Memorandum of Understanding between the Pest Management Regulatory Agency of Health Canada and Canadian Food Inspection Agency

Memorandum of Understanding between the Pest Management Regulatory Agency (PMRA) of Health Canada and Canadian Food Inspection Agency (CFIA)

1.0 Purpose

1.1 This Memorandum of Understanding (MOU) sets forth the terms and understanding between the (PMRA) and the (CFIA) on the regulation of nitrogen stabilizers in Canada.

2.1 Nitrification and urease inhibitors (i.e., nitrogen stabilizers) are nitrogen management products that can be applied with many forms of nitrogen-based fertilizers. Nitrogen stabilizers are used to increase nitrogen-use efficiency by reducing losses through volatilization, leaching, run-off and denitrification allowing for more of the applied nitrogen fertilizer to be used by the crop.
2.2 Urease inhibitors act on the enzyme urease, which is endemic in fields and an abundant soil enzyme, whereas nitrification inhibitors delay the conversion of ammonium to nitrate by temporarily inhibiting the ammonium monooxygenase enzyme within the Nitrosomonas bacterium.
2.3 Both categories of products underwent a detailed subject to regulation review including a review of the scientific information available on the products and an analysis of Health Canada's authorities under the Pest Control Products Act (PCPA) and the Pest Control Products Regulations (PCPR) as well as the Fertilizers Act.

3.1 As a result of the analysis it has been determined that:
1. nitrogen stabilizers meet the definition of a "supplement" under the Fertilizers Act.
2. urease inhibitors are not within the definition of a pest control product as defined under section 2 of the PCPA. As such, PMRA has no regulatory authority over these types of products;
3. nitrification inhibitors have a direct effect on soil bacteria and as such fall within the definition of a pest control product under section 2 of the PCPA. In addition, nitrification inhibitors do not qualify for an exemption from regulation or the registration requirement as outlined under sections 3 and 4 of the PCPR.
3.2 To this end, the analysis concluded that nitrification inhibitors fall under the jurisdiction of both the PCPA and the Fertilizers Act; both of which focus on health and environmental protection.

4.1 This regulatory duplication has created confusion for both industry and government. As such, Health Canada will propose to amend the PCPR to exempt nitrification inhibitors that act directly on soil bacteria from the PCPA. This proposed regulatory amendment is aimed to eliminate regulatory duplication and provide industry with a single, consistent regulatory approach for these products.
4.2 Health Canada has determined that the scientific risk assessments conducted by the CFIA adequately addresses the health and environmental risks and value associated with these products.
4.3 Effective immediately, until the regulatory amendment to the PCPR is in place exempting nitrification inhibitors that act on soil bacteria from the PCPA, Health Canada will not be requiring registration of these products under the PCPA.
4.4 Nitrogen stabilizer products continue to be regulated by the CFIA under the Fertilizers Act.

5.1 This MOU may be modified by mutual consent of authorized officials from the PMRA and CFIA. This MOU shall become effective upon signature by the authorized officials from the PMRA and the CFIA and will remain in effect until modified or terminated by any one of the partners by mutual consent.

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

Peter Brander
Chief Registrar
Pest Management Regulatory Agency
Health Canada
Date Signed: 19 November 2018

William Anderson
Executive Director
Policy and Programs Branch
Canadian Food Inspection Agency
Date Signed: 16 November 2018