ASSESSORS' CONSOLIDATED REPORT ON PIONEER HI-BRED'S APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING OF CORN DAS 59122-7 | BCH-IRA-SCBD-114756 | Risk Assessment generated by an independent or non-regulatory process | Biosafety Clearing-House

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Risk Assessment generated by an independent or non-regulatory process (IRA)
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BCH-IRA-PH-114756-1   |   PDF   |   Print   |  
last updated: 30 May 2019
General Information
ASSESSORS' CONSOLIDATED REPORT ON PIONEER HI-BRED'S APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING OF CORN DAS 59122-7
EN
04 Apr 2018
Risk assessment details
  • DAS-59122-7 - Herculex™ RW Rootworm Protection maize
    | Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Coleoptera (beetles)), Resistance to herbicides (Glufosinate)
Methodology and points to consider
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.
EN
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.
EN
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.

EN
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.
EN
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
EN
DAS 59122-7 maize is safe for human food, livestock feed and for processing as its conventional counterparts.
EN
This application is not for propagation of the DAS 59122-7 maize. 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.
EN
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.
EN