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OECD Unique Identifier details

ACS-GMØØ6-4
Commodity: Soyabean / Soybeans
Traits: Glufosinate tolerance
Argentina
Name of product applicant: Bayer Crop Science
Summary of application:
Resistance to Glufosinate Ammonium (GA) is conferred by the expression of the gene phosphinothricin acetyl transferase (pat), derived from Streptomyces viridochromogenes.
GA controls weeds through the inhibition of glutamine synthetase (GS), which produces the accumulation of phytotoxic levels of ammonia in the plant. GS is responsible for the synthesis of amino acid glutamine as from glutamic and ammonia acid. It is the only enzyme in the plant that can detoxificate the ammonia released by photo breathing, the reduction of nitrate and the degradation of amino acids. Ammonia, still a plant nutrient and a metabolite, is toxic in excess and produces the death of the plant cell.
Although GS of S. viridochromogenes is sensitive to an L-phosphinothricin, the bacteria produce an inactivating enzyme, PAT.
PAT catalyzes the conversion of L- phosphinothricin to N-acetyl-L-phosphinothricin in the presence of acetyl-CoA as a co-substrate. N-acetyl-L- phosphinothricin does not inactivate GS, and therefore it does not have an herbicide activity. As a consequence, plants that express the PAT enzyme are resistant to phosphinothricin herbicides.
The stability and the mendelian segregation of the event was demonstrated.
PAT is the new expressed protein with low levels in grains and in forage. Have not similarity with allergenic or toxic proteins and have rapid degradation in SGF (simulated gastric fluids).
The event A5547-127 is substantial and nutritionally equivalent to its non transgenic counterpart, the parental line (A5547) and conventional varieties.
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Date of authorization: 21/05/2008
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:
Please see decision document weblinks
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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: Principles for the Assessment of Food and Feed derived from GMO in Argentina - Resolution Nº 412
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Authorization expiration date:
E-mail:
mjunco@senasa.gov.ar
Organization/agency name (Full name):
SENASA (National Service for Agrifood Health and Quality)
Contact person name:
Mariano Junco
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 4121 5276
Fax number:
54 11 4121 5258
Country introduction:
The food 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), regulatory agency depending on the Ministery of Agriculture, Livestock and Fisheries. The Agrifood Quality Directorate of Senasa, is the area responsible for carrying out this task. It has an specific scientific team and the advise of a Technical Advisory Committee composed of experts from different scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.
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Relevant documents
Stacked events:
Argentina hasn't a specific authorization mechanism for food/feed safety assessment for stacked events. In principle, stacked events are assessed like another single event 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) (http://www.senasa.gov.ar)
Australia
Name of product applicant: Bayer CropScience Pty Ltd
Summary of application:
The GM soybean variety is known commercially as LibertyLink soybeans. Bayer CropScience is seeking approval for two lines; line A2704-12 and line A5547-127. Only line A2704-12 is intended for commercialisation at this stage.

Soybean lines A2704-12 and A5547-127 have been genetically modified to be tolerant to the herbicide glufosinate ammonium. Glufosinate ammonium (also referred to as
phosphinothricin) is a non-selective, contact herbicide that provides effective post-emergence control of many broadleaf and grassy weeds. The mode of action of the herbicide is to inhibit the enzyme glutamine synthetase, an essential enzyme involved with ammonium accumulation and nitrogen metabolism in plants. The inhibition of glutamine synthetase results in an over accumulation of ammonia in the plant, which leads to cell death. Tolerance to glufosinate ammonium is conferred though the expression in the plant of the enzyme phosphinothricin acetyltransferase (PAT), encoded by the pat gene from the soil bacteria Streptomyces viridochromogenes. The production of PAT by soybean lines A2704-12 and A5547-127 enables the post emergence use of glufosinate ammonium herbicides without risk
of damaging the crop. The applicant has stated that development of GM glufosinate
ammonium tolerant soybeans will provide a selective use for glufosinate ammonium, creating a valuable new weed management tool for soybean producers.

Soybean lines A2704-12 and A5547-127 have been developed for cultivation in the major soybean producing countries of the world. The applicant has indicated that at present they have no plans to develop glufosinate ammonium tolerant soybeans for cropping in either Australia or New Zealand. Food from soybean lines A2704-12 and A5547-127 will therefore be entering the Australian and New Zealand food supply as imported, processed, food products only.

There are three major food products derived from soybeans – seeds, oil and meal. Whole soybeans are used to produce soy sprouts, baked soybeans, roasted soybeans, full fat soy flour and the traditional soy foods such as miso, tofu, soy sauce and soymilk. Soybean oil has many food uses including in cooking oils, mayonnaise, margarine, salad dressings, sandwich spreads, and shortenings. Soybeans are also processed into lecithin, an emulsifying agent (food additive) found in a wide variety of foods. Finished food products containing soybean ingredients therefore include beer, noodles, breads, flours, sausage casings, pastries, crackers, meat substitutes, milk substitutes and confectionery among other things.

Soybean lines A2704-12 and A5547-127 will be used in conventional breeding programs to produce soybean hybrids tolerant to glufosinate ammonium. LibertyLink soybeans have been cleared for food use in the United States, Canada, Japan, South Africa (A2704-12 only) and Russia.
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Date of authorization: 29/04/2004
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:
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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: Application A481 - 'LibertyLink' Glufosinate-ammonium Tolerant Soybean A2704-12 A5547-127
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E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:
Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of 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. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
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Relevant documents
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)
Brazil
Name of product applicant: Bayer S.A
Summary of application:
Commercial release of soybean, event A2704-12, styled Liberty Link Soybean (LL Soybean), for the purpose of free registering, using, conducting essays, testing, sowing, transporting, storing, marketing, consuming, importing, releasing into the environment and disposing. LL Soybean was developed by inserting in the plant a pat gene responsible for synthesizing enzyme phosphinothricin N-acetyltransferase (PAT), which catalyzes conversion of L-phosphinothricin (gluphosinate ammonium) into non-toxic products, inactivating the active ingredient and this way granting the plant the trait of tolerance to the herbicide.
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Date of authorization: 11/02/2010
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.): Center for Environmental Risk Assessment
Summary of the safety assessment:
event A2704-12, styled Liberty Link Soybean (LL Soybean), for the purpose of free registering, using, conducting essays, testing, sowing, transporting, storing, marketing, consuming, importing, releasing into the environment and disposing. LL Soybean was developed by inserting in the plant a pat gene responsible for synthesizing enzyme phosphinothricin N-acetyltransferase (PAT), which catalyzes conversion of L-phosphinothricin (gluphosinate ammonium) into non-toxic products, inactivating the active ingredient and this way granting the plant the trait of tolerance to the herbicide. Gene pat used was a modified version of a gene isolated from a soil-natural bacterium, Streptomyces viridochromogenes, and was inserted in the plant cells through a transformation process via biobalistics. The modification introduced in the pat gene was one of reducing, via site-directed mutagenesis, the content of G:C bases (frequent in bacteria genomes, yet atypical in plant genomes). The modifications conducted failed to modify the original sequence of PAT protein amino acids. The genetic elements present in the insert were pat gene, promoter 35S derived from Cauliflower Mosaic Virus (CaMV), and ƒÒ-Lactamase selection marker gene (ƒÒla) coming from Escherichia coli, which grants resistance to the antibiotic ampicillin. Plasmid vector used to replicate the insert was plasmid pB2/35SAcK derived from plasmid pUC19. The plasmid vector was linearized prior to the transformation process in order to deactivate gene ƒÒla coding sequence. Southern blot analyses showed that the LL Soybean genome contains two (2) copies of gene pat inserted in the genome of event A2704-12. A single copy of 3’ end fragment and a single copy of 5’ fragment of gene ƒÒla are present in the genome between the two pat cassettes and in inverted orientations, making expression of the antibiotic characteristic impossible. Stability of event A2704-12 for several generations was demonstrated by Southern blot analyses. The PAT protein is expressed in adequate intensity, enabling soybean A2704-12 to resist up to three times to the recommended amount of ammonium gluphosinate to be used in the field, being the only exogenous protein to be expressed in A2704-12 soybean. PAT protein was detected in low levels in plant tissues assayed (from 0.001% to 0.002% of total protein) and, as expected, no amount was detected in refined oil. Besides, it was shown that the protein is rapidly degraded in gastric and intestinal fluids, presenting great susceptibility to digestion and denaturation. In silico, in vitro and in animal analyses demonstrated that PAT protein fails to display allergenicity and toxicity. Assessment conducted by international organisms and data supplied by applicant demonstrated that the event failed to cause any harmful effect to both, the environment and non-target organisms, and that it fails to posses any other characteristic that may grant adaptive advantages. Evidence indicates that there is substantial equivalence, that is to say, transgenic LL plants are not fundamentally different from the non-transformed soybean genotypes, except for the tolerance to the herbicide ammonium gluphosinate. Regarding horizontal gene flow, it is practically impossible, since there are no feral kindred of soybean in the Brazilian territory. Besides, soybean is an autogamous plant, which makes vertical gene flow very difficult. A2704-12 soybean was approved for use in foods since 1998, in the United States; 2000, in Canada; 2002, in Japan; 2003, in Mexico; 2004, in Australia; 2007, in Taiwan; and 2009, in Korea and the Philippines. EFSA, the European Food Safety Authority reached a conclusion that products containing, or produced from, event A2704-12 fail to present any adverse effect to human or animal health, as well as to the environment, and the European Union approved imports of event A2704-12 for human and animal consumption in September 2008. Although the issue is beyond the scope of CTNBio, it is worth stressing that gluphosinate ammonium is a non-systemic and non-selective herbicide, used mainly in the control of invading plants in post-emergence, both of large leave and narrow leave invaders, and is registered, approved and free to be marketed in Brazil by the Ministry of Agriculture and Supply (MAPA), IBAMA and the Ministry of Health, used in Brazil and several other countries to control pest plants, either with or without farming of transgenic plants resistant to the herbicide. The worldwide use of the herbicide relies on its biodegradability, low residual activity and low toxicity to humans, animals and other organisms of the food chain. For the foregoing, the conclusion is that farming and consumption of Liberty Link Soybean (LL Soybean event A2704-12) is neither a potential cause of significant degradation of the environment nor a cause of risks to human and animal health. For the reasons above, there are no restrictions to the use of this soybean and its derivatives. Applicant shall submit a post-commercial release monitoring pursuant to CTNBio Ruling Resolution nº 5 within thirty days from publication of this Summary of Technical Opinion.   TECHNICAL OPINION I. Identification of GMO Name of GMO: Liberty Link Soybean, Event A2704-12. Applicant: Bayer S.A. Species: Glycine max L. Merr. Inserted Characteristics: Tolerance to gluphosinate ammonium. Method of insertion: Particle acceleration method (Biobalistics) in the soybean apical meristems, according to methodology described by Christou et al. (1988) and using previously fragmented plasmid pB2/35SAcK. Proposed use: Free registration, using, essaying, testing, sowing, transporting, storing, commercializing, consuming, releasing, discarding and any other activities related to the GMO. II. General Information Soybean (Glycine max (L.) Merr) is a diploided tetraploid species (2n=40, belonging to family Leguminosae, subfamily Papilionoideae, tribe Phaseolae¸ genus Glycine, subgenus Soja. Soybean is currently farmed in over 35 countries, being the United States, China, India, Argentina and Brazil the largest producers. Production of grains is targeted to several uses, such as oils (for margarines, salads, cooking), alimentary products including tofu, soy sauce, soymilk, soy meat (texturized protein). In addition, it is used as alimentary supplement in animal ration. Soybean has an extensive industrial use, ranging from production of antibodies to the use in soaps and disinfectants (OECD, 2000). In Brazil, soybean is farmed in all regions, mainly in the Centre West (9.6 million hectares) and South (8.2 million hectares) (CONAB, 2005). Presence of weed (plant species different from the cultivated plant that are present in the cultivated area) is a limiting factor for soybean farming, leading to a loss ranging from 42% to 62% in Brazil. This way, controlling weed is very important in soybean farming and is conducted mainly by chemical ways, with the use of herbicides. Use of plants genetically modified for tolerance to herbicides has been important in managing pests in commercial cultivation of large cultures. All over the world, the area cultivated with tolerant soybean reached, in 2008, about 65.9 million hectares. Since 1998, genetically modified glyphosate tolerant (Roundup Ready Monsanto) soybean is extensively farmed in Brazil. About 65% of soybean produced in Brazil was RR® transgenic, representing 21.9 million hectares. Up to this moment, no harmful effect to the environment has been reported due to gene flow caused by this GMP. However, massive use a same herbicide for consecutive crops, as the case of glyphosate, accelerates the process of invading plants that are naturally resistant to the herbicide (Owen, 2008). In this sense, the possible use of genetically modified soybean varieties that display resistance to another insecticide, such as the ammonium gluphosinate, represents an important tool for managing invaders, making increased longevity of such technologies possible. Soybean event A2704-12 plants display sensitiveness to other herbicides, such as glyphosate, indicating the substratum specificity of PAT protein and demonstrating that plants of this event may be managed by techniques usually used to eradicate undesired plants in the fields. III. Description of the GMO and Proteins Expressed Event A2704-12, styled LibertyLink Soybean, presents gene pat derived from a non-pathogenic soil bacterium (Wohlleben et al. 1992; Hérouet et al, 2005), Streptomyces viridochromogenes, which grants tolerance to herbicide gluphosinate ammonium. This exogenous gene codes for enzyme phosphinothricin N-acetyltransferase (PAT protein) that promotes inactivation of the herbicide. The nucleotide sequence of gene pat inserted in the soybean was modified, by site-directed mutagenesis, with the purpose of reducing the contents of G:C bases (frequent in bacterium genomes but atypical in plants) ensuring high expression of PAT protein. The modifications conducted failed to change the original sequence of the PAT protein amino acids. Gene pat was replicated using plasmid pB2/35SAcK and the nucleotide sequence was inserted in the genome through particle acceleration technique. The plasmid displayed gene pat, promoter and terminator 35S (derived from Cauliflower Mosaic Virus (CaMV) and marker gene ƒÒla (resistance to antibiotic ampicillin). Gene ƒÒla (ƒÒ-lactamase derived from Escherichia coli) that is present in the plasmid vector, was fragmented by restriction enzyme prior to the event insertion. Southern blot hybridizations and amplifications by DNA-polymerase chain reaction were presented to demonstrate integration of the exogenous DNA fragment to the plant genome, the number of gene copies, presence or absence of other DNA elements and location of transgene parts. The results submitted indicate that event A2704-12 has two copies of gene pat and two non-functional fragments of gene ƒÒla. The event has a gene ƒÒla fragment copy of the 3’end and a copy of the 5’end. However, ƒÒla fragments are unable to reconstitute the gene for they are invertedly oriented, making its expression impossible. The construct inserted in the soybean genome fails to present sequences associated to mobility in the genome. Homology analyses in event A2704-12 demonstrated that 2566 bp, of regions 5’-flanking 4044 bp, originated from the soybean chloroplast DNA and that the remaining sequences (1478 bp) originated from the soybean genomic DNA. Besides, 3430 bp of the pre-insertion site were amplified and sequenced, revealing deletion of 2082 bp of soybean genomic DNA in the transformation event site of insertion (Moens & Habex, 2006). The company attributed deletion and presence of chloroplast DNA sequence in the soybean genome to the biobalistics technique used. According to the results presented, the modifications failed to cause changes in aspects related to human and animal health and environment safety, as indicated by the studies described in the application for Commercial Release. The characteristic of resistance to the gluphosinate ammonium herbicide followed the Mendelian way in this event, regarding generations assayed by applicant, indicating genetic stability of the insert. Likewise, Southern blot analyses demonstrate that DNA samples of event leaves coming from three generations show no difference in their band patterns, indicating that the insert is genetically stable. Enzyme PAT is the only protein expressed by the transgene; it has 183 amino acids and molecular weight of 22 kDa. Plants of this event display 2.23 ƒÝg/g PAT protein in roots, 7.63 ƒÝg/g in stalks, 14.5 ƒÝg/g in leaves, and 1.66 ƒÝg/g in seeds (AgBios, 2009). Protein PAT failed to be identified in refined oil and lecithin fraction of the samples assayed. Though presence of PAT activity had been detected in peels and seeds, no activity was detected in soybean meal (AgBios, 2009). On average, contents of PAT protein in soybean A2704-12 fodder and straw are 0.0026% and 0.0012% respectively (Shillito, 1998). Although seeds present the lowest levels of PAT, averaging 0.00029% for event A2704-12 against the content of gross protein, the levels show high variation, ranging from 0.593 ƒÝg/g to 11.5 ƒÝg/g of fresh weight, according to location and cultivar. IV. Aspects Related to Human and Animal Health There is no available evidence indicating that PAT protein is toxic to human beings and other animals (OECD, 1999). Besides, data demonstrating the absence of acute oral toxicity of PAT protein in rats were assayed by FSANZ (2000) in a number of preceding occasions, where the conclusion was that the protein is atoxic to animals and humans (FSANZ, 2000, 2001a, b, 2003). Likewise, the conclusion applies to PAT protein present in A2704-12 soybean, since it is identical in the amino acid sequence to the PAT protein assessed in previous occasions. To assess PAT protein similarity with other known toxins, sequence tests by amino acid homology were conducted with all current sequences of protein on the following reference databases: Swiss Prot, trEMBL, GeneSeq-Prot, PIR, PDB, DAD and GenPept. BLASTP program was used to compare PAT protein amino acids sequence with all available sequences in the different databases. No relevant similarity between PAT protein and known toxins was found. As expected, similarities were observed with other PAT proteins of different origins. There is great interest in knowing whether new proteins introduced in food may cause allergic reactions to some individuals. Potential allergenicity of a new protein shall be assayed by a combination of different criteria, since no individual criterion is sufficient as a prevision character to allergenicity or non-allergenicity. The assessment concentrated on the study of amino acid similarity between the new protein and proteins containing known allergens, including structural properties and susceptibility to degradation by simulated digestion. Application of such criteria on a systematic way provides reasonable evidence on the potential of recently introduced proteins to act as allergen (Leher & Reese, 1998; Jones & Maryanski, 1991). PAT is the only new protein expressed in A2704-12 soybean. Therefore, this protein was assessed using these criteria for a possible allergenicity potential. PAT protein amino acid sequence was compared with the epitopes found in known allergens, present in available databases (SwissProt, trEMBL, GeneSeq-Prot, PIR, DAD and GenPept), with the purpose of identifying any amino acid sequence that might represent an isolated allergenic epitope. The criterion indicating allergenicity was one hundred percent identity to an allergen protein in a window size of eight amino acids. Results of the search failed to show such identity with known allergens. Allergens commonly present in foods originated in plants are in general glycosylated proteins and, in their majority, tolerant to denaturation by heat remaining stable during the high temperatures involved in food cooking or processing. Studies determined that the enzyme is not heat resistant and is fully inactivated by temperatures over 75 ºC. Regarding in vitro digestibility, the majority of allergens normally present in food resist to peptic and acid conditions of the digestive tract, reaching and passing through the intestine mucosa to initiate an allergic response (Kimber et al., 1999; Astwood Fuchs, 1996; Metcalfe et al., 1996). A large number of studies was conducted with PAT protein to determine its potential as a toxic and allergenicity agent. The studies demonstrated that the protein is non-toxic to mammals, including humans. PAT protein was investigated for digestibility in models simulating digestion. Two studies were conducted: one recording PAT protein digestion in fluid digestibility (SGF) and the other simulating intestinal liquid (SIF). SGF contained pepsin and SIF contained pancreatin, a mixture of enzymes including amylase, trypsin, lipases, ribonuclease and protease. PAT extracted from ammonium gluphosinate tolerant corn leaves was treated with SGF and was rapidly digested (less than five seconds). No degradation took place in SGF in absence of pepsin. Pure PAT in SIF was digested within fifteen minutes. Besides those tests, Wehrmann et al. (1996) described that when protein PAT was tested in the presence of conditions simulating gastric juice, it was digested within seconds. Studies conducted by Esdaile (2002) demonstrate that the protein was digested within thirty seconds when incubated in the presence of gastric juice. Summarizing, PAT protein has the following characteristics: 1. Has no homology with allergenic protein, toxin or nutrients; 2. Fails to display any glycosylation site (present in several allergenic products); 3. The protein is structurally unstable in acid environments; 4. It degrades and denatures rapidly in gastric and intestinal fluids of humans and domestic animals; 5. The protein has substrate-specific activity (acts solely on the GA compound and has no activity on glutamate amino acid); 6. Failed to show any adverse effect on mammals, even when high doses are administered in the vein; 7. The protein accumulates mainly in the seeds at very low levels, ranging from 0.003% to 0.0029% of total proteins. Protein levels were not affected when the culture was sprayed with ammonium gluphosinate herbicide. Based on compositional assay involving analyses of total proteins, fat acids, fibers, carbohydrates, ashes, minerals (Ca, P, K, Fe, Mg, Zn), one may assert that insertion of the pat gene failed to change Event A2704-12 compositional tenor of Event A2704-12 as compared to its non-modified equivalent. A2704-12 soybean is approved for use in foodstuffs since 1998 in the United States; 2000, in Canada; 2004, in Australia; 2002, in Japan; 2009, in Korea; 2003, in Mexico; 2009, in the Philippines; and 2007, in Taiwan. The European Unit approved its import for human and animal consumption in September 2008. V. Environmental Aspects Soybean is a predominantly autogamic species, with crossed pollination rates below 1.0% (Sediyama et al., 1999; Borém, 2000). A paper involving pollen dispersion in Brazilian cerrado (Abud et al., 2003) records that crossed pollination rate is 0.45% at a distance of 0.5 m, 0.14% at 1.0 m and does not occur in detectable form at a distance of 6.5 m. Besides, soybean is an exotic species, originating from China with no sexually compatible feral kindred in Brazil. Therefore, crossed pollination with sylvan species in the natural environment is not possible to occur in the national territory. Soybean is a domesticated species, highly dependent from humans for its survival. Therefore, there are no reasons to foresee survival of A2704-12 soybean outside farming environments. Besides, in the absence of selective pressure (use of the herbicide), expression of the gene grants no adaptive advantage. Plants derived from A2704-12 event displayed the same agronomic and adaptability behavior than conventional lineage, without changing survival regulation and species reproduction characteristics. Comparative analyses of morphologic, phenotypic and agronomic characteristics enabled a conclusion that none of such variables has been affected as a result of genetic modification (Freyssinet, 2002). No characters were recorded that may grant either selective advantage or atypical behavior to the species. According to applicant, experiments conducted in the United States and Porto Rico, involving visual observations along the evolution cycle to assess occurrence of atypical plants or plants responding differently to biotic pressure, indicate that insertion of the pat gene has not affected susceptibility/resistance to plagues and diseases of lineages derived from event A2704-12, even when subjected to different environmental conditions. Studies conducted in Paulínia, State of São Paulo, and São Gabriel do Oeste, State of Mato Grosso do Sul, failed to record abnormality in terms of occurrence of insects and fungi, and related to plant physiology. Post-harvest monitoring conducted in experimental areas recorded little soybean remaining plants, which were easily eliminated. This demonstrates that the GMP does not remain in the farm environment without human intervention and fails to display characteristics that would make it more aggressive or invading in the ecosystem than its conventional parental. Ammonium gluphosinate (AG) is a synthetic compound corresponding to phosphinothricin, which is naturally produced by some soil microorganisms, and is duly registered and regularly traded in Brazil under the brand FINALE. Other brands (LIBERTY, BASTA, IGNITE) are of international use. AG biodegradability is one of the main characteristics of the product, in addition to its low toxicity to birds, insects, earthworms, fish and bees, among others. AG is neither mutagenic nor carcinogenic and has low risk of leaving residues in soil and water due to its short half-life. Herbicide gluphosinate is rapidly degraded in soil by action of microorganisms that use this molecule as a source of nitrogen, liberating CO2 and phosphorus. Soils maintained in laboratory conditions demonstrated that, at a temperature of 20 ºC, gluphosinate has a half-life of 10 days (Smith, 1988; OECD, 2002). According to Hoerlein (1994), this synthetic phosphinothricin (ammonium gluphosinate) is not toxic to fungi, nematodes and insects, yet has a large range action against monocotyledons and dicotyledons, post-emergent and having very rapid effect in controlling plants since emergence from soil to more advanced phases. GA activity in the target plant is exclusive and specific (inhibition of glutamine synthetase enzyme), acting in a way to minimize appearance of resistant plant pest populations. VI. Restrictions to the use of GMO and its derivatives Studies submitted by applicant demonstrated an absence of significant difference between genetically modified soybean and its conventional isoline in what regards agronomic characteristics, means of reproduction, dissemination and survival ability. All evidence presented in the proceeding and bibliographic references confirm the transgenic variety level of risk as equivalent to that of the non-transgenic regarding soil microbiota, other plants and human and animal health. Therefore, farming and consumption of A2704-12 soybean are neither a potential cause of significant environment degradation nor the origin of risks origin for human and animal health. These are the reasons to release this soybean and its derivatives from restrictions, except in locations mentioned by Law nº 11,460, of March 21, 2007. VII. Considerations on particulars of different regions of the country (assistance to monitoring bodies): As established in Article 1 of Law nº 11,460, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous and conservation unit areas”. VIII. Conclusion The conclusions are that: • Soybean is a domesticated species, highly dependent from the human species for its survival and, therefore, there are no scientific reasons to foresee survival of plants derived from lineage A2704-12 outside farming environments; • Soybean is an exotic species, with no sexually compatible sylvan kindred in Brazil and crossed pollination with wild species in the natural environment may not occur in the Brazilian territory; • Molecular analysis of A2704-12 soybean evidenced that integrity and stability of the insert was maintained; • Analyses of segregation and genetic inheritance pattern are stable along successive generations; • Agronomic and efficacy assessments of A2704-12 soybean indicate that the insertion failed to lead to expression of any other characteristics than expected, namely tolerance to herbicide ammonium gluphosinate (AG), and that the GMP has the same agronomic and adaptability behavior than the conventional lineage, with no change of the characters that regulate the species survival and reproduction; • Herbicide gluphosinate is rapidly degraded in soil by action of microorganisms that use this molecule as a nitrogen source, liberating CO2 and phosphorus; • AG is a synthetic compound corresponding to phosphinothricin, produced in nature by some soil microorganisms; • Protein PAT has homology to no allergenic or toxic protein; • Protein PAT fails to display significant risk for human and animal health and to the environment according to oral acute toxicity and in vitro digestibility studies; • Foodstuffs based on soybean derived from Event A2704-12 have compositional/nutritional equivalence to products originating from non-modified soybean varieties; • Environmental safety aspects were analyzed in local field studies where it was shown that the lineage coming from Event A2704-12 does not negatively affect survival of other plants and animals. For the foregoing and taking provisions of Article 14 of Law nº 11,105, CTNBio holds that the request complies with applicable rules and legislations in effect aimed at securing environment, agriculture, and human and animal health biosafety, and concludes that Liberty Link Soybean (Event A2704-12) is substantially equivalent to conventional soybean and that its consumption is safe to human and animal health. Regarding the environment,
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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:
Molecular Traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Comission
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Authorization expiration date: Not Applicable
E-mail:
gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Flavio Finardi
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
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Relevant documents
Stacked events:
At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)
Canada
Name of product applicant: Bayer CropScience Canada
Summary of application:
The soybean lines A2704-12 and A5547-127 were developed through a specific genetic modification to be tolerant to glufosinate ammonium. The soybean plants have been transformed with a bacterial gene, phosphinothricin -N-acetyltransferase (PAT), that confers resistance to the glufosinate ammonium herbicides. The soybeans will be used in the same food applications as conventional soybeans.

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Date of authorization: 20/11/2000
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.): BioTrack Product Database
Summary of the safety assessment:
Please see decision document weblinks
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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: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date:
E-mail:
luc.bourbonniere@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Luc Bourbonniere
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-957-1405
Fax number:
613-952-6400
Country introduction:
Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods. The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations (see Figure 1). Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current document were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.
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Relevant documents
Stacked events:
Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Luc Bourbonniere, Section Head Novel Foods
Philippines
Name of product applicant: Bayer CropScience Inc
Summary of application:
Bayer CropScience Inc. has developed a new genetically modified soybean that is tolerant to glufosinate-ammonium herbicides. Soybean has been modified to express phosphinothricin acetyltransferase (PAT) in the cell tissue to produce the glufosinate-tolerant soybean designated as A5547-127. This soybean event will allow the use of glufosinate-ammonium as a post-emergence herbicide, thus providing an alternative weed control option in soybean production and reduces reliance on soil incorporated herbicides.
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Date of authorization: 23/06/2011
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:
Bayer Crop Science, Inc. submitted an application to the Bureau of Plant Industry (BPI) requesting a biosafety permit under DA A.O. #8 for soybean which has been genetically modified (GM) for herbicide tolerance. Soybean A5547-127 has been evaluated according to BPI‘s safety assessment procedures by the Department of Agriculture’s concerned agencies such as Bureau of Animal Industry (BAI) and Bureau of Agriculture Fisheries and Product Standards (BAFPS); and a Scientific Technical Review Panel (STRP) members. The process involved an intensive analysis of the nature of the genetic modification with a consideration of general safety issues, toxicological, allergenicity and nutritional issues associated with the modified soybeans. The petitioner/applicant published the said application in two (2) widely circulated newspapers for public comment/review. BPI received positive comments on the petition supporting the direct use for food, feed or for processing of Soybean A5547-127 during the 30-day comment period. Review of results of evaluation by the BPI Biotech Core Team completed the approval process.
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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:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Thelma L. Soriano
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:
The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and 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) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community. The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power. The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment. The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.
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Relevant documents
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.
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
United States of America
Name of product applicant: AgrEvo
Summary of application:
Soybean
Trait 1 Added Protein: Phosphinothricin acetyltransferase (PAT)
Source: Streptomyces viridochromogenes
Intended Effect: Tolerance to the herbicide glufosinate-ammonium
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Date of authorization: 15/05/1998
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:
Please consult the FDA website 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: FDA's webpage regarding this variety
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Authorization expiration date:
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:
The United States is currently in the process of populating this database.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food and Drug Administration (premarkt@fda.hhs.gov); Environmental Protection Agency