DD2006-57: (Supplement) Determination of the Safety of Monsanto Canada Inc.'s Glyphosate-Tolerant, Corn-Rootworm-Protected Corn (Zea mays L) Event MON 88017

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Issued: 2006-03

This Supplement to Decision Document has been prepared to explain the regulatory decision reached under the guidelines Dir94-08 Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits and its companion document BIO94-11 The Biology of Zea mays L. (Corn/Maize).

The Canadian Food Inspection Agency (CFIA), specifically the Plant Biosafety Office, has evaluated the information submitted by Monsanto Canada Inc. regarding the rootworm (Diabrotica spp..) resistant, glyphosate tolerant, corn event MON 88017. The CFIA has determined that this plant with novel traits does not present altered environmental interactions when compared to currently commercialized corn varieties in Canada.

The Feed Section of the Animal Health and Production Division has evaluated the information submitted by Monsanto Canada Inc. regarding the rootworm (Diabrotica spp.) resistant, glyphosate-tolerant, corn event MON 88017 and has determined that it is substantially equivalent to existing commercialized corn varieties.

Unconfined release into the environment and use as livestock feed of corn event MON 88017 and any of its descendants is authorized, without a time limit, provided (i) no inter-specific crosses are performed, (ii) the intended uses are similar, (iii) based on characterization, these plants do not display any additional novel traits and are substantially equivalent, in terms of their specific use and safety for the environment and for human and animal health, to corn currently grown in Canada, (iv) the novel genes are expressed at a level similar to that of the authorized line and (v) that insect resistance management requirements are applied.

Table of Contents

I. Brief Identification of Plant with Novel Traits(PNT)

II. Background Information

III. Environmental Assessment

IV. Regulatory Decision

i. Brief Identification of Plant with Novel Traits (PNT)

Designation(s) of the PNT: MON 88017, OECD identifier; MON-88017-3

Applicant: Monsanto Canada Inc.

Plant Species: Corn (Zea mays L.)

Novel Traits:: Resistance to Western and Northern Corn Rootworms. (Diabrotica virgifera virgifera and Diabrotica barberi);
Tolerance to glyphosate-based herbicides

Trait Introduction Method: Agrobacterium-mediated transformation

Proposed Use of PNT: Production of corn for human consumption (wet mill products, dry mill products and seed oil) and oil, meal, grain, silage and other by-products for livestock feed. These materials are not intended to be grown outside the normal production area for corn in Canada.

ii. Background Information

Monsanto Canada Inc. has developed corn lines from event MON 88017 resistant to corn rootworm (Diabrotica spp.) and tolerant to glyphosate-based herbicides. The corn event, designated as MON 88017, was developed to provide a method to control yield losses from insect feeding damage caused by rootworm larvae, as well as a method to control weeds in corn production.

The unconfined environmental release and livestock feed use of corn (Zea mays) event MON 88017 was originally authorized on February 20, 2006 until April 1, 2007. Extension of the authorization was made contingent on Monsanto Canada Inc. demonstrating significant progress in research related to insect resistance management (see DD2006-57).

Based on new information provided to the Plant Biosafety Office in 2006, the Plant Biosafety Office has made a decision regarding the indefinite unconfined environmental release of MON 88017 in Canada.

iii. Environmental Assessment

Monsanto Canada Inc. has developed an Insect Resistance Management (IRM) plan for MON 88017. IRM is intended to reduce or delay the development of resistance to MON 88017 in corn rootworm populations. The IRM plan for MON 88017 corn is identical to that of the related corn event MON 863 (see DD2003-43), in that both events have the same potential for development of corn root worm resistance to Cry3Bb1 protein.

The original IRM plan was determined to be acceptable for the period of the conditional authorization. However, extension of the authorization of MON 88017 was made contingent upon Monsanto Canada Inc. demonstrating significant progress in research related to insect resistance management for MON 863 corn. Progress on research related to the IRM plan has been used to determine if the original IRM plan should be maintained in its original form, or if it should be modified.

Based on the data submitted by Monsanto Canada Inc. in 2006 in support of the renewal of the authorization of MON 863 event (see Supplement to DD2003-43), the Plant Biosafety Office considers that the information submitted to date, including published literature, indicates that the current refuge requirements for corn event MON 88017 are adequate for managing resistance to MON 88017 in corn rootworm populations.

iv. Regulatory Decision

Based on the review of data and information submitted by Monsanto Canada Inc., the Plant Biosafety Office, CFIA, has come to the conclusion that indefinite unconfined environmental release of MON 88017 corn will not result in a significant risk to the environment when compared to currently commercialized corn varieties in Canada. Monsanto Canada Inc. has developed an insect resistance management plan for this product.

Unconfined release into the environment and use as livestock feed of corn event MON 88017 and any of its descendants is therefore authorized, without a time limit, provided (i) no inter-specific crosses are performed, (ii) the intended uses are similar, (iii) based on characterization, these plants do not display any additional novel traits and are substantially equivalent, in terms of their specific use and safety for the environment and for human and animal health, to corn currently grown in Canada, (iv) the novel genes are expressed at a level similar to that of the authorized line and (v) that insect resistance management requirements are applied.

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