Record details

General Information

Country

Philippines

Title of risk assessment

Determination of the Safety of Bayer's LLRICE62 event (Herbicide Tolerant) For Direct Use as Food and Feed or for Processing

Date of the risk assessment

2012-05-16

Competent National Authority(ies) responsible for the risk assessment

Department of Agriculture

Elliptical Circle, Diliman

Quezon City

Philippines, 1100

Phone:	+632 928-8762 to 65 loc. 2210/2214/2254 ;+632 920-4369
Fax:	+632 920-3986
Email:	spja_osec@da.gov.ph
Url:	DA

Record #46524

Risk assessment details

Living modified organism

ACS-OSØØ2-5 - Liberty Link™ rice

Resistance to herbicides - Glufosinate

Record #14859

Scope of the risk assessment

LMOs for direct use as feed
LMOs for direct use as food
LMOs for processing

Risk assessment report / Summary

DA-BPI Biotech Website

Methodology and points to consider

Potential adverse effects identified in the risk assessment

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.

Likelihood that the potential adverse effects will be realized

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.

Possible consequences:

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.

Estimation of the overall risk

LLRICE62 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health

Recommendation(s)

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.

Need(s) for further information on specific issues of concern

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.

Receiving environment(s) considered

This LMO will be directly used for food, feed and for processing. This application is not for propagation of LLRICE62.

LMO detection and identification methods proposed

Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.

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.