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Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 30 May 2019
ASSESSORS' CONSOLIDATED REPORT ON BAYER'S APPLICATION FOR DIRECT USE AS FOOD AND FEED, OR FOR PROCESSING OF SOYBEAN A5547-127
EN
01 Feb 2017
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- Competent National Authority: | BCH-CNA-PH-46524-5 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,Website: http://www.da.gov.ph, -
Competent National Authority:Department of Environment and Natural Resources ()Visayas AvenueQuezon City,
1100, PhilippinesPhone: +632 925-2329, +632 920-4352,Fax: +632 920-4301,Email: osec@denr.gov.ph,Website: http://www.denr.gov.ph, http://www.pawb.gov.ph, -
Competent National Authority:Department of Health ()San Lazaro Compound, Sta. CruzManila,
, PhilippinesPhone: +632 651 7801; +623 651 7800,Fax: +632 743 1829,Email: etona@co.doh.gov.ph,Website: http://www.doh.gov.ph,
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Person:Mr. Ariel J. BayotOfficer-In-Charge Chief, National Plant Quarantine Services DivisionSan AndresMalate, Manila
, PhilippinesPhone: +63 2 404-0409,Fax: +63 2 404-0409,Email: ajbayot@yahoo.com,Website:Related OrganizationBureau of Plant Industry (BPI)Government agency (National/Federal)San AndresMalate, Manila
, PhilippinesPhone: +63 2 404-0409,Fax: +63 2 404-0409,Email: ajbayot@yahoo.com,Website: -
Person:Ms. Ma. Lorelei U. AgbagalaSupervising Agriculturist, Post Entry QuarantineEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Government agency (National/Federal)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,
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ACS-GMØØ6-4 - Liberty Link™ soybean| Bayer CropScience | Resistance to herbicides (Glufosinate)
- ConsolidatedReportSoybeanA5547-127-revised.pdf [ English ]
- http://biotech.da.gov.ph/Decision_docs_jdc_direct.php [ English ]
EN
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.
EN
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.
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.
EN
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.
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.
EN
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.
EN
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.
Soybean A5547-127 is found substantially equivalent to conventional counterpart and does not pose any significant risk to animal and human health.
EN
This application is not for propagation of the Soybean A5547-127. This LMO will be directly used for food, feed and for processing.
EN
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.
EN
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.
EN
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.
- ISAAA [ English ]
