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Risk Assessment
Record information and status
Record ID
114756
Status
Published
Date of creation
2019-05-30 03:39 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:39 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
ASSESSORS' CONSOLIDATED REPORT ON PIONEER HI-BRED'S APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING OF CORN DAS 59122-7
Date of the risk assessment
2018-04-04
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 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
DAS-59122-7 - Herculex™ RW Rootworm Protection maize
Resistance to diseases and pests - Insects - Coleoptera (beetles) Resistance to herbicides - Glufosinate
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
They also unanimously concurred that there are no known toxicants present in corn and that it has a low allergenicity potential. However, some individuals show allergic reaction possibly brought about by the following proteins: 9kDa lipid transfer protein, and 50 kDa protein reduced in soluble fraction (zeins). Some case studies report that in few reported cases of corn allergy, symptoms are mild.
Likelihood that the potential adverse effects will be realized
All STRPs are in agreement that all information relative to the toxicological assessment done to the 3
proteins, namely Cry34Ab1, Cry35Ab1 and PAT are sufficiently described. They also agreed that the
information on the digestibility studies, heat inactivation studies, Amino acid sequence comparison
studies, acute oral gavage studies and protein equivalence to source proteins of the three expressed
novel proteins are adequate.
However, 2 of the STRPs has stated that the novel proteins are expressed independently of each
other while 1 has stated that they are expressed constitutively and together, however, all three of
them has stated that the proteins are expressed in different tissues. They also agree that
independently, Cry34Ab1 and Cry25Ab1 are ineffective since the 2 proteins are binary in nature and
do not have significant insecticidal activity independently and that they are not involved in
metabolic pathways in plants.

All STRPs are in agreement that all information relative to the allergenicity assessment done to the 3
proteins, namely Cry34Ab1, Cry35Ab1 and PAT are sufficiently described. They also agreed that the
information on the digestibility studies, heat inactivation studies, Amino acid sequence comparison
studies including physico-chemical properties, prevalence in food and serum screening studies of
the three expressed novel proteins are adequate.
They also concurred that the 3 proteins are easily digested, heat labile and have no known homology
to known toxins or allergens as demonstrated by the abovementioned studies enumerated. They
also concur that the three proteins are not glycosylated; that protein levels in food are expected to be
lower due to reductions that are likely to occur during processing; and that serum screening was not
needed since all three proteins are completely degraded, digested in the stomach, hence these
proteins are no longer available for absorption and thus are not present in the serum.
Possible consequences:
The STRP unanimously agreed that corn is a source of key nutrients both for human and animals. It
is a source of carbohydrates, proteins, lipids, minerals and vitamins. However, they also agree that it
contains a number of anti-nutrients, such as: phytic acid, DIMBOA, and raffinose, like all other corns
in cultivation.

Estimation of the overall risk
For the transgenic DAS 59122-7 maize, enough evidence is provided to support the equivalence
of the genetically modified crop, in terms of the nutritional composition, agronomic
characteristics and food safety, with the conventional maize other than the protection from corn
rootworm damages and tolerance to glufosinate ammonium herbicides. After reviewing the
provided material of Pioneer Hi-Bred Philippines, Inc., it is therefore concluded that DAS 59122-
7 maize is substantially equivalent as its conventional counterpart.
Recommendation(s)
After a thorough evaluation of the documents provided by the applicant, the assessors find scientific
evidence that the regulated article applied for human food and animal feed use is as safe as its
conventional counterpart and shall not pose any significant risk to human and animal health
Need(s) for further information on specific issues of concern
DAS 59122-7 maize is safe for human food, livestock feed and for processing as its conventional counterparts.
Receiving environment(s) considered
This application is not for propagation of the DAS 59122-7 maize. 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 DAS 59122-7 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