Food safety and quality
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OECD Unique Identifier details

ACS-ZMØØ3-2
Commodity: Corn / Maize
Traits: Glufosinate tolerance
Australia
Name of product applicant: Aventis Pty Ltd
Summary of application:
Aventis Pty. Ltd. have made an application to ANZFA to amend the Australian Food
Standards Code, to include food derived from corn which has been genetically modified to be tolerant to the herbicide glufosinate ammonium. The corn is marketed as Liberty Link® corn.

Tolerance in T25 corn to the herbicide glufosinate ammonium is achieved through the
expression of the pat gene, which produces the phosphinothricin acetyl transferase (PAT) enzyme that chemically modifies the herbicide, thus rendering it inactive.

Glufosinateammonium tolerant corn line T25 can be grown under application of this herbicide. Maize varieties are generally classified into flint, pop, dent and flour lines based on the hardness of the kernel. Flint varieties are preferred by dry millers for flour, grits and meal based products such as cereals and dent varieties are preferred by wet millers for starch and starch based products such as high fructose corn syrup. Corn oil may be produced from the germ of all varieties. Fermentation of cereal grains is also used for beverage and alcohol production.

A wide variety of food products are derived from the genetically modified corn including highly processed corn-based food ingredients such as high-fructose corn syrup, which is not currently manufactured in either Australia or New Zealand. Corn ingredients include flour, syrup, oil, starch, meal or whole kernels and cobs. Corn-based processed products include snap frozen vegetable packs, corn chips, corn oil, breads, flours, popcorn, pastries, crackers, meat substitutes, milk substitutes, breakfast cereals, and confectionary. There are also many industrial uses of corn products.

Food derived from glufosinate ammonium tolerant corn line T25 are most likely to be
imported as processed food products, containing whole, part or constituents of corn and as corn derivatives.
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Date of authorization: 09/05/2002
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 A375 - Glufosinate ammonium tolerant corn T25
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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.
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:
Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
Brazil
Name of product applicant: Bayer S.A
Summary of application:
commercial release of corn tolerant to glufosinate (phosphinotricin)
of ammonium herbicide, genetically modified, as well, as of
all the progenies coming from the transformation event T25
and its derivatives of the crossing of lines of nontransgenic
populations of corn with lines bearing the event
T25
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Date of authorization: 17/05/2007
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:
Liberty Link Corn – event T25. The plant received gene pat, which is responsible for the syntheses of enzyme phosphinotricin – N- acetyltransferase (PAT), that catalyzes the conversion of L-phosphinotricin (glufosinate of ammonium) to non-toxic products, inactivating the active ingredient, conferring then, on the plant the characteristic of tolerance to the herbicide. Gene pat is a modified version of the isolated gene of the soil natural bacteria, Streptomycin viridochromogenes, Tü 494 race, and was inserted into the vegetable cells through direct incorporation of DNA in corn protoplasts electroporation), through vector plasmid pUC/Ac. The initiating sequences drawn aiming at identifying the event, that are represented as confidential information in the document entitled “Previous communications to the presentation of the biosafety report of event T25” shall be made available to the public. Due to the fact that it is a commercial release, there is no need of keeping confidentiality. Protein PAT was detected in low levels on the vegetable tissues analyzed, and is fast degraded in gastric and intestinal fluids, presenting great susceptibility to digestion and thermal desnaturation, being highly improbable that it may have any toxic or allergenic effect. Genetic modification introduced in event T25 did not result in important differences of chemical composition regarding nutrients, being within the normal variation scope among the conventional varieties. The sylvan species closer to corn is the teosinte found in Mexico and in some Central America places. Therefore, there is no sylvan species in Brazil with which corn can be crossed. The coexistence between conventional corn cultivations (improved or creoles) and transgenic cultivations of corns is possible from the agronomic point of view. Thus, the probability of fixation of allele containing the gene sequence that confers tolerance to glufosinate of ammonium on the population is much reduced on the absence of selection pressure. Corn is a plant that is incapable of surviving in natural conditions, when not technically assisted. Therefore, there is no possibility of corn being transformed into an invasive plant or weed. Genetically modified cultures behave like correspondent conventional cultures, and up to now there is no registration of great alterations on the structures of microbial communities of soils. Additionally, gene pat already exists in the soil, once it comes from the soil natural bacteria, S. viridochromogenes. Glufosinate of ammonium is registered in Brazil, at the Ministry of Agriculture, Cattle Breeding and Supply (MAPA), at IBAMA, and its monograph is approved by the Ministry of Health, being commercialized in Brazil and in many other countries. Thus, other norms should be observed when corn T25 is registered, such as Law 7.802, of July 11th, 1989 (Agro toxic Law), especially regarding the limits acceptable for herbicides residues to be established by the registration and inspection organs and entities. The restrictions to the use of the GMO in analysis, and its derivatives are conditioned to the coexistence norms, and to the postcommercialization monitoring plan, to be eventually published by CTNBio. Thus, CTNBio considers that this activity is not potentially causing meaningful degradation of the environment, or aggravations to human and animal’s health. Zea gender belongs to Gramineae family and has four kinds, being corn Zea mays ssp.mays L., the species that has the biggest economical importance. The number of chromosomes in Z. mays is 2n = 20, 21, 22, 24(5). It has been widely known that the center of origin of Zea mays ssp.mays includes Mexico and Central America (12). Corn is an allogamous and annual plant. Genes dissemination may occur via crossed pollination with a sexually compatible plant or sylvan parental plants in the surroundings. Corn is pollinated by the wind, and the dissemination of the pollen is determined by the speed and direction of the winds. However, corn pollen feasibility, in extremely favorable conditions, is maximum 24 hours. The sylvan species closer to corn is teosinte, found in Mexico and in some places in Central America, where it can be crossed with corn cultivated in production fields. The cultivated corn can also be crossed with the most distant genre Tripsacum. However, this crossing occurs with great difficulty, and results on sterile-male progeny. Corn history is over eight thousand years old in the Americas, and nowadays it is the cultivated species that reached the highest degree of domestication, and only survives in nature when it is cultivated by men . Of all the cultivated plants, it is probably the one that has the biggest genetic variability. Today, there are around 300 identified corn races, and within each race, thousands of cultivations. The maintenance of this genetic variability has been usually made through individualized storage, in germoplasm banks, with controlled conditions of humidity and temperature. There are many corn germoplasm banks in Brazil and in the world. Embrapa has two germoplasm banks, one at Embrapa Genetic Resources and Biotechnology, in Brasília-DF, and another one at Embrapa Corn and Sorghum, in Sete Lagoas-MG. Corn is commercially cultivated in more than 100 countries, with a total production estimated in 705 million tons/year. The biggest corn world producers are: The United States, China, Brazil, Mexico, France and India. Corn is used mainly for the production of animal food and processed food, and recently, it has been used on the production of fuel alcohol. In the last harvest Brazil cultivated 12million hectares of corn. While the average productivity in the USA is 9.0, and in Argentina it is 7.0 tons/ha, the average productivity in Brazil was 3.5 tons/ha. Such low productivity of corn culture in Brazil is not because of lack of technology, but for the fact that a meaningful part of Brazilian agriculturists who plant corn do not use improved seeds, or do not have access to modern technologies of cultivation. Agriculturists of the Brazilian Center-West that use modern technology and tropical simple hybrid seeds manage to produce an average similar to the one obtained by its peers in the USA, that is, 9.0 tons/ha. Scientific work of corn improvement (“hybrid corn era”) started in Brazil around 1930, at the Agronomic Institute of Campinas – IAC, and at the Federal University of Viçosa – UFV. Today, we have in Brazil many national and foreign companies that at the 2006/2007 harvest made available around 275 different kinds of corn cultivation, improved and adapted to the tropical conditions of the country. This is the result of more than 50 years of genetically improved tropical corn that started with the so-called races of Creole corn. It is also important to highlight that, in this universe of 275 commercial genotypes, we have creoles varieties (corn improved by small agriculturists, whose seeds may be reused), and also state of the art simple hybrids (for high technology plantation, with production potential above 12 tons/ha). Today, Brazil develops the biggest, the most efficient, and the most traditional program of tropical corn improvement in the world. The commercial event Liberty Link Corn was obtained by the direct transformation of protoplasts through electroporation process. The tolerance to glufosinate of ammonium herbicide was obtained through the introduction of the gene that expresses the protein PAT (Phosphinotricin Nacetyltransferase) isolated from Streptomycin viridochromogenes that after catalyzing the acetilation of L-phosphinotricin (glufosinate of ammonium), promotes the inactivation of the active component. As a consequence, plants of the referred event of transformation are resistant to the herbicide, allowing its use in the control of invasive plants. In Brazil, many planned releases of corn T25 in the environment, in experimental character, were conducted after approval by CTNBio in regions that represent the corn culture, including the states of São Paulo, Minas Gerais, Mato Grosso do Sul, Paraná, Goiás, Rio Grande do Sul and Bahia. III. GMO description and expressed proteins The commercial event Liberty Link was obtained through the direct transformation of protoplasts of corn lineage He/89 through the use of polyethylene glycol (PEG) with the plasmodium pUC/Ac as a whole containing genic elements of interest. The transformed protoplasm were cultivated under selection conditions in the presence of glufosinate of ammonium herbicide, also known as L-Phosphinotricin (PPT – Phosphinotricin) until they originate cellular agglomerate that were later regenerated to normal plants according to protocol established by Mórocz and collaborators (14). The main elements that compose the cassette of expression containing pat gene, as well as the main elements present on the plasmid pUC/Ac are: a. plasmid pUC18: plasmid of Escherichia coli with high number of copies, used for cloning fragments of DNA; b. ampR – gene that confers resistance to ampicillin obtained from E. coli, and that codified b – Lactamase (bla), being express4ed only in bacteria, once it is under control of prokaryotic promoter; c. Ori-pUC – replication origin (ColE1) of plasmid pUC18; d. P-35S – promoter of transcribed 35S of virus of cauliflower mosaic; e. pat – codifying sequence of pat gene of S. viridochromogenes modified with codons preferential for plants, once the original sequence presents high content of G:C, atypical for plants; f. T-35S – terminator region not translated into proteins, obtained from the transcribed 35S of virus of cauliflower mosaic. Molecular studies of event T25 presented in the process allow to visualize how a copy of the insert was introduced into the genome of LL corn. Bla gene that confers resistance to ampicillin is present, but it was fragmented, and its portion of nucleotide 6 to 195 was eliminated from the event. The studies also show that a sequence similar to the promoter 35s is at the end of the insert flanking the other portion of bla gene present in the insert, corresponding to nucleotides 196 to 861. The replication region (ColE1) of the plasmid pUC18 is also present in the insert, as well as the cassette of expression with the codifying sequence of pat gene with the promoters and terminators regions of transcribed 35S in the correct conformation for the expression of pat gene, that was introduced into the corn genome in a sole copy through direct incorporation by the electroporation method. In the event T25 characterization, regions of genomic DNA of corn, which flank the place of the insert were also sequenced. That allowed identifying that the region where it was inserted presented high similarity with one of the gene alleles of alcoholic desidrogenase of corn. Such allele was probably inactivated, but as this gene presents high number of copies on the genome of the species, the insertion of the elements described above have not apparently harmed the development and the agronomic characteristics of the plants. No molecular data was presented confirming or not the inactivation of the alcohol-desidrogenase (gene bank access No. AF1223535). However, the event T25 was tested on the field, and in contention in the United States and in Canada, and the comparison between the event T25, and not genetically modified hybrid corn plants did not identify alterations on agronomic characteristics that are out of the normal range of variability for characteristics such as productivity, plants height, cycle, susceptibility to diseases and plagues, profitability components, and others. On planned releases in the environment conducted in Brazil, no alterations were observed in the agronomic characteristics of corn T25, which would be different from the patterns found in hybrids, and in not genetically modified corn lineages. Thus, it is possible to assume that the insertion of the fragment described above in the corn genome did not alter its normal fenotypical characteristics. The sequencing of the genomic regions of corn that flank the insert are also important, for they allow identifying this event as unique. The flanks were sequenced on region 5’, 151pb, and on the region 3’, 121pb from the insert. The starting sequences drawn to identify the event, and that are presented as confidential information on the document “Previous Communications to the submission of the biosafety report of event T25” are available to the public. The sequencing of the entire insert present in the event T25 also allowed to identify, on the junction between the major fragment of bla gene, and the region with elements similar to promoter 35S, two open reading frames (ORF – Open Reading Frame): ORF-1, codifying 253 amino acids and ORF-2, codifying 109 amino acids. The petitioner does not describe if these ORF codify some protein of known function. No data confirming or not the expression of these hypothetical proteins in event T25 have not been presented either. On both ORF, the initiation codon is found inside the fragment similar to promoter 35S, and not inside the fragment of bla gene. This situation, as well as the incomplete presence of the entire sequence of the promoter 35S in this region, would probably(16) make impractical the expression of ORF 1 and 2. The construction used on the transformation puts bla gene under control of a prokaryotic promoter, making this gene to be expressed only in bacteria(10). Even being the bla gene incomplete in event T25, tests were conducted to identify the presence of enzyme b-lactamase and of transcribed ones. Enzymatic or transcribed activity of bla gene was not detected in none of the vegetative and reproductive parts of Liberty Link corn. The analysis of PAT protein expression was made on leaves, roots, stems, grains and pollen through TLC, HPLC and ELISA. It was not possible to detect the presence of protein activity in pollen grains. In seeds, roots, leaves and stems the detected activity was of 0.68, 5.36, 41.32 and 50.95 mU/mg, respectively. Considering that the promoter used is constructive CaMV 35S, one could expect PAT expression in every tissue on similar levels. However, it is already known that promoter 35S, depending on the tissue and place of insertion in the genetically modified plant genome, may present variations in its gene activation capacity. The number of inserts was estimated through Southern Blots made with five enzymes of restriction, and confirmed as a copy through tests of segregation in the progeny of crossings made between hemizygote plants and nongenetically modified lineages. These results indicated that pat gene is transmitted in a stable way between generations and behaves as a normal and dominant gene. IV. Aspects related to Human and Animal’s Health The evaluation of food safety derived from genetically modified raw material is based on risk analysis, scientific methodology that encompass evaluation, management, and risk communication phases. On the risk evaluation phase one looks for the qualitative and quantitative characterization of potential adverse effects, having as base the concept of substantial equivalence, for the identification of eventual differences between the new food and its conventional correspondent. To evaluate safety of genetically modified food raw material, or its equivalence to conventional food, it is recommended that four main elements are analyzed, more notably: (1) parental variety, that is, the plant that originated the new genetically modified raw material; (2) the transformation process, including the characterization of the construction used, and of the resulting event; (3) the gene product inserted and the potential of toxicity and allergenicity, and finally; (4) the composition of the new variety deriving from the genetic transformation. The group of data of these analysis should allow for the identification and characterization of the potential different effects associated to the consume of the new raw material, subsidizing the management and risk communication phases. According to the petitioner, event T25 derives from the transformation of cells of lineage He/89 of common corn Zea mays, a species deeply characterized, and about which there is solid safety background for human and animal consume. Information about identity, origin and chemical composition are reported, and a copy of the publication was attached to the process, which provides abundant data regarding its composition, highlighting the variations naturally observed in the presence of nutrients. The analysis of chemical composition of the variety obtained through gene manipulation, mainly of the levels of its nutrients and eventual toxic compositions naturally present, aims at guaranteeing that this new variety is as nutritive and safe as its conventional equivalent. Thus, it serves to confirm that intentional effects of modification do not compromise its safety, or results in unintended effects. The introduction of cassette of expression containing pat gene, as well as other gene elements described before, do not alter the substantial equivalence of Liberty Link corn in relation to the quality and quantity of metabolite normally found in corn. The data presented by the petitioner are related to the centesimal composition, to the profiles of amino acids, fatty acids, mineral and vitamins, besides the content of phitate, both for the genetically modified variety, with and without the use of glufosinate, and for the conventional variety, cultivated under the same conditions and on the same region during the same period. At the beginning, results from analysis conducted with plants cultivated abroad in two regions were presented. Late on, due to questionings made by CTNBio’s members, data regarding plants cultivated in the country in different environments were presented, in the state of Goiás and Paraná. These compositions analysis were made in the country at the Institute Adolfo Lutz, of São Paulo. In general, for all the parameters analyzed, there was a meaningful difference between the genetically modified variety and the conventional one, or the differences noted were within the variability normally observed among conventional corn varieties. Anyway, the small differences found in relation to event T25 do not affect the nutritional value, or safety, for they were similar to the ones usually found in other varieties, or under different conditions of cultivation. In this regard, it is important to highlight that there were differences among the results obtained for the cultivations executed in Goiás and in Paraná, even for the conventional variety, without, thou, resulting in meaningful difference of the latter for the genetically modified variety. Thus, it is clear that the environmental conditions were more determining for the differences in the chemical composition, than the presence of pat gene in the genome of the transformation event T25. In relation to the levels of residues of glufosinate of ammonium left in the plant, due to its use during the cultivation of transgenic variety, studies executed in Brazil showed that there were no differences between those levels found in the parental variety when compared to the transgenic variety (event T25), when the herbicide is applied in accordance with the patterns of the Brazilian legislation for the evaluation of the maximum limits of residues. PAT protein is degraded by the gastric juice of animals and by similar artificial gastric juice of human beings, losing its physical-chemical characteristics after oral exposition. Thus, the protein is not expected to be fully absorbed, and, therefore, it is highly improbable that the protein may reduce different or toxic effects. Besides, PAT protein activity in the different parts of corn is low (around mU/mg of protein). References about acute toxicity were described in documents of the Environmental Protection Agency of the United States and of DG Health and Consumer Protection of the European Commission indicating lack of toxicity. “The oral acute toxicity test of PAT protein produced in bacteria showed lack of effects in a dose of 2,500 mg/kg”(19). “The enzyme phosphinotricin acetyltransferase (PAT) should not present biosafety problems. The quantitative level of PAT in grains is very low. Its enzymatic function is specific for a substrate that is naturally absent in human beings, called phosphinotricin. Besides, it is degraded and inactivated in human artificial gastric fluid containing pepsin in pH 1.0- 1.2. Therefore, it is improbable that it maintains any enzymatic activity in vivo. What’s more, no homology between PAT protein and toxins known was found. Native PAT protein (51% of purity) was evaluated for acute toxicity in rats, and no effect in 5.0 g doses per kg of corporal weight was reported” (4). There are no reports saying that PAT protein has allergenic activity. Analysis of sequences of PAT protein show that it does not present places capable of glicolisation what could theoretically, confer allergenicity to protein. However, a possible source of PAT protein allergenicity would be the expression of protein in pollen, what does not seem to occur. Gene pat sequence and PAT protein were compared to data banks, and it was observed that they do not present meaningful homology with other sequences of nucleotides and proteins, except for others genes of resistance to phosphinotricin including gene pat of S. viridochromogenes and bar gene of S. hygroscopicus. V. Environmental Aspects Corn is a monoic plant: a sole individual contains male and female flowers located separately. Corn plants are plants of crossed fecundation and widely pollinated with the wind help, insects, gravity and others. The introduction of gene elements previously described did not alter the reproductive characteristics of the plant. Therefore, the probability of crossed fecundation between plants of the event T25 and other corn plants is the same as the one that occurs between hybrids and corn lineages not genetically modified. Corn is the species that reached the highest level of domestication among cultivated plants, losing its characteristics of survival in nature as, for example, degrana elimination. Thus, corn is a plant that is incapable of surviving in natural conditions, when not technically assisted. Therefore, there is no possibility of corn being transformed into an invasive plant or weed. Gene flow in corn may occur through pollen transfer and seeds dispersion. Seeds dispersion is easily controlled, once the domestication of corn eliminated the ancient mechanisms of seeds dispersion, and, therefore, the pollen movement is the only effective escape mean of genes of corn plants. Studies about corn pollen dispersion have been conducted, and some of them show that corn pollen may travel long distances. However, most pollen that is released is deposited near the culture, with very low translocation rate outside the source culture. The predominant pollination agent for corn is the wind and the distance that viable pollen may travel depends on wind patterns, humidity and temperature. Luna et al. evaluate the distance of isolation and control of pollen and demonstrate that crossed pollination occurs in a maximum distance of 200m and no crossed pollination happened in the same distances or over 300 meters in relation to pollen sources, in non detasseling condition. The results indicate that pollen viability is kept for 2h, and that crossed pollination was not observed in 300 meters distances from the pollen source. Under low to moderate winds, it was estimated that comparing concentrations to 1 of source culture, approximately 2% of pollen are annotated at 60m, 1.1% at 200m and 0.75-0.5% at 500m of distance. At 10m from a field, in average, the number of pollen grains per area unit is ten times smaller than the one observed at 1m from the border. Therefore, if the established distances of separation developed for corn seed production are observed, it is expected that the pollen transfer to the adjacent varieties are minimized, and it shall not have any genetic material with tolerance to herbicide. Even in case of having a gene escape, the probability of allele fixation containing the gene sequence that confers tolerance to glufosinate of ammonium in the population is much reduced in the absence of selection pressure. The secondary ecological impacts, that refer to effect in the environment, especially in the ecosystem of the soil, are very discussed nowadays due to the complexity of the soil. The organisms of the soil are usually very exposed to the contact with genetically modified plants, both with direct contact, and through the fall of leaves, reticular exudates or even decomposition of roots. Through the reports in literature, genetically modified cultures behave similarly to conventional correspondent cultures, and meaningful alterations have not been detected until now on the structures of microbial communities of the soils. Studies of plants intact genes transfer to microorganisms show extremely low possibilities of transfer, suggesting that the probability of occurrence of this event is, in practice, extremely low. There is no evidence that plants genes have even been transferred to bacteria in natural conditions. Moreover, gene pat already exists in the soil, once it comes from a natural soil bacteria, S. viridochromogenes. Glufosinate of ammonium is a non systemic and non selective herbicide used, mainly, in the control of post-emergency invasive plants of wide leaves, and of thin ones. Such herbicide is registered in Brazil, at the Ministry of Agriculture, Cattle Breeding, and Supply (MAPA), at the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA), and with monograph approved by the Ministry of Health, being commercialized in Brazil and in other countries. Its wide use in the world is due to the fact that it is biodegradable, presents low residual activity, low toxicity to men, animals, and other organism of the food chain. It is considered persistent and movable in the soil, and in sandy soils up to 80% may be lixiviate. Depending on handling conditions, edafoclimatic conditions, microbial activity, and other factors, glufosinate of ammonium has half-life in the soil that varies from 12 to 70 days. However, residues have been found in the soil after 100 days. Therefore, if it is used outside its recommendations, glufosinate of ammonium herbicide has potential for contaminating water courses and groundwater as any other herbicide used in genetically modified cultures or not. However, it is highlighted that other norms should be observed when T25 corn is registered, such as Law 7.802, of July 11th, 1989 (Agro Toxic Law) especially regarding the acceptable limits for residues of herbicides to be established by the registration and inspection organs and entities mentioned above. VI. Restriction to the use of GMO and its derivatives: Technical opinions regarding the agronomic performance came to the conclusion that there is equivalence between transgenic and conventional plants. Thus, information indicate that transgenic plants do not fundamentally differ from non transformed corn genotypes, except for the tolerance to glufosinate of ammonium herbicide. Additionally, there is no evidence of different reactions to the use of Liberty Link corn. So, there is no restriction to the use of this corn, or of its derivatives, be it for human or for animal food. The vertical genic flow for local varieties (called creoles corns) of open pollination is possible and presents the same risk caused by commercial genotypes available in the market (80% of planted conventional corn in Brazil comes from commercial seeds that went through a process of genetic improvement). The coexistence between conventional corns cultivation (improved or creoles) and transgenic cultivations of corns is possible from the agronomic point of view (3,13). Therefore, CTNBio will eventually publish norms about coexistence of genetically modified corn with non modified varieties. VII. Considerations about the particularities of different regions of the country (subsidies to inspection organs): Small variations of centesimal composition, not meaningful ones, were found between the corn planted in the South region (Paraná), and the one planted in the Center West Region (Goiás) that were imputed, not to the presence of the transformation event, but to environment conditions. Therefore, there are no restrictions to the use of this corn, at least in relation to the South, Southeast and Center West of the country. The registration and inspection organs, in the ambit of their competences, will establish acceptable limits of residues to herbicide glufosinate of ammonium used in plantations cultivated with corn T25. According to what is established on art. 1 of Law 11.460, of March 21st, 2007, “it is vetoed the research and cultivation of genetically modified organisms in indigenous lands and areas of conservation units”. CTNBio will eventually publish norms about the coexistence of genetically modified corn with non modified varieties. VII. Conclusion Considering that event T25 derives from the lineage He/89 of common corn (Zea mays), species with solid safety background for human and animal consume, and that the introduced gene, pat, does not codified proteins known as toxic or allergenic, and results on the enzyme Lphosphinotricin- N-acetyltransferase, with high specificity for the herbicide glufosinate of ammonium. Considering that the gene construction used on the transformation resulted on the instable insertion of a copy of pat gene, and regulating regions of the mosaic virus of cauliflower on the genome of corn, besides a non-functional incomplete sequence of the gene of resistance to ampicillin, resulting only on PAT expression, without apparent harm to the plant or to the environment. Considering also that: 1. Corn is the species that reached the highest degree of domestication among plants cultivated, being able to survive in nature without human intervention. 2. The sylvan species closer to corn is teosinte, found in Mexico and in some places in Central America, where it can be crossed with corn cultivated in production fields. Therefore, there are no sylvan species in Brazil with which corn can be crossed. 3. Protein PAT has rapid degradation in gastric and intestinal fluids (7,20). 4. Recombinant enzyme PAT was detected in low levels of analyzed vegetable tissues, and presented great susceptibility to digestion and thermal denaturation by the processing, being highly improbable that it may have any toxic or allergenic effect 5. There are many proteins similar to PAT in nature without any evidence of adverse effect to men, animals, or plants have been described, and that its subtract is highly specific, not having any sequence of amino acids with homology to toxins or allergens. 6. Genetic modification introduced in event T25 did not result in important differences of chemical composition regarding nutrients, being within the normal variation scope among the conventional varieties. 7. Microorganisms S. hygroscopicus and S. viridochromogenes are saprophyte bacteria of the soil, and there are many species of Streptomycin genre similar to S. hygroscopicus and S. viridochromogenes, and among them, many containing pat and bar genes. 8. DNA molecule is a natural food component, not presenting any evidence that such molecule may have adverse molecule effect to men when ingested in food in acceptable quantities (no direct toxic effect). 9. There is no evidence that intact genes of plants may be transferred and functionally integrated in human genome, or of other mammals exposed to this DNA or foods manufactured with these elements 10. Plants tolerant to glufosinate of ammonium containing PAT protein have been cultivated in the United States and in Canada for approximately a decade without any registration of adverse effect to human and animal food. Besides, many regulating agencies of varied countries have approved these plants for these plants for human and animal use including Australia, Japan and European Union. 11. The petitioner answered to all questionings postulatedon the Normative Instruction No. 20 at CTNBio. 12. None of the questions indicate that this corn may present adverse effects on human and animal food. 13. After ten years of use in different countries, no problem was detected for human, animal’s health, or to the environment that may be attributed to transgenic corns. It is necessary to emphasize that the lack of negative effects resulting of corn transgenic plants does not mean that they may not happen. Zero risk and absolute safety does not exist in biologic world, although an accumulation of trustworthy scientific information already exists, and a safe background of ten years use allows us to state that corn T25 is as safe as conventional versions. Thus, thepetitioner is conditioned to conduct monitoring of postcommercial release on the terms to be eventually established by CTNBio. 14. The coexistence among cultivations of conventional corns (improved or creoles) and transgenic cultivations is possible from the agronomic point of view. 15. The probability of allele fixation, containing the gene sequence that confers tolerance to glufosinate of ammonium on the population is much reduced in the absence of selection pressure. 16. There is no need of maintenance of confidentiality in relation to the commercial release.
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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:
Traditional Molecular Methods.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Comission
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Authorization expiration date: Not Applicable
E-mail:
gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
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)
Canada
Name of product applicant: Bayer CropScience Canada
Summary of application:
Corn transformants T14 and T25 were developed through genetic modification to be tolerant to glufosinate ammonium, which is the active ingredient of the herbicide Liberty®. The modification permits farmers to use the broad-spectrum herbicide for weed control in the cultivation of corn without damaging the crop.

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Date of authorization: 03/04/1997
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment:
Please see decision document weblinks
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date:
E-mail:
luc.bourbonniere@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Luc Bourbonniere
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-957-1405
Fax number:
613-952-6400
Country introduction:
Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods. The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations (see Figure 1). Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current document were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.
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Stacked events:
Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Luc Bourbonniere, Section Head Novel Foods
China
Name of product applicant: Bayer Cropscience
Summary of application:

Genetically modified organism: ACS-ZMØØ3-2  (T25)  line of maize (Zea mays L.); Exogenous gene:  pat, isolated from the common aerobic soil actinomycete, Streptomyces viridochromogenes;  Trait: Phosphinothricin (PPT) herbicide tolerance, specifically glufosinate ammonium; Transformation methods: Chemically mediated introduction into protoplasts and regeneration; Safety level: Ⅰ

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Date of authorization: 06/04/2004
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:
Please see decision document uploaded
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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:
Chinese Agriculture Department Announcement No. 869-14-2007: Detection of Genetically Modified Plants and Derived Products Qualitative PCR Method for Herbicide-Tolerant Maize T25 and Its Derivates
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Authority concern of GMO
Ministry of Agriculture of China
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Authorization expiration date: 6/4/2007
E-mail:
fuzhongwen@agri.gov.cn
Organization/agency name (Full name):
Development Center for Science and Technology, Ministry of Agriculture
Contact person name:
Fu Zhongwen
Website:
Physical full address:
Room 717, Nongfeng Building, No.96 Dong San Huan Nan Lu, Chaoyang District, Beijing, 100122, P. R. China
Phone number:
+86-10-59199389
Fax number:
+86-10-59199391
Country introduction:
Regulations on Safety of Agricultural Genetically Modified Organisms (hereafter referred to as the Regulations)was promulgated by Decree No. 304 of the State Council of the People’s Republic of China on May 23, 2001. Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms, Implementation Regulations on the Safety of Import of Agricultural Genetically Modified Organisms and Implementation Regulations on Labeling of Agricultural Genetically Modified Organisms are formulated by Ministry of Agriculture on January 5, 2002 in accordance with the Regulations. The State Council establishes a system of joint ministry conference for the safety administration of agricultural GMOs. The joint ministry conference for the safety administration of agricultural GMOs shall be composed of officials from relevant departments of agriculture, science and technology, environment protection, public health, foreign trade and economic cooperation, inspection and quarantine, and be responsible for the decision-making and coordination of major issues with respect to the safety administration of agricultural GMOs. According to Article 9 of the Regulations, a national biosafety committee (NBC) shall be established and in charge of safety assessment of agricultural GMOs. The NBC shall be composed of experts who are engaged in biological research, production, processing, inspection and quarantine with respect to agricultural GMOs, as well as experts in the fields of public health and environmental protection. The office term of the NBC shall be three years. Ministry of Agriculture is responsible for the nationwide supervision and administration of the safety of agricultural GMOs. The Ministry of Agriculture sets up an office for biosafety administration of agricultural GMOs(OBA), which will be in charge of the administration of the safety assessment of agricultural GMOs. OBA is Affiliated to the Department of Science, Technology and Education.
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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
office for biosafety administration of agricultural GMOs(OBA), the Department of Science, Technology and Education,MOA, P. R. China Tel:+86-10-59193059, Fax:+86-10-59193072, E-mail: gmo@agri.gov.cn
Malaysia
Name of product applicant: Bayer Co. (Malaysia) Sdn. Bhd.
Summary of application:
Please refer to uploaded document.
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Date of authorization: 08/01/2013
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.
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:
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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: Bayer CropScience Inc
Summary of application:
Bayer CropScience Inc. developed corn Event T25. The genetically modified corn plants are tolerant to glufosinate and were produced by the introduction of a modified phosphinothricin acetyltransferase (pat) gene from Streptomyces viridochromogenes.
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Date of authorization: 05/12/2008
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Corn T25 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 corn 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.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Thelma L. Soriano
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:
The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community. The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power. The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment. The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.
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Relevant documents
Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
United States of America
Name of product applicant: AgrEvo
Summary of application:
Corn
Trait 1 Added Protein: Phosphinothricin acetyltransferase (PAT)
Source: Streptomyces viridochromogenes
Intended Effect: Tolerance to the herbicide glufosinate-ammonium
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Date of authorization: 14/12/1995
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