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Submission Example: Data Summary—Introduction

The Canadian Food Inspection Agency (CFIA) is committed to increasing the transparency of its assessment process for new biotechnology-derived plants with novel traits (PNTs). For this reason, we are posting the following "Submission Example: Data Summary". It contains information submitted for an environmental safety assessment and livestock feed safety assessment.

The posting of the Submission Example complements other CFIA transparency initiatives that explain various stages of the CFIA’s assessment process for new biotechnology-derived PNTs. Such other initiatives are:

• the notices of submission pilot project, where developers’ submissions are posted on the CFIA Web site when a new plant with novel trait (PNT), or novel livestock feed or human food derived from a PNT, is submitted for safety assessments; and
• posting of simplified decision documents on the CFIA Web site.

The Submission Example that follows describes the type of data the CFIA requires to evaluate a PNT for environmental safety assessment and livestock feed safety assessment and provides examples of such data. The Submission Example was summarized from an actual submission. However, it has been edited and is intended for illustrative purposes.

The Submission Example is based on material developed by the CFIA’s Plant Biosafety Office and Feed Section and contains information from a submission previously provided to the CFIA by Monsanto Canada Inc. for assessment of its Bacillus thuringiensis(Bt) corn, designated MON810. Monsanto Canada Inc. has given the CFIA permission both to use the data in the Submission Example and to post it on the CFIA’s Internet site. MON810 has been approved for unconfined environmental release and for livestock feed use. Full submissions range from several hundred pages to several thousand pages, depending on the plant-trait combination and the studies required.

CFIA evaluators critically review all such submissions for the assessment of new PNTs to verify that all the CFIA’s data requirements are fully addressed. If there are deficiencies or questions of clarification, CFIA evaluators will ask the developer for more information; this typically results in the developer providing more data.

On completing their assessment, CFIA evaluators authorize the PNT for unconfined environmental release and livestock feed use or reject the application.

DISCLAIMER:

The "Submission Example: Data Summary" has been prepared as a public service to provide information about the type of data the CFIA requires for the purposes of evaluating new plants with novel traits. Even though the CFIA has taken great care in preparing the "Submission Example: Data Summary" published on this site, the CFIA cannot guarantee that it is accurate, exhaustive, or up-to-date and, as such, the CFIA publishes this document without warranties of any kind, either express or implied. Readers should at all times verify the information before acting on it and should, for all purposes of interpreting and applying the law, consult the official versions of relevant acts, regulations, and guidelines.