Risk Versus Benefit, Bisphenol A, Pesticide Management And Risk Assessment Priorities In Canada

1.Discuss the theory of “risk versus benefit” and the role that the “precautionary principle” typically plays in this theory and its application.

2.Most likely, at some point in recent history, you have heard about a chemical called Bisphenol A. This chemical has received a lot of press in recent years for a variety of reasons. Environment and Climate Change Canada (ECCC) conducted a review of Bisphenol A, and published a corresponding Proposed Risk Management Approach

Review the ECCC Bisphenol-A risk management report, and provide an Executive Summary in your own words addressing:

1. Why we need action
2. Current uses and industrial sectors
3. Exposure Sources
4. Proposed Risk Management

3.The various facets of pesticide management in Canada occurs at all levels of government.  Summarize the key responsibilities of federal, provincial and municipal governments being sure not to miss anything important for health and ecological risk assessment and risk management.

4.Risk assessments are not without cost and time commitments.  It is simply not possible to assess risks associated with all compounds already on the market and, and as such, priorities must be identified. Review the report indicated below, and provide a summary of the process and criteria used by Environment Canada and Health Canada to stay current with new information regarding setting priorities for risk assessment.

Theory of Risk versus Benefit

1.The evidence based medicine provides support to the healthcare professionals so that they are able to evaluate and select the most suitable information regarding the efficiency of treatment. Various works by different researchers show that there is proof of harm as well as the benefit related to medicines that have to be assessed by various criteria. Osimani (2013), has contended that the evidence hierarchy used in recognizing the predicted advantages of a medication should be reversed when the question is related to determining the unintended reactions. Hence, it has been presented in this theory that there is both risks and benefits associated with drugs but the evaluation has to be carried out as per required questions.

The precautionary principle was emerged as a response for the lessons that were learnt from the unexpected natural disasters or the impact of chemical compounds on the health of human and animal. According to Rosenberg, Verthelyi and Cherney (2012), it is being considered as the ‘The principle of preventive care’ that is gradually emerging as a legal theorizing and making laws or regulations for protection of the environment. Whereas, Hansson (2017), stated that this principle is a response to meet the demand of complex societies where uncertainty is prevalent. The precautionary principle does not reflects any emotional attitude towards risk however, it simply provides a platform for acknowledging the radical uncertainty from a legal perspective. This principle is based on classic justification of the rules for decision making and expected maximization of utility such that it is not irrational or there is no aversion of risk and loss.

2.In this report, the focus is on a chemical substance Bisphenol A that is incoming into the environment at a certain amount or concentration. The impact of this substance is a significant danger for the human health or life in Canada. The data accumulated on the neurodevelopmental and behavior of rodent denies this fact of toxicities or potential effects of the chemical substance. The data against the toxicokinetic and metabolism indicates there is potential impact of the substance on pregnant woman/fetus and infant. It has also been identified that there is high susceptibility of the substance during the initial development stages of rodents (Juhola et al., 2018). Hence, a precautionary approach is essential to be applied for characterization of risks. In this report, it has also been stated that there may be immediate or long-term effects of the substance on the biodiversity as it is entering into the environment.

According to a survey that was conducted under section 71 of CEPA 1999, it has been stated that no more than 100 Kg Bispehnol A was being produced by Canada in the year 2006 however, 25 companies imported almost 0.5 million kg of Bisphenol A and 0.1 to 1 million kg of Bisphenol A was being used by 5 companies either as a standalone product or mixed in other manufacturing items (Ec.gc.ca, 2018). It is been analyzed that Bisphenol A is being mainly used as monomer for manufacturing polycarbonates. It is also widely used as a precursor or even starting material for the monomers contained in some epoxy resins. Polycarbonate is being used for manufacturing compact disc, various containers, medical devices and etc. The substance Bisphenol A is being used for producing phenolplast, phenolic as well as unsaturated polyester resins along with thermal papers (Oltmanns et al., 2018). Bisphenol A may be also contained in various other products such as protective window glazing, materials used in buildings along with optical lenses or even dyes.

Precautionary Principle in Practice

From the report, it has been identified that Bisphenol A is not being produced naturally but the humans are exposed to this substance from food packaging, repeating use of containers, environmental media and other customer products. Infants are considered to be the highly exposed across the entire population (Ec.gc.ca, 2018). The major source of their exposure is food that occurs due to migration of the substance from food packaging. The release of Bisphenol A mainly occurs from production, processing, usage or disposal of the materials that consists of the substance. Another way the substance may be leaked into the environment while handling in closed systems or during transportation.

The proposed risk management in context to this particular case of Bisphenol A comprises of four aspects that is banning the use of bisphenol A monomer for making polycarbonate baby bottles (Ec.gc.ca, 2018). Further, it has also been determined that a precautionary approach have to be adopted in food packaging of products as well as canned foods. It has also been proposed that a regulatory process is also required for managing the Bisphenol A exposure into the environment.

3.In Canada, pesticides are being carefully regulated and the activities required for regulation of pesticides are shared in between federal, provincial as well as municipal governments. The authorities are governed by various rule and regulations.  

Federal role: It mainly refers to The Pest Management Regulatory Agency (PMRA) of Health in Canada for protecting the health of human and environment through minimization of risks that are associated with the products related to pest control. The principal role of the federal government is to ensure human health and safety which is done through proper registration and re-evaluation of pesticides (Oag-bvg.gc.ca, 2018). It also comprises of developing and implementing policy and legislation for the products related to pest control.

Provincial role: This government plays the role of regulating sales, usage, storage, transporting along with disposing pesticides that are being registered under their jurisdiction. The Provinces and territories are also involved with classifying the pesticides for sales and usage. It also checks for license of the vendors and the training of pesticide applicators so that the products are being used responsibly. This authority is also responsible for setting the policies and regulations for transport, storage and disposal of pesticides (Spok, Arvanitakis & McClung, 2018). The authorities of this government also sets compliance requirements and enforcement laws for the usage of pesticides.

Municipal role: The municipalities or cities and towns are being allowed by the provincial jurisdictions for enactment of the bylaws that sets the further conditions for the usage of pesticides (Fairbrother et al., 2016). These authorities sets specific conditions on the time and place of using certain pesticides.

4.The criteria that is used by Environment Canada and Health Canada to stay current with new information regarding setting priorities for risk assessment is through categorization as below:

Substances that are toxic to humans or the environment that may be:

Persistent

Bioaccumulative

Substances that have the greatest potential of exposure for people.  

Review of ECCC Risk Management report on Bisphenol A

The process that is being used by Environment Canada and Health Canada to stay current with new information regarding setting priorities for risk assessment is carried out in steps as below:

Acquisition – It refers to the active as well as passive information collection that are relevant for the potential risks of substances related to health and ecology. The information that is relevant to prioritize the chemicals for assessment of risks can be gathered from various sources (Ec.gc.ca, 2018). The information is being compiled by Environment Canada and Health Canada for obtaining an integrated view so that the substances could be easily selected and prioritized for further work. The publicly available information is also monitored and obtained by the Environment Canada and Health Canada to determine the initiatives of risk assessment and management being carried out on the substances. Another potential source of information is the work being done by scientists of Environment Canada and Health Canada with the help of research, monitoring as well as surveillance activities.  

Evaluation – It refers to the ordering of substances from the new information that is collected. This step requires expert decision and consideration of the various type of information with regards to a specific provided substance. The staffs of Environment Canada and Health Canada reviews the new information that is gathered on the various substances to check indications of any presence or potential for any harm. This process is carried out more typically from the result of periodic analysis of the collected information (Gobas et al., 2018). There are various factors being considered and weighed so that judgment could be made regarding relative importance of the diverse indicators. The emphasis is given on the reliability of information during the evaluation process so that the applicability in context to Canada and potential uncertainties could be easily determined. The evaluation helps to identify whether immediate intervention is required to mitigate the potential risks in a timely manner.

Action – It refers to the type of activity that will be carried on the substances that are being recognized as candidates to execute further work. There are various actions that could be taken such as risk assessment or management, collection of data, development of methodology and generating new idea or so on (Saxe, Predale & Sharples, 2018). The acquisition of new information on a constant basis helps the Government to stay updated with the current developments in the global chemical policies and regulations. The new information also informs the Government about the exposure and potential hazards of chemical substances in context to Canada. From the collected information, if a substance is being identified as potential candidate so that further work can be carried out on it then there are various actions which could be taken for management of the risks associated with those substances.

References

Ec.gc.ca. (2018). Retrieved 2 December 2018, from https://www.ec.gc.ca/ese-ees/A10191AD-973D-4059-AFC4-4DEEC36C4DB1/Assessment%20Triggers%20Approach_EN.pdf

Ec.gc.ca. (2018). Retrieved 2 December 2018, from https://www.ec.gc.ca/ese-ees/6FA54372-A09E-45CD-8A5F-39EBDD55D13A/batch2_80-05-7_rm_en.pdf

Fairbrother, A., Hartl, B., Hope, B. K., Jenkins, J. J., Li, Y. W., & Moore, D. R. (2016). Risk management decisions for pesticides and threatened and endangered species: The role of uncertainty analysis. Human and Ecological Risk Assessment: An International Journal, 22(2), 502-518.

Gobas, F. A., Mayer, P., Parkerton, T. F., Burgess, R. M., Van de Meent, D., & Gouin, T. (2018). A chemical activity approach to exposure and risk assessment of chemicals: Focus articles are part of a regular series intended to sharpen understanding of current and emerging topics of interest to the scientific community. Environmental toxicology and chemistry, 37(5), 1235-1251.

Hansson, S. O. (2017). The precautionary principle. Handbook of Safety Principles, 258-283.

Islam, M. N., Bint-E-Naser, S. F., & Khan, M. S. (2017). Pesticide Food Laws and Regulations. In Pesticide Residue in Foods (pp. 37-51). Springer, Cham.

Juhola, R., Runtti, H., Kangas, T., Hu, T., Romar, H., & Tuomikoski, S. (2018). Bisphenol A removal from water by biomass-based carbon: Isotherms, kinetics and thermodynamics studies. Environmental technology, 1-10.

Oag-bvg.gc.ca. (2018). Retrieved 2 December 2018, from https://www.oag-bvg.gc.ca/internet/docs/fs_pestreg-e.pdf

Oltmanns, J., Licht, O., Bitsch, A., Bohlen, M. L., Escher, S. E., Silano, V., ... & Merten, C. (2018). Development of a novel scoring system for identifying emerging chemical risks in the food chain. Environmental Science: Processes & Impacts, 20(2), 340-353.

Osimani, B. (2013). The precautionary principle in the pharmaceutical domain: a philosophical enquiry into probabilistic reasoning and risk aversion. Health, risk & society, 15(2), 123-143.

Rosenberg, A. S., Verthelyi, D., & Cherney, B. W. (2012). Managing uncertainty: a perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins. Journal of pharmaceutical sciences, 101(10), 3560-3567.

Saxe, J. K., Predale, R. A., & Sharples, R. (2018). Reducing the environmental risks of formulated personal care products using an end-of-life scoring and ranking system for ingredients: Method and case studies. Journal of Cleaner Production, 180, 263-271.

Spok, A., Arvanitakis, G., & McClung, G. (2018). Status of microbial based cleaning products in statutory regulations and ecolabelling in Europe, the USA, and Canada. Food and Chemical Toxicology, 116, 10-19.