| | english | español | français |
Go to record ID

  Home|Finding Information|Record details   Printer-friendly version

Risk Assessment
Record information and status
Record ID
114753
Status
Published
Date of creation
2019-05-30 03:37 UTC (estaciojulietafe@gmail.com)
Date of publication
2019-05-30 03:37 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
ASSESSORS' CONSOLIDATED REPORT ON BAYER'S APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING OF SOYBEAN A5547-127
Date of the risk assessment
2017-02-01
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
Mr. Ariel J. Bayot
Officer-In-Charge Chief
National Plant Quarantine Services Division
Bureau of Plant Industry (BPI)
San Andres
Malate, Manila
Philippines
Phone:+63 2 404-0409
Fax:+63 2 404-0409
Email:ajbayot@yahoo.com
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
ACS-GMØØ6-4 - Liberty Link™ soybean
Resistance to herbicides - Glufosinate
Show detection method(s)
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
Likelihood that the potential adverse effects will be realized
The amino acid sequence of PAT protein showed no homology to known toxins based on bioinformatics
analysis, wherein over-all identity search compared the PAT sequence with all proteins in available
databases, including those for allergens and toxins. There were also no biologically relevant identities found
with any toxic proteins from the Bayer toxin database.
Moreover, acute oral toxicity for the PAT protein was tested using 10 male and 10 female C57BL/6J mice by
oral gavage at the highest dose possible of 2000 mg/kg body weight. It was found that there was no
treatment-related clinical signs, no adverse effects on body weight or food consumption, and no macroscopic
changes in organs at necropsy, thus, PAT at 2000 mg/kg, body weight through oral route, did not result in
systemic toxicity on the test subjects.

The amino acid sequence of PAT protein showed no homology to known toxins based on bioinformatics
analysis, wherein over-all identity search compared the PAT sequence with all proteins in available
databases, including those for allergens and toxins. There were also no biologically relevant identities found
with any toxic proteins from the Bayer toxin database. In addition, it was also found out through homology
search that glycosylation sequences yielded no potential N-glycosylation sites in the PAT query sequence.
Furthermore, it was also found out that the predicted dietary intake of PAT after consumption of A5547-127
soybean in regional diets ranges between 1.1 (Latin America) to 47.3 (Middle east) microgram per person per
day, and that, after serum screening of soy extracted from two parental soybean lines and corresponding
transgenic varieties, the results show that there was no significant difference in the level of native soy
allergen in the transgenic soybean extracts as compared to the soy extracts from parental lines.
Possible consequences:
The STRPs concurred that the information submitted by the applicant regarding the nutritional data of
soybean A5547-127 are adequate. It was found out through proximate analysis between event A5547-127
and its non-transgenic counterpart, and those from reported soybean varieties found in the literature, with
the following parameters: crude fat, ash, total carbohydrate, ADF and NDF, that all the values between the
transgene and non-transgene are within reference range, thus soybean seed from event A5547-127 have the
same nutritional value as conventional soybean.

In addition, minerals and vitamins were also tested comparing soybean 15547-127 and its non-transgenic
counterpart, with the values reported in literature. It was found out that the minerals and vitamin contents of
the transgenic and non transgenic soybean were within reference range, except for one non-transgenic
sample for iron. The analysis for iron was repeated and together with statistical analysis by site, the
discrepancy was not found in the majority of the site.

Further, tocopherol and food grade oil were also analyzed in the transgenic soybean compared to its nontransgenic counterpart, and was found that the alpha, gamma and total tocopherol values were slightly higher in transgenic, glufosinate-treated soybean than non-transgenic counterpart. However, these were still within
reported reference ranges.

Moreover, amino acids and fatty acids were analyzed comparing the transgenic soybean and its nontransgenic counterpart. It was found that all values of both transgenic and non transgenic soybean are well within reference range.
Anti-nutrients such as raffinose, stachyose, trypsin inhibitors, and isoflavones were also analyzed to complete the nutritional data of the transgenic soybean compared to its non-transgenic counterpart. The results showed that all the values were comparable and were all within literature range.
Estimation of the overall risk
After a thorough scientific review and evaluation of the documents, DOH find sufficient evidence that Soybean A5547-127 applied for direct use will not pose any significant risk to health and environment and that any hazards could be managed by the measures set by DOH.
Recommendation(s)
The STRPs unanimously find the scientific evidence provided by the applicant is sufficient in showing that the
regulated article being applied for direct use is as safe for human and animal health, and the environment, as its conventional counterpart.

Based on BAI Core Team's evaluation, all information or data provided were supported by a documented
scientific evidence or study. Results observed in most studies conducted showed no significant
differences between the transgenic and non-transgenic sources. The values of nutrients and antinutrients from the transgenic and traditional and other commercial varieties of soybean are comparable.
As a result of this evaluation, based on the documents submitted, the BAI poses no objection should the
scientific panel recommends the approval of Bayer's soybean A5547-127 for direct use as food and feed,
or for processing.
After a thorough scientific review and evaluation of the documents provided by the Bureau of Plant Industry
(BPI) to the DENR Biosafety Committee, a biosafety permit may be issued to the proponent if the conditions set by DENR are followed.
DOH find sufficient evidence that the regulated article applied for direct use will not pose any significant risk to thehealth and environment and that any hazards could be managed by the measures set by the DOH.
The SEC expert does not have any socio-economic, social, and ethical issues to raise regarding the approval of the applicant's application for biosafety permit for direct use as food and feed, or for processing of Soybean A5547-127.






Need(s) for further information on specific issues of concern
Soybean A5547-127 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 A5547-127. 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 A5547-127 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