ENVI Committee Report

9.    RISK MANAGEMENT

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9.1    In managing risks associated with pesticides there are two options: to reduce the toxicity of available products or to reduce the quantity of pesticides to which humans and the environment are exposed. The PMRA has a number of tools at its disposal to achieve these goals. The main focus of this report on pesticides and the PMRA has been on risk assessment and risk management practices associated with registration activities. The PMRA can, however, also develop strategies such as integrated pest management and can also encourage organic farming. These pesticide reduction techniques are discussed at length in the Chapter entitled Alternatives to Pesticides.

9.2    After the risk assessment portion of the registration process, possible risks to the environment and/or to human health can be managed by the refusal to register a product or by the application of restrictions pertaining to use. It is important that risk managers be fully aware of any uncertainties that are present in the risk assessment and of any precautionary steps, such as the application of safety factors that are used. The availability of this type of information makes risk management decisions, such as when to apply the precautionary principle, easier to make.

9.3    This Chapter discusses the management of pesticide risks (via regulations), the precautionary principle and unacceptable risk. In January 2000 the Privy Council Office released a report entitled Risk Management in Public Policy: Report of the Assistant Deputy Minister Working Group on Risk Management. This report points out that effective risk management relies more on the existence of a flexible process than on rigid rules. The report states that, "while there will always be pressure for a rules-based system for managing risk, the very nature of risk and uncertainty makes such a system inappropriate in many circumstances." The Committee understands this concept and, as such, we have attempted to provide guiding principles for risk management rather than strict rules and definitions.

The Pest Control Product Act and Regulations

9.4    The primary method by which the PMRA manages the risks associated with pesticides is the implementation of the Pest Control Product Regulations. Section 6 of the Pest Control Product Act states that regulations can be made regarding the registration of controlled products and the procedures to be followed should registration be refused, suspended or cancelled. Regulations may also be made regarding the requirements to demonstrate the efficacy and safety of pesticides, their manufacture, storage and use, as well as requirements regarding the information on the label (sections 6 (1)(i), (j), and (k) of the Act). Label information must identify any significant hazard to public health, plants, animals or the environment and instructions respecting the procedures to mitigate these hazards (section 27(k)(ii) of the Regulations). Currently, section 18(d)(ii) of the Regulations require the Minister to refuse to register a pesticide if its use would lead to an unacceptable risk of harm to public health, plants, animals or the environment. Section 45 of the Regulations states that no person shall use a product in a manner inconsistent with the directions and restrictions shown on the label.

9.5    Furthermore, section 20 of the Regulations authorizes the Minister to cancel or suspend a registration when, based on current available information, the safety or value of the product is no longer acceptable.

Refusal to Register

9.6    The refusal to register a product under section 18(d)(ii) of the Regulations relies on the concept of "unacceptable risk." This term is not defined in the Act or the Regulations. Interpretation of unacceptable risk is, however, of paramount importance in risk management. The Commission of the European Communities recently published a report on the precautionary principle.¹⁵⁷ This discussion document describes the determination of what constitutes an acceptable level of risk as a political responsibility. The Committee is in agreement and, based on information received throughout this study, has concluded that children's health should be the focus, and indicator of, what constitutes 'unacceptable risk' for the regulation of pesticides. This focus on children must start with the methods used to assess risk and continue to post-registration monitoring and risk communication (please refer to Appendix 8.1).¹⁵⁸

9.7    The Committee feels that, because pesticides are toxic by design and because there are gaps in the data on pesticides and their effects on children, especially long term, the precautionary principle should be applied. In effect, where there is a lack of full scientific certainty, preventative action should be taken, including further research and refusal to register a product. Incorporating this principle into the operational portion of the legislation and having the regulations guide its implementation will make its application mandatory for all risk management decisions where lack of certainty exists.

9.8    The application of the precautionary principle to the interpretation of unacceptable risk would help to minimize the risks to human and environmental health. Chapter 2 entitled 'The Need for New Legislation' recommends a definition for the 'precautionary principle.'

9.9    The issue of how and when to use the precautionary principle has given rise to considerable debate both nationally and internationally. In a policy framework it is necessary to find the correct balance between differing views so that proportionate, non-discriminating, consistent and transparent actions can be taken in the name of this principle.

9.10    Within the risk analysis framework (see Appendix 8.1), the precautionary principle is part of risk management. The precautionary principle should not be confused with the element of caution that scientists apply when conducting risk assessments.¹⁵⁹ In the risk management decision tree in Appendix 9.1 the areas where the precautionary principle is likely to be invoked are indicated. Different areas and disciplines will apply the precautionary principle in slightly different ways depending on the desired level of protection. In the case of pesticides, a high level of protection is desired because they are toxic by design. Essentially, given the a priori hypothesis that pesticides are toxic, the PMRA should apply the precautionary principle whenever the answers to risk management questions are unclear.

9.11    In more general terms, the Commission of the European Communities has identified measures for the application of the precautionary principle. Measures should be:

• proportional to the chosen level of protection;
• non-discriminatory in their application;
• consistent with similar measures already taken;
• based on an examination of the potential benefits and costs of action or lack of action;
• subject to review in light of new findings; and
• capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

9.12    As the discussions surrounding the implementation of the precautionary principle are ongoing, we believe that it is important for the PMRA to continue to take part in both national and international discussions to ensure that consistent policies are developed.

9.13    The Committee heard from some witnesses who feel that risk management decisions should be based solely on the hazard (or inherent toxicity) of a substance without taking expected exposure into account. Dr. Rosalie Bertell believes that the use of the precautionary principle based on hazard assessment alone is warranted because the potential harm to children is so great.¹⁶⁰ Indeed, the Canadian government has planned for the virtual elimination of the most dangerous substances although the process for identifying these substances under the federal Toxic Substances Management Policy takes into account potential exposure as well as inherent toxicity. To eliminate all chemicals that pose any sort of hazard is impractical. This being said, there are policies that can be put in place that can influence how precautionary the risk management will be.

9.14    In risk management, there are two types of situations where errors can occur. One is when a decision is made not to register a pesticide when, in fact, future evidence demonstrates that the risk would have been acceptable. The second is when a decision is made to register a pesticide when, in fact, future evidence (such as monitoring data) demonstrates that the risk was unacceptable. Obviously, there are consequences that may result from both of these scenarios.

9.15    A precautionary approach dictates that when the evidence suggests that there is probably a risk associated with a pesticide, it must not be registered, thus possibly making the first type of error. There are those, including Dr. Rosalie Bertell and Ms. Melissa McDonald, who would permit only this type of error and none of the second kind thus effectively banning all pesticides.¹⁶¹ Others are willing to accept the possibility of making the error of having some pesticides registered, though they should not have been if the decisions are based on sound science.¹⁶² As the Commissioner of the Environment and Sustainable Development pointed out to the Committee on December 13, 1999, the precautionary principle should not be used as an excuse not to do sound science. Risk managers acknowledge that risk can rarely be reduced to zero.¹⁶³ Thus, the registration of pesticides that should not have been registered does occur. The goal remains however, to keep this type of error to a minimum by demanding that scientific studies be the most current and rigorous available.

9.16    In June 1995, the federal government released the Toxic Substances Management Policy (TSMP), a policy that provides a framework for managing toxic substances that are released into the environment. The key management objectives of this policy are:

• virtual elimination from the environment of toxic substances that result predominantly from human activity and that are persistent and bioaccumulative (referred to in the policy as Track 1 substances); and
• management of other toxic substances and substances of concern, throughout their entire life cycles, to prevent or minimize their release into the environment (referred to in the policy as Track 2 substances).

9.17    In 1998, the PMRA published a regulatory proposal entitled 'The Pest Management Regulatory Agency's Strategy for Implementing the Toxic Substances Management Policy'. Some Committee members are concerned that this document does not apply the conditions of the TSMP strictly enough. During the meeting of November 2, 1999, one Committee member questioned the difference between elimination to below the limits of quantification, as per the TSMP, versus to very low, as per the PMRA implementation document, and asked the PMRA if they thought that this made their document inconsistent with the TSMP.

9.18    Noting that the interdepartmental TSMP Forum reviewed the implementation document and that it did not find any inconsistencies, the PMRA told the Committee that it finds its implementation document to be consistent with the TSMP.¹⁶⁴ Nonetheless, the Committee feels that the PMRA's implementation document could be improved by using the exact terms found in the Policy.

9.19    The Committee is also very concerned that pesticides containing dioxin (a Track 1 substance) as a microcontaminant are still being registered by the PMRA.¹⁶⁵ The World Wildlife Fund,¹⁶⁶ the Canadian Environmental Law Association and the Ontario College of Family Physicians and the Inuit Circumpolar Conference¹⁶⁷ propose an immediate ban of all pesticides that contain Track 1 substances and a PMRA implementation document that reflects this commitment. (Please refer to Table 4.1 for a list of pesticide active ingredients that are classified as Track 1.)

 

9.20    The TSMP establishes criteria for substances that immediately trigger a process to eliminate them from the environment by preventing their measurable release. Many witnesses recommended the adoption of toxicity criteria that would trigger a decision not to register a pesticide.¹⁶⁸ These would include criteria for endocrine disruption, neurotoxicity and carcinogenicity. If a substance meets certain criteria then it is automatically deemed to pose an unacceptable risk without investigation of potential exposure.

Restrictions on the Use of Pesticides

9.21    The PMRA may decide that a pesticide can be registered but it may manage the human and environmental risks by imposing restrictions on its use. Restrictions that can be applied to reduce risks include:

• restrictions on where the product can be used (e.g. greenhouses only);
• conditions of use (e.g. specifying protective equipment that should be worn, spray equipment that should be used, weather conditions for application, etc.);
• protecting specific parts of the environment (e.g. specifying buffer zones between pesticide application and rivers and lakes or other sensitive areas); and
• limiting how much pesticide can be used and on what crops it can be applied (e.g. if the risk assessment suggests that the residues will be above the Maximum Residue Limits then the pesticide may not be allowed for use on food or feed crops).

9.22    Information regarding restrictions is usually printed on the label and under section 45 of the Pest Control Product Regulations it is an offence not to follow the instructions. The Canadian Environmental Law Association and the Ontario College of Family Physicians and the Government of Prince Edward Island indicated that since the PMRA's risk management relies so heavily on the label, compliance with label instructions is very important.¹⁶⁹ They indicated that the PMRA should improve its inspection and enforcement operations and that it must not hesitate to apply the full range of enforcement penalties that are available to it in order to ensure compliance. Indeed, the PMRA indicated that it is ready to implement the process of Administrative Monetary Penalties (AMPs) and the proposed new legislation is supposed to include enhanced enforcement capabilities through clearly defined offences, increased powers for inspectors and higher maximum penalties. This type of inspection and enforcement, while critical, is targeted at the manufacturer/registrants. The use of pesticides should be investigated to determine whether end-users comply with label instructions.¹⁷⁰ This will enable the PMRA (and indeed the government in general) to determine whether they can continue to rely on product labels as a key risk management tool.

Cancellation or Suspension of Registration

9.23    The Committee recognizes that serious harm can result from the use of pesticides despite the restrictions placed on pesticide use and despite compliance with label instructions. For example, witnesses from the Department of Technology and Environment from Prince Edward Island told the Committee about fish kills that resulted from pesticides applications made according to the label instructions. Sometimes, even when the best science is applied to the risk assessment process, the true risks cannot be fully determined and unanticipated impacts may come to light post-registration. The Minister of Health has the power to suspend or cancel a registration if it is found, after registration, that the pesticide does pose an unacceptable risk. The witnesses from P.E.I. pointed out that the PMRA risk managers thus require an effective feedback mechanism to inform them of when label restrictions are not adequate.¹⁷¹ The ability to manage pesticide risks after registration therefore depends greatly on post-registration monitoring. Feedback in the form of monitoring and evaluation is a key component in risk management.

9.24    The Committee is concerned about the current state of post-registration monitoring. In his 1999 report, the Commissioner of the Environment and Sustainable Development stated that none of the stakeholders (registrant, PMRA, other government agencies) are specifically required to monitor for environmental contamination or impacts of chemicals on non-target species. In addition, there are no requirements for reporting any adverse effects that come to light, for example, as a result of post-registration fieldwork, laboratory studies or hospital admissions.

9.25    The World Wildlife Fund witness noted in her testimony of June 10, 1999, that reviews of environmental effects are very difficult to undertake without monitoring data.¹⁷² The Federation of Canadian Municipalities indicated that the PMRA should use the strong federal mandate with respect to toxic substances to establish a thorough system for the monitoring of pesticides.¹⁷³ Dr. Pierre Mineau (Environment Canada, National Wildlife Research Centre) stressed that the manufacturer should bear the responsibility of providing monitoring data since Environment Canada is not in the position to monitor every product's environmental effects.¹⁷⁴ The Committee is in agreement with the Commissioner on Environment and Sustainable Development, the World Wildlife Fund and the Federation of Canadian Municipalities that post-registration monitoring of pesticides is lacking and needs to be improved in terms of extent and co-ordination. Specifically, monitoring and research need to be conducted with a view to determining effects on children. In addition, monitoring will be required to ascertain the PMRA's progress towards the policy of risk reduction that will be discussed in the Chapter on Alternatives to Pesticides.

 

Appendix 9.1: Risk Management Decision Tree

   

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¹⁵⁷ Commission of the European Communities, Communication from the Commission on the Precautionary Principle, February 2, 2000.

¹⁵⁸ Conrad Brunk, Risk Management Workshop, 1998.

¹⁵⁹ Commission of European Communities, Communication from the Commission on the Precautionary Principle, February 2, 2000.

¹⁶⁰ Rosalie Bertell, Correspondence to the Committee, February 27, 2000.

¹⁶¹ Evidence, Meeting No. 16, December 14, 1999; Evidence, Meeting No. 3, November 4, 1999. Campaign for Pesticide Reduction, Brief to the Committee.

¹⁶² Canadian Environmental Law Association and Ontario College of Family Physicians, Brief to the Committee; Canadian Association of Physicians for the Environment, Brief to the Committee; Learning Disabilities Association of Canada, Brief to the Committee.

¹⁶³ Commission of European Communities, Communication from the Commission on the Precautionary Principle, February 2, 2000.

¹⁶⁴ Evidence, Meeting No. 2, November 2, 1999.

¹⁶⁵ Ibid.

¹⁶⁶ World Wildlife Fund, The Problem with Pesticides in Canada: A Briefing Book for Parliamentarians, April 1999.

¹⁶⁷ Canadian Environmental Law Association and the Ontario College of Family Physicians, Brief to the Committee; Inuit Circumpolar Conference and the Inuit Tapirisat of Canada, Brief to the Committee.

¹⁶⁸ Evidence, Meeting No. 4, November 16, 1999. Evidence, Meeting No. 5, November 17, 1999. Evidence, Meeting No. 16, December 14, 1999. Canadian Environmental Law Association and the Ontario College of Family Physicians, Brief to the Committee; Action Chelsea for the Respect of the Environment, Brief to the Committee.

¹⁶⁹ Canadian Environmental Law Association and the Ontario College of Family Physicians, Brief to the Committee; Evidence, Meeting No. 14, December 8, 1999.

¹⁷⁰ Report of the Commissioner of the Environment and Sustainable Development, Chapter 4, 1999.

¹⁷¹ Evidence, Meeting No. 14, December 8, 1999.

¹⁷² Evidence, Meeting No. 129, June 10, 1999.

¹⁷³ Evidence, Meeting No. 10, November 30, 1999.

¹⁷⁴ Evidence, Meeting No. 12, December 2, 1999.