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OECD Unique Identifier details

MON-87419-8
Commodity: Corn / Maize
Traits: Dicamba tolerance,Glufosinate tolerance
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C.
Summary of application:

Monsanto has developed, using modern biotechnology techniques, the carrier corn of the MON 87419 event that presents a single T-DNA insert which contains: (a) an expression cassette of the dmo gene from which the Dicamba Mono-Oxygenase protein is produced or BMD, which gives corn plants tolerance to herbicides formulated with dicamba (3,6-dichloro-2-methoxybenzoic acid), and (b) a cassette for expressing the gene pat to synthesize the protein Fosfinotricin Acetil Transferasa or PAT (for its acronym in English, Phosphinotricin Acetyl-Transferase), which gives corn plants tolerance to formulated herbicides based on glufosinate (2-amino-4-hydroxymethylphosphinyl butanoic acid ), a broad spectrum herbicide.

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Date of authorization: 19/04/2018
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. It is concluded that the event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: GMO commercial approvals in Argentina
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 5222 5986
Fax number:
Country introduction:

In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.

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Stacked events:

Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

National Service for Agrifood Health and Quality (Senasa)

https://www.argentina.gob.ar/senasa

 

https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia

Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

MON 87419 line, a maize tolerant to dicamba and glufosinate herbicides

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Date of authorization: 16/02/2017
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Food safety assessment performed by Food Safety Commission of Japan (food) (in Japanese)
Food safety assessment performed by Food Safety Commission of Japan (feed) (in Japanese)
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
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Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

Malaysia
Name of product applicant: Monsanto Malaysia Sdn. Bhd.
Summary of application:

Please refer to the decision document of the National Biosafety Board.

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Date of authorization: 15/03/2021
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Department of Biosafety Malaysia
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to the Risk Assessment Report.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Department of Biosafety Ministry of Environment and Water Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia
Phone number:
+60380917322
Fax number:
+60380917371
Country introduction:

GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House.

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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Department of Biosafety Malaysia, Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: [email protected] Url: www. biosafety.gov.my

 

Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
Mexico
Name of product applicant: Monsanto Comercial, S. de R. L. de C.V.
Summary of application:

Authorization by COFEPRIS: 172


Maize (Zea mays) genetically modified, tolerant to dicamba and glufosinate herbicides

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Date of authorization: 04/12/2017
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
No documentary evidence indicating toxicological and / or allergenic effects was observed; as well as substantial nutritional changes in the Maize (MON-87419-8), so it is concluded that the Corn (Zea mays) genetically modified with OECD Identifier: MON-87419-8 is, based on the existing knowledge to date, as innocuous as its conventional counterpart.
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Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Biól. Erica L. Hagman Aguilar
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 53227700
Fax number:
Country introduction:

México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población. Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano. En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.

Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley. Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

 

Courtesy translation

Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.

The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: [email protected]%20

New Zealand
Name of product applicant: Monsanto Australia Ltd
Summary of application:

Application A1118 was submitted by Monsanto Australia Ltd on 11 August 2015. It sought approval for food derived from herbicide-tolerant corn line MON87419 with OECD Unique Identifier MON-87419-8 (herein referred to as MON87419). MON87419 has been modified to be tolerant to the herbicides dicamba and glufosinate ammonium. Tolerance to dicamba is achieved through expression of the enzyme dicamba monooxygenase (DMO) encoded by the dmo gene derived from a common soil and aquatic bacterium Stenotrophomonas maltophilia. Tolerance to glufosinate is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat gene derived from the common soil bacterium Streptomyces viridochromogenes. The safety of both proteins has previously been assessed by FSANZ.

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Date of authorization: 28/09/2016
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
In conducting a safety assessment of food derived from MON87419, a number of criteria have been addressed including: a characterisation of the transferred gene sequences, their origin, function and stability in the corn genome; the changes at the level of DNA, and protein in the whole food; compositional analyses; and evaluation of intended and unintended changes. No potential public health and safety concerns have been identified in the assessment of herbicide tolerant corn line MON87419. On the basis of data provided in accordance with the FSANZ Handbook, and other available information, food derived from MON87419 is considered to be as safe for human consumption as food derived from conventional corn varieties.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1118 – Food derived from Herbicide-tolerant Corn Line MON87419
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
Fax number:
Country introduction:

New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island.

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Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Philippines
Name of product applicant: Monsanto Philippines, Inc.
Summary of application:

On August 11, 2017, Monsanto Philippines Inc. submitted corn MON87419 for direct use as food and feed, or for processing, as original application under the DOST-DA- DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016. 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 MON87419 is as safe for human food and animal feed as its conventional counterpart.

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Date of authorization: 22/08/2019
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Toxicological Assessment Digestibility and degradation of the DMO protein by pepsin and pancreatin is evaluated through SDS-PAGE and Western blot analysis. It was demonstrated that DMO degrades by 96.5% in pepsin within a reaction time of 30 sec which was confirmed by Western blots that applied specific DMO antibodies. A peptide fragment ~3kDa is seen with the 2-min pepsin treatment but complete digestion is attained in 5 min. About 98.4% of DMO protein degrades in pancreatin within 5 min as shown by 2 peptide fragments with ~12 and ~21 kDa but complete degradation is accomplished within 15 min. Data on digestibility show that large and intact fragments of MON 87419 DMO protein are unlikely to be absorbed in the small intestines after oral ingestion. It was also shown that the functional activity of DMO is retained at 25°C and 37°C for a heating period of 15 or 30 min. Heating at 55°C and 75°C reportedly caused reduction of functional activity. Heating at 75°C for 30 min caused slight reduction in intensity of bands while heating at 95°C for 30 min resulted to visible reduction in bands. These findings reportedly explain the predictable loss of functional activity and denaturation of the DMO protein at elevated temperature for a relatively longer period of interaction. The aligned amino acid sequences of MON 87419 DMO protein is compared with the amino acid sequences of toxins and toxic proteins in databases (FASTA, TOX_2014) and the alignment data is utilized to conclude shared or similarity of sequences. It was shown that no relevant alignment in MON 87419 DMO protein is in common with proteins in TOX_2014 database and that no alignment with E-score below 1 x 10-5 (0.00001) rules out a tangible sequence similarity. A toxicity assay for MON 87419 DMO protein involved oral administration of DMO at 1000 mg/kg body weight to mice. No mortality, test substance-related clinical findings and no MON 87419 DMO protein-related differences in body weight changes, food consumption and gross necropsy findings that can be associated with the oral administration of DMO. This establishes the NOAEL (No observable adverse effect level) of the MON 87419 DMO protein at 1000 mg/kg body weight. It was shown that the DMO protein from MON 87419 is substantially equivalent with the E.coli-produced MON 87419 DMO protein in terms of electrophoretic mobility and molecular weight, purity, immunoreactivity properties, consistent peptide masses, expected N-terminal sequences, non-glycosylation patterns and enzymatic activities. Meanwhile, digestibility and degradation of PAT protein by pepsin and pancreatin is evaluated through SDS and Western blot analysis. It was demonstrated that more than 99.6% of the PAT protein is degraded by pepsin within 30 sec and 98.2% is digested with 30 sec interaction when evaluated by a specific antibody in Western blot. PAT protein also degrades by 99.1% in pancreatin within 5 min of interaction as shown by Western blot. A purified PAT protein is also heated at different temperatures (25, 37, 55, 75 and 95 degrees Celsius) for 15 and 30 minutes and result of heat treatment involved analysis of protein through SDS-PAGE. Functional activity of PAT protein is reportedly retained after heat treatment at 25 and 37 degrees Celsius for 15 and 30 minutes. At 55 and 75 degrees Celsius, functional activity of PAT protein reduced by 90% or greater. These demonstrate a predictable tendency of the functional activity of PAT protein to be lost at temperatures above 55 degrees Celsius. The PAT protein sequence is screened for potential structural similarity with amino acid sequences in a database using FASTA sequence alignment tool. Based on bioinformatic alignment searches, no structurally relevant sequence similarity of PAT protein with sequences of allergens, toxins and active proteins is reported. PAT protein was also administered to mice (C57BL/6J strain) by oral gavage at a dose of 2000 mg/kg body weight. Animals are monitored for clinical signs, changes in body weight, food consumption, necropsy findings, and gross pathological examination. Oral administration of PAT protein does not induce mortality, treatment-related clinical signs, body weight changes, food consumption pattern and gross pathological findings at indicated concentration. It can be deduced that the NOAEL (No Observable Adverse Effect Level) of MON 87419 PAT protein is established at 2000 mg/kg body weight. PAT protein from MON 87419 grain is expressed in bacteria. Physico-chemical and functional evaluation of the MON 87419 PAT protein and E.coli-produced PAT protein are undertaken to assess equivalence of the two proteins. Substantial equivalence of the two above mentioned PAT proteins is based on evaluation of molecular weight confirmed through SDS-PAGE immunoreactivity validated by Western blot, non- glycosylation pattern and functional activity evaluated through co-enzyme release assay. Allergenicity Assessment It was shown that based on the results of N-terminal sequencing, the deduced sequences of the DMO proteins expressed in MON 87419 are consistent with the amino acid sequence of E.coli-produced MON 87419 DMO protein. Results of MALDI-TOF MS Analysis identified about 37 peptide masses which are consistent with expected peptide mass of the MON 87419-produced DMO sequence. Western blot analysis demonstrates immunoreactive bands with molecular weight of ~39.5 kDA in both MON 87419- produced DMO proteins and E.coli-produced DMO proteins. Functional enzymatic activity of both proteins are demonstrated within limits of 99.3 – 251.5 nmol x mean-1 x milligram-1. Glycosylation analysis demonstrate that both proteins are non- glycosylated. The percentage of DMO protein in MON 87419 grain is ~0.00016% or 1.6 ppm of total grain protein, calculated based on the mean level in grain (0.19 µg/g dry weight) divided by mean percent dry weight of the total grain protein in MON 87419. The amount of DMO protein represents a very small portion of the total protein content of MON 87419 grain. On the other hand, no biologically relevant sequence similarities were observed between PAT protein and allergen or other biologically active proteins. When searching the TOX_2014 database, PAST protein generated alignments with bacterial toxinanti- toxin system proteins, but it does not provide any indication that PAT protein would adversely have an impact on human and animal health if consumed. the mean level of PAT protein in the grain of MON 87419 is 0.93 μg/g dw. The mean percent dry weight of total protein in th3e grain of MON 87419 is 11.52 % (115200 μg/g). The percentage of PAT protein in MON 87419 grain is (0.93 μg/g g ÷ 115200 μg/g ) x 100 % = .0008 % or 8 ppm of total grain protein. PAT protein represents a very small portion of the total protein in the grain. Serum screening is not done as no allergens and toxins are contained in the transgenic event MON 87419 that should require toxicological test. J. Nutritional Data Proximate analysis of forage MON 87419 corn treated with dicamba and glufosinate under agronomic field conditions demonstrate mean levels of ash (% DW, 3.86+0.54), carbohydrates by calculation (% DW, 87.12+0.85), protein (% DW, 7.40+0.36) and total fat (% DW, 1.59+0.17) which are comparable (P>0.05) with those of conventional non- transgenic corn control. While, proximate analysis of grain from MON 87419 treated with dicamba and glufosinate under agronomic field conditions demonstrate mean levels of carbohydrates by calculation (% DW, 83.57+0.54) and ash (% DW, 1.39+0.021) contents are also comparable (P>0.05) with grains of conventional non-transgenic corn control. Secondly, analysis of forage from MON 87419 treated with dicamba and glufosinate under agronomic field conditions for fiber demonstrated mean acid detergent fiber (%DW, 26.52+1.15) and mean neutral detergent fiber (% DW, 41.28+1.40) are comparable (P>0.05) with those of conventional non-transgenic corn control. Analysis of forage from MON 87419 treated with dicamba and glufosinate under agronomic field conditions for mineral components demonstrated mean calcium (% DW, 0.21+0.021) and mean phosphorus levels (% DW, 0.20+0.018) are also comparable (P>0.05) with those of conventional non-transgenic corn control. Third, analyses of MON 87419 corn grains treated with dicamba and glufosinate under agronomic field conditions demonstrate mean acid detergent fiber (% DW, 3.97+0.12), neutral detergent fiber (% DW, 9.70+0.11) and total dietary fiber (% DW, 9.18+0.23) which are comparable (P>0.05) with those of grains of conventional non-transgenic corn control. Meanwhile, analyses of MON 87419 corn grains treated with dicamba and glufosinate under agronomic field conditions demonstrate mean Calcium (% DW, 0.0031+0.00017), Iron (mg/kg DW, 16.83+0.54), Magnesiun (% DW, 0.13+0.0 019), Phosphorus (% DW, 0.36+0.0059), Potassium (% DW, 0.36+0.0081), Sodium (mg/kg DW, 5.45+1.92) and Zinc (mg/kg DW, 22.10+1.13) which are comparable (P>0.05) with those of grains of conventional non-transgenic corn control except for manganese (mg/kg DW, 6.03+0.45) which significantly differs (P<0.05) from="" those="" of="" grains="" conventional="" non-transgenic="" corn="" control="" analyses="" mon="" 87419="" treated="" with="" dicamba="" and="" glufosinate="" under="" agronomic="" field="" conditions="" also="" demonstrate="" mean="" levels="" protein="" 1152055="" alanine="" 0920057="" arginine="" 0460014="" aspartic="" acid="" 0730036="" cystine="" 02200050="" glutamic="" 243015="" glycine="" 0410011="" histidine="" 0330011="" isoleucine="" 0420024="" leucine="" 159011="" lysine="" 02800061="" methionine="" 02300074="" phenylalanine="" 0630040="" proline="" 1080044="" serine="" 0590032="" threonine="" 0420018="" tryptophan="" 007000017="" tyrosine="" 0310018="" which="" are="" comparable="" p="">0.05) with those of grains of conventional non-transgenic corn control except for valine (0.54+0.025) which significantly differs (P<0.05) from="" those="" of="" grains="" conventional="" non-transgenic="" corn="" control="" analyses="" mon="" 87419="" treated="" with="" dicamba="" and="" glufosinate="" under="" agronomic="" field="" conditions="" for="" fatty="" acids="" total="" demonstrate="" mean="" levels="" fat="" 3400081="" palmitic="" 1451012="" palmitoleic="" 01200040="" stearic="" 1620028="" oleic="" 2186020="" linoleic="" 6008027="" linolenic="" 1000027="" arachidic="" 04000079="" eicosenoic="" 02700049="" behenic="" 01400070="" components="" that="" are="" comparable="" p="">0.05) with those of grains of conventional non-transgenic corn control. Analysis of MON 87419 corn grains treated with dicamba and glufosinate under agronomic field conditions for vitamins (mg/kg DW) demonstrate folic acid (0.65+0.035), niacin (10.22+0.41), Vit A (5.44+0.45), Vit B1 (2.46+0.12), Riboflavin/B2 (2.18+0.13), Pyridoxine HCL/Vit B6 (5.42+0.25) and Vit E (11.56+0.43) components which are comparable (P>0.05) with those of the grains of conventional non-transgenic corn control Lastly, analysis of MON 87419 corn grains treated with dicamba and glufosinate under agronomic field conditions for anti-nutrients (% DW) such as phytic acid (0.99+0.031) and raffinose (0.28+0.010) show values that are comparable (P>0.05) with those of the grains of conventional non-transgenic corn control. Analysis of MON 87460 corn grains treated with dicamba and glufosinate under agronomic field conditions for secondary metabolites (µg/g DW) such as ferulic acid (2352.80+45.66) and p-Coumaric acid (196.51+12.40) show values that which are comparable (P>0.05) with those of the grains of conventional non-transgenic corn control. STRP’S RECOMMENDATION Find scientific evidence that 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.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date) August 21, 2024
E-mail:
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
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In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.

 

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Stacked events:

Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.

 

Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:

A full risk assessnent as to  food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:

(a) genetic engineering, or

(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.

Notificatlon Requirement for Plant Products Carrying Stacked Genes

All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.

The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004

Republic of Korea
Name of product applicant: Monsanto Korea Ltd.
Summary of application:

Glufosinate herbicide tolerance , Dicamba herbicide tolerance

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Date of authorization: 31/01/2017
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the link below(in Korean).
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
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Organization/agency name (Full name):
Ministry of Food and Drug Safety
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Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: