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Risk Assessment
Record information and status
Record ID
114758
Status
Published
Date of creation
2019-05-30 03:42 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:42 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
ASSESORS' CONSOLIDATED REPORT ON SYNGENTA'S STACKED HERBICIDE TOLERANCE (GLUFOSINATE TOLERANT AND MESOTRIONE HERBICIDE TOLETANT) APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING OF SOYBEAN SYHT0H2
Date of the risk assessment
2018-06-22
Institution responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Department of Environment and Natural Resources
Visayas Avenue
Quezon City
Philippines, 1100
Phone:+632 925-2329, +632 920-4352
Fax:+632 920-4301
Email:osec@denr.gov.ph
Url:DENR,PAWB
Department of Health
San Lazaro Compound, Sta. Cruz
Manila
Philippines
Phone:+632 651 7801; +623 651 7800
Fax:+632 743 1829
Email:etona@co.doh.gov.ph
Url:DOH Website
Contact details of the main responsible risk assessor
Ms. Ma. Lorelei U. Agbagala
Supervising Agriculturist
Post Entry Quarantine
Bureau of Plant Industry (BPI)
Economic Garden
Los Banos, Laguna
Philippines, 4030
Phone:+63 49 536 1678
Fax:+63 49 536 1678
Email:lorelieu5@gmail.com
Url:Bureau of Plant Industry
Risk assessment details
Living modified organism
SYN-ØØØH2-5 - Soy modified for tolerance to Mesotrione and Glufosinate
Resistance to herbicides - Glufosinate
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Methodology and points to consider
Potential adverse effects identified in the risk assessment
No unintended, adverse consequences of the transformation process or expression of the transgenes in SYHT0H2 were evident that will affect human health and no possible risk in animal health as shown in the poultry feeding study.
Likelihood that the potential adverse effects will be realized
The protein used in the assessment of toxicity was microbially produced AvHPPD03 from Eschericia coli and is reportedly non-toxic to mice as evidenced by the absence of mortality during two and 14-day observation. Sufficient data and analyses were provided by the developer indicating that the microbially produced AvHPPD-03 is biochemically and functionally equivalent to AvHPPD-03 produced in SYHT0H2 soybean and therefore is a suitable surrogate to evaluate the safety of AvHPPD-03 produced in SYHT0H2 soybean.

Safety evaluation supports the innocuousness of the PAT gene which does not possess characteristics of a toxin or allergen, no N-glycosylation sites, easily degraded by gastric and intestinal fluids and devoid of adverse effects in mice after IV injection of a high dose. Utilizing the NCBI Entrez Protein Database in search of the similarity of the PAT amino acid sequences shows that it has no homologies with known toxins.

Acute Oral Gavage tests were performed and reasonable certainty of safety is expected from the inclusion of PAT proteins inhuman food and animal feed.

Both proteins were degraded by SGF and were inactivated at 65 oC and 55 0C respectively, no homology with any known or putative allergen, and there are reportedly no post-translational glycosylation in plant and microbiologically produced PAT proteins. There is a minimal chance of dietary exposure to the AvHPPD-03 and PAT protein via the transgenic soybean since they are estimated to be destroyed during processing when subjected to high temperatures.
Possible consequences:
No unintended, adverse consequences of the transformation process or expression of the transgenes in SYHT0H2 were evident that will affect human health and no possible risk in animal health as shown in the poultry feeding study.
Estimation of the overall risk
The regulated article applied for human food and animal feed use is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health.
Recommendation(s)
After reviewing the Risk Assessment Report and attachments submitted by the applicant, the assessors namely: Scientific and Technical Review Panel (STRP), BPI Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry- Biotech Team (BAI-BT), concurred that corn soybean SYHT0H2 is as safe for human food and animal feed as its conventional counterpart.

The Department of Environment and Natural Resources - Biosafety Committee (DENR-BC), after a thorough scientific review and evaluation of the documents related to Environmental Risk along with the submitted sworn statement and accountability of the proponent, recommended the issuance of a biosafety permit for this regulated event provided the conditions set by DENR are complied. Also, the Department of Health - Biosafety Committee (DOH-BC), after a thorough scientific review and evaluation of documents related to Environmental Health Impact, concluded that soybean SYHT0H2 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department. DOH-BC also recommended for the issuance of biosafety permit for soybean SYHT0H2.
Need(s) for further information on specific issues of concern
SOYBEAN SYHT0H2 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
Receiving environment(s) considered
This application is not for propagation of the SOYBEAN SYHT0H2. This LMO will be directly used for food, feed and for processing.
LMO detection and identification methods proposed
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR may be used.
Additional Information
Additional Information
Soybean SYHT0H2 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, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.
Other relevant website address or attached documents