| Commodity: |
Soyabean / Soybeans |
| Traits: |
Glufosinate tolerance |
| Name of product applicant: |
Bayer |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
08/09/2008 |
| 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.): |
Biosafety Clearing House (BCH)
OECD BioTrack Product Database
|
| Summary of the safety assessment (food safety): |
Please see the EU relevant links below. |
| Upload: |
|
| Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained: |
Event specific real-time quantitative PCR based method for genetically modified soybean ACS-GMØØ5-3. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links. |
| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Opinion of the European Food Safety Authority
Method for Detection
Reference Material
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
7/9/2018 |
E-mail:
Organization/agency name (Full name): European Union
Contact person name: Alexandre Huchelmann
Website:
Physical full address: European Commission B232 04/106 1047 Brussels
Phone number: 3222954092
Fax number:
Country introduction: The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable). Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| 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. |
| Upload: |
|
| 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 (food safety): |
|
| Upload: |
|
| 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
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Food Standards Australia New Zealand
Contact person name: Gaya Subramaniam
Website:
Physical full address: Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number: +61 2 6271 2222
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 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island. Useful links
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)
No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.
No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.
Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given 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)
| Name of product applicant: |
Bayer S.A |
| Summary of application: |
commercial release of genetically modified gluphosinate ammonium tolerant soybean, as well as all progenies coming from transformation event A5547-127 and its derivatives through crossing of non-transgenic soybean lineages and populations with lineages carrying event A5547-127 |
| Upload: |
|
| 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 (food safety): |
LL Soybean was developed through a specific genetic modification by inserting in the plant the 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 attribute 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 the pat gene, the promoter 35S derived from Cauliflower Mosaic Virus (CaMV), and the ƒÒ-Lactamase selection marker gene (ƒÒla) coming from Escherichia coli, which grants resistance to the antibiotic ampicilin. Plasmid vector used to replicate the insert was 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 one single copy of gene pat, which is flanked by fragments of gene ƒÒla. The PAT protein was the only exogenous protein to be expressed in the transgenic event. Amounts of PAT protein produced in different tissues of LL Soybean were assayed using the immunologic test ELISA and the results were 0.017% in leaves and 0.003% in hay and grain, against total protein in related tissues. Thus, the PAT protein was detected in low level in plant tissues assayed and, as expected, no amount was detected in refined oil. Besides, the protein is rapidly degraded in gastric and intestinal fluids, with great susceptibility to digestion and denaturation. The safe history of LL Soybean cultivation in the United States (since 1998), Canada (2000) and Japan (2006) grants the product a strong evidence of environment safety. To these results one shall aggregate assessments conducted by international organizations, as well as data supplied by applicant showing that the event fails to present any harmful effect to the environment and non-target organisms and fails to possess any characteristic that may grant adaptive advantages. Available information indicates that there is substantial equivalence, that is to say, transgenic plants of LL Soybean are not fundamentally different from the non-transformed soybean genotypes, except for the gluphosinate ammonium tolerance. 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 the vertical gene flow very difficult. 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 herbicide wide use worldwide is due to 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 A5547-127) is neither a potential cause of significant degradation of the environment nor 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 conduct the post-commercial release monitoring pursuant to CTNBio Ruling Resolution nº 5. 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”. CTNBio analyzed the reports submitted by applicant as well as the independent scientific literature.
Under Article 14 of Law nº 11,105/05, CTNBio held that the request complies with applicable rules and legislation in effect aimed at securing biosafety of the environment, agriculture, human and animal health and concludes that Liberty Link Soybean is substantially equivalent to conventional soybean, being therefore its consumption safe for human and animal health. Regarding the environment, CTNBio concluded that farming of Liberty Link Soybean is not potentially a cause of significant degradation of the environment, keeping with the biota a relation identical to that of conventional soybean.
CTNBio TECHNICAL OPINION
I. Identification of GMO
Name of GMO: Genetically modified soybean tolerant to gluphosinate ammonium – Liberty Link Soybean, Event A5547-127.
Applicant: Bayer S.A.
Species: Glycine Max
Inserted Characteristics: Tolerance to gluphosinate ammonium.
Method of insertion: Particle acceleration method (Biobalistics)
Proposed use: Farming, production of grain, human and animal consumption of the product and its derivatives.
II. General Information
Soybean is a predominantly autogamous plant, whose crossed pollination rate is as low as 1.0%. Soybean cross pollination rate in an environment such as the Brazilian cerrado (Abud et al., 2003) is about 0.45% at a distance of 0.5 m; 0.14% at 1.0 m and detectable absence at a distance of 6.5 m. Soybean is an exotic species with no feral kindred sexually compatible in Brazil. Therefore, crossed pollination with feral species in the natural environment may not occur in the national territory.
Soybean is a domesticated species that depends highly on the human species for its survival. Therefore, there are no scientific reasons to foresee survival of plants derived from lineage A5547-127 outside farm environments. Besides, in absence of selective pressure (use of herbicide), expression of the inserted gene fails to grant any adaptive advantage.
Around the world, the area farmed with herbicide tolerant soybean in 2008 was about 65.9 million hectares. Since 1998, genetically modified soybean tolerant to glyphosate herbicide (Roundup Ready – Monsanto) is extensively cultivated in Brazil. About 65% of the soybean produced in Brazil during 2008 was RR® transgenic, representing 21.9 million hectares (ISI, 2008). Until now no report of harmful effect of this GMP to the environment due to gene flow has come to light.
However, the massive use of the same type of herbicide crop after crop, as in the case of glyphosate, accelerates appearance of invading plants naturally resistant to such herbicide (Owen, 2008). In this case, the possibility of using varieties of genetically modified soybean that are tolerant to another herbicide, such as the gluphosinate ammonium, may be an important tool to help manage invaders, making possible to increase longevity of such technologies.
Soybean plants of event A5547-127 are sensitive to other herbicides, such as glyphosate, indicating the substrate specificity of protein PAT and showing that the plants of this event may be managed by the techniques usually employed in the field to eradicate undesirable plants.
Herbicide gluphosinate ammonium is rapidly degraded in the soil by action of microorganisms using this molecule as a source of nitrogen, releasing 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 (gluphosinate ammonium) is not toxic to fungi, nematodes and insects.
III. Description of the GMO and Proteins Expressed
Event A5547-127, styled LibertyLink Soybean, presents gene pat derived from Streptomyces viridochromogenes that grants tolerance to herbicide gluphosinate ammonium. This exogenous gene codes for enzyme phosphinothricin N-acetyltransferase (PAT protein) that promotes inactivation of the herbicide.
Gene pat was replicated using plasmid pB2/35Sack and the nucleotide sequence was inserted in the soybean genome by 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 ampicilin).
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.
Hybridizations of Southern blots and amplifications by chain reaction of DNA-polymerase 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 A5547-127 has a single copy of gene pat in orientation 5’„_3’.
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.
The characteristic of resistance to the gluphosinate ammonium herbicide followed the Mendelian way in the event, regarding generations assayed by applicant, indicating genetic stability of the insert.
Enzyme PAT is the only protein expressed by the transgene; it has 183 amino acids and molecular weight of 22 kDa. Event A5547-127 plants display PAT protein in concentrations of 26.22 ƒÝg/g in leaves, 13.85 ƒÝg/g in stalks, 3.6 ƒÝg/g in roots (Annex 11) and 9.0 ƒÝg/g in seeds (Annex 32) (AgBios, 2009).
During the event A5547-127 transformation, three new junctions, originating eight ORFs (open reading frames), were created. Based on bioinformatics analyses, the likelihood that a new protein expression created because of DNA insertion in event A5547-127 is very low for ORF-1, ORF-2, ORF-3, 0RF-4, ORF-6, ORF-7 and ORF-8. However, ORF-5 has all the regulating elements needed to initiate transcription and translation, though in non-optimal form and spacing, and one may not exclude the fact that it may lead to expression of a freshly created protein (Annex 35).
Northern blot analyses were conducted for A5547-127 soybean to demonstrate expression of gene pat introduced and to assay absence of a putative cryptic gene expression coming from different junction regions. The study characterized the presence of gene pat mRNA in all tissues tested. Downstream cryptic expression on junctions II and III were noticed in transgenic samples only, though no cryptic expression has been found in non-transgenic samples. However it is not likely that a fresh protein, in addition to PAT, is translated in such transcriptions (Annex 36).
Comparisons of event A5547-127 with its non-transgenic isoline A5547-127 showed that there are no differences regarding allergenic potential. In this assay, slight differences were found in some nutritional components. However, the variations were within the range normally found in conventional soybean lineages (FSANZ – Food Standards Australia and New Zealand, 2003), and resulted in no risks.
Gluphosinate ammonium (synthetic phosphinotricin) acts through controlling invading plants by inhibiting enzyme glutamine synthetase. The enzyme is responsible for incorporating ammonia to glutamic acid, forming glutamine. Inhibition of glutamine synthase promotes both a reduction in the levels of glutamine and collection of ammonium in plant tissues, leading the plant to death.
Glutamine synthetase is a protein produced by the cell nucleus that catalyzes formation of L-glutamine in the cytoplasm and predominantly in chloroplasts. The reaction is the main route of ammonium assimilation in plants. Gluphosinate ammonium is racemic, where the L-isomer has the function of inhibiting glutamine synthetase. The L-isomer has a structure similar to that of L-glutamate, leading to inhibition of glutamine synthetase by competition. However, ammonium collection is not directly responsible for the gluphosinate toxic effect. Gluphosinate indirectly inhibits the photochemical phase of photosynthesis, blocking the electron transportation chain, leading to disorganization of thylakoid membranes (Tan et al., 2006).
Protein PAT is able to inactivate gluphosinate through acetylation, by converting gluphosinate into N-acetyl-L-gluphosinate, which is atoxic. The rapid activity of PAT enzyme either eliminates or reduces the odds of gluphosinate to inhibit glutamine synthetase. Up to now, no occurrence of this protein has been identified in any plant. However, experiments have shown that some plants display reduced ability to naturally detoxify gluphosinate through deamination reactions, as it is the case for soybean, wheat, maize, tobacco, alfafa and carrot (Dropege-Laser et al., 1994), resulting an atoxic composite (4-methylphosphinic-2-oxo-butanoic acid, PPO). This natural inactivation route is quite slow, leading the plant to death prior to complete gluphosinate detoxification. Presence of exogenous PAT protein inactivates gluphosinate in a fast way, leading to increased tolerance to the herbicide (OECD, 2002). Up to now, there is no record of invading plants naturally tolerant to gluphosinate.
IV. Aspects Related to Human and Animal Health
World production of soybean is about 200 million tons, and the grain is used as edible oil, animal ration, foodstuff component to humans, besides being input for meal, soap, cosmetics, resins, paint, solvents and biodiesel. Due to presence of anti-nutrients, such as stachyose, rafinose, trypsin and lectin inhibitors, soybean shall be submitted to a thermal process before being used for consumption.
PAT protein is degraded by animal gastric fluid and by artificial gastric fluid similar to that of humans, weakening its physic-chemical characteristics after oral exposure. Therefore it is not expected that the protein may be wholly absorbed, being thereby impossible for it to cause adverse or toxic effects.
Innocuity of transformation by gene pat is warranted by works developed by different research groups. A detailed study on PAT protein innocuity was conducted focusing structural assay, search for glycosylation sites, thermal stability and in vitro digestibility. Protein expressed by pat gene was analyzed and the conclusion was that it is safe for use in plant modification regarding all aspects investigated (Hérouet et al., 2004). Results of such study enable inferring that protein PAT fails to display any characteristics of allergenicity to sensitized individuals, either by direct action or by cross-reaction with other allergenic molecules.
Allergens originated in foodstuffs are generally resistant to heat, acid and proteases, may be glycosylated and are present in high concentration. The protein analyzed is readily digested by gastric juices, is not glycosylated and exposure to heat leads to protein bioactivity loss.
In order to ensure safety of LibertyLink® soybean in animal food, Bayer and other research institutions demonstrated that the genetically modified soybean by introduction of the pat gene:
1. Has a bromatological composition similar to its unmodified parental;
2. Fails to present any adverse effect to mammals, even when intravenously administered in high doses;
3. Protein PAT has no homology with allergenic or toxic proteins;
4. Protein PAT fails to present any glycosylation site;
5. Protein PAT is not structurally unstable in acid environments;
6. Protein PAT has substrate-specific activity.
The search for PAT protein glycosylation sites, thermal stability, in vitro digestibility and allergenicity is fully described in studies conducted by applicant and other laboratories, upon applicant’s request, and is available in the Annexes of the proceedings.
Composition analyses were comparatively conducted in genetically modified plants and its respective conventional analogues (control lineages), which had been developed in similar environmental conditions to avoid possible variations in composition that are unrelated to genetic modifications. Thus, different parameters were assayed for Event A5547-127 and for the unmodified conventional lineage. Chart 3 of the topic “Assessment of Risk to Human and Animal Health” describes the analyzed groups and respective components, for instance: centesimal composition: humidity, gross fat, proteins, ashes, among others; minerals and vitamins: Ca, P, K, B1 vitamins, vitamin B2, vitamin E, folic acid, among others.
The similarity noticed for average values of analyzed composts indicates that the genetic modification resulting from insertion of pat gene to Event A5547-127 failed to affect any other metabolic function that might result in changed percentage of nutritional chemical components.
Effects on growth and mortality of chicken (Gallus gallus domesticus) brought by food containing or not the GM soybean were measured in an experiment with 240 birds. The birds were fed with ration containing 18,25% of soybean during the first seventeen days of life. During this growth phase and after slaughtering the chicken, several parameters compiled in Table 13 were analyzed. Results showed that there was no significant change in analyzed zootechnical characteristics as well as in other parameters studied.
Assessment of PAT protein cumulative toxicity was conducted in Wistar rats. Rat groups (10 animals) were fed on different concentrations of PAT protein, from zero to 50,000 ppm. The results showed no clinical effects as a result of the treatments and parameters, such as body weight, were not affected. The full details of the study are in the Annexes to the proceedings.
Information and studies submitted, besides all other works in the literature (see references below) establish the safety of LibertyLink® soybean Event A5547-127. This variant shows low risk to human and animal health and has no risk of changing into a plant pest. Gene insertion failed to change plant composition and nutritive value. It was verified that PAT protein poses no significant risk to human and environmental health according to acute oral toxicity and in vitro digestibility studies. Studies showed absence of toxicity in rats and birds fed on PAT protein.
Gene pat introduced in soybean has no similarity to known allergens; PAT protein does not share any immunologically significant sequence of amino acids with known allergens. These results, coupled with the rapid rupture of the protein in digestive conditions, confirm that protein PAT shall not pose significant allergenic risk. PAT protein may be widely found in nature, has a safe use history and well known action mechanism.
In September, 2007, the European Food Safety Authority (EFSA) issued a positive opinion on LL soybean. LL soybean was approved in the United States, Canada for food and farming; LL soybean is approved for import by Australia, Japan, Mexico, New Zealand, Taiwan and South Africa and approved as foodstuff in Russia.
V. Environmental Aspects
Gluphosinate ammonium (GA) is a synthetic compound correspondent to phosphinothricin, which is naturally produced by some soil microorganisms and is regularly registered and traded in Brazil under the brand FINALE. Other commercial names (LIBERTY, BASTA, IGNITE) are internationally used. GA biodegradability is one of the main characteristics of the product, in addition to its low toxicity on fowl, insects, earthworms and bees; it is a non-mutagenic non-carcinogenic product with low risk of leaving residuals in soil and water given its low half-life. GA has a broad range and is a fast acting herbicide on monocotyledon and dicotyledon plants, controlling plants from its emergence in soil to more advanced stages. GA activity on the target-plant is exclusive and specific (inhibition of glutamine synthetase enzyme), acting in a way to minimize appearance of resistant plant pest populations.
Plants derived from Event A5547-127 display the same agronomic behavior and adaptability than the conventional lineage, with no changes on the traits that regulate the species survival and reproduction. Comparative analyses of morphologic, phenotypic and agronomic characteristics enable a conclusion that none of such variables was changed by the genetic modification of the Event A5547-127. There are no records of traits that may grant either selective advantage or atypical behavior to the species.
PAT protein, product of expression of the gene inserted in the Event, displays some characteristics in risk assessment, such as:
(i) lack of homology with allergenic protein, toxin or antinutrients;
(ii) lack of glycosilation site (that is present in a number of allergenic components);
(iii) the protein is unstable in acid environments;
(iv) the protein is rapidly degraded and denatured in gastric and intestinal fluids of mammals;
(v) the protein has substrate-specific activity (acts solely on gluphosinate); and
(vi) the protein failed to display any adverse effect in mammals, even when administered pure, in high doses, in the vein.
According to applicant, possible effects to relevant indicator organisms in experiments conducted in the United States and Porto Rico, with visual observations during the evolutionary cycle to assess occurrence of atypical plants or plants that respond differently to biotic pressure, suggested that insertion of the pat gene has failed to influence susceptibility/influence to pests and diseases of lineages derived from A5547-127, even when they are subject to different environmental conditions. Studies conducted in the cities of Paulínia and São Gabriel do Oeste revealed no anomaly in terms of insect and fungus occurrence and anomalies related to plant physiology.
Safety to environment aspects, analyzed in local field studies, demonstrated that the lineage originated from Event A5547-127 displays the same agronomic behavior and adaptability of the conventional lineage, with no changes on the species survival and reproduction regulating characteristics. Comparative analyses of morphologic, phenotypic and agronomic characteristics enabled a conclusion that none of such variables was changed as a result of the Event genetic modification. According to applicant, no traits that could grant selective advantage to the GM soybean or atypical behavior to the species were recorded. During post-harvest monitoring, carried out in experimental areas, few remaining soybean plants were recorded, and were easily eliminated. This is evidence that the GMP does not remain in the farming environment without human intervention, nor displays traits that make it more aggressive or invading on the ecosystem than its conventional parental lineage, according to applicant.
Event A5547-127 is already commercially released in Mexico (2003), United States of America (1998) and Japan (2006). Taking into account internationally accepted criteria in the process of analyzing genetically modified plant risks, one may conclude that Event A5547-127 is as safe as its conventional equivalent.
VI. Restrictions to the use of GMO and its derivatives
According to 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”.
Soybean is an exotic species in Brazil and there are no feral kindred able to cross and generate offspring. Gene flow among soybean plants is already studied in tropical conditions. Soybean is an autogamic species displaying full flowers, with crossed pollination rates ranging from 0.5% to 1% according to place and type of cultivar; gene flow may occur at no more than eight meters.
After ten years of use in different countries, no problem has been recorded as affecting human and animal health or the environment that may be attributable to transgenic soybeans. It shall be stressed that lack of negative results in farming transgenic plants is no guaranty that such results may not occur. Zero risk coupled with absolute safety do not exist in the biological world, although there is a host of reliable scientific information and a history of safe use of transgenic variety in agriculture. Therefore, applicant shall carry out post-commercial release monitoring under the provisions of CTNBio Ruling Resolution nº 5 and according to this Technical Opinion.
Proceedings nº 01200.003881/2008-92, Event A5547-127, submits a monitoring plan for Liberty Link soybean. The company intends to establish two areas (with about 2 ha of area each) in the States of Paraná, Rio Grande do Sul and Mato Grosso, totaling six experimental areas for data collection and observation. Each experimental area shall contain two genotypes (LibertyLink and Conventional soybean). Each genotype shall occupy an area or 0.24 ha. The area shall include four repetitions of each genotype, totaling 0.96 ha/genotype. An isolation of 8m is intended around the experimental area. Monitoring shall take five years, with yearly reports.
Parameters to be analyzed by applicant:
• Plant nutritional state and sanity;
• Chemical attributes of the soil related to fertility (including pH, Al, P, K, Re, Mn);
• Community assessment of invading plants and development of resistance to the herbicide ammonium gluphosinate;
• Soil microbiota assessment (protozoan, mycorrhiza, microbian biomass, soil respirometry).
This intended monitoring shall be modified to include the parameter to be assessed: flow of ammonium gluphosinate resistance gene to other soybean plants; Assessing occurrence of ammonium gluphosinate pat gene flow to other soybean plants in areas of commercial farming.
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
Whereas:
• 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 A5547-127 outside farming environments;
• Soybean is an exotic species, with no sexually compatible feral kindred in Brazil and crossed pollination with wild species in the natural environment may not occur in the Brazilian territory;
• Herbicide gluphosinate is rapidly degraded in soil by action of microorganisms that use this molecule as a nitrogen source, producing CO2 and phosphorus;
• Ammonium gluphosinate (AM) 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;
• Studies showed absence of toxicity in rats and birds fed on PAT protein;
• Gene pat introduced in soybean has no similarity with known allergens;
• Protein PAT fails to share immunologically significant sequences of amino acids with known allergens;
• Foods based on soybean derived from Event A5547-127 show compositional/nutritional equivalence to products coming from non-modified soybean varieties;
• Environmental safety aspects were analyzed in local field studies where it was shown that the lineage coming from Event A5547-127 displays the same agronomic behavior and adaptability of the conventional lineage, with no change on characteristics that regulate the species’ survival and reproduction.
For the foregoing and taking into consideration internationally accepted criteria in the process of risk analysis for genetically modified raw materials, one may conclude that LibertyLink Soybean is as safe as its conventional equivalents. According to Article 14 of Law 11,105/05, CTNBio held that the request complies with the rules and laws in effect aimed at securing biosafety of the environment, agriculture, human and animal health, and concluded that LibertyLink Soybean is equivalent to conventional soybean, and its consumption safe for human and animal health. Regarding the environment, CTNBio held that LibertyLink Soybean is not a potential cause of significant degradation of the environment, keeping with the biota a relation identical to that of the conventional soybean.
|
| Upload: |
|
| 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 Commission
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
Not Applicable |
E-mail:
Organization/agency name (Full name): National Biosafety Technical Commission
Contact person name: Paulo Augusto Viana Barroso
Website:
Physical full address: SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number: 556120335087
Fax number:
Country introduction: Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques. Useful links
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. Paulo Augusto Viana Barroso (President of national Biosafety Commission)
| 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.
|
| Upload: |
|
| 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 (food safety): |
Please see decision document weblinks |
| Upload: |
|
| 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
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Health Canada
Contact person name: Neil Strand
Website:
Physical full address: 251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number: 613-946-1317
Fax number:
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.
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 guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) 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. Useful links
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: Neil Strand, Section Head of Novel Foods
| Name of product applicant: |
Bayern Crop Science |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
22/09/2014 |
| 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.): |
|
| Summary of the safety assessment (food safety): |
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization. |
| Upload: |
|
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministerio de salud y proteccion social
Contact person name: Daniel Rubio
Website:
Physical full address: Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number: 330 5000 ext 1256
Fax number:
Country introduction: The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).
The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
PT. BASF Indonesia |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
20/04/2020 |
| 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.): |
Indonesia Biosafety Clearing House
|
| Summary of the safety assessment (food safety): |
Indonesian National Agency of Drug and Food certified food safety for GM Soybean event A2704-12 (tolerance to Glufosinate) |
| Upload: |
|
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Indonesian Agency for Agricultural Research and De
Contact person name: Sustiprijatno
Website:
Physical full address: BB Biogen Jl Tentara Pelajar 3A Bogor 16111 Indonesia
Phone number: +622518333440
Fax number: +622518334420
Country introduction:
- Indonesia has ratified Protocol on Biosafety to the Convention on Biological Diversity (CBD) through the Indonesian Law No. 21 / 2004. In the implementation, biosafety assessment for GM products, based on Goverment Regulation Number 21 /2005, Indonesia has regulated GM products on several items including : product kinds and requrements, research and developement, product importation, product assessment, release and distribution, supervision and monitoring, and institution and financing. We have also Law for food No. 18 /2012 which also consists of regulation for GM food.
- Indonesia already have procedure /application on GMO biosafety assessment and National Authorized Institution who conducting the biosafety assessment . Each GM food should have authorization from Goverment before it can be released and distributed. An application for authorisation for new GM food should be submited to Biosafety Commision through related Ministry or authorised Non Departement Goverment Agency (LPND) . Biosafety Commision, then sends the application to the National Agency for Drug and Food Control (Badan POM) for technical team to evaluate the GM food safety. The recommendation by technical team will be sent back to Biosafety Commision. The recommendation and GM Food safety certificate will be released by Biosafety Commision to the applicant through related ministry or LPND.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: National Agency of Food and Drug Control (BPOM): http://www.pom.go.id/new/home/en
| Name of product applicant: |
Bayer CropScience |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
24/04/2016 |
| 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.): |
|
| Summary of the safety assessment (food safety): |
Competent National Authority: Ministry of Health and Medical Education- Food & Drug Administration. Risk Assessment file is uploaded.
https://bch.cbd.int/en/database/RA/BCH-RA-IR-114060/2 |
| Upload: |
|
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): ABRII
Contact person name: Gholamreza Salehi Jouzani
Website:
Physical full address: Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number: 0098(26)32701132
Fax number: 0098(26)32701132
Country introduction: Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.
The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
|
Agricultural Jihad Ministry
Tehran, Tehran
Iran (Islamic Republic of)
|
|
Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
|
| Name of product applicant: |
Bayer Crop Science Ltd. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
08/07/2002 |
| 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 (food safety): |
Please see the link below (in Japanese). |
| Upload: |
|
| 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 Ministry of Health, Labour and Welfare of Japan (in Japanese)
|
| Upload: |
|
| 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: Kojiro Yokonuma
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. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
BASF (Malaysia) Sdn. Bhd. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
28/03/2012 |
| 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 uploaded document. |
| Upload: |
|
| 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: |
|
| Upload: |
|
| 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 Natural Resources and Environmental Sustainability
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. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Department of Biosafety, Ministry of Natural Resources and Environmental Sustainability, Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia. 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]
| Name of product applicant: |
Bayer CropScience Pty Ltd |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
22/07/2004 |
| 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 (food safety): |
Food from soybean lines A2704-12 and A5547-127 has been evaluated according to the
safety assessment guidelines prepared by FSANZ. The safety assessment included the
following:
• a detailed characterisation of the genetic modification to the plant;
• a consideration of the safety of any transferred antibiotic resistance genes;
• characterisation of any novel proteins, including their potential toxicity and
allergenicity;
• a consideration of the composition and nutritional adequacy of the food, including whether there had been any unintended changes to the food.
The applicant submitted a comprehensive data package in support of their application and provided studies on the molecular characterisation of lines A2704-12 and A5547-127, the potential toxicity and allergenicity of PAT, compositional analyses of food derived from lines A2704-12 and A5547-127, and animal feeding studies to demonstrate the nutritional adequacy of the food. In addition to information supplied by the applicant, the evaluation also had regard to other available information and evidence, including from the scientific literature, general technical information, other regulatory agencies and international bodies.
No potential public health and safety concerns were identified in the assessment of food from soybean lines A2704-12 and A5547-127. Therefore, on the basis of all the available evidence, including detailed studies provided by the Applicant, it has been concluded that food derived from soybean lines A2704-12 and A5547-127 is as safe and wholesome as food derived from other soybean varieties. |
| Upload: |
|
| 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
|
| Upload: |
|
| 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: john vandenbeuken
Website:
Physical full address: Pastoral House, 25 The Terrace, Wellington, 6012
Phone number: 0298942581
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. Useful links
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:
| Name of product applicant: |
Bayer CropScience Inc |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
05/11/2019 |
| 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): |
Soybean A2704-12 has been evaluated according to safety assessment by concerned agencies of the Department of Agriculture, such as the Bureau of Animal Industry (BAI) for feed safety, and Bureau of Fisheries and Product Standards (BAFPS) for food safety, and a Scientific Technical Review Panel (STRP) members. The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological and nutritional issues associated with the modified soybean
The petitioner/applicant published the Public Information Sheet (PIS) of the said application in two widely circulated newspapers to solicit comments from the public. During the 30-day posting period, the Bureau of Plant Industry (BPI) received no comment on the petition.
The STRP and agencies’ assessment and review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
|
| Upload: |
|
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
November 4, 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
Fax number:
Country introduction: 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.
Useful links
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.
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
| Name of product applicant: |
Bayer Korea Ltd. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
02/04/2009 |
| 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). |
| Upload: |
|
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministry of Food and Drug Safety
Contact person name:
Website:
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
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Bayer |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
26/11/2012 |
| 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): |
Soybean line A2704-12 (ACS-GM005-3) has been genetically modified to tolerate the herbicide glufosinate ammonium through the transfer of the pat gene derived from S. virochromogenes. The pat gene encodes the phosphinothricin acetyltransferase (PAT) enzyme that confers tolerance to glufosinate ammonium (phosphinothricin). The pat gene is stably integrated into the plant genome at a single site and is stably inherited from one generation to the next generation. The expressed PAT protein is non-toxic and unlikely allergenic to humans. Compositional analyses showed that food from soybean line A2704-12 is equivalent in composition to that from other soybean varieties. Food produced from soybean line A2704-12 can be considered as safe as food produced from other soybean varieties. |
| Upload: |
|
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Singapore Food Agency (SFA)
Contact person name: Dr Tan Yong Quan
Website:
Physical full address: 52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number: (65)68052750
Fax number:
Country introduction: The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food. SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption. The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Singapore Food Agency (SFA)
| Name of product applicant: |
BASF (Thai) Limited |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
04/12/2022 |
| 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.): |
|
| Summary of the safety assessment (food safety): |
The food safety assessment performed by the National Center for Genetic Engineering and Biotechnology (BIOTEC) as advisory and technical arm of Thai FDA. BIOTEC conduct food safety assessment according to codex guideline and based on the safety data and information provided by the applicant (as specified in Annex 2 attached to Notification of the Ministry of Public Health No.431). According to the existing scientific data and information available during the safety assessment, it is concluded that the soybean event A2704-12 is not different from the conventional counterpart soybean in terms of phenotype, food safety (toxicity and allergenicity), as well as nutritional profile form soybean counterpart. However, the risk assessment should be addressed if the information is changed. |
| Upload: |
|
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): National Burequ of Agricultural Commodity and Food
Contact person name: Director of Office of Standard Development
Website:
Physical full address: 50 Phahonyothin Rd., Lardyao, Chathuchak, Bangkok 10900
Phone number: +6625612277 ext.1401
Fax number: +6625613373
Country introduction: National Bureau of Agricultural Commodity and Food Standards (ACFS) is a governmental agency under the Ministry of Agriculture and Cooperatives (MOAC) responsible for the development of national agricultural and food standards. The Agricultural Standards Act B.E. 2551 (2008) establishes the mechanisms for the development of Thai Agricultural Standards (TAS) as either voluntary or mandatory standards. This is based on scientific data, consumer’s health and fair trade. Within the TAS, there are four standards relating GM food assessment, namely Principle for the Risk Analysis of Foods Derived from Biotechnology (TAS 9010-2006), Assessment of Possible Allergenicity (TAS 9011-2006), Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (TAS 9012-2006) and Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (TAS 9013-2006). These standards are adapted from relevant Codex standards. Safety assessment for imported GM crops and foods is done by the cooperation of the Food and Drug Administration (FDA) and the National Center for Genetic Engineering and Biotechnology (BIOTEC)via the Committees relating National Committees to consider technical and political issues. The Committees comprise representatives from all relevant governmental and non-governmental key sectors including experts on genetic modification, toxicity and others.
The safety assessment process of GM food in Thailand is on a voluntary basis. According to the current laws and regulations, there is no approval authority. Useful links
Relevant documents
Stacked events: The safety assessment for stacked events is divided into two patterns. The first pattern is for stacked events whose GM parents have never approved by FDA or other competent authority. Those stacked events shall be fully assessed in line with GM foods. Another pattern is introduced for the safety assessment of stacked event lines where from GM parents had already been approved. In the second pattern, the information of the parents could be used for consideration, as appropriate. However, the information relevant to interaction between genes and new proteins of stacked event should be mainly taken into account. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food and Drug Administration (FDA) and National Center for Genetic Engineering and Biotechnology (BIOTEC)
| Name of product applicant: |
Special case: please show below |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
26/01/2011 |
| Scope of authorization: |
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): |
After the evaluation of reports released by Scientific Risk Assessment Committee and
Socio- economic Assessment Committee Biosafety Board has approved the use
of genetically modified soybean A2704-12 and products thereof for animal feed.
|
| Upload: |
|
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): DG of Agricultural Research and Policies (TAGEM)
Contact person name: Ramazan BULBUL
Website:
Physical full address: Universiteler Mah. Dumlupınar Bulvarı, Eskişehir Yolu 10. Km
Çankaya/ANKARA/TURKEY
Phone number: +90 312 307 60 48
Fax number: +90 312 307 61 90
Country introduction: Turkey is party to the Cartagena Protocol on Biosafety (CPB) since Jan 24, 2004. Biosafety applications in Turkey are carried out within the framework of the Biosafety Law (no.5977) which entered into force in 26 September 2010 and its relevant regulations (“The Regulation on Genetically Modified Organisms and Products” and “The Regulation Connected with Working Procedure and Principles of Biosafety Board and Committees”). Biosafety Law and two regulations came into force on 26th September 2010.
Main objectives of the Biosafety Law are;
- to prevent risks that may arise from GMO’s and products which are produced by using of modern biotechnology by taking into account scientific and technological developments;
- to establish and implement biosafety system to ensure protection and sustainability of environment, biological diversity and health of human, animal and plant;
- to inspect, regulate and monitor the activities in the scope of the law.
The Law includes specific points regarding research, development, processing, releasing on the market, monitoring, using, import, export, handling, transportation, packaging, labelling, storage and similar operations in relation to GMO and GMOPs.
Veterinarian medicinal products and medicinal products for human use and also cosmetic products which are permitted or certified by the Ministry of Health are out of this Law’s scope.
According to Biosafety Law following actions connected with GMO and GMOPs are prohibited:
- Releasing GMO and GMOPs on the market without approval of Ministry of Agriculture and Forestry.
- Production of genetically modified plants and animals.
- Using GMO and GMOPs in baby food and baby formulae, follow-on baby food and follow-on formulae, infant and kid’s nutritional supplements
According to the Biosafety Law, which was enacted in 2010, the Biosafety Board, which was established within the scope of the Law, was responsible for evaluating the applications regarding GMO and its products.
However, the duties and powers of the Biosafety Board were assigned to the Ministry of Agriculture and Forestry with the Presidential Circular No. 2018/3 published in the Official Gazette on the date of August 2, 2018.
The task of evaluating the applications related to GMO and its products, performing the secretarial services of the Committees and other duties specified in the Biosafety Law and related regulations has been assigned to General Directorate of Agricultural Research and Policies (TAGEM) under the Ministry of Agriculture and Forestry pursuant to Ministerial Approval dated 05/12/2018.
Ministry of Agriculture and Forestry makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account.
For each application the Ministry of Agriculture and Forestry assigns a new committee and each committee makes different assessment for each application. It is important to note that in Turkey food and feed each have a different assessment application.
Members of scientific committees are selected from the List of Experts.
11 members are selected for each GMO application.
List of Experts has been made up by the evaluation of Ministry of Agriculture and Forestry from the applicants who applied via using the Biosafety Clearing-House Mechanism of Turkey. Applicants were faculty members and experts of Universities and TÜBİTAK (The Scientific and Technological Research Council of Turkey).
To date, 13 types of GM soybean and 23 types of GM maize were approved as feed for import.
Besides, by the use of aspergillus oryzae, developed through modern biotechnological methods, licences for industrial α-amylase, glucoamylase and hemicellulase enzyme production were granted.
Threshold of labeling of GMO products that are approved by Ministry of Agriculture and Forestry is 0.9%.
There are not any applications for using GMO and products as food.
After placing GMO and GMOPs on the market; the Ministry controls and inspects whether or not conditions designated by decision are met.
Activities of analysis are performed in laboratories designated by the Ministry.
In the case of any non-compliance detected with relation to the GMO Legislation (such as a failure to specify the contained GMO on the label, identification of an unapproved gene, etc.) legal action is taken.
Application evaluation process is like below:
- Evaluation of application by Ministry of Agriculture and Forestry 90 days
- Feedback to the applicant 15 days
- Ministry of Agriculture and Forestry’s “Decision” 270 days
(Starts from feedback to the applicant)
Establishing of Scientific Committees
Report preparation of Committees
Report’s public release
Evaluation of public opinions by Committees
Ministry of Agriculture and Forestry’s final decision after taking reports and public opinions into
account
- Publishing the Positive Decision 30 days
- Reclamation period to Negative Decision 60 days
- Evaluation of reclamation by Ministry of Agriculture and Forestry 60 days
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Ministry of Agriculture and Forestry
General Directorate of Agricultural Research and Policies
Focal Point of the FAO GM Foods Platform
Ramazan BULBUL
Email: [email protected]
| 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
|
| Upload: |
|
| 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 (food safety): |
Please consult the FDA website links below. |
| Upload: |
|
| 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
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
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. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration. Useful links
Relevant documents
Stacked events: Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized. Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Bayer Crop Science |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
19/09/2012 |
| 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.): |
BCH
|
| Summary of the safety assessment (food safety): |
Please refer to uploaded document |
| Upload: |
|
| 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: |
GNBio
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministerio de Ganadería, Agricultura y Pesca
Contact person name: Alejandra Ferenczi
Website:
Physical full address: Constituyente 1476, Piso 2, Of. 212B. Montevideo, Uruguay
Phone number: +598 2 4104155 int 3
Fax number:
Country introduction: The Uruguayan National Biosafety System (SNB for its acronym in Spanish) includes safety assessments of food end feed, environmental risk assessment, risk management, and risk communication. The National Biosafety Cabinet (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy (MEF); Minister of Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry (MIEM). This Cabinet is the last responsible to make decisions over a submitted request. It has the authority to define policies to be followed with respect to biosafety in all scopes of GMO application. Other committees of experts and scientists give support to decisions of GNBio through risk analysis of biotechnological products. The Risk Management Commission (CGR) is composed by one delegate of each of the ministries represented within GNBio. The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the risk communication participation process; is responsible for follow-up and monitoring of authorized events. The Risk Assessment in Biosecurity (ERB) is composed of experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. Is responsible for considering, on a case-by-case basis, the potential risks and benefits of each new biotech product; assure case-by-case risk assessment evaluation based on scientific methods; writes an operational plan (pre-report) of risk assessment according to CGR directives; advises CGR based on the results of the analysis of risk assessment, and provides information during the consultation process. The Institutional Articulation Committee (CAI) is a committee of technical experts from nine different national public and research institutions, which analyzes the risk assessment of new events and prepares a technical report. The technical analysis is coordinated by ERB organized in different ad hoc groups of experts. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis of GMO events like characterization and molecular identification of events, environmental and food safety aspects. Useful links
Relevant documents
Stacked events: GM vegetables from cross-pollinated species, such as corn, with stacked events are not considered as a new product. In the case of GM vegetables from self-pollinated species, such as soybean, are considered as a new product even if all single events stacked have already been approved. However, there is an abbreviated analysis procedure in cases where single events were already analyzed. Stacked events not yet analyzed must have the individual risk assessment report. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: GNBio office. E-mail: [email protected]; Adress: Constituyente 1476, piso 2, oficina 212B, Montevideo 11200, Uruguay.
| Name of product applicant: |
A 2704-12 |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
09/09/2015 |
| 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): |
A2704-12 soybean is as safe as and substantially equivalent to its conventional counterpart. It shows no different allergenic or toxic potential compared to conventional soybean currently in the market. Compositional analyses of beans from A2704-12 soybean and current commercial soybean varieties were compared for compositional and nutritional parameters including moisture, crude fat, crude protein, crude fiber, ash, carbohydrates, mineral content, amino acid profile, and fatty acid composition. The data and findings show that A2704-12 soybean is compositionally and nutritionally equivalent to currently grown conventional commercial soybean varieties.
The low potential for toxicity of the PAT protein expressed in A2704-12 soybean is demonstrated by examining the amino acid sequence homology, chemical characteristics of the protein and by acute oral toxicity testing in rats. The nucleotide sequence of the pat gene and the deduced amino acid sequence of the PAT protein were compared with sequences available for known toxins in the GenBank database and showed no significant homology with any known toxins or allergens.
- The PAT enzyme expressed in A2704-12 soybean does not possess characteristics typical of known protein allergens and is extremely unlikely to be allergenic. There were no regions of homology when the sequences of the introduced protein were compared to the amino acid sequences of known protein allergens. There was no evidence found of post-translational modifications such as acetylation, glycosylation or phosphorylation of the PAT protein. Unlike known protein allergens, the PAT protein was rapidly degraded by acid and/or enzymatic hydrolysis when exposed to simulated gastric fluids. In vitro digestibility studies, under simulated mammalian gastric conditions, demonstrated that the PAT enzyme was inactivated within one minute and was rapidly degraded. No adverse effects have been reported to be associated with this enzyme.
- To date A2704-12 soybean has been approved for food and feed uses in 19 countries worldwide. There are no adverse effects assumed with use of A2704-12 soybean and as a consequence there is no need for a case specific monitoring plan relating to import of herbicide tolerant A2704-12 soybean. The beans derived from A2704-12 soybean needs no specific or additional treatment and will be handled in the same way as any other conventional soybean commodity. |
| Upload: |
|
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministry of Agriculture and Rural development
Contact person name: Nguyen Thi Thanh Thuy
Website:
Physical full address: 2, Ngoc Ha, Ba Dinh, Ha Noi, Viet Nam
Phone number: +84 08044643
Fax number: +83 4 38433637
Country introduction: The process for authorizing a GM food, feed is based on the Vietnam regulation on GM food and feed (Circular No. 02/2014/TT-BNNPTNT). An application for authorizing food, feed derived or made from a GM plant must be submitted to national authorities (Ministry of Agriculture and Rural Development-MARD). The national authority proceeds prior review the dossier/application and makes the application summary report available to the public. The authority then sends the application to the Food, Feed Safety Committee (FFSC) members for reviewing and risk assessment. FFSC is inter-ministerial committee established by the Minister of Agriculture and Rural Development in order to consult to MARD’s minister for issuance, revocation the Food, feed safety Certificate. Once FFSC performing the risk assessment (desktop reviewing), the public has 30 days to comment on MARD website for application. Within 180 days of receiving the appropriate application, FFSC complete the assessment and submit the final report to the national authority/MARD under Circular 02/2014/TT-BNNPTNT. Within 30 days receiving FFSC comment and conclusion, the national authority grants or refuses to issuing certificate.
Safety regulations have derived based upon the internationally established scientific guidelines and principles of Codex Alimentarius Commission, FAO, WHO and OECD.
FFSC does not separately assess food, feed from stacked event lines where food, feed from the GM parental events has already been approved separately; Mandate notification of stacked events by developers. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
|
|
