PRACTICING PRECAUTION and ADAPTIVE MANAGEMENT ...

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transparent regulatory process. The October 2000 Government Response to the Report of theStanding Committee on Environment and Sustainable Development described how thegovernment places protection of human health and the environment as its top priority inregulating pesticides using a fundamentally precautionary approach, and in 2002, then Ministerof Health Anne McLellan introduced the first substantive amendments to the PCPA in 31 years.IV. THE STATUTORY CONTEXTIV.A. The Pest Control Products Act (PCPA)The Pest Control Products Act (PCPA) and associated Regulations are the primary federallegislation for the regulation of pesticides in Canada. The Act governs pesticide importation,manufacture, sale and use and provides the authority for risk-based decision-making and riskmanagement. Part of the regulatory context is consideration of the compatibility of pesticideregistrations with federal policies, such as the Toxic Substances Management Policy (TSMP),international agreements on Persistent Organic Pollutants (POPs), and the Montreal Protocol onozone depleting substances. Substances identified as Track 1 under the federal TSMP, ozonedepleting substances and POPs are not acceptable for registration as new pesticide activeingredients. Moreover, pesticides cannot be approved for use under the PCPA if the usecontravenes other federal statutes.Under the PCPA (1985), the Minister shall refuse to register, or amend the registration ofa product, if:18. (d) the use of the control product would lead to an unacceptable risk of harm to(i) things on or in relation to which the control product is intended to be used, or(ii) public health, plants, animals or the environment; (Pest Control Products Regulations)Thus with respect to impacts or effects, the critical regulatory question is whether the product inquestion poses “unacceptable” environmental or human health risks.The new Pest Control Products Act (PCPA, 2002) received royal assent on Dec. 12,2002, but is not yet in force. The new act represents the response of the federal government ingeneral, and Health Canada in particular, to the major criticisms pointed out by the SCESD in2000. The Act has as its primary objective the prevention of unacceptable risks to people and theenvironment from exposure to pesticides (PCPA 2002, section 4.1). Ancillary objectives includethe promotion of sustainable development such that the needs of the present are met withoutcompromising the ability of future generations to meet their needs (para 4.2(a)), and theminimization of the health and environmental risks posed by pesticide products (para 4.21. (b)).The new Act provides explicit authority for risk-based decision-making with the criticalregulatory question being whether the product in question poses “unacceptable” risks to humanhealth or the environment, with acceptable being defined as:(2) For the purposes of this Act, the health or environmental risks of a pest control productare acceptable if there is reasonable certainty that no harm to human health, futuregenerations or the environment will result from exposure to or use of the product, takingC. Scott Findlay & Annik Déziel – Potentially Practicing Precaution: Canadian Pesticide D-67Regulation and the Pest Regulation Management Agency
into account its conditions or proposed conditions of registration (PCPA 2002,interpretation)IV.B. The Food and Drug Act and the Pesticides Residues Compensation ActThe PMRA is also responsible for regulating the nature and amount of pesticide residues in foodunder the Food and Drugs Act (FDA) and Regulations (FDAR). Section 4(a) and 4(d) of theFDA authorizes PMRA to set a maximum residue limit (MRL) within Regulation B.15.002(1) ofthe Food and Drugs Regulations (FDR) or an exemption from the requirement of a MRL underRegulation B.15.002(2) of the FDR. The Agency performs various types of risk assessments toevaluate the safety of pesticides in food, including analyses to determine the nature and theamounts of pesticides that people might be exposed to in a single day. Moreover, the agencymust, in rendering decisions, also consider other acts that have an impact on pest management, inparticular the Pesticides Residues Compensation Act (PRCA) which provides for compensationof farmers whose agricultural products have been contaminated by pesticide residues.V. THE PEST MANGEMENT REGULATORY AGENCYThe Pest Management Regulatory Agency (PMRA) was created as a branch of Health Canada in1995 following the transfer of legislative authority from Agriculture and Agri-Food Canada(AAFC). PMRA’s mandate is:To protect human health and the environment by minimizing the risks associated with pestcontrol products in an open and transparent manner, while enabling access to pestmanagement tools, namely, these products and sustainable pest management strategies.(PMRA 2004b, p. 4)The PMRA’s overall administrative decision-making structure includes input from a variety ofsections within PMRA and from external agencies, notably Environment Canada, HealthCanada, Natural Resources Canada, and Fisheries and Oceans Canada. The Executive Director’sOffice oversees the operation of the PMRA and is comprised of the directors of all divisions.The Business Line Improvement Section is responsible for cost recovery policy and business lineimprovement projects. The Chief Registrar ensures that the PMRA makes integrated, sciencebasedregistration decisions, investigates registration appeals, and provides policy advice. TheSubmission Management and Information Division manages and tracks submissions, conductsscientific screenings, and publishes regulatory documents.The remaining divisions provide specific expertise on various topics of interest in thedecision-making process for various pesticides. The Product Sustainability and CoordinationDivision provides expertise on antimicrobials, fungicides, herbicides, insecticides and otherpesticides, and conducts efficacy assessments, sustainability evaluations and value assessmentsfor PCPs. The Health Evaluation Division provides expertise on human health hazards, riskassessments and risk mitigation and conducts toxicology evaluation and exposure assessments ofPCPs. The Environmental Assessment Division provides expertise on environmental hazards,risk assessments and risk mitigation and conducts assessments of the environmental fate andC. Scott Findlay & Annik Déziel – Potentially Practicing Precaution: Canadian Pesticide D-68Regulation and the Pest Regulation Management Agency
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PRACTICING PRECAUTION and ADAPTIVE
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ACKNOWLEDGEMENTSPracticing Precauti
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A- EXECUTIVE SUMMARYINTRODUCTIONWit
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This study must be considered as an
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The regulatory scheme does not expl
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increased the TAC. However, for cod
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B - INTRODUCTION: UNCERTAINTY, PREC
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mechanisms of participation, such a
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Some causes of uncertainty are more
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The distinction between principle a
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estimates serve as a notional bench
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1 As Jonathan Wiener emphasizes, re
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C- RESEARCH METHODOLOGYEVALUATING I
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questionnaire: for each concept, th
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D-2
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Nathalie Chalifour & Yves Prévost
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III.B.4. Principe 4.4 Il devrait y
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Le Canada a aussi des obligations e
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En septembre 2001, le gouvernement
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données de l’ACIA. Le Service ca
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II.B. Les NIMP 2 et les ARP’s de
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Page 45 and 46: II.C. Les règlements additionnels
Page 47 and 48: II.C.1e. Règlement sur l’indemni
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Page 51 and 52: défi est donc de savoir quand s’
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Page 57 and 58: VI. ANNEXE I. ABRÉVIATIONSACIAAgen
Page 59 and 60: 29 Kai N. Lee, « Appraising Adapti
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Page 63 and 64: Jennifer A. Chandler - The Regulati
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Page 67 and 68: As a result, a new plant is exempt
Page 69 and 70: decision-maker “shall” refuse t
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Page 79 and 80: Biosafety Office (PBO). The plants
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Page 83 and 84: espect to the test data submitted a
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Page 87 and 88: 93 Ibid.94 Directive 94-08, supra n
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Page 97 and 98: manner representative of the route,
Page 99 and 100: Precisely how the various uncertain
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Page 103 and 104: VIII.C. Is PMRA practicing precauti
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Page 107 and 108: effects of decisions are systematic
Page 109 and 110: eported. Note furthermore that this
Page 111 and 112: Pest Management Regulatory Agency (
Page 113 and 114: Dan E. Lane - Setting TACs in the 4
Page 115 and 116: LIST OF TABLESTable 1. Stock Status
Page 117 and 118: Environment). As it expanded, Canad
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Page 125 and 126: ultimate authority for all access a
Page 127 and 128: II. CASE STUDYII.A. Setting TACs in
Page 129 and 130: Scotian Shelf. Approximately 50% of
Page 131 and 132: The prognoses of the stocks for 200
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Page 135 and 136: Sources ofUncertaintyAge Structure:
Page 137 and 138: Sources ofUncertaintyPrincipal sour
Page 139 and 140: OutlookIndicators of Abundance:Indi
Page 141 and 142: ManagementConsiderationsEcosystemCo
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expected growth in the stock, and t
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IV. RECOMMENDATIONSIV.A. Case study
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V. REFERENCESCanada 2005. A Framewo
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Hutchings, J.A. 1996. Spatial and t
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VI. APPENDIX AStock Status Report D
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VII. Appendix B2002 and 2003 Docume
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Sources of UncertaintyOutlookSPA -
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E- COMMENTARY AND ANALYSIS OF RESEA
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COMMENTARY AND ANALYSIS OF RESEARCH
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TABLE OF CONTENTSI. PRACTICING PREC
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I. PRACTICING PRECAUTION - EXPLORAT
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Table 3: Questions with missing dat
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Figure 1. The raw data from the que
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Figure 4. S(n) versus n for Part II
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I.F.2. Approach #2 (dimension reduc
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Data reduction to 2 variablesII_220
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I_1210-1-21pest 2fish 3gmo 4frstcas
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II. PRACTICING PRECAUTION EXPLORATO
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II.C. GoalsThe goal of this examina
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Figures 16, 17, and 18 do not contr
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Conclusions & Summary F-2
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Conclusions & Summary F-4
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one government department to anothe
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involves the scrutiny of procedural
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can assess the risks inherent in a
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entrenched in the treaties and legi
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III. REFORM POSSIBILITIESFactoring
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ased decision-making. Finally, thes
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The answers will depend on context,
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ased on the administrative principl
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decisions must maintain the adminis
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Potential Future WorkAmong the many
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On the South Australia Environment,
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G - APPENDICES:i. Document Question
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Practicing PrecautionTo which case
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10) The following is a list of "pre
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15) There are many different source
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• Decisions are treated as scient
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Revised February 25, 2005PRACTICING
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II.1. Does the legislation constitu
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III.2.a Does the legislation contai
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III.8.i “endangered”III.8.j “
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III.13.a Uncertainty about effects
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IV.5.g Monitoring is conducted by t
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V.7.Do decision-makers have access
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iii. WORKSHOP SUMMARY“Precaution,
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science, to Type I and Type II erro
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iv. WORKSHOP PARTICIPANTSMARCH 8 th
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NATHALIE DES ROSIERS613-562-5902nat
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Mike WilsonDirector, Strategic Issu
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