ARCHIVED - Memoranda of Understanding between Agriculture and Agri-Food Canada and Pest Management Regulatory Agency and Treasury Board Secretariat

Memorandum of Understanding between Agriculture and Agri-Food Canada (AAFC) (represented by the Minister of Agriculture and Agri-Food) and Health Canada's Pest Management Regulatory Agency (represented by the Minister of Health) and Treasury Board Secretariat (represented by the President of Treasury Board) pertaining to three initiatives to"

1. Develop and implement commodity-based risk reduction strategies for the agriculture and agri-food sector;
2. Improve access to agricultural minor-use pesticides, and reduced-risk pesticides for agricultural use; and
3. Conduct research to support the introduction of minor-use pesticides that pose a reduced risk to the environment

1. Objectives

1.1 This Memorandum of Understanding (MOU) pertains to three initiatives that are to

1. develop and implement commodity-based risk reduction strategies for the agriculture and agri-food sector;
2. improve access to agricultural minor-use pesticides, and reduced risk pesticides for agricultural use; and
3. conduct research to support the introduction of minor-use pesticides that pose a reduced risk to the environment. The MOU describes how Agriculture and Agri-Food Canada (AAFC) and Health Canada's Pest Management Regulatory Agency (PMRA) will work together for shared outcomes, measure performance on delivery, and review progress achieved.

2. Background

2.1 As expressed by witnesses who have appeared before the federal Standing Committee on Environment and Sustainable Development and the federal Standing Committee on Agriculture and Agri-Food, the public and the agri-food sector have both been concerned about pesticide use in Canada. Growers. for example, have been concerned about the possible removal of existing pesticides from the market as a result of Canadian and United States agencies re-evaluations while having limited access to reduced-risk and minor-use pesticides, making it difficult for them to compete in international markets. The public has been concerned about the long term impact of pesticide use and is seeking more information on this matter.

2.2 The federal government has fully endorsed the principles set out in the Report of the House of Commons Standing Committee on the Environment and Sustainable Development, Making the Right Choice for the Protection of Health and the Environment, and in the Report of the House of Commons Standing Committee on Agriculture and Agri-Food, Registration of Pesticides and the Competitiveness of Canadian Farmers. In its response to the Reports, the federal government committed to further reform the pesticide regulatory system and to renew the approach to pest management.

2.3 On May 23rd, 2002, the federal government announced funding for AAFC and Health Canada's PMRA for initiatives to reduce risks of pesticides and enhance environmental sustainability. AAFC will work with industry and the provinces to increase the availability of reduced-risk and more environmentally friendly pesticides for Canadian farmers. AAFC will have the capability to coordinate and prioritize activities on reduced-risk pesticides for agricultural use and on agricultural "minor-use" pesticides with the cooperative efforts of governments, manufacturers and growers. Activities funded include the development of crop profiles and risk reduction strategies for the agriculture and agri-food sector, and agricultural minor-use activities such as priority setting and beginning of data generation from field testing and laboratory analysis. Health Canada's PMRA will be developing and implementing strategies for reducing risks to both health and the environment and encouraging reduction in the use of pesticides. The PMRA also introduced a program to encourage pesticide manufacturers to seek registration in Canada of reduced-risk pesticide products that are already registered in the US. The program complements the existing North American Free Trade Agreement (NAFTA) Joint Review Programs for Reduced-risk Pesticides. The PMRA is using the same criteria as the US EPA to determine eligibility for the program.

2.4 Further funding was provided for research into risk reduction alternatives, integrated pest management, and new or replacement pest control products. AAFC is also doubling the current allotment of resources within AAFC's Research Branch to the equivalent of $2 million for data generation on agricultural "minor-use" pesticides. This data generation, coupled with the new investment, will be used to develop the submissions required to register agricultural "minor-use" pesticides with PMRA. $1 million of Canadian Adaptation and Rural Development (CARD) funding from AAFC was allocated in 2002 to fast track production of crop profiles and risk reduction strategies.

2.5 On June 24th, 2002, the federal government announced additional funding to give Canadian producers better access to agricultural "minor-use" pesticides, and reduced-risk pesticides for agricultural use. AAFC will continue its work to help reduce pesticide risks through research and further development of pest management systems that control pests using technologies such as crop rotation, cultivation, and biological and chemical controls. AAFC's funding is for field trials, liaison with stakeholders, to integrate data generation with US Department of Agriculture (USDA)'s Interregional Research Project Number 4 (IR-4) and prepare submissions to the PMRA. PMRA's funding will support the review of submissions for reduced-risk pesticides, including those for minor-use, in accordance with workplans that are agreed upon between AAFC and PMRA. PMRA will use their portion of these new funds to augment staff to meet the demand for reviewing the increased number of minor-use submissions and to expedite the review of reduced-risk pesticides.

2.6 The objectives of this MOU are supportive of the Agricultural Policy Framework (APF) and in particular support the outcome goals of the Environment chapter of that framework. The outcome goals which this MOU supports are: reduce agricultural risks and provide benefits to health and supply of water, with key priority areas being nutrients, pesticides and water conservation (24.1.1) and increase the use of beneficial pest and pesticide management practices (24.2.3.2).

2.7 The funding details are as shown for the Program entitled Developing and Implementing Commodity Specific Risk Reduction Strategies in the Treasury Board submission Building Public Confidence in Pesticide Regulation and Improving Access to Pest Management Products (September, 2002), and in Annex A of this MOU.

3. Purpose

3.1 This MOU sets out the general terms, roles and responsibilities for AAFC and PMRA respecting the management of the joint initiatives to:

1. develop and implement commodity-based risk reduction strategies for the agriculture and agri-food sector
2. improve access to agricultural minor-use pesticides, and reduced-risk pesticides for agricultural use
3. conduct research to support the introduction of minor-use pesticides that pose a reduced risk to the environment

3.2 The three initiatives jointly aim at increasing public and stakeholder confidence in pesticide regulation, protecting health and environment, and increasing the competitiveness of the agri-food sector.

3.3 The initiatives are part of the Federal Government's commitments as outlined in the Treasury Board Submission "Building Public Confidence in Pesticide Regulation and Improving Access to Pest Management Products ". This MOU provides further detail regaiding the commitments made by AAFC and PMRA in the Treasury Board submission and its associated Results-based Management and Accountability Framework (RMAF). RMAFs describe the integrated approach by which initiatives will be measured, managed and reported throughout their life cycle. Key elements of the RMAF are contained in this MOU. An important element of the commitments made through the Treasury Board submission is that stakeholders and public will be kept informed through a transparent management system.

4. Results/Outcomes

4.1 The initiatives fall under three activity areas and will benefit the public and stakeholders by achieving the results and outcomes as shown in Table 1 herein.

* The activities that fall under each area are detailed in Section 7 (Program Delivery) of this MOU.

4.2 The results (outputs) of the initiatives and how they are expected to lead to the achievement of the expected outcomes are illustrated in the logic model in Annex B. This logic model will be the basis for the selection of performance indicators and the foundation for ongoing performance measurement, evaluation and accountability.

4.3 Performance in achieving the results and outcomes will be measured using the indicators identified in annual costed work plans. Approval of any changes to the performance measures will be sought from Deputy Ministers. As well, the whole program will be systematically evaluated at the end of Year 3 and Year 5, and reported on, as described in Sections 14 and 9 of this MOU.

5. Principles

5.1 The commitments made in the Treasury Board submission (2002) entitled Building Public Confidence in Pesticide Regulation and Improving Access to Pest Management Products and associated Results-based Management and Accountability Framework (RMAF) will be respected.

5.2 The commitments made in the Government Response to the Report of the House of Commons Standing Committee on Agriculture and Agri-Food, Registration of Pesticides and the Competitiveness of Canadian Farmers (2002) will be respected.

5.3 The commitments made in the Government Response to the Report of the House of Commons Standing Committee on the Environment and Sustainable Development, Pesticides: Making the Right Choice for the Protection of Health and the Environment (2001) will be respected.

5.4 The mandate of PMRA, as defined in the current and new Pest Control Products Act (PCPA), will be respected. It consists of a primary objective to prevent unacceptable risks to people and the environment from the use of pest control products.

5.5 AAFC's mandate to provide information, research and technology, and policies and programs to achieve security of the food system, health of the environment and innovation for growth will be respected.

5.6 The principles, goals and objectives of the Agricultural Policy Framework will be respected.

5.7 Stakeholders and the public will be kept informed through a transparent management system.

5.8 The funding for the new initiatives described in this MOU will be for incremental activities to achieve the specified results/outcomes, and it will not be used to replace existing work of either Party. Both Parties are responsible for adhering to this principle and for providing an annual confirmation to this effect.

6. Governance

6.1 AAFC/PMRA Deputy Minister Committee

6.1.1 A Deputy Ministers' (DMs) Committee will be established to oversee the management of this MOU. The Committee will be comprised of Deputy Ministers from Health Canada and AAFC. The DMs Committee will:

1. meet at least annually to discuss performance of the initiatives undertaken under this MOU;
2. meet at least annually to review and approve any re-allocation of funds between fiscal years, using existing mechanisms, as recommended by the Joint Management Committee and communicate their decision to the Treasury Board Secretariat;
3. meet as required to resolve any dispute arising from the implementation of this MOU where informal negotiation by the AAFC/PMRA Joint Management Committee failed to resolve the matter to the mutual satisfaction; and
4. recommend and obtain Ministers' approval of changes, where objectives of this MOU change materially.

6.2 AAFC/PMRA Joint Management Committee

6.2.1 AAFC and PMRA will establish a Joint Management Committee (JMC) to manage the implementation of this MOU. Membership of this Committee will consist of the Assistant Deputy Minister (ADM) of the Farm Financial Programs Branch, AAFC, the ADM of Research Branch, AAFC, and the Executive Director, PMRA, Health Canada. The Treasury Board Secretariat will participate in the Committee as an ex-officio member by providing advick and guidance, but will not be responsible for the delivery of the initiatives under this MOU. The Committee will report to their respective Deputy Ministers (DMs).

6.2.2 The AAFC/PMRA JMC will:

1. Develop terms of reference to outline its governance structure,
2. Concur on business cases (i.e., Annex A of this MOU) that outline the key commitments to be achieved over the years of funding.
3. Concur on annual costed work plans, with milestones, indicators and targets, to deliver on implementation.
4. Review quarterly reports and evaluation reports to assess progress on outputs and outcomes achievement and to provide direction for successful delivery
5. Review quarterly budget and expenditures to date.
6. Assess options to manage fund transfers within and between years to support work commitments under this MOU.
7. Report semi-annually on results achievements to DMs.
8. Agree on incremental changes to the objectives, as applicable, where objectives are achieved and funding remains.
9. Recommending changes to the objectives of this MOU for Deputy Ministers' Committee review, where objectives of the MOU change significantly.
10. Recommending for Deputy Ministers' Committee approval the annual amount of funding to be reallocated between fiscal years, if required, using existing mechanisms.
11. Review requests for dispute resolution and, if required, forward them to DMs as per Section 1 1.

6.2.3 The JMC will also seek the advice of the Pest Management Advisory Council (PMAC) and AAFC's Stakeholder Advisory Committee on the management of all three initiatives, as appropriate.

6.3 AAFC/PMRA Working Groups

6.3.1 AAFC and PMRA will establish a working group for each of the three initiatives described in Section 7 (Program Delivery) of this MOU:

1. Risk Reduction Strategies Working Group. Membership will include official(s) of AAFC's Pest Management Center, and PMRA's Alternative Strategies and Regulatory Affairs Division.
2. Minor-Use and Reduced-risk Pesticides Working Group. Membership will include AAFC's Pest Management Centre and PMRA's Chief Registrar.
3. Research Working Group. Membership will include AAFC's Program Director of Research Planning and Coordination, and PMRA's Head of Policy and Strategic Advice, Alternative Strategies and Regulatory Affairs Division

6.3.2 Each working group will provide the AAFC/PMRA JMC with their respective:

1. Business cases (i.e., Annex A of this MOU) that outline the key commitments to be achieved over the years of funding.
2. Annual costed work plans, with milestones, indicators and targets, to deliver on implementation.
3. Quarterly reports and evaluation reports to assess progress on outputs and outcomes achievement and to provide direction.
4. Quarterly budget and expenditures to date.
5. Options to manage fund transfers within and between years to support work commitments under this program.

6.3.4 The working groups will also assume any additional responsibilities as assigned by the AAFC/PMRA JMC, as needed.

6.3.5 The working groups will seek the advice of the AAFC/PMRA JMC on the management of their respective initiative, as needed; and resolve any disputes as per Section 11.

7.0 Program Delivery

AAFC and PMRA will undertake the following three initiatives. The funding allotted to each initiative is shown in Annex A.

7.1 Developing and Implementing Commodity-based Risk Reduction Strategies

1. With regard to developing risk reduction strategies for the agriculture and agri-food sector, PMRA and AAFC will jointly facilitate the development of a risk reduction strategy for each commodity, which identifies and prioritizes risks to be reduced and sets out the actions that are required to reduce the risks.
2. AAFC and PMRA will establish a working group. See Section 6 for the working group's roles and responsibilities.
3. AAFC and PMRA will, through the working group, jointly identify, prior to the beginning of each fiscal year, priorities for the development and implementation of commodity-based risk reduction strategies, based on criteria that include stakeholder interest and commitment. Priorities for the development of the strategies will be based on factors such as interest from grower groups in finding and implementing new approaches, the need to address key pest management problems, the importance of the crop in the diet of consumers, especially children, and the value and size of the area of crop production and thus the opportunity for the application of reduced-risk approaches.
4. AAFC will lead, with PMRA participation, in work with stakeholders to develop crop profiles on a national basis, according to a mutually agreed template. The crop profiles will describe how commodities are produced, with emphasis on pest management practices, including the role of integrated pest management in commodity production, and will identify the critical pest management issues to underpin the development of a commodity risk reduction strategy. PMRA may use the pesticide-use information contained in these crop profiles when assessing the risks of new pest control products and those under re-evaluation. AAFC will make profiles publicly available, via its website, and will develop an approach for updates of the profiles as required.
5. AAFC and PMRA will work with interested stakeholders including growers, the pesticide industry, consumer and environmental groups and provincial colleagues to facilitate the development of risk reduction strategies. These strategies will identify the priority needs of stakeholders for sustainable pest and crop management, and can include, for example, the need for research into pest problems and crop management problems, requirements for new products, requirements for educational and information tools, and needs for promotion to adopt beneficial management practices, as well as ways in which to measure accomplishment.
6. AAFC and PMRA will cooperate in developing criteria, approaches and processes to measure the adoption and impact of risk reduction strategies.
7. AAFC will undertake activities to support the development and implementation of commodity-based risk reduction strategies. This will include developing risk reduction best practices, and developing training modules and communication activities to support the technology transfer to industry.
8. PMRA will consider the strategies when making pesticide registration and re-registration decisions.

7.2 Improving Access to Agricultural Minor-Use Pesticides, and Reduced-risk Pesticides for Agricultural Use

1. Both AAFC and PMRA recognize that stakeholder input is critical in identifying the needs for products for minor-use in Canada, and in determining the priorities for the minor-use initiatives. AAFC and PMRA commit to improve access to agricultural pesticide minor uses, and reduced-risk pesticides for agricultural use by undertaking the following activities.
2. AAFC and PMRA will establish a working group. See Section 6 for the working group's roles and responsibilities.
3. AAFC will ensure it provides quality, complete and priority submission data packages for the registration of agricultural minor-use pesticides, and reduced-risk pesticides for agricultural use to PMRA, in accordance with the workplans that are agreed upon between AAFC and PMRA. This will involve the following:
   
   
   1. Annually, through the working group, AAFC will determine priorities, liaising with PMRA, international bodies (such as the US IR-4 ofice) and stakeholders. Priority setting will make use of a list of priorities determined annually by stakeholders. A more formalized process has been put in place to determine priority projects for 2004 and beyond. This will ensure that grower groups are more involved, and that the pesticide industry will be involved much earlier in the process.
   2. AAFC will initiate pre-submission consultations with PMRA, as needed.
   3. Annually, AAFC will advise PMRA of planned trials and number of submissions, after the priorities have been set and field trials plans have been developed for the next season. This will allow PMRA to assess whether adjustments in the submission review process will be needed to meet the demand.
   4. AAFC will generate data, including laboratory analyses, for the registration of priority agricultural minor-use pesticides, and reduced-risk pesticides for agricultural use, including biologically based pest control products. Residue data generated for submissions will be Good Laboratory Practices (GLP) compliant.
   5. AAFC will manage, coordinate and accelerate activities at the field sites.
4. PMRA will strengthen its capacity to review submissions to register agricultural minor pesticide use, and reduced-risk pesticides for agricultural use, and improve its capacity to support the pesticide registration process. This will involve:
   
   
   1. Providing pre-submission consultation to registrants who are seeking registration of agricultural minor-use pesticides or reduced-risk products.
   2. Screening submissions for completeness, organization and formatting to ensure that these satisfy the reduced-risk criteria and that they can be processed in accordance with the workplans that are agreed upon between AAFC and PMRA.
   3. Reviewing submissions for minor pesticide uses, and reduced-risk pesticides, in accordance with the workplans that are agreed upon between AAFC and PMRA.
   4. Registering pesticides if the health and environmental risks, and value are acceptable.
   5. Supporting electronic systems for managing the review of pesticide registration submissions and for tracking and analyzing data related to submissions and registrations of reduced-risk pesticides, including products for minor-use. Information about submissions received PMRA will be available to the public, including growers, as allowed under the new Pest Control Products Act (PCPA), once it is proclaimed.
5. PMRA will continue to have a minor-use advisor who will liaise with growers, registrants, provincial minor-use coordinators (PMUCs), the US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA)'s Interregional Research Project Number 4 R-4), and AAFC's minor-use administration, as specified in the Government Response to the Report of the House of Commons Standing Committee on Agriculture & Agri-Food, Registration of Pesticides and the Competitiveness of Canadian Farmers (2002).

7.3 Conducting Research to Support the Introduction of Minor-Use Pesticides that Pose a Reduced Risk to the Environment

1. To support the introduction of minor-use pesticides that pose a reduced risk to the environment, PMRA and AAFC will develop and execute a research plan over a five year period. This will involve the following activities.
2. AAFC and PMRA will establish a working group. See Section 6 for the working group's roles and responsibilities.
3. AAFC and PMRA, through the working group, will share research needs, priorities and costed work plans with targets, milestones and indicators. This horizontal initiative will be designed to avoid duplication of research and provide for effective use of resources. The research plans will be shared by both organizations with the 5NR¹ Working Group on Pesticides and Pest Management in order to facilitate its integration with the pesticide research plans of other federal departments.
4. The scope of the applied research and priorities will include research that will support the introduction of minor-use pesticides that pose a reduced risk to the environment. This will include research that will produce information useful within the pesticide regulatory decision making process, which in turn will support the introduction of reduced-risk pesticides, and that will contribute to the development of alternatives to conventional pesticides.
5. Research will primarily be coordinated between AAFC and PMRA to ensure this initiative contributes to the long term shared outcomes by supporting the objectives of this MOU described in Section 1.

8.0 Funding

8.1 Each department will be responsible and accountable for the decisions made about their respective funding. Annex A shows the breakdown of all activities and associated funding. The two Parties to this MOU will ensure financial controls and prepare expenditure reports for the initiatives of this program. There will be annual costed work plans provided to the JMC (described in Section 6 of this MOU). When fund; intended for work under any of the three initiatives cannot be utilized, options will be presented to the JMC regarding potential transfers within and between years to support work commitments under this program.

9. Performance Reporting

9.1 AAFC and PMRA will each report on performance about the joint initiatives through the Parliamentary reporting process, using the Report on Plans and Priorities (RPP) and the Departmental Performance Report (DPR). The content of RPP and DPR will be drawn from the ongoing reports of results achievement as well as evaluation reports. The performance on the initiatives forms part of the plans and results achieved for:

1. the Health Promotion and Protection business line under Health Canada's planning, reporting and accountability structure, and
2. the Health of the Environment business line under Agriculture and Agri-Food Canada's planning, reporting and accountability structure.

9.2 In addition, PMRA will report to Parliament annually, as required under the new PCPA. This annual report will include, among other things, a status report on the registration of pest control products that pose lower risks, reevaluations and special reviews under the PCPA.

9.3 AAFC will use the information from any performance reports as input for the preparation of the Agricultural Policy Framework (APF) Report to Canadians, in consultation with the AAFC/PMRA Joint Management Committee. Prior to issuing any such reports, there will be an exchange of information between AAFC and PMRA.

9.4 The report template shown in Annex C may be used to report on the initiatives.

10. Communications

10.1 With respect to all communication activities, projects and products in connection with the three initiatives - except the activities of the Minor-use Advisor, who can directly and independently liaise with stakeholders- PMRA and AAFC will:

1. consult with each other on the planning and development of such activities; and
2. where applicable, refer to the Agricultural Policy Framework and its objectives, and shall fully and fairly reflect the contribution of each Party.

10.2 The above will not prevent either of the two organisations from engaging in communication activities to meet their respective mandates/obligations.

10.3 Both organizations will have websites that provide information regarding the initiatives, but will avoid, as much as possible, duplication of information by linking the two sites.

11. Dispute Resolution

11.1 Dispute resolution involves early recognition of conflict, promotion of cooperation and building stronger relationship through effectively and fairly managed conflict. The Parties agree to resolve any dispute arising from implementation of this MOU through informal negotiations and development of mutually satisfactory options. Where informal negotiations by the Director General of the Adaptation and Financial Guarantee Programs, AAFC, and the Director of the Alternative Strategies and Regulatory Affairs Division, PMRA, have failed to resolve the matter to the mutual satisfaction, the Parties agree to refer the matter to the JMC (see Section 6). Where informal negotiations by the JMC have failed to resolve the matter to the mutual satisfaction, the Parties agree to refer the matter to the Deputy Ministers' Committee. In case the dispute still remains unresolved, the Secretary of the Treasury Board may be invited to intervene to resolve the dispute. As a last resort, if the dispute is still unresolved, it will be referred to Ministers (including the President of the Treasury Board) for final resolution.

12. Duration of MOU

12.1 This MOU will be in effect upon the date the last signature is affixed and will remain in effect until March 31, 2008, at which time it will be subject to review and renewal.

13. Amendment

13.1 This MOU can be amended, with the written consent of the signatories, based upon mutual agreement, at any Party's request. The operation of this MOU will be reviewed annually by both parties.

14. Audits and Evaluations

14.1 The program delivery and design will be the subject of overall evaluations at the end of Year 3 and Year 5, in accordance with the existing Results-based Management and Accountability Framework (2002) and any applicable Risk-based Audit Framework and Internal Audit Plan (RBAF) that may come in the future. A RBAF will be created as required under Treasury Board Secretariat's Policy on Transfer Payments should the organizations start using the funding shown in Annex A for transfer payments. Transfer payments are transfers of money, goods, services or assets made from an appropriation to individuals, organizations or other levels of government, without the federal government directly receiving goods or services in return.

14.2 The evaluation strategy will draw on the performance data as one of the lines of evidence in an in-depth study of outcomes achievement that would include testing of the causality described in Section 4 of this MOU and examining unintended outcomes within the program and on other programs. While PMRA will coordinate the conduct of the aforementioned evaluations, the cost of these evaluations will be shared among Parties. Funds to implement the evaluations will come from the program funding.

14.3 Should an audit related specifically to the initiatives described in this MOU be performed by one of the Parties, a copy of the audited financial statements and audit report will be forwarded to all Parties by no later than nine (9) months following the year covered by the audit. All audits will be conducted in accordance with Generally Accepted Auditing Standards and with any applicable RBAF that may come in the future. The purpose and scope of the audit will be approved and shared by both Parties.

15. Signatories

15.1 This is to certify that the terms contained in this Memorandum of Understanding are acceptable to both parties.

Minister, Agriculture and Agri-food

Minister, Health

President, Treasury Board

December 2-9, 2003

Annex A

* Indirect support by AAFC towards integrated pest management research was estimated to be $38.6 million (65 FTEs) annually

Annex B

Building Public Confidence in Pesticide Regulation & Improving Access to Pest Management Products

A Part of the Agricultural Policy Framework's World Leadership in Environmentally Responsible Stewardship Program for Reduced Environment Risks from Agriculture
(Pest Management -Reduced Risk and Minor Use)
Logic Model

Diagram not available

Annex C - Performance and Financial Reporting Template

Report Title: Insert herein the relevant title

DRAFT

Part III: Financial Report

* Variance in Expenditures and Results: Identify and explain any variance in performance or level of expenditure for programs as well as actions taken to address the variance(s). Note: further information similar to the Business Case details may be requested where program anomalies are being reviewed by the AAFC / PMRA Joint Management Committee.