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PUBLIC INFORMATION SHEET FOR PROPAGATION

PROPOSAL FOR THE PROPAGATION OF
1507 MAIZE



1. Applicants Name, Address, Telephone Number, Facsimile Number, E-Mail
Address

Pioneer Hi-Bred Philippines, Inc.
24
th
F, Antel Global Corporate Center,
Doa Julia Vargas Avenue, Ortigas Center, Pasig City
Tel. No: +63 2 6371234
Fax No: +63 2 6875114
Email Add: jet.parma@pioneer.com; jan.samson@pioneer.com


2. Name of Responsible Officer/Authorized Representative

Jet Marcial G. Parma / Jan Alfred F. Samson


3. Description of the Regulated Article for Propagation

Maize (Zea mays L.) line, DAS-157-1 (referred to as 1507 maize), was generated by
the insertion of a synthetic truncated cry1F gene, which was isolated from Bacillus
thuringiensis (Bt) subspecies aizawai and a gene for phosphinothricin acetyltransferase
(pat), which was isolated from Streptomyces viridochromogenes.

The Cry1F protein, encoded by the cry1F gene in 1507 maize, confers protection
against certain lepidopteran pests. In local field trials, 1507 maize provided protection
against Asian corn borer (Ostrinia furnacalis), corn semi-looper (Chrysodeixis
eriosoma), common cutworm (Spodoptera litura), black cutworm (Agrotis ipsilon), and
corn earworm (Helicoverpa armigera).

The PAT protein, encoded by the pat gene, confers tolerance to the herbicidal active
ingredient glufosinate ammonium. The PAT enzyme catalyzes the conversion of L-
phosphinothricin, the active ingredient in glufosinate-ammonium, to an inactive form and
thereby detoxifies the glufosinate-ammonium herbicide. The herbicide tolerance trait in
1507 maize is utilized as a selectable marker.

These two novel genes were introduced into the parental maize hybrid line Hi-II by
particle acceleration (biolistic) transformation.


4. If to be imported, Country (ies) of Origin of the Regulated Article.

U.S.A. and other cultivating countries.



BPI BIOSAFETY PR 013
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5. Brief Summary of Potential Effects on Human and Animal Health and the
Environment (summarize human and animal health and environmental assessments done and
studies implemented indicating potential effects on human and animal health and the
environment)

The specificity of the Cry1F protein has been well-established and is limited to a small
subset of lepidopteran pest species. The safety of the PAT protein has also been well
established. The Cry1F and PAT proteins do not regulate the normal metabolic
pathways of maize plants and therefore will not interfere with the plants normal growth
and development. No significant homology to known nucleic acid sequences that code
for a protein toxic to humans or antibiotic resistance were found to have been
introduced into maize line 1507. Similarly, no significant homology was demonstrated
for the Cry1F and PAT proteins with known allergens, and both proteins have little
probability of being allergenic. Neither protein is stable in a simulated gastric fluid.

Comprehensive field studies have confirmed that 1507 maize is substantially equivalent
to conventional maize. All compositional parameters (e.g. nutrients, antinutrients,
proximates, etc.) and agronomic parameters of 1507 maize are within the normal range
of conventional maize and no unintended changes in biochemical composition or
agronomic characteristics were identified. Therefore, 1507 maize is considered
substantially equivalent and as safe as conventional maize.

1507 maize is no more likely to become a weed than an insect-resistant or herbicide-
tolerant corn that is currently being cultivated in the country. Introgression from 1507
maize into wild relatives is extremely unlikely, and any rare introgression into wild
relatives is not likely to increase the weediness potential of any resulting progeny nor
adversely affect genetic diversity of related plant species any more than would
introgression from traditional corn varieties. The cultivation of 1507 maize is not known
to have any significant adverse impact on non-target organisms, including those
beneficial to agriculture.

1507 maize has been cultivated in major corn growing countries such as Argentina,
Brazil, Canada, South Africa and USA and no scientific evidence of adverse effects in
environment and in human and animal health has been recorded.


6. Brief Summary of Potential Benefits (Describe how the new trait will benefit farming, the
farmer, the farming environment, and society as a whole)

The introduction of biotech maize in the Philippines has increased every year since it
was first introduced for cultivation in 2003. The area planted to biotech maize in 2011
reached 644,000 hectares wherein about 85% have been planted with stacked traits of
Bt and herbicide tolerant maize. Consistent with the experience of other biotech maize
growing countries the steady increase in adoption reflects the significant and consistent
benefits generated by biotech maize to farmers in the Philippines such as productivity
gains and reduction in pesticide use.

1507 maize has been shown under field conditions in the Philippines to be highly
efficacious against Asian corn borer, which remains to be the most destructive pest of
corn in the country. Additionally, 1507 maize is expected to provide effective control of
common cutworm, corn semi-looper, and black cutworm; and suppression of corn
earworm. The insect protection conferred by 1507 maize will safeguard yield and
improve farm incomes.

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Cultivation of 1507 maize can also provide a new tool for managing target insects that
might become resistant to other insecticides currently used, including Bt-based insect
control technologies. Furthermore, the approval of 1507 maize for propagation would
enable the stacking of Bt traits and deploy hybrid products producing multiple Bt
proteins active against the target pests within a single plant variety, thereby reducing
the risk of insect resistance development.


7. Countries Where Approvals Have Been Granted (for FFP; for Propagation)

Country Environment/Propagation Food and/or Feed
Argentina 2005 2005
Australia

2003
Brazil 2008 2008
Canada 2002 2002
China

2004
Columbia

2006
European Union

2006 (food), 2005 (feed)
Honduras 2009

Japan 2005 2002
Korea

2002 (food), 2004 (feed)
Mexico

2003
Philippines

2003 (renewed 2008)
Singapore

2011
South Africa 2012 2002
Taiwan

2003
United States

2001 2001
Uruguay 2011 2011

Source: Pioneer Hi-Bred International Regulatory Information


The public is hereby invited to submit their comments to the BPI Director (within 30
days from the date of publication) on the proposed propagation of 1507 maize.


The Director
Bureau of Plant Industry
692 San Andres St., Malate, Manila
Tel. No: +63 2 5257857
Fax No: +63 2 5217650
E-Mail Address: buplant@yahoo.com and bpibiotechsecretariat@yahoo.com



Approved for Publication: ___________________________
Director
Bureau of Plant Industry
Date: