Update from the Pest Management Regulatory Agency (PMRA)

1. Update from the Pest Management Regulatory Agency (PMRA) Trevor Satchwill Health Evaluation Division

2. Topics • Overview of PMRA mandate • PMRA Re-evaluation program • Canadian MRLs • Use of residue surveillance data in DRA

3. PMRA – brief history • Established in 1995 based on recommendations from a stakeholder review team. • Formed from the pesticide evaluations elements of three Departments: • Health Canada • Agriculture and Agri-Food Canada • Environment Canada

4. PMRA • PMRA is a branch of Health Canada, and administers the Pest Control Products Act for the Minister of Health. • PMRA is the regulator responsible for recommending pesticide MRLs under authority of Foods and Drugs Act, • MRLs are specified in Division 15 of the Food and Drugs Regulations • http://www.pmra-arla.gc.ca/

5. CFIA - overview • The Canadian Food Inspection Agency Act (CFIA Act), proclaimed in April 1997, established the CFIA with an objective to consolidate and enhance the efficiency and effectiveness of federal inspection services related to food, animal and plant health, and to increase collaboration with provincial governments in this area. • Administer federal food safety Acts and aspects of other acts as they relate to food, including: • Canada Agricultural Products Act, Consumer Packaging and Labeling Act, Feeds Act, Fertilizers Act, Food and Drugs Act

6. CFIA - overview • Protect Canadians from preventable health risks • Protect consumers through a fair and effective food, animal and plant regulatory regime that supports competitive domestic and international markets • Responsible to the Minister of Agriculture and Agri-Food (AAFC) • Enforce MRLs • Consult with PMRA regarding MRL violations • http://www.inspection.gc.ca/

7. PMRA Risk Assessments • Data requirements for registration and risk assessment approaches largely harmonized with EPA • NAFTA Technical Working Group on Pesticides (NAFTA TWG), • (OECD) Pesticides Forum • PMRA adopted by policy health protection elements of FQPA, including: • Additional protection for sensitive populations, • Aggregate risk assessments to consider exposure from all routes and sources, • Cumulative risk assessments where a common mechanism of human toxicity is identified, • Systematic re-evaluation of registered pesticides • Now formally implemented in law under PCPA(2002).

8. International Harmonization (MRLs) • NAFTA-TWG on pesticides is highly successful: • Framework to identify and resolve trade irritants • NAFTA Guidance Document on Data Requirements for Tolerances on Imported Commodities in the United States and Canada • http://www.pmra-arla.gc.ca/english/pdf/nafta/TWGImport_Tolerance-e.pdf • Guidance for Setting Pesticide Maximum Residue Limits Based on Field Trial Data • http://www.pmra-arla.gc.ca/english/pdf/pro/pro2005-04-e.pdf

9. Dietary Exposure Models • Peer-reviewed models such as DEEM, LifeLine, CARES acceptable. • Adopted underlying CSFII demographic data and FCID ‘recipes’. • Canadian Community Health Survey (CCHS 2.2) collected diet and demographic data in 2006 by Statistics Canada. • Recent survey undertaken to update 1972 national data.

10. Re-evaluation

11. PMRA Re-evaluation • The re-evaluation program was initiated under Section 19 of the previous PCPA, and announced in PRO99-01 A new approach to re-evaluation. • Current phase of re-evaluation includes all active ingredients registered before 1995 (405 a.i.). To be completed by 2009. • Focus on risk reduction rather than Tolerance Reassessment. • Re-evaluations use existing database as well as contemporary foreign reviews. • Intent to co-ordinate next phase of re-evaluation on a 15-year cycle with EPA

12. PMRA Re-evaluation • Organized into 4 review streams Program 1: based on EPA RED, match up of use pattern, started with non-food uses Program 2: detailed in-house evaluations Program 3: FQPA chemicals (OP’s, n-methyl carbamates) Program 4: Special Review of emerging issues, national priorities, international obligations.

13. MRLs

14. Canadian MRLs • DIVISION 15 of the Food and Drug regulations cover adulteration of food. • MRLs established for specific pesticide-commodity pairs in Table II of Division 15, Food and Drug Regulations. • All other agricultural chemical residues are regulated by B.15.002(1) - not to exceed 0.1 ppm or food is considered to be adulterated.

15. B.15.002(1) as a General MRL • By virtue of the GMRL, residues are allowed on all foods up to 0.1 ppm unless a specific MRL is established. • Most industrialized countries set specific MRLs for every pesticide on each food commodity • PMRA does the same for new uses since 1998. • GMRL still applies for existing domestic uses and for imports. • 4500 food uses registered prior to 1998 regulated by the GMRL (domestic and imports).

16. B.15.002(1) as a General MRL • The intent of B.15.002(1) was to prohibit adulteration of food. However this is not being accomplished. • GMRL establishes the level of enforcement at 0.1 ppm. • Difficult to prohibit residues. • No US equivalent.

17. Proposal to revoke the GMRL • Objective: • Achieve the intent of the General MRL, to prohibit food that is adulterated because MRLs are exceeded or have not been established. • Maintain the safety of the Canadian food supply. • Facilitate trade and minimize the impact on: • existing registered Canadian food uses by continuing to allow residues on foods that result from the legitimate use of registered pesticides. • trade through harmonization in a number of areas, and avoiding new trade irritants.

18. Refined proposal • Use of U.S. tolerances at or below 0.1 ppm, post FQPA as the basis for specific Canadian MRLs. Also consider contemporary CODEX MRLs at or below 0.1 ppm • Continued consideration of the needs of Canadian growers - commodities grown in Canada considered separately from imports • Detailed comparison of Canadian pesticide-commodity pairs affected by revocation of the General MRL, with U.S. tolerances. • http://www.pmra-arla.gc.ca/english/legis/maxres-e.html

19. Residues

20. Residue Surveillance Data • CFIA conduct the National Chemical Residue Monitoring Program (NCRMP). • Used to monitor compliance (vs. risk assessment), and to identify priorities and action items to contribute to a safe food supply. • Apply multiresidue methods to allow the fast detection of a broad range of pesticides. • GC-MS workhorse method; complementary LC-MS-MS method under development. • Detection limits of at least 0.01 ppm to address those pesticides subject to the general MRL of 0.1 ppm.

21. Residue Surveillance Data (2) Domestic fruits and vegetable data

22. Canadian Exports: e.g. grains, beef/hog/poultry, potatoes, greenhouse vegetables, wine

23. Canadian Imports: e.g. Fruits, citrus, seasonal commodities

24. Significance of Imports • Imported commodities are routinely considered in dietary risk assessments. • Refinement of screening level assumptions for re-evaluation chemicals needed e.g.100% crop treated, residues at MRL level.

25. Refined Residue Estimates • Use weighted estimate of domestically produced and imported foods • % crop treated (Canadian profile, BEAD) • % domestic production • Source of imported foods (primarily US) • Residue surveillance (CFIA import and domestic data, USDA PDP) • Assume that USDA PDP is representative of imports to Canada.

26. Data Sources: Statistics Canada Food Consumption in Canada

27. Data Sources: Statistics Canada Imports by Commodity Table Grape Imports to Canada

28. Questions?