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Risk Assessment
Record information and status
Record ID
114751
Status
Published
Date of creation
2019-05-30 03:36 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:36 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
ASSESSORS' CONSOLIDATED REPORT OF MONSANTO'S CORN MON88017 FOR FOOD, FEED AND OR PROCESSING
Date of the risk assessment
2018-01-04
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 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
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
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-88Ø17-3 - YieldGard™ VT™ Rootworm/RR2™ Maize
Resistance to diseases and pests - Insects - Coleoptera (beetles) Resistance to herbicides - Glyphosate
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
Potential adverse effects identified in the risk assessment
DENR Observations:
1. 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 nonviable form, there is no danger to the environment;
2. 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)
(Article Vlll, Section 26 of JDC No,1 s.2016);

DOH Observation:
1. On the description of the phases or stages of the biotechnology project, Monsanto
Philippines Inc. claimed that Corn MON88017 does not pose greater risks to human when
brought to loading/unloading, transport, storage or processing.
2. On the risk to Health Matrix (Integration of the health consequence rating with incident
potential rating), the Monsanto Philippines, Inc. rated the activities of the phases of project
a very low incident/exposure potential rating.
3. Scientific pieces of evidences from provided references i.e. literatures show that
regulated article 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.
Likelihood that the potential adverse effects will be realized
In its very long history of safe use and utilization, the assessors accepted that corn
MON88017 is not a source of toxicants. They also accepted that it is not a source of
common allergen although some case studies reported that individuals could have allergic
reaction to corn due to presence of a 9 kilodalton (kd) lipid transfer protein, 16 kd trypsin
inhibitor and zeins. These reported allergic effects for maize include skin, gastrointestinal
and respiratory complaints. However, clinical relevance of these findings is uncertain
(Hefle, 1996 and OECD, 2002 p. 29).
Possible consequences:
The levels of anti-nutrient in MON88017 are compositionally equivalent to that of
the conventional corn. Processing may lower the level of anti-nutrient in MON 88017 as
same amount as it reduces the level in the conventional corn. PPSSD site examples that
processing may lower the level of anti-nutrient. The raffinose can be removed in corn by
soaking, cooking, enzyme or solvent treatment and by irradiation. On the other hand,
phytic acid is present in maize and binds about 60-75% of the phosphorus in the form of
phytate (NRC, 1998). Bioavailability of phosphorus in maize is 15% for non-ruminants.
Ruminants utilize considerably more phosphorus and can produce phytase that breaks
down the phytate and releases phosphorus (Ensminger et al., 1990). Processing of maize,
fresh and dry for the production of various traditional products results in the loss of phytic
acid. Fresh mature corn contains less phytic acid (1.71 g kg−1) than dry corn (7.15-7.60 g
kg−1). The loss of phytic acid varies from 18.1 to 46.7% for fresh maize and from 11.5 to
52.6% for dry maize respectively among the heat treatments given (Khan et al., 1991).
Estimation of the overall risk
The STRPs together with BAI and PPSSD unanimously find the scientific evidence provided
by the applicant is sufficient in showing that the regulated article being applied for direct
use is as safe for human and animal health, and the environment, as its conventional
counterpart.
Recommendation(s)
DENR suggested that BPI ensure the following:
a) development of guidelines on the EMP in coordination with DENR;
b) implementation of the EMP by the traders/importers involved in the import,
handling, processing and transport of viable Corn MON88017 commodity
products; and
c) 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 suggested that BPI ensure the following:
a. Strict monitoring of the regulated article from port of entry to the trader's/
importers storage/warehouse as stated in Section 32 of the JDC No. 1 series,
2016.
b. The BPI to include in the issuance of permit for the release of this product the
following conditions:
b.1. Any spillage (during unloading and loading/hauling and transport unloading
and storage) shall be collected and cleaned up immediately.
b.2. Transportation of the consignment from the port of entry to any destination
within the country shall be in closed containers.
b.3. There shall be a clear labeling of the product from importation down to all levels
of marketing stating that it is only for the purpose of direct use as food and feed
or processing and is not to be used as planting materials.


Need(s) for further information on specific issues of concern
The STRPs together with BAI and PPSSD unanimously find the scientific evidence provided
by the applicant is sufficient in showing that the regulated article being applied for direct
use is as safe for human and animal health, and the environment, as its conventional
counterpart.
Receiving environment(s) considered
This application is not for propagation of the Corn MON88017. 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
Corn MON88017 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