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OECD Unique Identifier details

BPS-CV127-9
Commodity: Soyabean / Soybeans
Traits: Imidazolinone tolerance
Australia
Name of product applicant: BASF Plant Science Company GmbH
Summary of application:
A genetically modified (GM) soybean line BPS-CV127-9, hereafter referred to as CV127, has been developed that is tolerant to the imidazolinone class of herbicides.
Tolerance to imidazolinone herbicides in soybean line CV127 is achieved through expression of an imidazolinone-tolerant acetohydroxyacid synthase (AHAS)1 catalytic subunit encoded by the csr1-2 gene derived from the plant Arabidopsis thaliana. AHAS, which catalyses the first step in the biosynthesis of the branched-chain amino acids (valine, leucine, and isoleucine), is the target of several classes of structurally unrelated herbicides, including the imidazolinones, the sulfonylcarboxamides, the sulfonylureas and the triazolopyrimidines.
The AHAS catalytic subunit combines with a smaller regulatory subunit to form the AHAS enzyme complex. The regulatory subunit is necessary for full enzymatic activity and also for end-product feedback inhibition by the branched chain amino acids. The A. thaliana AHAS catalytic subunit expressed in soybean line CV127 has altered herbicide binding properties such that imidazolinone herbicides are unable to bind, and therefore inhibit, its activity. It is able to combine with the endogenous soybean regulatory subunit to form an imidazolinone-tolerant AHAS enzyme which is able to function in the presence of imidazolinone herbicides.
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Date of authorization: 12/07/2012
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment:
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Application A1064 - Food derived from Herbicide-tolerant Soybean Line CV127
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Authorization expiration date:
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:
Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
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Relevant documents
Stacked events:
FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
Brazil
Name of product applicant: Embrapa Soja and BASF S.A
Summary of application:
This GMOs is a genetically modified soybean, tolerant to herbicides of chemical class imidazolinones, Soybean CV127, Event BPS-CV127-9, for the purpose of its release into the environment, marketing, consumption and any other activity related to this GMO and derived progenies. The event has gene csr1-2 that codes for enzyme acetohydroxyacid-synthase (AHAS), which acts in the first phase of branched chain amino acid (valine, leucine and isoleucine) synthesis in plants and microorganisms. Inhibition of AHAS enzyme activity by imidazolinone binding causes cell death by the inability of cells to produce these amino acids, fundamental to synthesis of proteins and other derived amino acids that are fundamental for other metabolic routes. The gene codes for a single transit peptide that directs the translation product to plastids, where synthesis of such amino acids takes place. Soybean CV127 was the result of a transformation by means of biobalistics
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Date of authorization: 10/12/2009
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.): Center For environmental Risk Assessment
Summary of the safety assessment:
The gene codes for a single transit peptide that directs the translation product to plastids, where synthesis of such amino acids takes place. Soybean CV127 was the result of a transformation by means of biobalistics. The following biochemical characteristics related to protein AHAS were assayed: (i) molecular mass; (ii) immunoreactivity; (iii) enzymatic activity and its inhibition through feedback by product amino acids; (iv) glycosilation; (v) determination of peptide amino acids sequences derived from the purified protein. Preparations of the recombinant protein were obtained from young leaves of Soybean CV127 cultivated under field conditions. All results indicated full equivalence of the recombinant protein derived from Soybean CV127 to the same protein produced by a heterolog system. Environmental safety of Soybean CV127 was comparatively analyzed with its non-GM isoline and two other conventional varieties of soybean in essays held in different places that represent soybean farming in Brazil. The following phenotypic, agronomic and ecologic characteristics were assayed: (i) seed germination rate; (ii) seed vigor; (iii) comparative follow-up along time of main development phases; (iv) height of plants; (v) leaf-dropping; (vi) susceptibility of diseases and field pest-insects; (vii) grain yield; (viii) insect population in plants and soil (microfauna); (ix) populations of parasitic and free-living nematodes; (x) soil microbial biomass; and (xi) relevant factors for nitrogen fixation to soil by Bradyrhizobium symbiosis. All data obtained in this study demonstrated that Soybean CV127 is equivalent to its non-GM equivalent and two soybean varieties used as controls. Results of the study on number, germination patterns and morphologic and microspore (pollen) characteristics, as well as germination characteristics, indicated that there were no significant differences between the transgenic variety and its non-GM isoline. Equally, there was no difference recorded in seed dormancy and likelihood of emergence of long-term reproduction structures, which are practically non-existing in soybean. Additionally, studies were submitted supporting that the GM soybean analyzed has no difference from its non-GM isoline regarding ability to extract or introduce substances into the soil, equaling, therefore, the potential impact to environment caused by conventional soybean. Biodegradability of plant soybean tissues in soil after harvest was assayed, as well as that of protein AHAS, and the result was that GM and non-GM plants behave equally. Regarding aspects of human and animal feeding safety assessment and harmful effects to the environment, data submitted lead to an understanding that there were no pleiotropic and epistatic effects caused by inserted genes in the course of at least seventeen generations of soybean containing the transgenic construct. Besides, no allergenic potential was detected in the protein introduced, and studies demonstrated its digestibility in simulated gastric fluid and in guinea-pigs. Results submitted confirm the transgenic variety risk level as equivalent to that of non-transgenic ones regarding soil microbiota, non-target vertebrate and invertebrate animals and other plants. In conclusion, alimentary safety of Soybean CV127 is rooted in the transgene nature and remaining exogenous DNA sequences introduced in the plant, its behavior, and the plant proliferation environment that is restricted to tillage of small, middle and large extensions. CTNBio analyzed the reports submitted by applicants in addition to independent scientific literature. TECHNICAL OPINION I GMO identification: GMO Designation: Soybean CV127 Applicant: BASF S.A. and Embrapa Soja Species: Glycine max (L.) Merr Inserted Characteristics: Tolerance to herbicide of the imidazolinone chemical class Insertion Method: Soybean CV127, classified as Risk Class I, was obtained by transformation through biobalistics of a commercial variety of Conquista soybean, using a plasmid Pac321 DNA fragment of about 6.2 kb, containing the expression cassette of Arabidopsis thaliana gene csr1-2 (granting tolerance to herbicides of the imidazolinone chemical class) and the complete sequence of protein AsSEC61y gamma subunit. Prospective Use: Free registration, use, essays, tests, sowing, transport, storage, marketing, consumption, release and discarding and any other activities related to this GMO. II. General Information Applicants developed a soybean variety tolerant to herbicides of imidazolinone chemical class, an event styled BPS-CV127-9, “Soybean CV127” hereinafter. This soybean derives from a single transformation event obtained by biobalistic introduction of Arabidopsis thaliana genes csr1-2 with its native promoter and untranslated native region (UTR) 3’. Gene csr1-2 codes a major subunit of acetohydroxiacid synthase that grants tolerance to imidazolinone chemical class herbicides. A fragment of plasmid pAC321 DNA, containing the expression cassette, was used to modify the original apical meristheme tissue embryo axis of a soybean seed belonging to Conquista, a Brazilian variety most used by soybean farmers, widely adaptable to Brazilian regions. The resulting phenotype is a soybean that enables farmers to use imidazolinone group herbicide while causing no harm to the plant. Gene csr1-2 codes for a single polypeptide, formed by 670 amino acids including protein AtAHASL (or AHAS), the Arabidopsis thaliana cytoplast transit peptide (CTP), responsible for directing the protein to chloroplasts (where branched chain amino acids biosynthesis takes place). During the transport phase of protein ArAHASL to the chloroplast, the transit peptide is removed to produce active enzyme AHAS. The enzyme grants tolerance to imidazolinone group herbicide given by a punctual mutation that results in substituting one asparagine for the serine amino acid in position 653. Enzyme AHAS catalytic subunit has a property to link with herbicides while keeping the normal plant biosynthetic function (Pang et al., 2002). III. Aspects Related to Human and Animal Health The weed control by imidazolinones results from inhibition of acetohydroxyacid synthase enzyme in plants, which acts in the valine, leukine and isoleucine amino acid synthesis route. They act in both mono- and dicotiledoneae (Shaner and Mallipudi, 1991). The initial transformer came from buds of meristhem tissues with plant regeneration while exposed to the herbicide. Reselection occurred up to the F4 generation. Molecular follow-up monitoring the inserted gene single copy stability and agronomic performance. Development followed with retrocrossing between T4 and Conquista soybean that gave way to the new line (603) conducted up to F8, once more under agronomic and molecular monitoring, followed by a new crossing with the Conquista variety to obtain the 127 line (generation F7), the origin of Soybean CV127. Genetic maps detailing the plasmid and insert were submitted by applicants. The Arabidopsis thaliana DNA sequences were presented, together with the protein amino acid sequence. Southern blots demonstrated existence of a single insertion event and pointed out to the location of several diagnostic probes evidencing an absence of elements from the vector used (such as the ampicillin antibiotic resistance gene). The analysis also evidenced absence of 501 pb open reading frame (ORF) expression generated by duplicating 376 base pairs of a sequence part that is the coder for gene csr1-2, directly before the 3’ integration point. Inserted gene csr1-2 codifies for a 670 amino acid protein that has a transit peptide to the chloroplast, which is removed after translocation. The gene, besides the mutation granting resistance to the herbicide, carries mutation R272K, with no recognized phenotype. The Arabidopsis thaliana gene still not recorded, AtSEC61-gamma, appears as part of its promoter upstream gene csr1-2. It codes for an endoplasmatic reticulum transport short protein (69 amino acids), ubiquitous in plants and other eucaryotes. It expression was assessed in soybean and its transcription was found in very low levels in leaf tissue, while remaining the protein undetectable in leaves and kernels within the detection levels of the Western blot method (5 and 15 ppb, respectively). Self-specific PCR tests were developed for identification and verification of Soybean CV127. Besides, Soybean CV127 and controls kernels collected in four locations within Brazil were processed to produce the most used soybean fractions in human and animal food: refined oil, soybean meal and protein fraction. Protein AHAS expression level was assayed in each of the processed fractions. Results confirmed that protein AHAS is present in very low levels, though effective in granting resistance to the herbicide. Genetic inheritance pattern was tested and showed to be typically Mendelian. No pleiotropic or epistatic effects resulting from insertion in Soybean CV127 were detected. Protein AHAS is expressed in soybean in small amounts. The assay was conducted with Brazilian samples, coming from seven field essays on the 2006 and 2007 crops, and from six essays on the 2007 late summer crop. ELISA tests revealed quantities lower than one part per million (dry tissue). The figures range from about 500 ng per gram (leaves) to about 15 ng per gram (kernels) considering dry weight (DW). In kernel processed fractions (oil, flour and isolated protein) detection of the protein was not possible. Applicants submitted additional information related to materials and methods for determining concentration of proteins AHAS and SEC61(gamma) in Soybean CV127 tissues, complying with a CTNBio request. The document describes in detail the procedures employed, using two biologic replicas for experiment, each one generating three technical replicas for the ELISA tests. A total of thirteen charts display the quantitative data of analyses conducted with the different samples that were collected. Protein AHAS was analyzed at the applicant laboratory in Brazil and tests for quantification of SEC61(gamma) protein were conducted in Germany. Allergenicity was tested in silico by comparison with a FARRP v. 8.0 database (containing 1,313 proteins) using two different methods of screening. The results failed to reveal any allergenic potential. High digestibility and instability to heath (60ºC) exhibited by both the optimized and feral protein are characteristics of non-allergenic proteins. Soybean has 33 known natural allergenic proteins and the patterns of such proteins in Soybean CV127 and Conquista were similar. Besides, the proteins were verified to be non-glycosylated, a positive fact since proteins with a potential to cause allergies are in general glycosylated. The BLASTP tool compared the csr1-2 protein sequence with the remaining ones deposited with GenBank and there was no significant homology with any toxic protein of a reference database. Acute toxicity tests in mice used a 2.62g/kg of body weight dose. There was no clinical sign of toxicity or effect on weight of animals treated. The weight of organs examined fourteen days after gavage (brain, spleen, kidney, liver and heart) was similar to the ones measured in control groups. Innocuity of the dose represents a safety factor above 5 x 108 regarding the human daily average consumption in Brazil, assuming that the protein is present in all soybeans consumed. A recent revision by the EFSA (Alink et al., 2008) on animal tests to assess safety of foods derived from genetically modified plants concluded that there is no biologically relevant difference, within the parameters of the test, in animals used to demonstrate food safety when fed with genetically modified plants. Digestibility of protein AHAS in gastric and intestinal fluids was fast (30 seconds). About seventy components were examined to assay centesimal composition, proteins, lipids, ashes, carbohydrates, calories, alimentary fibers, humidity, post-treatment fibers, amino acids, fat acids, minerals, vitamins, isoflavones, phospholipids, and antinutrients. Herbicide-treated Soybean CV127 was compared to assess any important alteration on the above parameters. Analyses included kernels, fodder and processed fraction of soybean (oil, soybean meal and concentrated protein). The data indicated equivalence in composition among Soybean CV127, Conquista soybean and two other non-transgenic commercial varieties currently marketed. This equivalence was also confirmed in feeding animals with broiler chickens (576 individuals) fed on a balanced diet (42 days) in treatments containing meals of two commercial soybeans and isoline. Results were equivalent in body weight gain, ration consumption, clinical signs, mortality, behavior, microscopic pathology, hematological and biochemical parameters, demonstrating nutritional equivalence. There was no evidence of adverse effects on animals fed on Soybean CV127. The studies conducted with rats failed to record any clinical sign of toxicity and there was no significant difference in body weight and average absolute weight on different organs selected (brain, spleen, kidneys, liver and heart) when compared with the control group. Besides no adverse effect or lesion related to the treatment was recorded in the study, ratifying the atoxic nature of protein AHAS in mammals. Although the request for this particular soybean is the first in the world, varieties of imidazolinones chemical class herbicide resistant plants, expressing enzyme AHASL were obtained by induced or spontaneous mutagenesis, with the same substitution for amino acid S653N in corn, canola, rice, lentil and sunflower. The varieties are commercial known as Clearfield and are already farmed in several countries, including Brazil, for over fifteen years. For the foregoing, there are no experimental evidences that Soybean CV127 presents any toxicological or nutritional risk for humans or animals, when compared with conventional soybean varieties. Taking into account internationally accepted criteria in the process of analyzing risk in genetically modified raw materials, based on the concept of substantial equivalence, the modification introduced by genetic manipulation, inserting a gene of a non-toxic or invasive model plant, such as Arabidopsis thaliana, simply granted the soybean resistance to imidazolinone class herbicides. IV. Environmental Aspects Varieties of herbicide resistant plants have been obtained by induced or spontaneous mutagenesis in corn, canola, lentil and sunflower. Specifically for the imidazolinone chemical class herbicides, this approach was already used in cultivated varieties in different countries with a technology named Clearfield. For the sake of alimentary and agronomic safety strategy, existence of herbicide resistant varieties with different action mechanisms is desirable so that a farmer may have tools for managing resistant invading plants whenever they appear as a result of the applied pressure (Fedoroff and Brown, 2004). Herbicide tolerant varieties have contributed in widening direct sowing cultivars, a highly beneficial practice to the environment. Attempts to obtain the imidazolinone resistance in soybeans through chemically induced mutation resulted in partial resistance only, which was useless in the fields. The mutagenesis process results in global alterations of gene expression that are higher than those obtained by genetic engineering, as shown in rice by Batista et al. (2008). The fact is an additional assurance of safety provided by directed genetic manipulation. The interested companies submitted a well grounded application with a complete molecular and chemical characterization of the insert and its products. Results of studies on number, germination pattern and morphological characterization of microspores (pollen), as well as germination characteristics indicate absence of significant differences between the plant transgenic and non-transgenic isolines. Equally, there was no recorded difference regarding seed dormancy or likelihood of establishment of long term reproduction structures that, on soybean, are practically nihil. Documents submitted by applicants discuss aspects of a possible horizontal transfer and consequences of the event. The conclusions, supported by competent bibliographic references, concur to the fact that, besides being unlikely, no relevant consequence will take place with horizontal transfer of the transgene to the microbiota inhabitants. A number of studies were submitted in this analysis that support the assertion that the GM soybean analyzed is no different from its non-GM isoline regarding ability to extract or introduce substances in soil, equaling, therefore, the potential impact to the environment under this viewpoint. Biodegradability of soybean plant tissues in soil was assessed after harvest, as well as that of the AHAS protein, providing equal results for modified and conventional plants. Quantitative and qualitative results of Soybean CV127 agronomic behavior were equivalent to conventional soybean plants either in the present or absence of imidazolinone class herbicides during two harvest periods in different places of the country. The aspects assessed were: seed size and germination, vigor of plants, initial and final stand, green stem, plant height, dehiscence, leaf-dropping, days to flourish and maturing, grain yield and seed quality. The conclusion was that Soybean CV127 plants and derivatives showed agronomic properties compatible with those of conventional plants of the farmed soybean in Brazil. All studies related to assessments of human and animal safety and adverse effects to the environment clearly lead to the understanding that there was not and are not pleiotropic and epistatic effects of the inserted genes along at least seventeen generations of soybean containing the genetic construct. Bibliographic data and results submitted confirmed the transgenic variety risk level as being equivalent to that of non-transgenic ones regarding soil microflora, non-target vertebrate and invertebrate animals, as well as other plants. Tests were additionally conducted to assess incidence of soybean foliar diseases, based on statistic studies of foliar area damage. In no place and for no disease any significant difference between Soybean CV127 and the isoline was recorded, demonstrating that insertion of gene csr1-2 failed to affect susceptibility to diseases. Studies were also conducted in seven places during the 2006-2007 harvest and in six places during the 2007 late summer harvest to assess Soybean CV127 effects to nematodes, with a number of treatments, in both presence and absence of some herbicides. Data enabled a conclusion that, independently from the herbicide, the soybean fails to cause impact in free-living nematode populations and to contribute for an increased number of parasite nematodes in the plant. Studies aimed at assessing incidence of predators, number of insects of orders Coleoptera, Lepidoptera and Hemiptera detected in Soybean CV127 failed to record statistically significant differences in plants of the isoline or of the conventional soybeans in the four moments of the sampling. Besides, the damage caused by insect feeding among treatments and among essay locations was minimal, no differences recorded among treatments. Resistance to insect damage and effect of Soybean CV127 in pest insect populations in the fields were no different from the ones found in the isoline and varieties of conventional soybean. Assessment of symbiontic organisms was conducted in seven essays during the 2006-2007 harvest and six during the 2007 late summer harvest. There were no significant differences in populations, and figures were compatible to the ones commonly found in experiments with bradyrhizobium-inoculated soybean. A good nodulation was recorded in all places and treatments. Regarding the remaining microorganisms, especially those of the microbial carbon biomass (MCB) there was no statistically significant differences recorded among treatments in any place and for different phases of plant development. Analysis of variance was conducted for all places and no significant differences were recorded among treatments. Equally, for the microbial nitrogen biomass, no statistically significant difference was found among treatments. The technique of rDNA profiles, also used in 2006-2007 harvest and 2007 late summer harvest samples, was used to qualitative assessment of the soil microbial community. The results showed that there were no effects caused by the different treatments or by application of different herbicides in the soil microbial community qualitative characteristics. Regarding soil microfauna, population and diversity were assayed in seven places during the 2006-2007 harvest and in six places during the late summer 2007 harvest. Results of the impact assessment in cultivation of herbicide-treated genetically modified soybean showed an absence of changes in populations and community diversity of soil macro-organisms when compared to the isoline and to commercial varieties used as standards. Regarding assessment of soybean dispersion mechanisms in the air, water and soil, insertion of the csr1-2 gene failed to change any botanical trait of the plant. Soybean has no natural dispersion mechanisms for its propagation and reproduction structures in air, water and soil; however it may be disseminated by insects, agricultural tools and man. Soybean is predominantly self-fertile. In case of pollen dissemination by insects, it may take place by hymenopters, though in significantly low rates (Beard and Knoles, 1971; Erickson et al., 1978). Thus, Soybean CV127 is botanically comparable to its isoline. Regarding horizontal gene transfer from plants to bacterium, followed by functional expression, it involves an extremely complex process that demands successive phases with very low probability of occurrence. As the first phase, the gene must be available intact in the environment, but this is extremely improbable in view of the endonuclease action of the plant itself. Besides, the quantity of the insert is significantly smaller when compared to the plant genomic DNA. Once made available in intact form, the gene must be captured by an able microorganism, yet not all microorganisms may be transformed in a laboratory facility that uses optimized conditions not found in nature. Studies concluded that after different transformation essays, the quantity of bacterium in the soil and rhizosphere that are naturally transformable is extremely low (Richter and Smalla, 2007). After the events have taken place, besides containing the complete gene coding sequence, the DNA fragment must contain, in addition, sequences that are homologue to the genome of the receiving organism to facilitate a stable integration to the fragment by homologue recombination. Finally, the gene must contain its appropriate sequences for expression; however in this case and in most transformation events, cassettes are constructed with promoters that do not act as transition promoters in bacteria and fungi, even facing the possibility of stable integration to the host genome. Thus, transference of gene csr1-2 features a very poor likelihood, under the demonstrated conditions, as shown in other studies (Miki and McHugh, 2004; Van de Eede et al., 2004). V. Restrictions to the use of the GMO and its derivatives As established by Article 1 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” Studies submitted by applicants demonstrated lack of significant difference between genetically modified soybean and its conventional isoline regarding agronomic characteristics, reproduction mode, dissemination and survival ability. All evidence submitted in the proceeding and bibliographic references confirm the risk level or the transgenic variety as being equivalent to that of the non-transgenic varieties regarding soil microbiota, as well as other plants and human and animal health. Thus, cultivation and consumption of Soybean CV127 are not a potential cause of significant degradation to the environment or risks to human and animal health. For these reasons, there are no restrictions to the use of such soybean and its derivatives, except in places mentioned in Law nº 11,460, of March 21, 2007. Soybean is an exotic species to Brazil and there are no feral kindred able to cross and originate descendants. Gene flow between soybean plants is already studied in tropical conditions. Soybean is an autogamous species, with full flowers, and crossed pollination rates of 0.5% to 1% have been recorded according to the type and place of the cultivar, being eight meters the maximum distance to enable gene flow. After ten years of use in different countries, no problem has been recorded to human and animal health or to the environment that could be traced to transgenic soybeans. It shall be emphasized that lack of negative effects in transgenic plant farming is not a guaranty that such effects may not occur. Zero risk and absolute safety do not exist in the biologic world, although there is a mass of reliable scientific information of use of transgenic varieties in agriculture. Therefore, applicant shall conduct post-commercial release monitoring under CTNBio Ruling Resolution nº 3 and according to this Technical Opinion. The monitoring plan includes assessment of GM and non-GM plants in regions that are representative in soybean farming, such as the States of Rio Grande do Sul, Paraná, Minas Gerais, Mato Grosso e Bahia, for five consecutive years and in areas not below three hectares in each location. The following indicators shall be assessed: (i) Change in composition of species in the infesting community (diasporas bank and invading plants); (ii) effects coming from herbicide resistance development in invading plants; (iii) study of nutritional status and phytosanity; (iv) changes in soil physical and chemical characteristics; (v) herbicide degraders; and (vi) studies of impacts to human and animal health. Each such assessment was adequately described in the proceeding. VI. Considerations on particulars of different regions of the country (background information to monitoring agencies). As established by Article 1 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” VII. Conclusion Considering that soybean is a well characterized plant with a solid history of safety for human consumption and the genes introduced into this variety code for proteins that are ubiquitous in nature. Considering that centesimal composition data fail to point out significant differences between genetically modified conventional varieties, suggesting their nutritional equivalence. Whereas: 1. AHAS protein is present in plants and microorganisms and in several natural mutants presenting tolerance to the imidazolinones class herbicides. Therefore, humans and animals have a long history of use of this protein in food; 2. Several imidazolinone tolerant that produce AHAS enzyme with the same substitution at position 653 (substitution of asparagine for serine), present in Soybean CV127, have been marketed under the brand name Clearfield® and farmed for several years without adversely affecting human and animal health and the environment; 3. Molecular analysis of Soybean CV127 evidenced that integrity and stability of the insert was maintained; 4. Segregation analysis and genetic inheritance pattern are stable along successive generations; and 5. Agronomic and efficacy assessments of Soybean CV127 indicated that the insertion failed to lead to expression of any other characteristic but the expected one, tolerance to herbicides of the imidazolinones chemical class. For the foregoing and considering internationally accepted criteria in the process of risk analysis of genetically modified raw materials one may conclude that Soybean CV127 is as safe as its conventional equivalents. In the context of the competences attributed to CTNBio under Article 14 of Law nº 11,105/05, CTNBio considered that the request complies with the rules and laws in effect aimed at securing biosafety of the environment, agriculture, human and animal health, and reached a conclusion that Soybean CV127 is substantially equivalent to conventional soybean and its consumption is equally safe for human and animal consumption. Regarding the environment, CTNBio concluded that Soybean CV127 is not a potential cause of significant degradation to the environment, maintaining with the biota a relation identical to conventional soybean. CTNBio holds this activity is not a potential cause of significant degradation to the environment and of harm to human and animal health. Restrictions to the use of the GMO studied and its derivatives are conditioned to the provisions of Law nº 11,460, of March 21, 2007. CTNBio analysis considered the opinions issued by the Commission Members; ad hoc consultants; documents submitted by applicant to CTNBio Office of the Executive Secretary; results of planned releases into the environment; lectures, texts. Independent scientific studies and publications submitted by applicant and conducted by third parties were also taken into account.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Molecular Traditional Methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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Authorization expiration date: Not Applicable
E-mail:
gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
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Stacked events:
At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)
Malaysia
Name of product applicant: BASF (Malaysia) Sdn. Bhd.
Summary of application:
Please refer to uploaded document.
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Date of authorization: 23/10/2013
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.): Malaysia Biosafety Clearing House
CBD Biosafety Clearing House
Summary of the safety assessment:
Please refer to uploaded document.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
E-mail:
biosafety@nre.gov.my
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Dept of Biosafety, Ministry of Natural Resources and Environment, Level 1, Podium 2, Wisma Sumber Asli, No. 25, Persiaran Perdana, Precinct 4, 62574 Putrajaya
Phone number:
+60388861153
Fax number:
+60388904935
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:
Malaysian Department of Biosafety Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: biosafety@nre.gov.my. Url: www. biosafety.nre.gov.my
Philippines
Name of product applicant: BASF Philippines, Inc
Summary of application:
BASF Philippines, Inc. has developed a new genetically modified soybean that is tolerant to the imidazolinone class of herbicides. The imidazolinone herbicides control a wide spectrum of grass and broadleaf weeds and possess high biological efficacy at low application rates. The herbicide tolerant BPS-CV127 soybean (also referred to as CV127) are derived from a single transformation event and was developed to address weed control challenges to soybean growers. Introduction of CV127 soybean varieties will offer soybean growers an additional tool for controlling problem weeds as well as an important option for weed resistance management. The imidazolinone-tolerant soybean exhibits similar herbicide tolerance properties as various imidazolinone-tolerant crops produced.
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Date of authorization: 29/10/2010
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.):
Summary of the safety assessment:
BASF Philippines, Inc. submitted an application to the Bureau of Plant Industry requesting for biosafety permit under A.O. #8 for soybean which has been genetically modified for weed resistance. BASF Philippines, Inc. has provided information on the safe history of use of the crop, the source of the donor gene, the molecular characterization of CV127 soybean, the stability of the inserted genetic elements, characterization and expression levels of AHAS proteins produced in the CV127 soybean plant, lack of any allergenicity or toxicity characteristics associated with AHAS protein and CV127 soybean, as well as the nutrient composition of the soybean grain, forage and grain processed fractions, and overall food and feed safety of CV127 soybean plants. Relevant scientific publications were also supplied. CV127-9 Soybean has been evaluated according to BPI‘s safety assessment by concerned agencies: Bureau of Animal Industry (BAI), Bureau of Agriculture Fisheries and Product Standards (BAFPS) and a Scientific Technical Review Panel (STRP) members. The process involved an intensive analysis of the nature of the genetic modification with a consideration of general safety issues, toxicological, nutritional and environmental issues associated with the modified soybeans. The petitioner/applicant published the said application in two (2) widely circulated newspapers for public comment/review. BPI received positive comments on the petition supporting the application for direct use as food and feed or for processing of CV127-9 Soybean during the 30-day comment period. Review of results of evaluation by the BPI Biotech Core Team completed the approval process.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Thelma L. Soriano
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:
The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community. The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power. The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment. The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.
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Relevant documents
Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
United States of America
Name of product applicant: BASF Plant Science
Summary of application:
Soybean
Trait 1 Added Protein: Large catalytic subunit of acetoxhydroxyacid synthase (At-AHAS-L)
Source: Arabidopsis thaliana
Intended Effect: Tolerance to imidazolinone herbicides
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Date of authorization: 01/02/2012
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:
Please consult the FDA website links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Authorization expiration date:
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:
The United States is currently in the process of populating this database. 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:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food and Drug Administration (premarkt@fda.hhs.gov); Environmental Protection Agency