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Risk Assessment
Record information and status
Record ID
114754
Status
Published
Date of creation
2019-05-30 03:38 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:38 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
CONSOLIDATED REPORT OF MONSANTO PHILIPPINES' COTTON MON15983 x MON88913 APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING
Date of the risk assessment
2018-05-28
Institution responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Department of Environment and Natural Resources
Visayas Avenue
Quezon City
Philippines, 1100
Phone:+632 925-2329, +632 920-4352
Fax:+632 920-4301
Email:osec@denr.gov.ph
Url:DENR,PAWB
Department of Health
San Lazaro Compound, Sta. Cruz
Manila
Philippines
Phone:+632 651 7801; +623 651 7800
Fax:+632 743 1829
Email:etona@co.doh.gov.ph
Url:DOH Website
Contact details of the main responsible risk assessor
Ms. Ma. Lorelei U. Agbagala
Supervising Agriculturist
Post Entry Quarantine
Bureau of Plant Industry (BPI)
Economic Garden
Los Banos, Laguna
Philippines, 4030
Phone:+63 49 536 1678
Fax:+63 49 536 1678
Email:lorelieu5@gmail.com
Url:Bureau of Plant Industry
Risk assessment details
Living modified organism
MON-88913-8 x MON-15985-7 - Roundup Ready™ Flex™ Bollgard II™ cotton
Resistance to antibiotics - Kanamycin, Streptomycin Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
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.
Possible consequences:
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).
Estimation of the overall risk
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.
Recommendation(s)
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.
Need(s) for further information on specific issues of concern
Cotton MON15983 x MON88913 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Receiving environment(s) considered
This application is not for propagation of the Cotton MON15983 x MON88913. This LMO will be directly used for food, feed and for processing.
LMO detection and identification methods proposed
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.
Additional Information
Additional Information
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.
Other relevant website address or attached documents