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OECD Unique Identifier details

DAS-Ø15Ø7-1
Commodity: Corn / Maize
Traits: Glufosinate tolerance,Lepidoptera resistance
Australia
Name of product applicant: Dow AgroSciences Australia Pty Ltd
Summary of application:
The new genetic traits in the corn resulted from the introduction of two new genes encoding the bacterial proteins Cry 1F, conferring resistance to certain insect pests, and phosphinothricin acetyltransferase (PAT), an enzyme conferring tolerance to the synthetic herbicide, glufosinate-ammonium.

Bacillus thuringiensis, a common soil bacterium, produces a number of Cry proteins, known also as Bt proteins, with very selective insecticidal activity. One of the family of Cry proteins, known as Cry1F, has been shown in field research to be effective in controlling certain lepidopteran insect larvae such as those from the European Corn Borer (Ostrinia nubilalis), Southwestern corn borer (Diatraea grandiosella), black cutworm (Agrotis ipsilon) and armyworms (Spodoptera sp.). These insects are common pests of corn in the United States where it is intended for this variety to be grown commercially. The Cry1F protein is encoded by the cry1F gene derived from Bacillus thuringiensis subsp. aizawai.

The applicant claims that the presence of this genetic modification also results in a reduction in moulds and associated mycotoxins in the corn, in addition to the significant control of insect pests.

The PAT enzyme metabolises the herbicide glufosinate-ammonium (or L-phosphinothricin) into an inactive form. The enzyme is encoded by the pat gene which is derived from Streptomyces viridochromogenes, a common soil bacterium.

Corn is used predominantly as an ingredient in the manufacture of breakfast cereals, baking products, extruded confectionery and corn chips. Maize starch is used extensively by the food industry for the manufacture of many processed foods including dessert mixes and canned foods.

Despite the diverse uses of corn products in many foods, corn is a relatively minor crop in both Australia and New Zealand, with a declining area planted over the last decade. When required, products such as high-fructose corn syrup and maize starch are imported from major corn growing regions in the Northern Hemisphere, to meet manufacturing demand.

The cry1F gene is registered for full commercial use in the United States in field corn
originating from maize line 1507. Corn line 1507 has food, feed and
environmental approval in Japan (2002) and food, feed and cultivation approval in Canada (2002). It is also undergoing assessment in Korea and is awaiting assessment in the European Union. Foods derived from corn line 1507 may enter the Australian and New Zealand markets in the future via imported products.
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Date of authorization: 31/07/2003
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 A446 - Insect/Glufosinate Resistant Corn line1507
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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: Du Pont do Brasil & Dow AgroSicence
Summary of application:
commercial release of genetically modified corn, resistant to insect of the Lepidoptera order (Bt Cry1F 1507- Event TC1507 corn)
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Date of authorization: 11/12/2008
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.): Center for Environmental Risk Assessment
Summary of the safety assessment:
TC1507 corn was obtained by genetic transformation through microparticle acceleration, or biobalistics. Immature corn embryo calluses of the hybrid Hi-II lineage corn were bombarded with insert PHI899A, containing genes cry1F and pat, region coming from plasmid PHP8999. Though plasmid PHP8999 has the nptII gene, it was not used in the process. Transformed calluses were cultivated in a selective medium containing glufosinate ammonium, and resistant plants were transferred to a plant nursery. The insecticide protein present in TC1507 corn is a Cry1F truncated protein derived from the PS81I (NRRL B-18484) of Bacillus thuringiensis var. aizawai. B. thuringiensis (Bt) is a gram-positive bacterium that has, at the moment of its sporulation, crystalline protein inclusions. The inclusions contain proteins denominated delta-endotoxins. These proteins are produced in the form of protoxines and transformed into toxic peptides at the insect bowels under the action of alkaline intestinal pH and proteases. The active toxin causes epithelial cell lysis and death of the larvae. Bacterium B. thuringiensis may be considered to be the biological agent with the greater potential to control forest and agricultural insect pests and disease vectors; given the specificity of delta-endotoxins to target insects and invertebrates, coupled with the bacterium innocuousness to vertebrates and the environment, including beneficial insects and natural enemies, make this agent a key component for strategies of plague controlled management. Since the sixties, B. thuringiensis (Bt) has been used in the United States as a pesticide to control butterflies. Different toxicity studies conducted in mammals with Bt clearly show the absence of toxicity and pathogenicity. Due to its use as a microbial pesticide, a long history of safe use has been associated to proteins produced by Bt. Nutritional and toxicological security tests have been reported evidencing innocuousness of the expressed protein. In addition to resistance to insects, corn TC1507 contains gene pat, derived from Streptomyces viridochromogenes strand Tu949, which is responsible for codifying enzyme phosphinothricin acetyltransferase (PAT), the sequence of which has 183 amino acids and is identical to the PAT protein present in hybrids of genetically modified commercially released corns. The recombinant enzyme PAT is able to chemically inactivate herbicides derived from phosphinothricin, like glufosinate ammonium, making cells and plants containing such enzyme resistant. PAT protein is degraded by gastric juices of animals and by artificial gastric juice similar to that of humans, losing its physicochemical characteristics after oral exposure. Therefore, one does not expect the protein to be entirely absorbed, being unlikely that it may bring adverse or toxic effects. Innocuousness of transformation by the pat gene is confirmed by works conducted by different research groups. A study with cows fed on a formulation containing isogenic and transgenic corn for such modification, revealed the similarity of yield and composition in milk produced by both groups of animals. The same work analyzed appearance of transgene fragments in 90 samples of milk along the experiment and failed to show any positive result of transposition of natural barriers and appearance of DNA fragments or fragments of its corresponding protein in the milk. Except for the characteristics of resistance to pest Lepidoptera insects and tolerance to glufosinate ammonium introduced by gens cry1F and pat, TC1507 corn did not undergo any other phenotypical change. Western Blot analysis confirmed that the cry1F and pat proteins expressed in the plant have the same molecular weight and immunoreactiveness of the protein derived from the microbial form expressed from P. fluorescens. Analyses of TC1507 corn regarding quality and quantity standards of metabolites normally found in corn demonstrated that event TC1507 is substantially equivalent to conventional varieties of corn. The assessments were conducted to define individual components that are part of human diet. Centesimal composition data analyses presented in the process encompass profile analysis of proteins, amino acids, fat acids, lipids, carbohydrates, minerals, vitamins, secondary metabolites, and composition of fodder and kernel, comparing event TC1507 with corn plants not genetically modified. The results obtained in Brazil and other countries failed to show variations that exceed the standards commonly found in non-genetically modified corn hybrids and lineages. Therefore, one may assume that TC1507 corn is substantially equivalent to non-genetically modified corn plants. Samples taken from leaves, pollen, kernel and the whole plant (vegetative tissues) of both, TC1507 and conventional corn lineages, were used to detect Cry1F and PAT proteins in transformed plants. Western Blot analyses showed that protein Cry1F is expressed in all tissues, in contrast to protein PAT that was detected only in leaves of the TC1507 lineage. In order to analyze the level of expression, samples of corn leaves, pollen, silk, stalk, whole plant, kernel, both normal and senescent of the TC1507 corn lineage, as well as samples from non-transformed corn plants were collected during the 1998-1999 crop and tested with the ELISA test. The results regarding total protein (TP) showed higher levels of the Cry1F protein expression in the whole plant (1063.8 pg Cry1F/ug TP), senescent whole plant (714.3 pg Cry1F/ug TP), stalk (550.0 pg Cry1F/ug TP) followed by pollen (135.5 pg Cry1F/ug TP), leaf (110.0 pg Cry1F/ug TP), grain (89.9pg Cry1F/ug TP) and silk (50.3 pg Cry1F/ug TP). Dispersion of corn seeds is easily controlled, since domestication of corn eliminated the ancient seed dispersion mechanisms and pollen movement is the only effective means for gene escaping of corn plants. Horizontal gene flow between TC1507 corn and other species, even those closely related, are practically unlikely to happen, since wile species related to corn do not occur naturally in Brazil. Coexistence between cultivars of conventional corn (either cultivated or Creole) and transgenic cultivars is possible from the agronomic viewpoint, and this is a reason to comply with the provisions of CTNBio Ruling Resolution no. 04. The use of genetically modified insect-tolerant plants has positive repercussions also in aspects related to obtaining, distributing and using chemical insecticides, for the significant reduction in the pollution brought by industrial waste and water used in insecticide sprinkling, in addition to avoiding contamination of man, food, rivers and water sources resulting from the use, transportation and storage of insecticides. For the foregoing, a conclusion is reached that cultivation and consumption of TC1507 corn is not a potential cause of significant degradation of the environment; or of risks to human and animal health. For these reasons, there is no restrictions to the use of this corn or its derivatives. The applicant shall conduct post-commercial release monitoring under the provisions of CTNBio Ruling Instruction no. 03. According to Article 1 of Law no. 11,460, of March 21, 2007, "research and cultivation of genetically modified organisms may not be conducted in Amerindian areas and conservation units”. ”. Regarding the scope of Article 14 of Law no. 11,105/05, CTNBio holds that the request complies with applicable legislation and regulation aimed at securing biosafety of the environment, agriculture, human and animal health. CTNBio Technical Opinion 1. GMO Identification GMO name: Bt Cry1F 1507 – Event TC1507 corn, Herculex Corn. Applicant: Dow Agrosciences Industrial Ltda. and Du Pont do Brasil S.A. – Division Pioneer Sementes. Species: Zea mays L. Inserted Feature: Tolerance to glufosinate ammonium herbicide and resistance to insects. Insertion method: Biobalistics, with the use of particle acceleration. Prospective use: Production of grains for human and animal consumption from the GMO and its derivatives. II. General Information Zea mays L., corn, is a monoic annual plant with height ranging from 1.0 to 4.0 meters(1). Its main stalk is composed of knots and inter-knots clearly defined. Inter-knots are wide at the basis and gradually diminish until inflorescence at the upper part of the plant. Leaves alternate along the stalk. Corn is the only grassy plant having both male and female flower structures in the same plant, though in different places(2). Corn has over eight thousand years of history in the Americas and is cultivated since the pre-Colombian period. Corn is one of the higher plants more well scientifically characterized, and today it is the cultivated species that reached the highest degree of domestication and can only survive in nature when cultivated by man(3). Currently, over 300 corn varieties have been identified and, within each variety, thousands of cultivars. Corn is one of the most important sources of food in the world and is the input for the production of a wide range of food products, fodder and industrial products. Brazil is the third largest world’s corn producer, and has harvested about 35 million tons in 2005, behind the United States of America (282 million tons) and China (139 million tons)(4). Corn is the second most cultivated grain in Brazil and is planted basically in two different crops (summer and safrinha, or small crop) and cultivated practically all over the domestic territory, with 75.68% concentrated in the Southern and Central Region and 24.32% in the Northern and Northeastern Region. In terms of Brazilian production, corn is second only to soybeans(5). It is a known fact that the insect population in the tropics is larger than in temperate zones, and that damages caused by them are more significant in the tropical zone. Among the most important corn plagues there is the fall armyworm (Spodoptera frugiperda). Cruz et. al.(6) estimated that losses in Brazil caused by infestations of S. frugiperda are about 400 million Dollars annually. Starting in 1999, there has been an increased occurrence of fall armyworm, and, consequently, larger losses have been recorded. Other species of the Lepidoptera order are also important corn plagues, such as corn earworm (Helicoverpa zea) and sugarcane borer (Diatraea saccharalis). It is estimated that these three species may damage up to 34% of corn kernel production. The main measure to control insects in corn culture has been the use of insecticides. In some areas of the Brazilian Center-Western Region, dozens of insecticide applications are needed in a single cultivation cycle. Another measure for pest control would be the use of resistant cultivars. Obtaining insect-resistant corn cultivars by classical genetic improvement has not attained the expected level of success. Considering fall armyworm, several attempts have achieved limited success(7). TC1507 corn possesses characteristics that grant resistance to insects and tolerance to the herbicide glufosinate ammonium. This means that the phenotype enables the corn to resist to the main pests of the Lepidoptera order affecting corn culture in Brazil. These characteristics result from genes that were introduced and codify a truncated form of the insecticide protein Cry1F, derived from strand PS81I (NRRL B-18484) of bacterium B. thuringiensis var. aizawai and one enzyme (phosphinothricin acetyltransferase, PAT), which grants tolerance to the herbicide glufosinate ammonium, also obtained from a soil bacterium, Streptomyces viridochromogenes. Corn varieties containing Cry proteins have been used in different countries of the world without any record that corn hybrids containing cry genes have caused damage to the environment, human and animal health. Commercial use of TC1507 corn has taken place in the United States of America since 2001, Argentina (2005), Colombia (2006), China (2004), Mexico (2003), South Africa (2002), Canada (2002), Australia (2003), Japan (2002), Korea (2002), Philippines (2003), Taiwan (2003), and European Union (2006) without identification of problems related to the agronomic characteristics of the event(8). Brazil is held as the third largest consumer of agriculture pest controlling substances in the world, where there are about 142 registered corn pesticides, from which 107 are intended for lizards. There are several reports of resistance caused by the constant and indiscriminate use of corn culture insecticides in Brazil. Besides, one of the most important causes of harm to the health of farmers in the country is the use of chemical pesticides, responsible for intoxicating one million individuals each year(9). TC1507 corn was tested in Brazilian fields, in several important regions for corn production since 1998. The TC1507 lineage has also been assessed in essays conducted in Argentina, Chile, South Africa, Colombia, United States and Europe since 1997. Plants derived from TC1507 corn lineage attained the expected yield, without evidence of unexpected changes in morphological and phenotypic characteristics. There was also no evidence that event TC1507 had acquired characteristics of a plant pest, both in experimental plots and in fields where the event is recorded for cultivation. III. Description of the GO and Proteins Expressed TC1507 corn was developed from a germplasm deemed appropriate for genetic modification. In order to transform corn embryos, a linear portion of plasmid PHP8999 DNA was extracted containing gene cry1F and the gene used as selective marker: pat. The linear DNA portion, namely the insert, was used in the transformation process. Corn plants of lineage TC1507 were obtained by microparticle bombarding, using a Biolistics accelerator PDS-1000He-Bio-Rad(10). No vector was used in the transformation of corn to generate event TC1507. From plasmid PHP8999 a linear fragment was extracted, named PHI8999A, containing the coding sequence of genes cry1F and pat, jointly with their associated elements of genic expression. The insecticide protein present in TC1507 corn is a truncated Cry1F protein derived from strain PS81I (NRRL B-18484) of Bacillus thuringiensis var. aizawai(11). B. thuringiensis (Bt) is a gram positive bacterium belonging to family Bacillaceae, producing, at the moment of sporulation, crystalline protein inclusions. The inclusions contain proteins named delta-endotoxins that currently form a family of 300 members, classified in 49 different groups(12). The proteins are produced as protoxines and are transformed into toxic peptides in the insect bowels under action of the intestinal alkaline pH and proteases. The active toxin causes lysis of epithelial cells and death of larvae(13, 14). B. thuringiensis may be considered the biologic agent of greater power in controlling forest, agricultural insect pests and disease vectors; due to the specificity of delta-endotoxins towards target insects and invertebrates and innocuousness to vertebrates and the environment, including beneficial insects and natural enemies(15), making this agent a key component in pest integrated management strategies(16). In addition to resistance to insects, TC1507 corn contains the pat gene, derived from Streptomyces viridochromogenes strain Tu494, responsible for codifying enzyme phosphinothricin acetyltransferase (PAT), the sequence of which has 183 amino acids and is identical to the PAT protein present in hybrids of genetically modified commercially released corns(17). The original sequence of the pat gene was modified to reduce G/C content and change the codon of the beginning of GTG translation into ATG, in a way to enable and optimize synthesizing the original protein. The final version of gene pat has 558 pb. Again, a sequence of 551 pb of CaMV 35S promoter (isolated Cabb-s) and the 178 pb IVS2 intron sequence of the corn gene adhS1 were used to promote and enhance the pat gene transcription. Sequence 3’-nos of 220 pb was used as a stop element of the transgene. The cassette therefore enables synthesizing the recombinant protein PAT, able to chemically inactivate herbicides derived from phosphinotricin, such as glufosinate ammonium, making resistant the cells and plants containing it. The PAT enzyme has its activity described and well known(18, 19, 20). Except for its resistance to Lepidoptera pest insects and tolerance to the glufosinate ammonium herbicide introduced by genes cry1F and pat, the TC1507 corn has no other phenotypic change. Western Blot analyses confirmed that proteins Cry1F and PAT expressed in the plant have the same molecular weight and immunoreactivity of the protein derived from the microbian form expressed from P. fluorescens (21). Gao et al.(22) also used similar methods to study the expression of gene cry1F in cotton. The results of a detailed molecular characterization of TC1507 corn using Southern Blot enabled a conclusion that this corn contain an almost complete copy of the DNA insert used in the transformation (i.e., 6186 pb of the 6235 pb fragment of insert PHI8999A, containing cry1F and pat genes jointly with the regulatory sequences needed in their expression). TC1507 corn is free from nptII gene and from any other detectable fragment of part of plasmid PHP8999 not intended in transforming the TC1507 corn. The flanking regions of the corn genomic DNA on borders 5’ and 3’ in the TC1507 insert were arranged in sequence and characterized in detail. IV. Aspects related to Human and Animal Health Security assessment of food derived from genetically modified raw-materials is based on risk analysis, a scientific methodology encompassing the phases of risk assessment, risk management and risk communication. In the risk assessment, one pursues the qualitative and quantitative characterization of potential adverse effects, based on the concept of substantial equivalence to identify any differences between the new food and its conventional correspondent. The Principle of Substantial Equivalence is a key concept in assessing the innocuousness of food generated from new technologies(23). When assessing the security of a genetically modified food raw-material, or its equivalence to conventional food, it is recommended that four elements are analyzed, namely: (1) Parental variety, i.e. the plant originating the new genetically modified raw-material; (2) Transformation process, including a characterization of the construct used and the resulting event; (3) Product of the inserted gene and potential toxicity and allergenicity and, finally; (4) Composition of the new variety resulting from genetic transformation. The data set of such analyses shall enable identifying and characterizing any potential adverse effect associated with consumption of the new raw-material, providing information to the risk management and risk communication phases. Since the sixties, B. thuringiensis (Bt) has been used in the United States of America as a pesticide to control Lepidoptera. Several toxicity studies in mammals conducted with Bt clearly show an absence of toxicity and pathogenicity(24). Due to its use as microbian pesticide, a long history of safe use has been associated to proteins produced by Bt(25). According to an assessment conducted by the United States Environment Protection Agency (EPA), Bt corns, including event TC1507 expressing protein Cry1F are harmless to human health(25). Grain nutrient analysis (proteins, fats, acid detergent fiber, neutral detergent fiber, carbohydrates, ashes and moist content) from the TC1507 corn hybrid, showed comparability with grain of commercial corn hybrids. Nutritional and toxicologic safety tests have been reported evidencing the innocuousness of the protein expressed. Highly relevant scientific articles attest the low risk and innocuousness of cultures containing the Bt toxin gene(26, 27). Assessment of substantial equivalence was made by Herman et al.(28). Concurrently with insect resistance, the Bt toxin contributes for reducing the development of corn ears molds, organisms responsible by the production of mycotoxins and consequent contamination of corn(29). A subchronic toxicity study was conducted with event TC1507 corn in male and female Sprague-Dawley rats(30). They received ad libitum food containing either TC1507 or conventional corn (control) grains, in a maximum concentration of 33%, for about ninety days. No significant toxicologic differences were recorded between the animals consuming genetically modified and non-modified corn regarding nutritional, ophthalmic, clinic and neurobehavioral parameters, as well as differences in weight of their organs. According to the authors of the study, these results verify that event TC1507 is as safe and nutritional than the non-genetically modified corn. Parameters of health status and development were assessed in lactating cows fed with fodder and event TC1507 corn grains(31). No difference was reported between the group fed with fodder containing and non containing transgenic corn regarding milk production and composition, as well as regarding parameters of health status (physical measurements and blood tests). Poultry fed with fodder containing event TC1507 corn failed to display any difference regarding mortality and growth when compared with poultry fed with non-transgenic corn(32). Compositional analyses of event TC1507 corn were also conducted for macronutrients, minerals, vitamins, amino acid and fat acid profiles, antinutrients and secondary metabolites. Results were similar to the ones involving conventional corn and were recorded in tiers described in the literature(33, 34, 30). Additionally, a study of acute oral toxicity was conducted in male and female CD1 mice, which received 5.050 mg/kg of protein Cry1F through gastric intubation(35). There was no mortality, clinic signs of toxicity, effects on animal growth and macroscopic lesion in organs, and therefore oral LD50 was assumed to be higher than 5.050 mg/kg. The PAT protein was degraded by gastric juice of animals and by artificial human gastric juice, losing its physicochemical characteristics after oral exposure. Therefore, it is not expected the protein to be fully absorbed, making unlikely that it may have adverse or toxic effects. Innocuousness of the transformation by pat gene is verified in works developed by different research teams. A study conducted with cows fed with fodder formulated with isogenic and transgenic corn for this modification, showed the similarity in yield and composition of milk produced by both groups of animals(36). The same work also analyzed the appearance of transgene fragments in 90 milk samples along the experimental period, with no positive result of transposing natural barriers or appearance of DNA fragments or its corresponding protein in the milk. A detailed study on PAT protein innocuousness was conducted approaching structural assessment, research of glycosylation sites, thermal stability and in vitro digestibility. The protein expressed by gene pat was analyzed, and the conclusion was for the safety of its use in plant modifications under all the investigated aspects(37). These results enable, in addition, an inference that the PAT protein fails to present any characteristics of allergenicity to sensitive individuals, either by direct action or by crossed reaction with other allergenic molecules. Allergens originated from food are commonly resistant to heat, acid and proteases, may be glycosed and are present in high concentrations. Proteins essayed are readily digested by gastric juice, are not glycosylated and the heating leads to bioactivity loss. Experiments conducted with animals failed to indicate any allergenic potential. No significant similarity was recorded between the Cry1F protein and dermal, respiratory and food allergens. Besides, the protein, coming from a non-allergenic source, is thermolabile, rapidly hydrolyzed when submitted to in vitro essay of resistance to pepsin, being not glycosylated(38, 39). The data, simultaneously analyzed, indicate lack of Cry1F allergenic potential(39). This conclusion was reached by Hérouet et al.(37) regarding PAT, after different analyses conducted with the protein. The authors recorded that the protein sequence did not display homology with known allergens or toxins. Besides, PAT has no N-glycosylation site, is rapidly degraded by gastric and intestinal fluids and has a source held as innocuous. Similar results have been described in other studies(40, 38). Corn and its derivatives are not considered toxic. The genetic modification of TC507 corn lineage results from the expression of Cry1F and PAT proteins. Protein Cry1F displays specific toxicity against certain Lepidoptera plague insects (target organisms), however there is no evidence that Cry proteins generated from Bacillus thuringiensis may harm human and animal health(41, 42). The potential toxicity for humans and animals of protein Cry1F was examined in an acute oral toxicological study where acute toxicity potential in rats(35) of the Cry1F delta-endotoxin of B. thuringiensis var. aizawai was assessed. The highest dose used in the essay was 5050 mg/kg LW, adjusting the purity of the essayed material (11.4%), the dose was 576 mg Cry1F/kg of body weight. In the course of the study, notes were taken on mortality, clinical pathology and behavioral symptoms, as well as on body weights, performing full necropsies at the end of the study. No mortality was recorded in the course of the study. During the experiment, no adverse clinical signs were present, and no adverse results were recorded in the necropsies. Changes in the dose used in this study failed to provoke mortality among individuals submitted to the essay, and therefore it was not possible to determine the LD50 of the Cry1F protein. In another oral acute toxicity study, rats were fed with 6000 mg/kg of an essay material containing about 500 mg of protein PAT/kg LW(43). No clinical observations were produced related to the treatment. All rats gained weight during the two weeks of observation and none displayed pathologic lesions. In study conditions, and due to absence of any observable toxicity, determination of PAT protein LD50 was not possible. PAT protein toxicity safety was determined in detail during the evaluation of glufosinate ammonium tolerant corn(41, 44, 45, 46, 47). Gene pat was originally obtained from strain Tü494 of bacterium Streptomyces viridochromogenes that does not have known toxic or pathogenic potential. PAT protein is enzymatically active. However, it displays high specificity for a substratum that does not exist in corn plants or in human and animal diets. A study was conducted on feeding chicken through incorporation to the diet of TC1507 corn lineage grains and non-transgenic control grains of comparable germplasm(48). Mortality, weight gain and alimentary conversion of chicken fed on a diet containing grain from corn TC1507 lineage were compared with chicken fed on a standard diet containing common corn. No significant statistical difference in mortality, weight gain and alimentary conversion was recorded between chicken feeding on the TC1507 corn and those on the control diet. When assessing the allergenic potential, the most important issue to consider is the biologic origin of the gene introduced and whether it expresses the allergenic product(49). Both, Bacillus thuringiensis (origin of the cry1F gene) and Streptomyces viridochromogenes (origin of the pat gene) have no history of allergy triggering factors. These donors are common soil bacteria. In over 30 years of commercial use, there was no verifiable information of Bacillus thuringiensis allergenicity, including occupational allergies related to the manufacture of products containing it(41). The biochemical profile of proteins Cry1F and PAT provide the background for an allergenic assessment by comparing them with allergens of known proteins. Comparison of amino acid sequences of an introduced protein with amino acid sequences of known allergens may result in a useful indicator of allergenic potential(50). Meyer(38) conducted a search assisted by the Wisconsin Genetics Computer Group (GCG) sequence analyzer computer program, looking up for “allergenic” in the database of standard DNA and protein sequences. A significant homology is the one recording a sequence identity of 8 or more contiguous amino acids. A comparison of the 15 sequences of the most homologous data bases confirmed that protein Cry1F does not share a significant amino acid sequence homology with known allergenic proteins. In a similar way, PAT protein amino acid sequences were compared with allergens of known proteins(38). The comparison showed that the PAT protein does not share significant amino acid homology with known allergenic proteins. The PAT protein had already been assessed for previous safety of genetically modified plants(41, 44, 45, 46, 47), including commercial release proceedings passed by CTNBio. Allergens in food proteins are generally stable in digestion by pepsin and trypsin and in acid conditions of the human digestive tract, so that they may pass through the intestinal mucosa to generate an allergenic response. Both Cry1F and PAT proteins are easily degradable in simulated digestive fluid, minimizing any potential the proteins may have of being absorbed by the intestinal mucosa when consumed. After one minute, protein Cry1F is almost completely hydrolyzed in simulated gastric conditions at a 100:1 molar reaction (Cry1F:pepsin)(51). The immunoelectrotransfer blot detection technique also showed that protein Cry1F is not glycosylated. On the other hand, protein Cry1F loses immunoreactivity after being processed by heat and has not history of harmful use in microbial pesticides. The PAT protein was degraded to undetectable levels within 5 seconds from introduction of a simulated gastric fluid containing pepsin (40,47). Therefore, genes cry1F and pat introduced in the TC1507 corn lineage do not code known allergens and both proteins, Cry1F and PAT, do not share immunologically significant amino acid sequences with known allergens. These results, coupled with the rapid rupture of the proteins under digestive conditions, confirm that Cry1F and PAT proteins are unlikely to pose any significant allergenic risk. Corn is extensively cultivated and has a history of safe use as human and animal food. Corn is not considered to be harmful to humans, domestic animals and the wild fauna. With the exception of the new characteristics introduced, including resistance to certain Lepidoptera pests granted by gene cry1F and tolerance to glufosinate ammonium granted by gene pat, the TC1507 corn lineage is substantially equivalent to other corn lineages commercially found. No other characteristic of the original organism was modified that may be harmful or pose a risk to health. No adverse effects were recorded in TC1507 corn lineage to human health and the environment. V. Environmental and Agronomic Aspects Corn is an annual plant with low dormancy ability. The corn seed can survive from one cultivation season to another, and may successfully germinate under adequate temperature and moist conditions. These so-called volunteer plants are easily identified and controlled by manual, mechanical and chemical means. Corn does not exhibit tendency to proliferate as a plant pest and is not invasive in natural ecosystems(45). Some species of the Zea genus are sylvan plants developing successfully in Central America without any considerable trend to proliferate as a plant pest. Event TC1507 was carefully cultivated and monitored in what regards its proliferation ability as plant pest and agronomic behavior in over eighty locations around the world, including Argentina, United States, Chile, Italy, Brazil, France and South Africa. In Brazil, several planned releases to the environment were presented by applicants and duly passed by CTNBio. In all cases, TC1507 corn exhibited a behavior similar to the one expected from non-transgenic corn, without evidencing any development of unforeseen morphologic or phenotypic characteristics. In experimental and field essays conducted in Brazil by Dow AgroSciences during the 2005-2006 crops to compare TC1507 corn with the conventional material, several agronomic parameters were measured, such as: plant height, ear, stalk breaking, root size and yield, among other agronomic characteristics and resistance to diseases. Results reached in experiments conducted in domestic soil were comparable to those attained in Argentina and United States, where it was demonstrated that the genetic modification does not affect the plant phenotype and field behavior. Experimental essays conducted all over the world with TC1507 corn lineage since 1997 confirmed that event TC1507 does not show any unexpected change in plant vigor. Assessment by simple observation of field essays showed that the development from an emerging plantlet to one-leaved plantlet, and from three to five leaves plantlet, TC1507 corn lineage is comparable to the non-genetically modified corn. Applicants additionally conducted field essays in Brazil, where resistance to common rust (Puccinia sorghi), Polysora rust (Puccinia Polysora), cercosporiosis (Cercospora zea-maydis), Northern corn leaf blight (Exserohilum turcicum), Phaeosphaeria leaf spot (Phaeosphaeria maydis), and Diplodia leaf spot (Diplodia macrospora) was assessed. The data indicate that in the four hybrid essayed there was no differences in disease severity between the hybrid with TC1507 event and the correspondent conventional hybrid. Comparatively, essays were conducted to assess resistance characteristics of hybrids derived from TC1507 corn lineage and their corresponding non-genetically modified corn to diseases such as Exserohilum turcicum leaf spot, Bipolaris maydis leaf spot, Polysora rust, cercosporiosis, Erwinia stewartii bacterial spot, Ustilago zeae smut and resistance to pests, such as armyworm Spodoptera frugiperda, corn earworm Helicoverpa zea, Frankliniella sp. thrips, Aphis sp. aphis, Chaetocnema pulicaria corn flea beetle, red acarus, among others. These essays showed that there was no difference to be recorded on severity of disease symptoms; damage caused by insects, except for organisms identified as susceptible to protein Cry1F among plants of event TC1507 and those of genetically modified corn. The biological activity of protein Cry1F was studied in a range of pest insects feeding on corn plants. The essays were conducted by exposing insects to artificial diets treated with aqueous formulations of Cry1F protein produced from a microbial source (P. fluorescens). Evans(51) showed that the biochemical characteristics of a protein produced in either plant or microbial form are equivalent. Insects studied were: armyworm (Spodoptera Frugiperda), moth borer (Diatraea saccharalis), European corn borer (Ostrinia nubialis), corn earworm (Helicoverpa zea), black cutworm (Agrotis ipsilon), lesser cornstalk borer (Elasmopalpus lignosellus), Southwest corn borer (Diatraea grandiosella), Western corn rootworm (Diabrotica virgifera virgifera), corn leaf aphid (Rhopalosiphum maidis) and corn leafhopper (Dalbulus maidis). Huang et al.(55) have already assessed Cry proteins specificity through essays in connection with cell vesicles, evidencing the high specificity of this protein complex to insect receptors. Efficacy essay was conducted in the cities of Itumbiara, (GO), Toledo (PR), Indianápolis (MG), and Jardinópolis (SP) during the 2005 calendar year. Experiments were conducted according to cultural practices recommended for each region. In that same year, a first assessment was made, including incidence of initial pests and predators. Incidence of the lesser cornstalk borer, Elasmopalpus lignoselus (Zeller), was not recorded in any of the localities. Pooled variance analysis of data in the four localities revealed significant difference among the three treatments studied: conventional Pioneer P30F33 corn with application of insecticide, conventional Pioneer P30F33 corn without application of insecticide, and the same hybrid P30F33 – 1507 (Bt), using F test. Analysis of data related to assessment of herbivory and incidence of green stink bug, based on the percentage of plants with damage symptoms, revealed that interaction site x treatment was significant. The result showing the comparison of averages for herbivory is lower for the P30F33 – TC1507 in each site. Currently there is an indiscriminate use of insecticides in Brazil, including a mix of chemical products, in an attempt to control insects, especially S frugiperda. With the massive employment of these chemical products an agricultural desert is created in certain Brazilian regions, since the natural enemies of such pests are the first to be eliminated. Frequent employment of chemical insecticides contributes to environmental degradation, pollution and an environmental breakdown in corn culture and even in other rotation crops. By adopting insect resistant genetically modified plants, reduction in insecticides has been considerable in countries where this technology has been adopted for over ten year. In the United States, for instance, farmers have obtained reductions of over 8,000 tons of active insecticide ingredient in 2001 alone(52, 53, 54). In China, the employment of insecticides were reduced 67% on average, and reduction in volume of active insecticide ingredient reached 80%(55). In South Africa, the reduction was around 66%(56). For the foregoing, one may argue that the use of the Bt technology in Brazil may contribute towards a reduced employment of insecticides and, consequently, mitigating the impacts to the environment and human and animal health resulting from the use of these pesticides. Furthermore, the use of Bt technologies may positively affect the preservation of non-target populations and beneficial insects, facilitating an integrated management of farm pests(57, 55, 58). In addition, adoption of technologies that minimize the spraying of chemical products in crops may bring secondary benefits such as reduced use of inputs in the production of pesticides, conservation of fuels used to produce, distribute and apply the pesticides and elimination of the need for use and discard of pesticide packing. VI. Restrictions to the use of the GMO and its derivatives. Studies submitted by applicant showed that there was no significant difference between corn hybrids derived from non-modified lineages and TC1507 corn regarding agronomic characteristics such as productivity, moist at harvest, root bedding and plant height, among others. Besides, there was no significant differences in the method of reproduction, dissemination and survival ability of the genetically modified corn compared with non-modified lineages. All evidences submitted in the proceedings and bibliographic references(60, 61, 62, 63, 64, 65, 66) confirm the risk level of the transgenic variety as equivalent to those of non-transgenic in what regards soil microbiota, non-target vertebrate and invertebrate animals, other plants and human and animal health. Therefore, cultivation of TC1507 corn is not potentially a cause of significant degradation of the environment and of risks to human and animal health. For the foregoing, there is no restrictions to the use of this corn and its derivatives. After being used for ten years in different countries, there was no record of problem to human and animal health or to the environment that may be attributable to transgenic corns. It is worth emphasizing that absence of negative effects resulting from cultivation of transgenic corn plants does not imply that they may not happen in the future. Zero risk coupled with absolute safety does not exist in the biologic world, although there is a host of trustworthy scientific information and a safe use history of ten years that enables us to say that TC1507 corn is as safe as conventional corn versions. This way, applicant shall conduct a post-commercial release monitoring according to the provisions of CTNBio Ruling Resolution no. 03. The vertical genic flow to local varieties, the so-called Creole corns, of open pollination is possible and displays the same risk caused by commercial genotypes available in the market (80% of conventional corn planted in Brazil comes from commercial seed that underwent a process of genetic improvement. Coexistence between cultivars of conventional corns (improved or Creole) and transgenic corn cultivars is possible from the agronomic viewpoint(43, 67) and shall follow the provisions of CTNBio Ruling Resolution no. 4. VII. Considerations about Particulars of Different Regions in the Country (subsidy to monitoring agencies): According to Article 1 of Law no. 11,460, of March 21, 2007 ”research and cultivation of genetically modified organisms may not be conducted in Amerindian areas and conservation units”. VIII. Conclusion Considering that TC1507 corn is derived from a transformation of common Zea mays corn, a fully characterized species with a solid history of safety for human and animal consumption; that the transformation process caused insertion of a single copy of a DNA fragment containing genetic constructs with pat and cry1f genes. Considering that safety of corn containing the pat gene was exhaustively assessed by CTNBio in proceedings 01200.005154/1998-36, and analyzed corn containing genes cry1A(b) and pat in proceedings 01200.002109/2000-04; and that all aspects regarding corn biosafety were studied for corns Liberty Link and Bt11 in Technical Opinions no. 987/2007 and 1255/2008. Whereas: 1. Corn is the species that reached the highest domestication level among cultivated plants, and is unable to survive in nature with no human intervention. 2. In Brazil, there are no wild species with which corn may intercross, since the closest wild corn species is teosinte, found only in Mexico and in some Central America locations, where it may cross with corn cultivated in production fields. 3. Protein Cry1F was detected in low levels in tissues analyzed and displayed high susceptibility to digestion in simulated gastric fluids, failing to show acute toxicity in mammals and similarity with known allergens(38). 4. The DNA molecule is a natural component of food and there is no evidence that this molecule may have adverse effect to man when ingested in food in acceptable amounts. 5. There is no evidence that intact genes of plants may be transferred and functionally integrated to the human genome or genome of other mammals exposed to such DNA or to foods manufactured with such elements(50). 6. Applicant answered to all questions mentioned in CTNBio Ruling Instruction no. 05 and there is no issue indicating that this corn may present adverse effects to human and animal health. 7. There is no likelihood that TC1507 corn may perform or cause invasion of uncultivated areas. 8. Proteins Cry1F and PAT are rapidly degraded in gastric conditions, thus minimizing any absorption potential in an intestinal system(51, 40). 9. Bacterium B. thuringiensis may be considered the most potent biological agent to control forest and agricultural pest insects and disease vectors for the specificity of delta-endotoxins to insects and target-invertebrates, and its innocuousness to vertebrates and the environment, including beneficial insects and natural enemies, making this agent a key component in integrated management of pests. 10. Cultures of B. thuringiensis are filed with Agência Nacional de Vigilância Sanitária – ANVISA, the National Sanitary Surveillance Agency, under different formulations for application in thirty types of plant cultures for food use(68). 11. Biopesticides based on such toxin are widely used as an alternative to chemical insecticides in terms of safety to non-target organisms and when development of resistance to chemical insecticides is the case(69). 12. The use of Bt technology in Brazil may contribute to reduce the use of insecticides and, consequently, mitigate the impact resulting from the use of such pesticides to the environment, human and animal health, and to positively affect the preservation of non-target organisms and beneficial insects, facilitating the integrated management of farm pests. 13. This corn variety shows low risk to human health, animal health and is no likely to change into a plant pest. 14. The gene insertion did not change the composition and nutritive value and the presence of protein Cry1F in proportion to the total corn protein does not imply significant contribution to the amount or proteins in human diet. 15. Nutritional, equivalence and toxicological tests have been reported showing the expressed protein to be innocuous(26, 27, 28). 16. Concurrently to resistance to insects, the Bt toxin contributes to reduce mold development in corn ears, which are responsible for production and contamination of corn with mycotoxins(29). 17. No other characteristic of the original organisms that represents risks to human health was modified and there was no record of adverse effects resulting from TC1507 corn in studies related to human health and the environment. 18. Commercial use of TC1507 corn lineage is occurring in the United States since 2001, Argentina (2005), Colombia (2006), China (2004), Mexico (2003), South Africa (2002), Canada (2002), Australia (2003), Japan (2002), Korea (2002), Philippines (2003), Taiwan (2003) and European Union (2006) without any record of problems linked to the agronomic characteristics of the event. 19. Comments, opinions, suggestions and documents resulting from a Public Hearing related to TC1507 corn held on March 20, 2007, failed to register any relevant scientific fact, corroborated by scientific evidence, that may compromise the environmental safety and human and animal health. 20. Coexistence of conventional corn cultivars (improved or Creole) and transgenic cultivars is possible from the agronomic viewpoint, and the provisions of CTNBio Ruling Instruction no. 04 shall be complied with. For the foregoing, and considering internationally accepted criteria in the process of risk analysis for genetically modified raw-materials, a conclusion emerges that TC1507 corn is as safe as its conventional equivalent. CTNBio holds that commercial cultivation and consumption of TC1507 corn are not potential causes of significant degradation to the environment or of harm to human and animal health. Restrictions to the use of the GMO analyzed and its derivatives are conditioned to the provisions of CTNBio Ruling Resolutions no. 03 and 04. Additionally, this risk analysis took into consideration and consulted third party independent studies and scientific publication submitted by applicant. IX. Bibliography 1. Watson Leslie. Dallwitz, Michael J. The grass genera of world. C.A.B. International. Wallingford, OX. c1992. 2. KIESSELBACH T.A. The structure and reproduction of corn. Lincoln : University of Nebraska, 1980. 96p. 3. BAHIA FILHO A.F.C.; GARCIA J.C. 2000. Análise e avaliação do mercado brasileiro de sementes de milho. In: UDRY C.V.; DUARTE W.F. (Org.) Uma história brasileira do milho: o valor de recursos genéticos. Brasília: Paralelo 15, 167-172. 4. FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS – FAO. 2007. FAOSTAT. Available at: http://faostat.fao.org/site/340/default.aspx. 5. Companhia Nacional de Abastecimento – CONAB. 2007. Milho total (1ª e 2ª safra) Brasil – Série histórica de área plantada: safra 1976-77 a 2007-07. http://www.conav.gov.br/conabweb/download/safra/MilhoTotalSerieHist.xls 6. CRUZ I.; FIGUEIREDO M.L.C.; OLIVEIRA A.C.; VASCONCELOS C.A. 1999. Damage of Spodoptera frugiperda (Smith) in different maize genotypes cultivated in soil under three levels of aluminium saturation. International Journal of Pest Management 45:293-296. 7. WAQUIL J.M.; VILLELA F.M.F.; FOSTES J.E. 2002. Resistência do milho ( Zea mays L.) transgênico ( Bt) à lagarta-do-cartucho, Spodoptera frugiperda (Smith) ( Lepidoptera: Noctuidae). Revista Brasileira de Milho e Sorgo 1(3): 1-11. 8. AGBIOS, Information on GM Approved Products. http://www.agbios.com/dbase,hph (available on 12/05/2008). 2008 9. ALVES FILHO J.P. 2001. Agrotóxicos e Agenda 21: sinais e desafios da transição para uma agricultura sustentável. In: II SINTAG Anais. II Simpósio Internacional de Tecnologia de Aplicação de Agrotóxicos: Eficiência, Economia e Preservação da Saúde Humana e do Ambiente, Jundiaí, SP, 07/17/2001 a 07/20/2001. 10. Klein T.M., E.D. Wolf, R. Wu, and J.C. Sanford. 1987. High velocity microprojectiles for delivering nucleic acids into living cells. Nature 327: 70-73. 11. Narva K., Zeph L., and Jayne S.; 1998. Product characterization data for Bacillus thurigiensis var. aizawai Cry1F insect control protein as expressed in maize. An unpublished technical report by Mycogen c/o Dow AgroSciences LCC. 12. CRICKMORE N. 2007. Bacillus thuringiensis Toxin Nomenclature. http://www.lifesci.sussex.ac.uk/home/Neil_Crickmore/Bt/ available on 12/05/2008. 13. MONNERAT R.G.; BRAVO A. 2000. Proteínas bioinseticidas produzidas pela bacteria Bacillus thuringiensis: modo de ação e resistência. In: MELLO I.S.; AZEVEDO J.L. (ed.) 2000. Controle Biológico. Jaguariúna: Embrapa Meio Ambiente, 163-200. 14. De MAAGD R.A.; BRAVO A.; BERRY C. CRICKMORE N. SHNEPF H.E. 2003. Structure, diversity, and evolution of protein toxin from spore-forming entomapathogenic bacteria. Ann. Rev. Genet. 37: 409-433. 15. KRIEG A.; LANGENBRUCH G.A. 1981. Susceptibility of arthropod species to Bacillus thuringiensis. In: BURGES H.D. (Ed.) Microbial control of pests and plant diseases 1970-1980. London: Academic, 837-896. 16. Schenepf E., Crickmore N., Van Rie J.; Lereclus D.; Baum J.; Feitelson J.; Zeigler D. R., and Dean D.H. 1998 Bacillus thuringiensis and Its Pesticidal Crystal Proteins. Microbiol. Mol. Biol. Reviews. Sept, 1988. p. 775-806. 17. Van Wert, 1994. Petition for Determination of Nonregulated Satus: Glufosinate Resistant Corn Transformation Events T14 and T25. U.S. Department of Agriculture, Washington, DC. 18. FORLANI G.; OBJSKA A.; BERLICKI, £; KAFARSKI P. 2006. Phosphinothricin analogues as inhibitors of plant glutamine synthetases. J. Agric. Food Chem. 54: 796-806. 19. TAN S.; EVANS R.; SINGH B. 2006. Herbicidal inhibitors of amino acid biosynthesis and herbicide-tolerant crops. Amino Acids 30: 195-204. 20. YI G.; SHIN Y.M.; CHOE G.; SHIN B.; KIM Y.S.; K.M. 2007. Production of herbicide-resistant sweet potato plants transformed with the bar gene. Biotechnol. Lett. 29:669-675. 21. Alarcon C. and Marshall L. 200. Characterization of proteins as expressed in B.t. Cry1F maize tissues. Report number 99-023, an unpublished technical report by Pioneer Hi-Bred International, Inc. 22. Gao Y. Fencil K.J; Xu X.; Schwedler D.A.; Gilbert J.R & Herman R.D. Purification and Characterization of a Chimeric Cry1F-Endotoxin Expressed in Transgenic Cotton Plants. J. Agric. Food Chem. 2006, 54, 829-835. 23. FAO/WHO – Organización de las Naciones Unidas para la Agricultura y la Alimentación / Organización Mundial de la Salud. 2004. Codex Alimentarius: Alimentos obtenidos por medios biotecnológicos. Roma: FAO, 57pp. 24. McClintock, JT, Schaffer CR, Sjoblad RD. A comparative review of the mammalian toxicity of Bacillus thuringiensis-based pesticides. Pestic Sci, 45: 95-105, 1995. 25. Mendelsohn M, Kough J, Vaituzis Z, Matthews K. Are Bt crops safe? Nat Biotechnol, 21: 1003-9, 2003. 26. Bets FS, Hammond BG, Fuchs R.L. Safety and advantages of Bacillus thuringiensis-protected plants to control insect pests. Regul Toxicol Pharmacol. 32(2):156-73,2000. 27. Aumaitre A.; Aulrich K.; Chesson A.; Flachowsky, G.; Piva G. New feeds from genetically modified plants: substantial equivalence, nutritional equivalence, digestibility, and safety for animals and the food chain. Livestock Prod. Sci., v.74, p.223-238, 2002. 28. Herman R.A.; Phillips A.M.; Collin R.A.; Tagliani L.A.; Claussen F.A.; Graham C.D.; Bickers B.L.; Harris T.A.; Prochaska L.M. Compositional equivalency of Cry1F corn event TC6275 and conventional corn (Zea mays L.). J. Agric. Food Chem. 52, 2726-2734, 2004. 29. Williams W.P.; Windham G.L.; Buchley, P.M.; Perkins, J.M. Southwestern corn borer damage and aflatoxin accumulation in conventional and transgenic corn hybrids. Fields Crop. Res.; v.91, p.239-336, 2005. 30. Mackenzie S.A.; Lamb I.; Schmidt J.; Deege L.; Morrisey M.J.; Harper M.; Layton R.J.; Prochaska L.M.; Sanders C.; Locke M.; Mattsson J.L.; Fuentes A.; Delaney B. 2007. Thirteen week feeding study with transgenic maize grain containing event DAS-01507-1 in Sprague-Dawley rats. Food Chem. Toxicol., v.45, p.551-562. 31. Faust M, Smith B, Rive D, Owens F, Hinds M, Dana G, Hunst P. 2007. Performance of lactating dairy cows fed silage and grain from a maize hybrid with the cry1F trait versus its nonbiotech counterpart. J Dairy Sci, 90:5706-13. 32. Zeph L. Nutritional equivalence of B.t. Cry1F maize – poultry feeding study. Pioneer Hi-Bred International, Inc., Johnston, Iowa. Study number PHI99-010, 2000. 33. Stauffer C. and Zeph L. 2000. Compositional Analysis of Maize MPS Hybrid Line 1507. Report number PHI98-012, an unpublished technical report by pioneer Hi-Bred International, Inc. 34. Stauffer C. 2000. Quantitative ELISA Analysis of poCry1F and PAT Protein Expression Levels, Compositon and Efficacy of Hybrid Lines 1360 and 1507 – EU Field Sites. Report number PHI99-005, an unpublished technical report by Pioneer Hi-Bred International, Inc. 35. KUHN J.O. Cry1F Bt var. aizawai Delta-endoprotein: Acute Oral Toxicity Study in Mice (Delta-endoproteina Cry1F de lar var. azawai del Bt: Estudio de toxicidad aguda oral em ratones). Report number 42-81-98, an unpublished technical report by Mycogen Seeds c/o Dow AgroSciencies LCC. 1998. 36. Phipps R.H.; Jones A.K.; Tingey A.P.; Abeyasekera S.2005. Effect of corn silage from an herbicide-tolerant genetically modified variety on milk production and absence of transgenic DNA in milk. J. Dairy Sci. v.88, p. 2670-2978. 37. Herouet C, Esdaile DJ, Mallyin BA, Debruyne E, Schulz A, Currier T, Hendrickx K, van der Klis RJ, Rouan D. Safety evaluation of the phosphinothricin acetyltransferese proteins encoded by the pat and bar sequences that confer tolerance to glufosinate-ammonium herbicide in transgenic plants. Regul Toxicol Pharmacol. 41(2):134-49, 2005. 38. Meyer T. 1999. Comparison of Amino Acid Sequence Similarity of Cry1F and PAT Proteins to Known Allergen Proteins (Comparación de la similitud de la secuencia de aminoácidos de las proteínas Cry1F PAT con proteínas alérgenas conocidas). Report number PHI99-013, an unpublished technical report by Pioneer Hi-Bred International, Inc. 39. Ladics GS, Bardina L, Cressman RF, Mattsson JL, Sampson HA. Lack of cross-reactivity between the Bacillus Thuringiensis derived protein Cry1F in maize grain and dust mite Der p7 protein with human sera positive for Der p7-IgE. Regul Toxicol Pharmcol, 44:136-43,2006. 40. GLATT C.M. Phosphinothricin acetyltranferase (PAT) protein: In Vitro Digestibility Study, Report number DuPont 3365, an unpublished technical report by E.I. du Pont de Nemours an Company, 1999. 41. EPA. 1995a. Plant Pesticide Bacillus thuringiensis CryIIIa delta-endotoxin and the genetic material necessary for its production; tolerance exemption. Fed. Reg. PP3F4273/R2132; FRL-4953-2. 42. EPA.1996.a, Bacillus thuringiensis CryIA(b) delta-endotoxin and the genetic material necessary for its production in all plants; exemption from requirement of a tolerance Fed. Reg., 61,150, pp. 40340-40343. 43. BROOKS K.J. PAT microbial protein (FL): Acute Oral Toxicity Study in Cd-1 Mice. Report number 991249, an unpublished technical report by Micogen c/o Dow AgroSciences LLC. 2000. 44. EPA 1997. Phosphinothricin Acetyltranferase and the Genetic Material Necessary for its Production in All Plants; Exemption from the Requirement of a Tolerance On All Plants; Exemption from the Requirement of a Tolerance On All Raw Agricultural Commodities. Fed. Reg. 62:17717-17720. 45. CFIA.1994. Regulatory Directive Dir94-11: The Biology of Zea mays L. (Corn / Maize). Canadian Food Inspection Agency, Plant Products Division, Plant Biotechnology Office, Ottawa. 46. SCP 1998. Opinion of the Scientific Committee on Plants regarding submission for placing on the market of glufosinate tolerant corns (Zea mays) transformation event T25by the AgEvo Company (Notification C/F/95/12/07). 47. OECD. 1999. Consensus document on general information concerning the genes and their enzymes that confer tolerance to phosphinothricin herbicide. Series on Harmonization of Regulatory Oversight in Biotechonoly No.11. 48. Zeph L. Nutritional equivalence of B.t. Cry1F maize – poultry feeding study. Pioneer Hi-Bred International, Inc., Johnston, Iowa. Study number PHI99-010, 2000. 49. FDA (Food and Drug Administration). 1992. U. S. Food and Drug Administration. Statement of Policy: foods derived from new plant varieties. Fed. Ref. (USA) 57:22984-23005. 50. FAO/WHO – Food and Agriculture Organization of the United Nations. 2000. Safety Aspects of Genetically Modified Foods of Plant Origin. Report of Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology, 29 May – 2 June 2000. World Health Organization, WHO Headquarters, Geneva, Switzerland. 35pp. http://www.who.int/foodsafety/publications/biotech/en/ec_june2000_en.pdf. (Available on 15/05/2008). 51. EVANS S.L. Equivalency of Microbial and Maize Expressed Cry1F Protein; Characterization of Test Substances for Biochemical and Toxicological Studies. Report number MYCO98-001, an unpublished technical report by Mycogen Seeds c/ o Dow AgroSciences, 1998. 52. CARPENTER J.; FELSOT A; GOODE T.; HAMMING M.; ONSTAD D.; SANKULA S. 2002. Comparative environmental impacts of biotechnology-derived and traditional soybean, corn, and cotton crops (CAST: 1-189). Ames, IA: Council for Agricultural Science and Technology. 53. EDGE J.M.; BENEDICT J.H.; CARROLL J.P.; REDING H.K. 2001. Bollgard Cotton: An assessment of global economic, environmental and social benefits. J. Cotton Sci 5: 121-136. 54. GIANESSI L.; SILVERS C.; SANKULA S.; CARPENTER J.A. 2002. Plant biotechnology: current and potential impact for improving pest management in U.S. agriculture – an analysis of 40 case studies (executive summary). Washington, DC: National Center for Food and Agricultural Policy. http://www.ncfap.org/40CaseStudies/NCFAV%20Exec%20Sum.pdf 55. HUANG J.; ROZELLE S.; PRAY C.; WANG Q. 2002. Plant biotechnology in China. Science 295:674-676. 56. ISMAEL Y.; BENNETT R.; MORSE S. 2002. Bt cotton, pesticides, labour and health: a case study of smallholder farmers in the Makhatini Flats, republic of South Africa. Paper presented at the 6th International ICABR Conference, Ravellho, Italy. 57. XIA, JY.; CUI J.J.; MA L.H.; DONG S.X.; CUI X.F. 1999. The role of transgenic Bt cotton in integrated insect pest management. Ata Gossypii Sim 11: 57-64. 58. BENEDICT J.; ALTMAN D. 2001. Commercialization of transgenic cotton expressing insecticidal crystal protein. In: JENKINS J.; SAHA S. ( eds). Genetic improvement of cotton: emerging technologies. Enfield: Science Publishers, 137-201. 59. LEONARD R.; SMITH R. 2001. IPM and environmental impacts of bt cotton: a new era of crop protection and consumer benefits. ISN N° 00401074. 60. SHULER T.H.; DENHOLM I.; JOUANIN L.; CLARK S.J.; CARK A.J. POPPY G.M. 2001. Populations-scale laboratory studies of the effect of transgenic plants on nontarget insects. Mol. Ecol. 10: 1845-1853. 61. DE MAAGD R.A.; BRAVO A,. CRICKMORE N. 2001. How Bacillus thuringiensis has evolved specific toxins to colonize insect world. Trends Genet. 17: 193-199. 62. CANDAS M.; LOSEVA O.; OPPERT B.; KOSARAJU P.; BULLA JUNIOR L.A. 2003. Insect resistance to Bacillus thuringiensis: alterations in the indianmeal moth larval gut proteome. Molec, Cel, Proteomics 2.1: 19-28. 63. BROOKES G.; BARFOOT P.; MELÉ E.; MESSEGUER J.; BÉNÉTRIX F. BLOC D.; FOUEILLASSAR X; FABIÉ A.; POEYDOMENGE C. 2004. Genetically modified maize: pollen movement and crop coexistence. Dorchester UK: PG Economics, 20pp. (www.pgeconomics.co.uk/pdf/Maizepollennov2004.final.pdf) 64. BRODERICK N.A.; RAFFA K.F.; HANDELSMAN J. 2006. Midgut bacteria required for Bacillus thuringiensis insecticidal activity. Proc. Natl. Acad. Sci. USA 103:15196-15199. 65. SANDEN M.; BERNTSSEN M.H.G.; KROGDAHL D.; HERME G-I.; MCKELLEP A-M. 2005. An examination of the intestinal tract of Atlantic salmon, Salmo salar L.; parrfed different varieties of soy and maize. J. Fish Dis. 28:317-30. 66. OKUNUKI H.; TESHIMA R.; SHIGETA T.; SAKUSHIMA J.; AKIYAMA H.; GODA Y., TOYODA M.; SAWADA J. 2002 Increased digestibility of two products in genetically modified food (CP4-EPSPS an Cry1Ab) after preheating. Shokuhin Eiseigaku Zasshi 43:68-73. 67. MESSEGUER J.; PEÑAS G.; BALLESTER J.; BAS M.; SERRA J.; SALVIA J.; PALAUDEMÀS M.; MELÉ E. 2006. Pollen-mediated gene flow in maize in real situations of coexistence. Plant Biotecnology Journal. 4:633-645. 68. Agencia Nacional de Vigilância Sanitária – ANVISA. 2006. http://www.anvisa.gov.br/toxicologia/monogradias/b01.pdf., Available on 10/15/2006. 69. RODRIGO-SIMÓN A.; DE MAAGD R.A.; AVILLA C.; BAKKER P.L.; MOLTHOFF J.; GONZÁLEX-XAMORA J.E.; FERRÉ, J.2006. Lack of detrimental effects of Bacillus thuringiensis Cry toxins on insect predator Chrysoperla carnea: a toxicological, histopathological, and biochemical analysis. Appl. Environ. Microbiol. 72: 1595-1603
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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@mcti.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: Dow AgroSciences Canada Inc.
Summary of application:
Dow Agrosciences Canada Inc. developed Maize line 1507 through genetic modification to be tolerant to glufosinate-ammonium herbicides and protect the plant from certain lepidopteran larvae (including European corn borer, southwestern corn borer, fall armyworm, and black cutworm). The modified corn line permits farmers to use the herbicide for weed control and prevents loss in crop production due to the damaging insect pests.

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Date of authorization: 11/10/2002
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment:
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: Dupont China Holding Co.,LTd. and Dow Agrosciences China Ltd.
Summary of application:

Genetically modified organism: DAS-Ø15Ø7-1  (TC1507)  line of maize (Zea mays L.); Exogenous gene: cry1F gene, isolated from the common soil bacterium Bacillus thuringiensis and pat, isolated from the common aerobic soil actinomycete, Streptomyces viridochromogenes ;  Trait: Resistance to European corn borer (Ostrinia nubilalis); phosphinothricin (PPT) herbicide tolerance, specifically glufosinate ammonium; Transformation methods: Microparticle bombardment of plant cells or tissue; 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. 869-7-2007: Detection of Genetically Modified Plants and Derived Products Qualitative PCR Method for Insect-Resistant and Herbicide-Tolerant Maize TC1507 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: Du Pont 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.
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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.
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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: Pioneer Hi Bred and Dow AgroSciences
Summary of application:
Pioneer Hi-Bred International, Inc. (PHI) and Dow Agro Sciences (DAS) have developed a corn line resistant to the Asiatic Corn Borer (ACB) larvae, a periodic pest of corn in the Philippines. This corn line, referred to in this document as Cry1F, was developed to provide a method to control yield losses from insect feeding damage caused by the larval stages of ACB, without the use of conventional pesticides. In addition, Cry1F was transformed with a gene that confers tolerance to the herbicide glufosinate.
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Date of authorization: 07/10/2013
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.):
Summary of the safety assessment:
Pioneer Hi-Bred and Dow AgroSciences submitted an application to the Bureau of Plant Industry (BPI) requesting for biosafety permit under Administrative Order #8 for Cry1F insect-resistant, glufosinate tolerant maize line containing transformation event 1507. Extensive safety evaluation of B.t. Cry 1F maize line 1507 in terms of genetic stability, agronomic characteristics, food compositional analysis, and potential toxicity and allergenicity was undertaken by the concerned agencies of the Department of Agriculture (DA): [Bureau of Animal Industry (BAI), and Bureau of Agriculture, Fisheries and Product Standards (BAFPS)] and a Scientific Technical Review Panel (STRP) following the DA AO8 guidelines for the release of genetically modified organisms. The Public Information Sheet (PIS) of the said application was published in two widely circulated newspapers for public comments/review. BPI received no comment on the petition during the 30-day comment period. 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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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