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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-103781-3   |   PDF   |   Print   |  
published: 16 Aug 2012 last updated: 25 Mar 2025
General Information
Determination of the Safety of Bayer's LLRICE62 event (Herbicide Tolerant) For Direct Use as Food and Feed or for Processing
EN
16 May 2012
Risk assessment details
Methodology and points to consider
The PAT protein belongs to a class of acetyltransferase enzymes that are common to plants and animals. There are no reports of toxicity or allergenicity associated with these proteins.
EN
Glufosinate ammonium plants expressing PAT proteins have been in commercial cultivation since the late 1990s. There is no evidence for any adverse effects resulting from the use of these products in food or feed.
EN
The PAT enzyme expressed by LLRICE62 does not possess characteristics associated with food toxins or allergens: it shares no sequence homology with known allergens or toxins, it has no N-glycosylation sites, and it is rapidly degraded in simulated gastric and intestinal fluids.
EN
LLRICE62 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health
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A biosafety permit for LLRICE62 and all progenies derived from crosses of the product with any conventionally bred rice for direct use was issued to Bayer CropScience, Inc. on May 16, 2012.After thorough assessment, the following conclusion was made: LLRICE62 is as safe and nutritious as conventional rice for consumptions by humans and animals. 
EN
It is concluded that rice containing the LLRICE62 event is as safe as conventional rice. This conclusion applies to any rice containing the LLRICE62 event, except where it is combined with other biotech traits through conventional breeding. Rice containing the LLRICE62 event is as safe and nutritious as conventional rice and is therefore approved for direct use as food and feed or for processing. 
EN
This LMO will be directly used for food, feed and for processing. This application is not for propagation of LLRICE62.
EN
Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
EN
Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
LLRICE62 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 and DA Regulatory  Agencies during the evaluation of this event.
EN
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