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Risk Assessment generated by a regulatory process
(RA)
last updated: 05 Apr 2025
Safety Assessment of Alfalfa J101 for Direct Use as Food and Feed, or for Processing
EN
10 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-ØØ1Ø1-8 - 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 (BAI), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC)— found that there is no significant difference between Alfalfa J101 and its conventional counterpart. Further, the assessors concluded that Alfalfa J101 will not pose any significant risk to human and animal health, and to the environment.
The novel protein expressed by Alfalfa J101, cp4EPSPS, may be a potential new allergen or toxin.
In order to determine the likelihood of the potential adverse effects of Alfalfa J101 being realized, it is important to trace the pathway to harm. Assessors, therefore, framed the problem in terms of exposure to the regulated article through the diet. By looking at the concentration of cp4EPSPS in various plant tissues, as quantified through enzyme-linked immunosorbent assay (ELISA), the assessors noted that the mean level of cp4EPSPS in J101 alfalfa is 276 μg/g fresh weight. This
represents a meager 0.6% of the total protein in alfalfa forage. Dietary exposure to cp4EPSPS and, therefore, the likelihood of the potential adverse effects being realized is highly unlikely.
represents a meager 0.6% of the total protein in alfalfa forage. Dietary exposure to cp4EPSPS and, therefore, the likelihood of the potential adverse effects being realized is highly unlikely.
The possible consequences of the potential adverse effects of Alfalfa J101 were assessed in terms of the potential allergenicity and toxicity of the novel protein cp4EPSPS.
Using SDS-PAGE and western blot assay, cp4EPSPS was shown to be rapidly degraded (within 15 seconds) after incubation in simulated gastric fluid (SGF). The determination of the enzymatic activity of cp4EPSPS following heat treatment showed that at 75°C, the functional activity of cp4EPSPS is below the limit of detection, indicating that cp4EPSPS was denatured.
Bioinformatics analyses at ALLPEPTIDES, a protein database, indicated that cp4EPSPS does not share homology with any known toxin. Lastly, oral gavage study in mice demonstrated that the no effect level (NOEL) for cp4EPSPS is 572 mg/kg body weight, which was notably the highest dose tested.
Taken together, the results indicate that cp4EPSPS is unlikely to pose a concern to human and animal health since it does not possess characteristics associated to allergens or toxins.
Using SDS-PAGE and western blot assay, cp4EPSPS was shown to be rapidly degraded (within 15 seconds) after incubation in simulated gastric fluid (SGF). The determination of the enzymatic activity of cp4EPSPS following heat treatment showed that at 75°C, the functional activity of cp4EPSPS is below the limit of detection, indicating that cp4EPSPS was denatured.
Bioinformatics analyses at ALLPEPTIDES, a protein database, indicated that cp4EPSPS does not share homology with any known toxin. Lastly, oral gavage study in mice demonstrated that the no effect level (NOEL) for cp4EPSPS is 572 mg/kg body weight, which was notably the highest dose tested.
Taken together, the results indicate that cp4EPSPS is unlikely to pose a concern to human and animal health since it does not possess characteristics associated to allergens or toxins.
To establish substantial equivalence of Alfalfa J101 to its conventional counterpart, the levels of protein, fat, ash, and moisture were compared. There were no significant differences observed in the levels of the analytes for Alfalfa J101 and non-transgenic alfalfa. Key nutrients and some amino acid levels, however, were found to have statistically significant differences with the non-transgenic alfalfa. When compared to data of other alfalfa varieties grown under the same environmental conditions, the test values of key nutrients were found to be within the tolerance interval. Therefore, compositional analysis of Alfalfa J101 indicates that it is as safe as its conventional counterpart.
In view of the results of the toxicological and allergenicity studies, the minimal likelihood of exposure to cp4EPSPS, and the substantial equivalence of Alfalfa J101 to its conventional counterpart, the assessors concluded that the overall risk for Alfalfa J101 is negligible.
In view of the results of the toxicological and allergenicity studies, the minimal likelihood of exposure to cp4EPSPS, and the substantial equivalence of Alfalfa J101 to its conventional counterpart, the assessors concluded that the overall risk for Alfalfa J101 is negligible.
The assessors deemed that the risks associated with Alfalfa J101 are acceptable and manageable, as long as the regulated article is strictly used for the application for which it is submitted. As such, the assessors recommended for the biosafety permit for the direct use as food and feed, or for processing, of Alfalfa J101.
EN
The chances of the unintended release of the regulated article is very minimal because the receiving environment, which coincide with the route of transport (ports, roads, railways, etc.), is not conducive for plant growth. In addition, these areas do not possess the necessary conditions that the alfalfa plant requires in order to grow.
Event-specific real-time quantitative PCR based method for Alfalfa J101 is available.
Yes
Yes
Yes
Yes
Yes
EN
