically supported by premises, statements, or factual information) Clarity (e.g. writing is concise, understandable, and contains sufficient detail or examples) Objectivity (e.g. avoid use of first person and subjective bias) Module 4 - Home USES AND LIMITATIONS OF RISK ASSESSMENT Modular Learning Outcomes Upon successful completion of this module, the student will be able to satisfy the following outcomes: Case o Examine the limitations of using models (validated and unvalidated) to assess exposure as it applies to risk assessment. SLP o Identify and analyze risk-management options for a project based on a risk assessment. Discussion o Explore factors that determine the need for a risk assessment. Module Overview Explain the problems associated with assessing risk from exposure to trace chemicals. (TD) Uses and Limitations of Risk Assessment In this module we will discuss some of the limitations of risk assessments based on toxicity assessments, exposure assessments, and ecological risk assessments. Toxicity assessments -- Any risk management decision based on toxicity assessments must be very carefully considered for the following reasons. Most human toxicity and exposure studies are usually extrapolated from a few studies of a population's exposure to a contaminated source. The studies are usually not controlled and exposure data is commonly collected after exposure has occurred. In other cases, exposure measures and effects are based on workers in the workplace who have been exposed accidentally to very high levels of a specific chemical. The most common source of data used in toxicity assessments, however, is derived from toxicity test with laboratory animals. These results then are extrapolated to humans. Rarely is there an opportunity to accurately measure the chemical exposure on a sufficiently large population to make a reliable toxicity assessment. Exposure assessments -- Exposure assessments are based on measurements in the field and/or are calculated from models. Assumptions are associated with both sources. The more complex the exposure assessment and the greater the number of assumptions, the less value should be placed on it by risk management decision makers. The Risk Characterization, which is the final step of the risk assessment, should discuss uncertainty in the risk assessment to include that associated with assumption. Simple exposure methods should be considered before the more complex exposure methods. In addition, due to statutory requirements many risk assessments have estimated risks for a hypothetical, nonexistent "maximally exposed individual" (MEI) and have failed to obtain information about the frequency, duration, and magnitude of actual population exposures. The challenge for those conducting exposure assessments is to develop an acceptable and credible exposure assessment for a population that by definition is exposed to a multitude of chemicals and other environmental stressors that may be more significant than the problem exposure. This is why it is so important that the problem is defined within the proper context. Ecological risk assessments -- One problem with ecological risk assessments is that they have no commonly accepted starting point. In addition, many ecological risk assessments are actually ecological risk case studies. Ecological risk assessments usually consist of two different parts of the study. The first part is a characterization of exposure followed by, the second part, which is a characterization of ecological effects. Another problem with ecological risk assessments is that there is very little standardization among them. As you review the background material for this module try to focus on the strengths and weaknesses of each method of assessment. Examining Options There are many options to consider that have the potential to reduce risk associated with a problem. Their outcome can range from accepting all risk (i.e., doing nothing) to mitigating risk to some acceptable level to completely eliminating risk. Some of these options are as follows: Limiting pollutant emissions Taxing industry Reducing or eliminating the use of hazardous chemicals Recycling Using recycled materials Establishing market incentives Removing or eliminating the source of the risk There are other options that may be considered; however, the process of identifying all viable options and assessing each options' cost and benefits will be strengthened by assuring that all stakeholders are involved in the process. Another aspect of analyzing options is the process of or the manner in which the feasibility of the various options are considered. This is where the technological, legal, political, and economic considerations play an important role. Module 4 - Background USES AND LIMITATIONS OF RISK ASSESSMENT Required Readings Centers for Disease Control, National Institutes for Occupational Safety and Health (2002). Exposure Assessment Methods: Research Needs and Priorities. DHHS (NIOSH) Publication number 2002-126. Retrieved on September 12, 2011 at http://www.cdc.gov/niosh/docs/2002-126/pdfs/2002-126.pdf Environmental Protection Agency (2008). Watershed Ecological Risk Assessment. Retrieved on February 21, 2011 at http://cfpub.epa.gov/watertrain/moduleFrame.cfm? module_id=5&parent_object_id=5&object_id=5 Tannenbaum, L.. (2007). And So We Model: The Ineffective Use of Mathematical Models in Ecological Risk Assessments. Integrated Environmental Assessment and Management, 3(4), 473-475. Retrieved May 3, 2012, from ProQuest Science Journals. (Document ID: 1381829541). Jim Wharfe, William Adams, Sabine E Apitz, Ricardo Barra, & et al. (2007). In Situ Methods of Measurement-An Important Line of Evidence in the Environmental Risk Framework. Integrated Environmental Assessment and Management, 3(2), 268-274. Retrieved May 3, 2012, from ProQuest Science Journals. (Document ID: 1258266991). Optional Readings Kenny S Crump. (2003). Quantitative risk assessment since the Red Book: Where have we come and where should we be going? Human and Ecological Risk Assessment, 9(5), 1105-1112. Retrieved May 3, 2012, from Research Library. (Document ID: 489624801). Adam Finkel. (2007, August). RISK ASSESSMENT AND PRECAUTION: COMMON STRENGTHS AND FLAWS. Rachel's Democracy & Health News,(920), ***[insert pages]***. Retrieved May 3, 2012, from ProQuest Central. (Document ID: 1331975081). Environmental Protection Agency (1992). Guidelines for Exposure Assessment. Retrieved on February 21, 2011 at http://oaspub.epa.gov/eims/eimscomm.getfile? p_download_id=429103 Olin SS, Neumann DA, Foran JA, and Scarano GJ. 1997. Topics in Cancer Risk Assessment. Environmental Health Perspectives 105 (Supplement) in the Trident Online Library. Stenzel, M. (2010). An Overview of Exposure Assessment Techniques Retrieved on February 21, 2011 at: http://www.geosociety.org/meetings/08geoHealthI/presentations/Ste nzel.pdf Vlaanderen J, Vermeulen R, Heederik D, and Kromhout H. 2008. Guidelines to Evaluate Human Observational Studies for Quantitative Risk Assessment. Environ Health Perspect 116:1700- 1705 at: http://ehp03.niehs.nih.gov/article/fetchArticle.action? articleURI=info%3Adoi%2F10.1289%2Fehp.11530#abstract0 Module 4 - Case USES AND LIMITATIONS OF RISK ASSESSMENT Case Assignment Understanding the Limitations in Risk Assessment A prominent group of citizens approach you to discuss the new uses and limitations of risk assessments for risk management decision making. They expressed to you their concern that the State's decision makers (State Senate and Assembly) were overly impressed with scientific studies and refused to see its limitations. Specifically, they were concerned that exposure assessments were based on invalidated mathematical models which used too many assumptions about population's exposure. Write a 3-5+ page paper in which you respond to the following questions: 1. How would you respond to the citizens concerns? 2. Should all exposure assessments be based only on validated models? (Support your response with appropriate references.) 3. How would you determine if the assumptions made about the population's exposure are valid? Be sure to justify your opinions with evidence from the literature. Your answer should be supported by references and the references should be cited in the body of your discussion as well as in a reference list. Assignment Expectations Length: Case Assignment Module assignments should be at least 35+ pages (600-1200 words) in length. References: At least three references should be included from academic sources (e.g. peer-reviewed journal articles). Required readings are included. Quoted material should not exceed 10% of the total paper (since the focus of these assignments is critical thinking). Use your own words and build on the ideas of others. When material is copied verbatim from external sources, it MUST be enclosed in quotes. The references should be cited within the text and also listed at the end of the assignment in the References section (preferably in APA format). Organization: Subheadings should be used to organize your paper according to question Format: APA format is recommended (but not required) for this assignment. See Syllabus page for more information on APA format. Grammar and Spelling: While no points are deducted, assignments are expected to adhere to standards guidelines of grammar, spelling, punctuation, and sentence syntax. Points may be deducted if grammar and spelling impact clarity. The following items will be assessed in particular: Relevance (e.g. all content is connected to the question) Precision (e.g. specific question is addressed. Statements, facts, and statistics are specific and accurate). Depth of discussion (e.g. present and integrate points that lead to deeper issues) Breadth (e.g. multiple perspectives and references, multiple issues/factors considered) Evidence (e.g. points are well-supported with facts, statistics and references) Logic (e.g. presented discussion makes sense, conclusions are logically supported by premises, statements, or factual information) Clarity (e.g. writing is concise, understandable, and contains sufficient detail or examples) Objectivity (e.g. avoid use of first person and subjective bias) Module 4 - SLP USES AND LIMITATIONS OF RISK ASSESSMENT For your session-long project, you were to develop an environmental health risk management plan for a project type of your choice. The plan will be divided into five parts. The framework for the risk management plan is as follows: 1. Identifying the project and defining the problem. This step includes identifying the specific chemical and the situation that may cause an adverse impact on human health or the ecosystem. (Module 1) 2. Identifying the Stakeholders. (Module 2) 3. Placing the problem in the proper context. (Module 3) 4. Examining options for addressing the risks. (Module 4) 5. Making a decision about which option to implement. (Module 5) Module 4 Assignment For this SLP, write a 3-5+ page paper in which you: 1. Identify and examine risk management options for the project, and 2. Describe how project impacts are controlled. Examples of options include regulatory and non-regulatory approaches to reducing risk such as recycling, taxing industries on the basis of pollution, limiting pollutant emissions, and eliminating the use of hazardous materials. Try to consider all reasonable alternatives including the alternative of no project. Be sure to justify your opinions with evidence from the literature. Your answer should be supported by references and the references should be cited in the body of your discussion as well as in a reference list. SLP Assignment Expectations Length: The completed SLP should be approximately 25 pages, double spaced. (Plus/minus 3 pages). Each module SLP should be approximately 3-5 pages or appr oximately 600 to 1200 words. References: At least three references should be included from academic sources (e.g. peer-reviewed journal articles). Required readings are included. Quoted material should not exceed 10% of the total paper (since the focus of these assignments is critical thinking). Use your own words and build on the ideas of others. When material is copied verbatim from external sources, it MUST be enclosed in quotes. The references should be cited within the text and also listed at the end of the assignment in the References section (preferably in APA format). Organization: Subheadings should be used to organize your paper according to question Format: APA format is recommended (but not required) for this assignment. See Syllabus page for more information on APA format. Grammar and Spelling: While no points are deducted, assignments are expected to adhere to standards guidelines of grammar, spelling, punctuation, and sentence syntax. Points may be deducted if grammar and spelling impact clarity. The following items will be assessed in particular: Relevance (e.g. all content is connected to the question) Precision (e.g. specific question is addressed. Statements, facts, and statistics are specific and accurate). Depth of discussion (e.g. present and integrate points that lead to deeper issues) Breadth (e.g. multiple perspectives and references, multiple issues/factors considered) Evidence (e.g. points are well-supported with facts, statistics and references) Logic (e.g. presented discussion makes sense, conclusions are logically supported by premises, statements, or factual information) Clarity (e.g. writing is concise, understandable, and contains sufficient detail or examples) Objectivity (e.g. avoid use of first person and subjective bias) Citizens' concerns regarding the pattern followed by state decision makers are right. There are various limitations to the risk assessment. Risk management provides a mechanism to make intelligent decisions with risk reduction as a key input driver. The citizens' concerns are right with regards to the use of invalidated models since relying on them may cause wrong man ineffective decisions to be made and also create a number of other difficulties . In this regard however, it is essential to enlighten the citizens regarding the negatives of using invalidated models so they can raise the right points against their use before the decision makers (Lavell, 2002). Risk management depends upon many things but on top of all is the input used to make decisions. There is a major problem with the invalidated models which is that the invalidated models are mainly based on assumptions and not on validated conclusions and so one cannot be certain about their outcomes. As a result there is always a chance of making wrong decisions. Conceptual as well as empirical verification of models is important in this regard to note that validation becomes important for the purpose of knowing \"Validation their is a process applicability. of substantiating explicit claims on the applicability of predictions with reference to the intended purpose of the model. Validation is also concerned with the accuracy of these predictions for the system that is represented. All models are, by their nature, incomplete representations of the system they are intended to model, but, in spite of this limitation, models can be useful. Strictly speaking, a model cannot be validated in the sense that the validation proves that the model is true, only whether the model is well founded and applicable\" (Montforts, 2005). Validation is also important to address the quality of the science applied. It is why models need to be validated before they can be applied so that their applicability may be known. Otherwise there being based on assumptions may give rise to severe risks for the population since the decisions made on the basis of inaccurate decisions will also be inaccurate. Assumptions may have an important impact on decisions and experiments. To know if the assumptions made about exposure of the population are valid one should ensure that the indicators being used are suitable as well as a necessary amount of specimens are being used to conduct the assessment. There are a few other important questions to be asked in this regard also. First of all, it is important to check if the models used predict the field results. It is also important to check of the methodology is sound and what are the implications of the choices made? Overall, validity has a very important role to play with regards to risk assessment and risk management too. In fact the entire risk management procedure and the outcomes may depend on the validity of the models being used. Unvalidated models can always be harmful and if the citizens are feeling concerned regarding the applicability of such models then there is nothing wrong with it. To respond to the citizens' concerns in this regard the best thing would be to help them highlight the shortcomings of such models and the gaps that may be created due to use of such models. Any type of assumptions made on their basis may be very far from the reality and therefore the damages it may cause should also be highlighted. So, it will help know the shortcomings of the invalidated models as well as the difficulties that may arise due to them. References: Montforts, M. H. (2005). Validation of the EU Environmental Risk Assessment for Veterinary Medicines. In Open Access. Retrieved January 25, 2016, from https://openaccess.leidenuniv.nl/bitstream/handle/1887/648/ThesisMontforts.pdf?sequence=4 Lavell, A. (2002). DECISION MAKING AND RISK MANAGEMENT *. In Open Access. Retrieved January 25, 2016, from http://desenredando.org/public/articulos/1998/dmrm/dmrm1998_mar-12002.pdf 1. Identifying the project and defining the problem Over the last few decades the humans have managed to dump several tons of garbage into the ocean. Pollution in the oceans can be highly devastating for the ocean life and the ecosystem. The first main problem that is caused due to the dumping of the plastics in the ocean is that plastics takes several years to decay and keeps floating on the surface of the ocean (Carleton, 2016). This has an intoxicating effect which can be highly disastrous for the sea life including the fishes and the other aquatic lives. In a large number of places the mass of plastics is up to six times higher than the plankton. It is sufficient evidence to show that the problem of sea pollution may be having highly disastrous effect on the sea life and the amount of cleaning effort required to completely clean the decaying plastics may be enormous. 2. There are some important stakeholders in this regard that would need to be considered. It is first our environment. Oceans form a very important part of our environment. If oceans are impacted the life inside the oceans are also impacted. It has an impact on the fish as well as on eth other forms of aquatic life living inside the oceans. However, most important thing to note in this regard is that it leads to a diminution in the number of sea -dwelling organisms. This pollution also gets to reach the human beings in multiple ways. It has an intoxicating and deadly effect on the sea creatures and they are a part of our food chain so in turn the effect is on the amount of sea food that we receive (Carleton, 2016). Not just this, the pollution also contaminates our food that we obtain from the seas and as a result those who consume the food are also impacted. The result is a spread of diseases as well as a decline in the amount of sea food being produced. 3. Placing the problem in context: The problem is widespread and there are different plastics spread throughout the ocean. As the Styrofoam breaks into smaller components, they sink lower into the ocean, so its pollutants spread throughout the sea. The problem can be seen in an ecological context were we make attempts to preserve the nature while also destroy it with our own hands on the other side (Carleton, 2016). Plastic is dangerous not only for the aquatic animals but also for the humans. 4. Examining options for addressing the risks: Humans have an important role to play in this regard since without their efforts, it would be difficult to prevent the dumping of plastics in the ocean. Apart from trade activities there are other human activities that also lead to ocean pollution. So, restricting trade activities that lead to water pollution inside the oceans can have a good impact, but it is even important to restrict the production of polythene since it may have an important impact on the level of pollution inside the oceans. 5. Making a decision about which option to implement: While it is not difficult to decide which is the best option obviously controlling the production of polythene would have a larger impact on the entire scenario. Controlling the plastics being produced around the world will have a good impact on nature since it will find one or the other way to reach the oceans where we dump most of our industrial garbage. This garbage in one way or her other affects human health too and therefore, handling it would require efforts on a wider scale. References: Andrews, G. (2016). Plastics in the Ocean Affecting Human Health. In Carleton. Retrieved January 25, 2016, from http://serc.carleton.edu/NAGTWorkshops/health/case_studies/plastics. html References: Citizens' concerns regarding the pattern followed by state decision makers are right. There are various limitations to the risk assessment. Risk management provides a mechanism to make intelligent decisions with risk reduction as a key input driver. The citizens' concerns are right with regards to the use of invalidated models since relying on them may cause wrong man ineffective decisions to be made and also create a number of other difficulties . In this regard however, it is essential to enlighten the citizens regarding the negatives of using invalidated models so they can raise the right points against their use before the decision makers (Lavell, 2002). Risk management depends upon many things but on top of all is the input used to make decisions. There is a major problem with the invalidated models which is that the invalidated models are mainly based on assumptions and not on validated conclusions and so one cannot be certain about their outcomes. As a result there is always a chance of making wrong decisions. Conceptual as well as empirical verification of models is important in this regard to note that validation becomes important for the purpose of knowing \"Validation their is a process applicability. of substantiating explicit claims on the applicability of predictions with reference to the intended purpose of the model. Validation is also concerned with the accuracy of these predictions for the system that is represented. All models are, by their nature, incomplete representations of the system they are intended to model, but, in spite of this limitation, models can be useful. Strictly speaking, a model cannot be validated in the sense that the validation proves that the model is true, only whether the model is well founded and applicable\" (Montforts, 2005). Validation is also important to address the quality of the science applied. It is why models need to be validated before they can be applied so that their applicability may be known. Otherwise there being based on assumptions may give rise to severe risks for the population since the decisions made on the basis of inaccurate decisions will also be inaccurate. Assumptions may have an important impact on decisions and experiments. To know if the assumptions made about exposure of the population are valid one should ensure that the indicators being used are suitable as well as a necessary amount of specimens are being used to conduct the assessment. There are a few other important questions to be asked in this regard also. First of all, it is important to check if the models used predict the field results. It is also important to check of the methodology is sound and what are the implications of the choices made? Overall, validity has a very important role to play with regards to risk assessment and risk management too. In fact the entire risk management procedure and the outcomes may depend on the validity of the models being used. Unvalidated models can always be harmful and if the citizens are feeling concerned regarding the applicability of such models then there is nothing wrong with it. To respond to the citizens' concerns in this regard the best thing would be to help them highlight the shortcomings of such models and the gaps that may be created due to use of such models. Any type of assumptions made on their basis may be very far from the reality and therefore the damages it may cause should also be highlighted. So, it will help know the shortcomings of the invalidated models as well as the difficulties that may arise due to them. References: Montforts, M. H. (2005). Validation of the EU Environmental Risk Assessment for Veterinary Medicines. In Open Access. Retrieved January 25, 2016, from https://openaccess.leidenuniv.nl/bitstream/handle/1887/648/ThesisMontforts.pdf?sequence=4 Lavell, A. (2002). DECISION MAKING AND RISK MANAGEMENT *. In Open Access. Retrieved January 25, 2016, from http://desenredando.org/public/articulos/1998/dmrm/dmrm1998_mar-12002.pdf 1. Identifying the project and defining the problem Over the last few decades the humans have managed to dump several tons of garbage into the ocean. Pollution in the oceans can be highly devastating for the ocean life and the ecosystem. The first main problem that is caused due to the dumping of the plastics in the ocean is that plastics takes several years to decay and keeps floating on the surface of the ocean (Carleton, 2016). This has an intoxicating effect which can be highly disastrous for the sea life including the fishes and the other aquatic lives. In a large number of places the mass of plastics is up to six times higher than the plankton. It is sufficient evidence to show that the problem of sea pollution may be having highly disastrous effect on the sea life and the amount of cleaning effort required to completely clean the decaying plastics may be enormous. 2. There are some important stakeholders in this regard that would need to be considered. It is first our environment. Oceans form a very important part of our environment. If oceans are impacted the life inside the oceans are also impacted. It has an impact on the fish as well as on eth other forms of aquatic life living inside the oceans. However, most important thing to note in this regard is that it leads to a diminution in the number of sea -dwelling organisms. This pollution also gets to reach the human beings in multiple ways. It has an intoxicating and deadly effect on the sea creatures and they are a part of our food chain so in turn the effect is on the amount of sea food that we receive (Carleton, 2016). Not just this, the pollution also contaminates our food that we obtain from the seas and as a result those who consume the food are also impacted. The result is a spread of diseases as well as a decline in the amount of sea food being produced. 3. Placing the problem in context: The problem is widespread and there are different plastics spread throughout the ocean. As the Styrofoam breaks into smaller components, they sink lower into the ocean, so its pollutants spread throughout the sea. The problem can be seen in an ecological context were we make attempts to preserve the nature while also destroy it with our own hands on the other side (Carleton, 2016). Plastic is dangerous not only for the aquatic animals but also for the humans. 4. Examining options for addressing the risks: Humans have an important role to play in this regard since without their efforts, it would be difficult to prevent the dumping of plastics in the ocean. Apart from trade activities there are other human activities that also lead to ocean pollution. So, restricting trade activities that lead to water pollution inside the oceans can have a good impact, but it is even important to restrict the production of polythene since it may have an important impact on the level of pollution inside the oceans. 5. Making a decision about which option to implement: While it is not difficult to decide which is the best option obviously controlling the production of polythene would have a larger impact on the entire scenario. Controlling the plastics being produced around the world will have a good impact on nature since it will find one or the other way to reach the oceans where we dump most of our industrial garbage. This garbage in one way or her other affects human health too and therefore, handling it would require efforts on a wider scale. References: Andrews, G. (2016). Plastics in the Ocean Affecting Human Health. In Carleton. Retrieved January 25, 2016, from http://serc.carleton.edu/NAGTWorkshops/health/case_studies/plastics. html References