DD2003-43: (Supplement) Determination of the Safety of Monsanto Canada Inc.'s Insect Resistant Corn (Zea mays L.) Line MON 863

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Decision Document 03-43

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 corn rootworm (Diabrotica spp.) resistant corn event MON 863. The CFIA has determined that this plant with a novel trait 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 corn rootworm (Diabrotica spp.) resistant corn event MON 863 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 863 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)

Designation(s) of the PNT: MON 863, OECD identifier; MON-00863-5

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);
Resistance to aminoglycoside antibiotics

Trait Introduction Method: Microprojectile bombardment of plant cells.

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 a corn event resistant to corn rootworm (Diabrotica spp.), a periodic pest of corn in Canada. This event, designated as MON 863, was developed to provide a method to control yield losses from insect feeding damage caused by rootworm larvae.

The unconfined environmental release and livestock feed use of corn (Zea mays) event MON 863 was originally authorized on March 5, 2003 for one year. Renewal of one year the authorization was contingent on Monsanto Canada Inc. demonstrating lack of detrimental effects of MON 863 corn on additional beneficial insect species and demonstrating significant progress in research related to insect resistance management (see DD2003-43).

Based on the information provided in progress reports submitted to the Plant Biosafety Office in 2004 and 2005, the conditional one year authorization of MON 863 was renewed in 2004 and 2005, respectively. Following review of the third progress report submitted in 2006, the Plant Biosafety Office has made a decision regarding the indefinite unconfined environmental release of MON 863 in Canada.

III. Environmental Assessment

1. Potential Impact on Non-Target Organisms

As explained in DD2003-43, the Plant Biosafety Office has required that Monsanto Canada Inc. submit a new beneficial insect study to support the renewal of the one year of the authorization of MON 863 corn. Studies addressing the potential impact of MON863 on minute pirate bug (Orius insidiosus) and carabid beetle (Poecilus chalcites) have been submitted. No detrimental effect was observed at 930µg Cry3Bb1/g of diet on survival, development and behaviour of Orius nymphs. No detrimental effect was observed at 930µg Cry3Bb1/g of diet on survival, weight, development rate of carabid larvae. The test dose represents a conservative estimate of the dose that pirate bugs or carabids may be exposed to in the field. These results show that field exposure to the Cry3Bb1 toxin expressed in MON 863 tissues is very unlikely to have any adverse effects on O. insidiosus and P. chalcites.

Based on the above, the Plant Biosafety Office has determined that the indefinite unconfined release of MON 863 corn event will not result in altered impacts on non-target organisms, including humans, compared to current corn varieties in Canada.

2. Potential for Development of Rootworm Resistance to MON 863

Monsanto Canada Inc. has developed an Insect Resistance Management (IRM) plan for MON 863. IRM is intended to reduce or delay the development of resistance to MON 863 in corn rootworm populations. The original IRM plan was determined to be acceptable for the initial one year period of the conditional authorization. However, renewal of the one year authorization of MON 863 was contingent upon Monsanto Canada Inc. demonstrating significant progress in research related to insect resistance management. Progress on research related to the proposed IRM plan has been used to determine if the IRM plan should be maintained in its original form, or if it should be modified.

Based on the data submitted by Monsanto Canada Inc., the Plant Biosafety Office considers that the information submitted to date, including published literature, indicates that the current refuge requirements for corn event MON 863 are adequate for managing resistance to MON 863 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 863 will not result in a significant risk to the environment when compared to currently commercialized corn varieties in Canada. Monsanto Canada Inc. has developed and implemented an insect resistance management plan for this product.

Unconfined release into the environment and use as livestock feed of corn event MON 863 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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