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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' COTTON MON15983 x MON88913 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 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, -
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,
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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-88913-8 × MON-15985-7 - Roundup Ready™ Flex™ Bollgard II™ cotton| Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
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According to the STRP, it is very unlikely that the products of MON15985 and MON88913 will
interact with each other and produce new allergens or toxins. The mode of action of the
introduced genes are different from each other. MON15985 produces cry1Ac and cry2Ab2
proteins which is effective against Lepidopteran insects while MON88913 produces CP4EPSPS
protein which confers tolerance to glyphosate. The aforementioned proteins have different
structures and functions and are independent from each other. Also, they have different modes
of action and binding sites, thus no interactive or synergistic effects on the metabolism of the
plants is expected.
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interact with each other and produce new allergens or toxins. The mode of action of the
introduced genes are different from each other. MON15985 produces cry1Ac and cry2Ab2
proteins which is effective against Lepidopteran insects while MON88913 produces CP4EPSPS
protein which confers tolerance to glyphosate. The aforementioned proteins have different
structures and functions and are independent from each other. Also, they have different modes
of action and binding sites, thus no interactive or synergistic effects on the metabolism of the
plants is expected.
The developer provided sufficient information that there is no possibility of interaction among
the resulting products which could lead to the production of a new allergen or toxin due to the
differences in the mode of action, metabolic pathway and the specificity of each protein.
CP4 EPSPS protein confers to tolerance to glyphosate while Cry1Ac and Cry2Ab confers toxic
actions in the midgut of specific Lepidopteran insects and operate through independent,
unrelated biochemical mechanisms (OGTR, 2006). Cry1Ac and Cry2Ab have related
biochemical mechanisms and may have synergistic effects when ingested in combination, and
potentially impact on toxicity for invertebrates. Hammond et al. (2013) and other literatures
had indicated that exposure of mammals to Cry proteins has not been associated with additive
or synergistic toxicity due to the lack of high affinity Cry protein receptors in mammals.
Toxicological and allergenicity assessment of GM cotton lines including MON 15985 x MON
88913 were conducted in Australia. No risk relating to production of toxins or allergens were
identified as a result of growing cotton plants (OGTR, 2006).
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the resulting products which could lead to the production of a new allergen or toxin due to the
differences in the mode of action, metabolic pathway and the specificity of each protein.
CP4 EPSPS protein confers to tolerance to glyphosate while Cry1Ac and Cry2Ab confers toxic
actions in the midgut of specific Lepidopteran insects and operate through independent,
unrelated biochemical mechanisms (OGTR, 2006). Cry1Ac and Cry2Ab have related
biochemical mechanisms and may have synergistic effects when ingested in combination, and
potentially impact on toxicity for invertebrates. Hammond et al. (2013) and other literatures
had indicated that exposure of mammals to Cry proteins has not been associated with additive
or synergistic toxicity due to the lack of high affinity Cry protein receptors in mammals.
Toxicological and allergenicity assessment of GM cotton lines including MON 15985 x MON
88913 were conducted in Australia. No risk relating to production of toxins or allergens were
identified as a result of growing cotton plants (OGTR, 2006).
Scientific pieces of evidences from provided references i.e. literatures show that Cotton MON15983 x MON88913 applied for direct use is as safe as its conventional counterpart and shall not pose any
significant risk on human health, animal health and on the environment.
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significant risk on human health, animal health and on the environment.
Find scientific evidence that the regulated article applied for direct use has no evidence of
interaction on the resulting gene products.
DENR Recommendation:
The effect of the regulated article on the environment depends largely on the viability of the product to be
utilized for direct use. lf the article is transported in a non-viable form, there is no danger to
the environment; Due to the absence of a specified Environmental Management Plan (EMP) by
the traders/importers, the Committee would like to recommend that it be added to the
requirements for the issuance of an import permit by the Bureau of Plant lndustry (BPl)
(Section 26 of JDC No.1 s.2016); It is suggested that BPI ensure the following:
a) Implementation of the EMP by the traders/importers involved in the import, handling,
processing and transport of viable Cotton MON15985 x MON88913 commodity
products; and
b) Strict monitoring of the regulated article from port of entry to the trader's/importer's
storage/warehouse (Section 32 of the JDC No. 1 s.2016);
DOH Recommendation:
It is suggested that the Bureau of Plant Industry (BPI) ensure the following:
1) Strict monitoring of the regulated article from port of entry to the trader’s/importer’s
storage/warehouse as stated in Section 32 of the DC No.1 series, 2016
2) The BPI to include in the issuance of permit for the release of this product the following
conditions:
a. Any spillage (during unloading and loading/hauling and transport unloading
and storage) shall be collected and cleaned up immediately
b. Transportation of the consignment from the port of entry to any destination
within the country shall be in closed containers.
c. There shall be clear instructions that the product is only for the purpose of
direct use for food, feed or processing and is not to be used as planting
materials.
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interaction on the resulting gene products.
DENR Recommendation:
The effect of the regulated article on the environment depends largely on the viability of the product to be
utilized for direct use. lf the article is transported in a non-viable form, there is no danger to
the environment; Due to the absence of a specified Environmental Management Plan (EMP) by
the traders/importers, the Committee would like to recommend that it be added to the
requirements for the issuance of an import permit by the Bureau of Plant lndustry (BPl)
(Section 26 of JDC No.1 s.2016); It is suggested that BPI ensure the following:
a) Implementation of the EMP by the traders/importers involved in the import, handling,
processing and transport of viable Cotton MON15985 x MON88913 commodity
products; and
b) Strict monitoring of the regulated article from port of entry to the trader's/importer's
storage/warehouse (Section 32 of the JDC No. 1 s.2016);
DOH Recommendation:
It is suggested that the Bureau of Plant Industry (BPI) ensure the following:
1) Strict monitoring of the regulated article from port of entry to the trader’s/importer’s
storage/warehouse as stated in Section 32 of the DC No.1 series, 2016
2) The BPI to include in the issuance of permit for the release of this product the following
conditions:
a. Any spillage (during unloading and loading/hauling and transport unloading
and storage) shall be collected and cleaned up immediately
b. Transportation of the consignment from the port of entry to any destination
within the country shall be in closed containers.
c. There shall be clear instructions that the product is only for the purpose of
direct use for food, feed or processing and is not to be used as planting
materials.
Cotton MON15983 x MON88913 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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This application is not for propagation of the Cotton MON15983 x MON88913. This LMO will be directly used for food, feed and for processing.
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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.
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Cotton MON15983 x MON88913 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.
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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 ]
