ARCHIVED - Data Requirements for Garlic Products

31 August 2010

Chemical Information Requirements for Garlic Products

Garlic oil, garlic powder and garlic juice are three types of garlic products that have pesticidal uses. Since the use of these products is expected to pose lower health and environmental risks, chemistry data requirements may be reduced.

For all three types of products the applicants must provide the following documentation:

1. Statement of Product Specification Form (SPSF) (DACO 2.12.2), including information on the manufacturer and manufacturing site;
2. Description of the Starting Materials (DACO 2.11.2); and
3. Detailed Production Process Description (DACO 2.11.3).

In addition the following information is required based on the nature of the garlic product:

1. For garlic oil:
   Since garlic oil is listed in the Food Chemicals Codex (FCC) as a food grade product, the applicant must provide results of tests listed in FCC to show that the product meets the food grade criteria.
2. For garlic powder:
   Garlic powder and any other garlic product that is meant for human consumption requires a certificate stating that the product is used in the food industry.
3. For garlic juice:
   Garlic juice and other products which are obtained by simple mechanical processing require a certificate describing the product quality.

DACO 5.2 Use Description / Scenario (application and post application)

Information that fully describes the use of the product and human activity associated with its use. Qualitative information which will help characterize exposure should be included here and can be divided into mixer/loader/applicator and post-application categories. The sources of the information should be cited (e.g., label, growers groups, surveys, custom applicators, agricultural experts, and associations). Where relevant, specific information should be provided for different product users (e.g., farmers vs. custom applicators). All numerical values should be reported as fully as possible (e.g., min, max, mean).

Value (including efficacy) Information Requirements for Garlic Products

• A scientific rationale may be submitted in lieu of data to waive any data requirements. The rationale may cite published scientific literature. Upon receiving the rationales, the suitability of any waiver will be assessed during a full evaluation.
• Three well designed, well replicated, scientific studies, preferably located either in Canada or the northern USA, is required to demonstrate that the product repels mosquitoes when applied according to the proposed use pattern. At least two of these must be field studies, but the third may be a laboratory study. Additional laboratory studies may be submitted as supporting data, but cannot be used in lieu of field studies. At least three representative Canadian mosquito genera (e.g., Aedes, Culex and Anopheles) should be tested over the course of these trials. Pests should be collected during each field study and identified to species.
• Studies must be well-designed and well-conducted, i.e., they must be conducted under sufficient pest pressure; they must contain a treatment using the proposed product; they must have a large enough sample size and number of replicates to draw a sound conclusion; and untreated control data must be provided.
• Any efficacy claims made on the label (e.g., protection from mosquitoes for x hours) must be justified with data or sound scientific rationales.
• Any phytotoxicity observed during efficacy trials should be noted.
• Data on species that are not found in Canada may be considered supplemental. If studies are conducted outside of Canada or the northern United States, the reports must justify how data generated on species not found in Canada can be extrapolated to Canadian pest species.
• Experimental protocols may be submitted to the PMRA for evaluation prior to running the studies, for assistance in assuring that they are acceptable for producing the required data.

Example Labels of Garlic Products

An example of a domestic product (PDF Version - 159 K) label is available in PDF

An example of a product label for use in manufacturing, formulating or repackaging (PDF Version - 156 K) is available in PDF format.

Administrative

• The applicant must obtain a research authorization from the Pest Management Regulatory Agency prior to conducting any trials involving human subjects. A research authorization may also be required in other situations. For further information, please contact the Pest Management Information Service.
• Please note that if data which are not owned by the applicant are cited, or rationales based on such data are submitted, the applicant may be required to compensate the owner of the data. For further information, please refer to the Regulations Amending the Pest Control Products Regulations.