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Risk Assessment
Record information and status
Record ID
114765
Status
Published
Date of creation
2019-05-30 03:46 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:46 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of the Safety of BASF's Oilseed Rape RF3 for Direct use as Food, Feed, or Processing
Date of the risk assessment
2018-11-21
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
ACS-BNØØ3-6 - InVigor™ canola
Changes in physiology and/or production - Fertility restoration 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
Likelihood that the potential adverse effects will be realized
Safety assessments conducted on RF3 oilseed rape demonstrate no potential effects on human and animal health and the environment. Barstar in RF3 is expressed selectively in the tapetum during anther development therefore no exposure is expected to the Barstar 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.
Possible consequences:
Some anti-nutrients are present in low erucic acid rapeseed meal like glucosinolates, sinapine, tannins and phytic acid in very small amount, hence not considered a health concern for man and animals. Glucosinolates, considered toxicants, are low to zero. While these may be considered "toxicants" the bioactive compound may also be beneficial in cases of the Brassica species, e.g., cabbage, which is considered in phytomedicine as "anti-cancer."

Allergy to plants of Brassica species have been seen to have a shared sensitivity to other food allergens and is likely to be from other food allergens than from Brassica. The overall risk is very low as an allergen.
Estimation of the overall risk
Oilseed Rape RF3 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Recommendation(s)
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 RF3, 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.
Need(s) for further information on specific issues of concern
Oilseed Rape RF3 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Receiving environment(s) considered
This application is not for propagation of the Oilseed Rape RF3. 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
Oilseed Rape RF3 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