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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 30 May 2019
CONSOLIDATED REPORT OF MONSANTO PHILIPPINES' CORN MON88017 X MON810 APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING
EN
28 May 2018
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph, -
Competent National Authority:Department of Health ()Tayuman, Sta. CruzManila, Metro Manila
1003, PhilippinesPhone: (632) 8651-7800,Fax:Email: callcenter@doh.gov.ph,Website: http://www.doh.gov.ph, -
Competent National Authority:Department of Environment and Natural Resources ()Visayas Avenue, DilimanQuezon City, Metro Manila
1100, PhilippinesPhone: (02) 8925-8277,Fax:Email: actioncenter@denr.gov.ph, osec@denr.gov.ph,Website: http://www.denr.gov.ph,
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Person:Ms. Ma. Lorelei U. AgbagalaSupervising Agriculturist, Post Entry QuarantineEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,
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MON-88Ø17-3 × MON-ØØ81Ø-6 - YieldGard™ VT Triple| Monsanto | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths), European corn borer (Ostrinia nubilalis)), Resistance to herbicides (Glyphosate)
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The STRP agreed with the applicant that there is no likelihood of interaction among the
Cry (Cry1 Ab and Cry3Bb1) and the CP4 EPSPS proteins that will produce new
allergens and new toxins based on their distinct mode of action.
The STRP reported that Cry proteins are contained in the plant tissue in microgram
levels and are produced at low levels in the pollen (Betz, 2000) while the CP4 EPSPS
proteins are localized in the chloroplasts or plastids (Padgette, 1996).
According to BPI-PPSSD, the developer provided supporting documents indicating that
any likelihood of interaction among the resulting products in MON 88017 x MON 810
could not lead to the production of new allergen or toxin. This is due to the difference in
the mode of actions of the expressed proteins (Cry1Ab, Cry3Bb1 and CP4 EPSPS),
genetic stability and low protein expression levels. There is no known mechanisms of
interaction among these proteins that could lead to adverse effects in humans and
other organisms in the environment.
-Toxicological and allergenicity analyses also indicated that MON 88017 x MON
810 did not produce any new toxins or allergens. Compositional analysis also
showed that the combined trait product is substantially equivalent with the
conventional corn (EFSA, 2009).
-Each single event, MON 88017 and MON 810, have been approved for Biosafety
for food and feed, or for processing by the Bureau of Plant Industry.
A new allergen or new toxin is unlikely to be produced out of the combined genes as
there are no known mechanism of interaction between these different classes of
protein. Each class of protein differs in structure and function from each other, such
that any likelihood of interaction with one another is not considered to be significant to
effect the stability and expression level of each gene nor could their interaction lead to
production a new allergen or toxin in the combined trait product.
In addition, the BAI confirmed that the gene products are contained in different
subcellular compartments of the plant parts. The Cry proteins are said to accumulate
at the cytoplasm while the CP4 EPSPS protein are expected to accumulate at the
chloroplast of the corn cells.
EN
Cry (Cry1 Ab and Cry3Bb1) and the CP4 EPSPS proteins that will produce new
allergens and new toxins based on their distinct mode of action.
The STRP reported that Cry proteins are contained in the plant tissue in microgram
levels and are produced at low levels in the pollen (Betz, 2000) while the CP4 EPSPS
proteins are localized in the chloroplasts or plastids (Padgette, 1996).
According to BPI-PPSSD, the developer provided supporting documents indicating that
any likelihood of interaction among the resulting products in MON 88017 x MON 810
could not lead to the production of new allergen or toxin. This is due to the difference in
the mode of actions of the expressed proteins (Cry1Ab, Cry3Bb1 and CP4 EPSPS),
genetic stability and low protein expression levels. There is no known mechanisms of
interaction among these proteins that could lead to adverse effects in humans and
other organisms in the environment.
-Toxicological and allergenicity analyses also indicated that MON 88017 x MON
810 did not produce any new toxins or allergens. Compositional analysis also
showed that the combined trait product is substantially equivalent with the
conventional corn (EFSA, 2009).
-Each single event, MON 88017 and MON 810, have been approved for Biosafety
for food and feed, or for processing by the Bureau of Plant Industry.
A new allergen or new toxin is unlikely to be produced out of the combined genes as
there are no known mechanism of interaction between these different classes of
protein. Each class of protein differs in structure and function from each other, such
that any likelihood of interaction with one another is not considered to be significant to
effect the stability and expression level of each gene nor could their interaction lead to
production a new allergen or toxin in the combined trait product.
In addition, the BAI confirmed that the gene products are contained in different
subcellular compartments of the plant parts. The Cry proteins are said to accumulate
at the cytoplasm while the CP4 EPSPS protein are expected to accumulate at the
chloroplast of the corn cells.
Toxicological and allergenicity analyses also indicated that MON 88017 x MON
810 did not produce any new toxins or allergens. Compositional analysis also
showed that the combined trait product is substantially equivalent with the
conventional corn (EFSA, 2009).
After a thorough scientific review and evaluation of the documents including the
Environmental Health Impact Assessment form, the DOH find sufficient evidence that the
regulated article applied for direct use will not pose any significant risk to the health and
environment. The Committee also suggested conditions which can also be included in the
Biosafety Permit to be issued to Monsanto.
EN
810 did not produce any new toxins or allergens. Compositional analysis also
showed that the combined trait product is substantially equivalent with the
conventional corn (EFSA, 2009).
After a thorough scientific review and evaluation of the documents including the
Environmental Health Impact Assessment form, the DOH find sufficient evidence that the
regulated article applied for direct use will not pose any significant risk to the health and
environment. The Committee also suggested conditions which can also be included in the
Biosafety Permit to be issued to Monsanto.
Stacked trait CORN MON88017 x MON810 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
After a thorough scientific review and evaluation of Monsanto Philippines’ duly
accomplished Environmental Risk Assessment (ERA) and Project Description Report (PDR)
forms, the Department of Environment and Natural Resources – Biosafety Committee
(DENR-BC), recommended for the issuance of a biosafety permit for this regulated event
provided that the conditions set by DENR are complied. Also, the Department of Health –
Biosafety Committee (DOH-BC), after a thorough scientific review and evaluation of the
accomplished Environmental Health Risk Assessment form, concluded that corn MON810 x
MON88017 will not pose any significant risk to the health and environment and that any
hazards could be managed by the measures set by the department. Hence, the DOH-BC also
recommended for the issuance of biosafety permit for the stacked trait product. Lastly, after
assessing that there will be no negative socio-economic, ethical and cultural concerns that
will arise from the adoption of Genetically Modified Organisms, the Socio-economic, Ethical
and Cultural (SEC) expert recommended for the approval and issuance of biosafety permit
of corn MON88017 x MON810 for direct use as food and feed, or for processing.
EN
accomplished Environmental Risk Assessment (ERA) and Project Description Report (PDR)
forms, the Department of Environment and Natural Resources – Biosafety Committee
(DENR-BC), recommended for the issuance of a biosafety permit for this regulated event
provided that the conditions set by DENR are complied. Also, the Department of Health –
Biosafety Committee (DOH-BC), after a thorough scientific review and evaluation of the
accomplished Environmental Health Risk Assessment form, concluded that corn MON810 x
MON88017 will not pose any significant risk to the health and environment and that any
hazards could be managed by the measures set by the department. Hence, the DOH-BC also
recommended for the issuance of biosafety permit for the stacked trait product. Lastly, after
assessing that there will be no negative socio-economic, ethical and cultural concerns that
will arise from the adoption of Genetically Modified Organisms, the Socio-economic, Ethical
and Cultural (SEC) expert recommended for the approval and issuance of biosafety permit
of corn MON88017 x MON810 for direct use as food and feed, or for processing.
Stacked trait CORN MON88017 x MON810 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
This LMO will be directly used for food, feed and processing. This does not include cultivation of stacked trait Corn MON88017 x MON810 in the Philippines.
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR may be used.
EN
Stacked Trait Corn MON88017 x MON810 is intended for direct use as food, feed and for processing.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.
- ISAAA [ English ]
