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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Apr 2025
Safety Assessment of Alfalfa J163 for Direct Use as Food and Feed, or for Processing
EN
23 Sep 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,
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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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MON-ØØ163-7 - Roundup Ready™ alfalfa| Monsanto | Resistance to herbicides (Glyphosate)
The assessors— the Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry Biotech Team (BAI-BT), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOST-BC)— after reviewing the risk assessment report and attachments submitted by the applicant, concurred that Alfalfa J163 is (1) as safe for human food and animal feed as its conventional counterpart and (2) will not pose any significant risk to health and the environment.
The novel protein expressed by Alfalfa J163, cp4EPSPS, could be a potential allergen or toxin.
Using enzyme-linked immunosorbent assay (ELISA), the level of cp4EPSPS in Alfalfa J163 was determined at 270 μg/g tissue fresh weight. This represents a minimal amount of total protein in the consumed plant part. Therefore, the likelihood of exposure to cp4EPSPS through dietary exposure is minimal.
The possible consequences of the potential adverse effects of Alfalfa J163 were assessed in terms of the potential allergenicity and toxicity of the novel protein cp4EPSPS. Data generated through bioinformatics analyses, digestibility assay, heat stability study, and oral gavage study were therefore considered in the assessment. The assessors, through the weight-of-evidence approach, concluded that the cp4EPSPS expressed in Alfalfa J163 is not allergenic nor toxic.
Digestion with simulated gastric fluid (SGF) , and subsequent gel electrophoresis and western blot, showed that cp4EPSPS is digested within 15 seconds. Enzyme activity was also recorded to be reduced by >90% within 15 seconds of incubation in SGF.
Heat treatment followed by gel electrophoresis showed that the functional activity of cp4EPSPS decreases with increasing temperature, starting at 55°C.
Bioinformatics analysis using FASTA sequence alignment algorithm on ALLERGEN3 database and ALLPEPTIDES protein database indicated that cp4EPSPS is not homologous to any known allergen or toxin.
Lastly, oral gavage study demonstrated that there was no observable effect on body weight or food consumption between the control group and the cp4EPSPS-fed mice.
Proximate analysis of Alfalfa J163 and conventional alfalfa showed that there is no significant difference for protein, fat, ash, and moisture levels. Meanwhile, statistically significant differences for cystine, histidine, lysine, tyrosine, acid detergent fiber, and neutral detergent fiber levels were observed. It was noted, however, that these levels were within the 90% tolerance interval and are unlikely to be biologically relevant.
In view of these results and the minimal likelihood of exposure to cp4EPSPS, the assessors concluded that the overall risk for Alfalfa J163 is negligible.
Heat treatment followed by gel electrophoresis showed that the functional activity of cp4EPSPS decreases with increasing temperature, starting at 55°C.
Bioinformatics analysis using FASTA sequence alignment algorithm on ALLERGEN3 database and ALLPEPTIDES protein database indicated that cp4EPSPS is not homologous to any known allergen or toxin.
Lastly, oral gavage study demonstrated that there was no observable effect on body weight or food consumption between the control group and the cp4EPSPS-fed mice.
Proximate analysis of Alfalfa J163 and conventional alfalfa showed that there is no significant difference for protein, fat, ash, and moisture levels. Meanwhile, statistically significant differences for cystine, histidine, lysine, tyrosine, acid detergent fiber, and neutral detergent fiber levels were observed. It was noted, however, that these levels were within the 90% tolerance interval and are unlikely to be biologically relevant.
In view of these results and the minimal likelihood of exposure to cp4EPSPS, the assessors concluded that the overall risk for Alfalfa J163 is negligible.
The assessors— after finding that there is enough evidence that the regulated article is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health— recommended for the issuance of a biosafety permit for direct use as food and feed, or for processing, for Alfalfa J163.
EN
The assessors noted that alfalfa requires specific soil and weather conditions for growth. This sensitivity makes alfalfa unable to grow in inconducive receiving environments such as areas near ports, roads, and railways. Therefore, the chances of unintended release of Alfalfa J163 is very minimal.
Alfalfa J163 can be detected via event-specific quantitative real-time quantitative PCR.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
