CFIA Detection and Identification Method Criteria
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In order to enhance the detection and identification capacity of the CFIA for regulatory purposes, regarding Plants with Novel Traits (PNTs) and livestock feeds derived therefrom, the CFIA requires that applicants provide a suitable detection method to accompany a PNT safety assessment submission. This method is required before any PNT will be authorized by the Plant Biosafety Office (PBO) for unconfined environmental release or by the Feed Section for livestock feed use.
The methods will be used to fulfill regulatory requirements (e.g. recall situations, confirm that any authorization conditions are being met).
The method of detection and identification is required to be specific to the trait and be capable of differentiating between currently authorized PNTs. Updated methods may be required as new PNTs are authorized.
The method must be able to detect and identify the PNT in a sample of seed (PBO requirement) and non-viable grain, or other single ingredient feed, for example alfalfa hay, sugar beet (Feed Section requirement).
Acceptable methods must address the following:
Test Type - Methods must be suitable and may be protein, RNA or DNA based. Phenotypic based methods will not generally be considered suitable.
Limit of detection - Methods must meet the following sensitivity and accuracy requirement:
- For those methods that are grain based, the method must be able to detect 0.2% modified grain (2 grains in 1000) with a 95% confidence interval.
- For those methods that are not grain based (e.g. single ingredient feed) the method must be able to detect 0.2% modified material in a sample with a 95% confidence interval.
Procedural clarity -The method must be complete and laid out in a step wise fashion that may be easily followed by a person unfamiliar with the method. Detailed descriptions of sample size, replicates, extraction procedure, expected results (figures/sequences), interpretation and acceptance criteria must be included.
Cross reactivity - The method must be shown to be specific to the PNT of interest. Any potential for cross reactivity must be clearly stated. Cross reactivity data must be provided demonstrating that the method does not cross-react with other commercially available PNTs of the same species with similar traits/modifications that are currently available in the Canadian marketplace.
Reference material - The company must provide appropriate reference materials to the CFIA upon request. Appropriate reference material will be determined by the CFIA based on the method provided.
Contact information - The company must provide contact information for a technical support person.
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