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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 30 May 2019
Determination of the Safety of Monsanto's Soybean MON87701 for Direct use as Food, Feed, or Processing
EN
22 Jun 2018
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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, -
Competent National Authority:Department of Environment and Natural Resources ()Visayas Avenue, DilimanQuezon City, Metro Manila
1100, PhilippinesPhone: (02) 8925-8277,Fax:Email: actioncenter@denr.gov.ph, osec@denr.gov.ph,Website: http://www.denr.gov.ph, -
Competent National Authority:Department of Health ()Tayuman, Sta. CruzManila, Metro Manila
1003, PhilippinesPhone: (632) 8651-7800,Fax:Email: callcenter@doh.gov.ph,Website: http://www.doh.gov.ph,
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Person:Ms. Ma. Lorelei U. AgbagalaSupervising Agriculturist, Post Entry QuarantineEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Government agency (National/Federal)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,
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MON-877Ø1-2 - Insect resistant soybean| Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths))
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The CryAc protein represents no more than 0.0012% of the total protein in the seed of MON 87701. Therefore, the CryAc protein would constitute a very small portion of the total protein present in feed and food derived from MON 87701. Bioinformatics analyses demonstrated that the CryAc protein do not share structurally or immunologically relevant amino acid sequence similarities with known allergens. Thus, it is highly unlikely that the CryAc protein contains immunologically cross-reactive allergenic epitopes. Digestive fate experiments conducted with E. coli-produced CryAc demonstrated that the protein is rapidly digested in simulated digestive fluids, a characteristic shared among proteins with a history of safe consumption. Taken together, these data support the conclusion that the CryAc protein presents in MON 87701 is not similar to known allergens and does not pose a significant allergenic risk to humans or animals.
EN
The levels of anti-nutrient in MON 87701 are compositionally equivalent to that of the conventional soybean. In addition, MON 87701 is intended to provide insect protection; therefore, no changes should be anticipated on amount of material consumed, the characteristics of the edible parts of the plant or in the use pattern and processing procedure of MON 87701, compared to conventional soybean.
In general, soybean processing for food use includes various procedures such as steam cooking, baking, drying and cooling, fermenting, roller milling, grinding and etc. Some degree of heating, mechanical and chemical disruption may accompany those processes, which may or may not affect the level of anti-nutrients. Nevertheless, the level of anti-nutrients in processed products of MON 87701 and the conventional control would be expected to be similar, as there was no difference in the levels of anti-nutrients in MON 87701 compared to control soybean.
EN
In general, soybean processing for food use includes various procedures such as steam cooking, baking, drying and cooling, fermenting, roller milling, grinding and etc. Some degree of heating, mechanical and chemical disruption may accompany those processes, which may or may not affect the level of anti-nutrients. Nevertheless, the level of anti-nutrients in processed products of MON 87701 and the conventional control would be expected to be similar, as there was no difference in the levels of anti-nutrients in MON 87701 compared to control soybean.
Soybean MON87701 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
Based on the results of the risk evaluation of the submitted scientific data and other information relevant to the application of Monsanto Philippines Inc., it is concluded that soybean MON87701, and all progenies derived from crosses of the product with any conventionally-bred soybean, and soybean containing approved-biotech events for direct use as food, feed or for processing, is as safe and substantially equivalent to its unmodified counterpart, and is therefore approved for direct use as food, feed or for processing
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Soybean MON87701 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
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This application is not for propagation of the Soybean MON87701. This LMO will be directly used for food, feed and for processing.
EN
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.
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Soybean MON87701 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.
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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.
- ISAAA [ English ]
