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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Apr 2025
Safety Assessment of Cotton MON88701 for Direct Use as Food and Feed, or for Processing
EN
31 May 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-887Ø1-3 - Dicamba- and Glufosinate-tolerant cotton| Monsanto | Resistance to herbicides (Glufosinate)
- MON88701_FFP.pdf [ English ]
The assessors— the Scientific and Technical Review Panel (STRP), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOST-BC)— conducted a risk assessment of the technical dossier and concluded that Cotton MON88701 is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health, as well as to the environment and biodiversity.
Cotton MON88701 expresses the novel proteins Stenotrophomonas maltophilia dicamba monooxygenase (DMO) and the Streptomyces hygroscopicus phosphinothricin N-acetyltransferase (PAT), which may potentially pose allergenic or toxic risks.
The history of safe use of the donor organisms (Stenotrophomonas maltophilia and Streptomyces hygroscopicus) are well documented and no safety or allergenicity issues have been identified. Hence, the transgenes derived from these donors are unlikely to pose new risks of adverse reaction.
With respect to exposure through the diet, the novel proteins DMO and PAT are present at low levels in the harvested cottonseed and are essentially at negligible levels in the final product (cottonseed flour and oil, and other forms used for food applications) due to the manufacturing process. Therefore, the likelihood of the potential adverse effects being realized, should there be any, is very low.
With respect to exposure through the diet, the novel proteins DMO and PAT are present at low levels in the harvested cottonseed and are essentially at negligible levels in the final product (cottonseed flour and oil, and other forms used for food applications) due to the manufacturing process. Therefore, the likelihood of the potential adverse effects being realized, should there be any, is very low.
Digestibility test, bioinformatics analyses, and heat stability studies were conducted to investigate the potential toxicity and allergenicity of PAT and DMO proteins. Both proteins showed rapid digestion (within 5 minutes) under incubation with simulated gastric fluid (SGF) and simulated intestinal fluid (SIF). PAT and DMO proteins were also shown to be inactivated and undetectable at high temperatures. Using the TOX_2011 database and FASTA sequence alignment program, the novel proteins were not shown to have significant similarity or homology with known toxins or allergens. Lastly, oral gavage study demonstrated no treatment-related effects on survival and clinical observations. Taken together, the results point to the conclusion that PAT and DMO proteins are unlikely to cause allergenic or toxic responses since these are easily degraded or inactivated.
Considering the low expression levels (which is further reduced during processing), and the absence of evidence of potential allergenicity and toxicity of the novel proteins, the estimated overall risk for Cotton MON88701 is negligible.
In view of these, the assessors recommended for the approval of Cotton MON88701 for direct use as food and feed, or for processing.
EN
The DENR-BC concurred that the chances of unintended release or planting of the regulated article is very minimal and will not cause any damaging and lasting effects because cotton cannot persist in unfavorable environments (such as areas near the port, roads, railways, etc.) without human assistance.
Cotton MON88701 can be detected via event-specific qPCR protocol.
Yes
Yes
Yes
Yes
Yes
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
