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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 BASF's Oilseed Rape MS8 for Direct use as Food, Feed, or Processing
EN
21 Nov 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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ACS-BNØØ5-8 - InVigor™ canola| Bayer CropScience | Changes in physiology and/or production (Reproduction, Male sterility), Resistance to antibiotics (Kanamycin), Resistance to herbicides (Glufosinate)
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Safety assessments conducted on MS8 oilseed rape demonstrate no potential effects on human and animal health and the environment. Barnase in MS8 is expressed selectively in the tapetum during anther development. Therefore, no exposure is expected to the Barnase protein for animals or humans. The PAT protein has well understood activity, substrate specificity and share similar structural and functional properties with the class of acetyltransferase proteins that are widely distributed in nature. The PAT proteins share no sequence homology with known allergens and toxins and are not stable in digestive environments. An acute gavage study in mice found no adverse effects from exposure to a high oral dose of the PAT protein. The donor organisms, the introduced genes and the expressed proteins are widely distributed in nature and ubiquitous in the environment.
EN
Low erucic acid rapeseed contains pigments such as chlorophyllides and pheophorbides which may present nutritional effect due to their phototoxicity which may be followed by photosensitive dermatitis. Such pigments are being removed in the bleaching step during the processing. Also, the poisoning effect of the catalysts are being mitigated through grading standards where the lots which exceed the maximum tolerance level are rejected. The seed contains glucosinolates and phenolic compounds such as tannin, sinapine and phytic acid while the meal is known to contain glucosinolates only.
OECD Consensus Document (2011) indicated that several published studies reporting sensitivity and allergenicity of adults to Brassica species. Most describe rare cases of respiratory symptoms are due to occupational exposure. Allergenicity to low erucic acid rapeseed oil has not yet been reported in scientific literatures. This is probably due to the very low levels or absence of protein in low erucic acid rapeseed oil.
EN
OECD Consensus Document (2011) indicated that several published studies reporting sensitivity and allergenicity of adults to Brassica species. Most describe rare cases of respiratory symptoms are due to occupational exposure. Allergenicity to low erucic acid rapeseed oil has not yet been reported in scientific literatures. This is probably due to the very low levels or absence of protein in low erucic acid rapeseed oil.
Oilseed Rape MS8 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 BASF Philippines Inc., it is concluded that oilseed rape MS8, and all progenies derived from crosses of the product with any conventionally-bred oilseed rape, and oilseed rape 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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Oilseed Rape MS8 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 Oilseed Rape MS8. 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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Oilseed Rape MS8 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 ]
