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Risk Assessment generated by a regulatory process
(RA)
published: 18 Sep 2008
last updated: 26 Mar 2025
Determination for the Safety Assessment of Corn 59122 for Direct Use as Food, Feed and for Processing
EN
09 Aug 2011
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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,
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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)
- DA-BPI Biotechnology Office [ English ]
EN
Bacillus thuringiensis, source of cry34Ab1 and cry35Ab1 genes has no history of causing allergies despite its use for over 30 years as microbial pesticide, Neither the PAT protein nor Streptomyces viridochromogenes, the source of pat gene have a history of causing allergy based on a numbers of published reports. Both Cry34Ab1 and Cry35Ab1 proteins show no homology to the sequence of known protein allergens as shown when using sequence evaluation scheme based on extensive assessment conducted.
Since the novel proteins are degraded on exposure to mammalian gastric fluid, non toxic to mice even at high dose, readily and deactivated by heat/cooking, all the inserted proteins/genes do not interact nor interfere with existing metabolic pathways.
EN
Since the novel proteins are degraded on exposure to mammalian gastric fluid, non toxic to mice even at high dose, readily and deactivated by heat/cooking, all the inserted proteins/genes do not interact nor interfere with existing metabolic pathways.
Many studies conducted demonstrated that Cry34AB1, Cry35Ab1 and PAT proteins are readily digested or degraded in mammalian gastric fluid, deactivated when exposed to heat and show no adverse effect to laboratory mice using acute toxicity test. Based on the supporting documents submitted by the applicant, all the three genes (cry34Ab1, cry35Ab1 and pat) were demonstrated to be non-toxic and non-allergenic, hence no concern or risk to animal and human health.
EN
59122 maize is comparable with its conventional counterpart and will not pose any significant risk through consumption by both animals (for feed) and humans (for food).
EN
A biosafety permit for 59122 maize and all progenies derived from crosses of the product with any conventionally-bred corn and corn containing approved-biotech events for direct use as food, feed and for processing was issued to Pioneer Hi-Bred and Dow AgroSciences
EN
59122 maize is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This LMO will be directly used for food, feed and for processing. This application is not for propagation of this event.
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
EN
Yes
Yes
Yes
Yes
Yes
59122 maize 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 during the evaluation of 59122 maize.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of 59122 maize.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of 59122 maize.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of 59122 maize.
- OECD Consensus Document on Corn [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
