Food safety and quality
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OECD Unique Identifier details

MON-ØØØ21-9
Commodity: Corn / Maize
Traits: Glyphosate tolerance
Australia
Name of product applicant: Monsanto Australia Pty Ltd
Summary of application:
Monsanto Australia Ltd have submitted an application to ANZFA to vary Standard
A18 of the Australian Food Standards Code to include food products derived from
glyphosate-tolerant corn, known commercially as Roundup Ready® (RR) corn.
Glyphosate is the active ingredient of the herbicide Roundup® which is used widely as
a non-selective agent for controlling weeds in primary crops. The mode of action of
glyphosate is to specifically bind to and block the activity of
5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), an essential enzyme involved
in the biosynthesis of aromatic amino acids in all plants, bacteria and fungi.
Biochemical studies on the EPSPS enzyme from a variety of different species have
shown that a natural variation in glyphosate binding affinity exists, particularly across
bacterial species. Further studies on bacterial and plant EPSPS enzymes demonstrated that sequence changes at the active site of the enzyme, a highly conserved region across species, could alter substrate and inhibitor binding properties. Tolerance to glyphosate in plants can therefore be achieved by introducing a version of the EPSPS gene producing a protein with a reduced binding affinity for glyphosate, thus allowing the plant to function normally in the presence ofthe herbicide.
The RR corn described in this application is glyphosate-tolerant corn line GA21. In
this line, the glyphosate-tolerant trait is generated in the plants through specific
changes to the corn (Zea mays) gene which results in the production of a modified
EPSPS enzyme, the so-called mEPSPS protein. The modification produces an enzyme
which is less sensitive to glyphosate, compared with the unmodified corn enzyme, and
thus imparts glyphosate tolerance to the whole plant. The mEPSPS protein exhibits
more than 99.3% amino acid homology with the conventional corn EPSPS protein.
Corn is used in the manufacture of breakfast cereals, baking products, extruded
confectionery and corn chips. Corn starch is used by the food industry for the
manufacture of dessert mixes and canned foods.
Approximately 30% of the corn grown in Australia is manufactured into foods for
human consumption, with the remainder used as stockfeed or exported. A small
proportion (400 tonne in 1995/96) of corn products is imported in the form of highfructose corn syrup, according to market demand. In New Zealand also, crop planting regimes are variable. Due to the diverse uses of corn products, there is a requirement to import corn products, mainly in the form of high-fructose corn syrup, to meet manufacturing demand. The RR trait has not been introduced into sweet corn or popcorn varieties.
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Date of authorization: 07/12/2000
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 A362 - Food derived from glyphosate-tolerant corn GA21
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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: Syngenta do Brasil Ltda
Summary of application:
commercial release of genetically modified glyphosate tolerant corn (GA21 Corn, Event GA21)
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Date of authorization: 21/02/2006
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Center for Environmental Risk Assessment
Summary of the safety assessment:
Event GA21 was produced through microprojectile bombarding with a suspension of culture cells, using plasmid pDPG434, derived from vector pSK, which is commonly used in molecular biology and is in turn derived from pUC19. Elements for insertion in the gene are contained within NotI restriction fragment, containing the expression cassette used to generate event GA21. GA21 corn contains the rice actin 1 gene that acts as promoter; mepsps gene (modified corn epsps gene) that codifies the mEPSPS protein and grants tolerance to glyphosate herbicide; nos gene, responsible for transcription termination; and OTP sequences, responsible for digesting the mEPSPS protein to chloroplast. The genic construct used to insert the mepsps gene in corn resulted from stable insertion of a functional copy of such gene, which granted plants tolerance to the glyphosate herbicide. The mEPSPS enzyme amino acid sequence expressed in GA21 corn is 99.3% identical to the conventional corn endogenous enzyme sequence , which is expressed in a concentration significantly lower than mEPSPS protein of GA21 event. Quantifiable concentration of mEPSPS protein has been detected in most part of tissues of plants derived from GA21. No sequence introduced in event GA21 or of its donors is known to be pathogenic to humans or animals. EPSPS proteins are ubiquitous in nature and are naturally present in food derived from plant and microbial sources, included in the everyday diet of humans and animals. Bromatology tests and procedures for quantification of corn kernel different nutritional components have been conducted. The analyses suggest that the level of measured components have not changed beyond corn natural variation. No consistent pattern emerged suggesting that biologically significant changes in composition or nutritive value of the kernel or forage took place following the transformation or expression of the mepsps transgene. Analysis of amino acids inserted in mEPSPS enzyme reveals no homology with toxic proteins for mammals and toxic potential for humans is not expected. Absence of toxicity was also verified in studies with animals using high doses of purified protein. The mEPSPS enzyme expressed in corn with the GA21 event has no typical characteristics of known allergens. There is no homology regions when the introduced sequence is compared with sequences of known allergens. The data submitted indicate an extremely low likelihood that the intact protein may be absorbed through the intestine mucosa during consumption and establish immunochemical affinity to antibodies, including IgE antibodies, primarily responsible for allergic reactions. In addition, mEPSPS enzyme is promptly degraded by acid and enzymatic hydrolysis when exposed to fluids similar to gastric and intestinal fluids. According to data on nutritional and compositional equivalence of GA21 corn with its conventional isogenic version, no GA21 corn metabolite has potential to concentrate in the food chain, in addition to what may be expected from the widely cultivated conventional corn. In Brazil, there are no kindred species of corn distributed in nature. However, genic flow for local open pollination varieties is possible, however this flow is as risky as the one caused by commercial genotypes available in the market. Coexistence of cultivars is possible between conventional corn (improved or local varieties) and transgenic from the agronomic viewpoint. The likelihood of a transgenic plant changing into a weed, as well as of originating a weed by crossing GA21 corn with other corn plants is negligible, due to the biologic characteristics of the species and the fact that corn does not survive well without human intervention. Therefore, it is expected that GA21 corn has an environmental behavior similar to that of common corn. The likelihood that a mepsps gene of a transgenic plant migrates to other organisms is practically inexistent. The epsps gene is common to plants, fungi and microorganisms, is abundant in nature, and is not a significant risk for soil microbiota. Besides, there is evidence that plant genes have sometimes been transferred to bacteria in natural conditions. Glyphosate is registered with the Ministry of Agriculture and Supply – MAPA, Ministry of Environment – MMA and a monograph on glyphosate is approved by the National Sanitary Surveillance Agency – ANVISA. The use of the glyphosate herbicide in GA21 crops shall comply with applicable rules, such as Law no. 7,802, of July 11, 1989 (Agricultural Defensives Act). CTNBio reached a conclusion that cultivation and consumption of GA21 corn are not potential causes of significant degradation to the environment and do not risk human and animal health. For these reasons, there are not restrictions to the use of this corn and derivatives, except in locations mentioned by Law no. 11,460, of March 21, 2007. Coexistence between cultivars of conventional corn (improved or local varieties) and transgenic corn is possible from the agronomic viewpoint and shall comply with the provisions of CTNBio Ruling Resolution no. 4. The applicant shall conduct a post-commercial release monitoring plan under CTNBio Ruling Resolution no. 3 and shall have a term of thirty (30) days from the date of publication of this Technical Opinion to adequate its proposed post-commercial release monitoring plan, according to Annex 1 of CTNBio Ruling Resolution no. 5, of March 12, 2008. Under Article 14 of Law no. 11,105/2005, CTNBio holds that the request complies with applicable rules and legislation aimed at securing the biosafety of the environment, agriculture and human and animal health. CTNBio TECHNICAL OPINION I. GMO Identification GMO name: GA21 corn, Event GA21. Applicant: Syngenta Seeds Ltda. Species: Zea mays – Corn Inserted characteristics: Tolerance to glyphosate herbicide Method of insertion: Particle bombarding (biobalistics) Prospective use: Production of fodder and kernels for human and animal consumption of the GMO and its derivatives. II. General Information Zea mays L., corn, is a species of the Maydae tribe, included in subfamily Panicoidae, family Graminea (Poacea). Genera belonging to the Maydae tribe include Zea and Tripsacum in the Western Hemisphere. Corn is a separate species within the Zea subgenus, with a chromosome number 2n = 20,21,22,24(16). Corn is a cereal essentially of American origin, the continent where its closest wild relatives, teosinte and Tripsacum(31), may be found. One assumes that the specific region of corn birth is Mexico and that it originates from teosinte, Z. mays Mexicana (Schrader) Itis, over eight thousand years ago. Teosinte may be found in Mexico and some locations of Central America, where it may cross with cultivated corn in production fields. Cultivated corn may also cross with a most distant genus, the Tripsacum. This crossing seldom happens and results in a male-sterile progeny. Maize is an annual plant, high and robust. It is one of the most efficient plants in converting solar energy into food and is the raw-material of several products, being one of the most important food sources in the world. Over the past eight hundred years, cultivated corn gained several valuable agronomic characteristics, at the cost of losing the ability to survive in nature. Out of all cultivated plants, corn is probably the one possessing the largest genetic variability. Today, about three hundred races of corn are identified and, within each such race, there are thousands of cultivars. Corn is currently the cultivated species that reached the highest degree of domestication and it may only survive in nature when raised by man(6). Normally, the maintenance of this genetic variability has been achieved through individualized storage, in germplasm banks, under controlled humidity and temperature. There are several germplasm banks, in Brazil and all over the world. Embrapa, the Brazilian Agricultural Research Agency, has two germplasm banks, one at Embrapa Recursos Genéticos e Biotecnologia, Embrapa Genetic Resources and Biotechnology, in Brasília, Federal District, Brazil, and another at Embrapa Milho e Sorgo, Embrapa Maize and Sorghum, in Sete Lagoas, Brazil. Corn is farmed in over 100 countries, with a total estimated production of 705 million tons per year. Brazil is the world third largest corn producer, with an output of about 35 million tons in 2005, behind the United States of America (282 million tons) and China (139 million tons)(18). In Brazil, corn is planted basically in two different crops (summer and safrinha, or small crop) and cultivated in practically all the domestic territory, with 92% concentrated in the Southern Region (47% of production), Southeastern Region (21% of production) and Center Western Region (24% of production)(9). Corn is one of the most efficient plants in converting solar energy in food and is used as raw material for several products. The increase in corn consumption exceeded 100 million tons between 1993 and 2001, representing an average yearly increase of 11.1 million tons per year. A large part of this increased production was due to genetic improvement, leading to ears containing about 1,000 seed-corns. Increased corn production and consumption all over the world is associated to its multiple uses, population growth, changes in feeding habits, and growth in the number of farmed swine and poultry. Weeds are among the main corn culture problems in Brazil. There are some alternatives for controlling weed and treatment with herbicides is the most used method. Brazil is the world’s third largest consumer of pesticides. The country has currently over 140 pesticides registered for corn and the use of agricultural defensives is one of the important factors affecting farmers’ health in Brazil, where it is responsible for intoxication of one million individuals each year(2). In this environment, the use of corn cultivars containing event GA21 would be one extra alternative to turn. Development of GA21 represents one option to control weeds that compete negatively with corn production. GA21 was obtained by transforming a culture of corn lineage through microprojetile bombardment (biobalistics) and expressed as a corn 5-Enolpiruvylshikimate-3-Phosphate double mutated synthase protein (mEPSPS), which grants tolerance to glyphosate herbicide. GA21 corn is already commercial released for cultivation in Argentina (1998), Canada (1998), Japan (1998) and USA (1997). It is used in human and animal food in Australia (2000), Canada (1998), European Union (2005), Japan (1999), Korea (since 2002), China (2004), Argentine (2005), Mexico (2002), Philippines (2003), South Africa (2002), Taiwan (2003) and USA (1996) (1). III. Description of the GMO and Proteins Expressed Corn plants of event GA21 express the mutated double corn 5-Enolpyryvilshikimate-3-phosphate synthase protein (mEPSPS). The enzyme belongs to the shikimic acid metabolic pathway, involved in the biosynthesis of aromatic amino acids (phenylanine, tryptophan and tyrosine), present in plants, fungi and bacteria, yet absent in animals (Figure 1). Figure 1 – Shikimic acid pathway Event GA21 was produced through microprojectile bombardment of a suspension of culture cells(23), using plasmid pDPG434, derived from vector pSK, which is commonly used in molecular biology and is derived from pUC19. Elements for the insertion of the gene of interest are within the restriction fragment NotI, containing the expression cassette used for generating event GA21: (a) Actin 1: Region 5’ of rice (Oryza sativa) actin 1 gene containing the promoter, the first exon and intron(27); (b) OTP: N-terminal sequences of chloroplast transit peptide (CTP) based on CTP sequences of sunflower Helianthus annus) and corn (Z. mays), present to drive the mEPSPS protein to the chloroplast(24); (c) mepsps: sequence coding the corn (Z. mays) mEPSPS modified protein, granting tolerance to glyphosate(25); (d) nos: region 3’ not translated of T-DNA Agrobacterium tumefaciens nopaline synthase gene, which terminates transcription and guides mRNA polyadenylation(10). The epsps genes are ubiquitous in nature. Mutant gene epsps (mepsps) results from two changes in corn epsps gene and were introduced to alter two specific amino acids of the wild epsps protein. The mutations are in the location of the 102 (from threonine to isoleucine) and 106 (from proline to serine) amino acids. Transformed corn plants with gene mepsps synthesize the mEPSPS protein that grants tolerance to herbicide products containing glyphosate. The result of the Chi-Square Test (X2>3.84 for all generations) accepts the hypothesis that the glyphosate tolerance characteristics behaves in a Mendelian way and segregates at rate of 1:1. The number of transgenic loci in the insertion of event GA21 was examined by Southern blot, using digestion with EcoRV and hybridization with two probes generated by PCR that represent the functional elements contained in the NotI transformation segment of pDPG434. The analysis showed that the whole of the GA21 insertion is in one single locus and is contained in a hybridization band of 20.5 kb. Southern blot hybridization analysis data on three generations of event GA21 showed that the insertion of the event is inherited in a stable way in all generations of plants derived from the event. The amino acid sequence of mEPSPS enzyme expressed in GA21 Corn is 99.3% identical to the sequence of the conventional corn endogenous enzyme. The EPSPS endogenous protein is expressed in a significantly lower concentration than the GA21 mEPSPS protein. Quantifiable concentrations of the mEPSPS protein were found in most tissues of plants derived from event GA21. In all growth phases of event GA21 hybrids, average concentrations of mEPSPS measured in leaves ranged from about 0.2 ƒÝg/g of fresh weight to 15 ƒÝg/g of fresh weight (<0.3 to 7.0 ƒÝg/g of dry weight); in roots, average concentrations ranged from about 2 ƒÝg/g to 15 ƒÝg/g of fresh weight (<14 to 44 ƒÝg/g of dry weight); and in the whole plant, ranged from about 3 ƒÝg/g to 15 ƒÝg/g of fresh weight (8 to 68 ƒÝg/g of dry weight). Average concentrations measured in kernels in seed maturity and senescence ranged from about 4 to 7 ƒÝg/g of fresh weight (5 to 10 ƒÝg/g of dry weight). Concentration of the mEPSPS protein overnight in the air exhibited an average of about 16 ƒÝg/g of fresh weight on the two GA21 event hybrids. mEPSPS concentrations in corn chips and corn oil samples were below detection limits. IV. Aspects Related to Human and Animal Health The arrangement proposed to estimate risk in whole food, either conventional or genetically modified, is different from the one classically conducted for well chemically characterized products, with a defined purity, with no relevant nutritional value and to which humans are exposed in low doses, as food additives, drugs, cosmetics and chemical substances of industrial use. Whole foods, however, are complex chemical mixtures, each of them subject to changes along time in its composition and nutritional value, which limits their use in toxicological essays with experimentation animals, as they are validated. The difficulty in performing traditional toxicological tests with whole foods, including GMO, led to an alternative proposal for assessing its food safety based on comparative analysis between a certain product and its similar, with an acceptable record of safe consumption. The idea behind this approach coincides with the concept of substantial equivalence, considered the most practical way of treating safety in foods and food components produced by biotechnology. This approach, formulated by FAO/WHO during the 1990s, was used by reference institutions, such as OECD(30), Codex Alimentarius(17), the North-American FDA(43), the European Food Safety Agency(12), and the American Society of Toxicology(33). In the substantial equivalence approach, an GMO is compared to its closest natural similar to identify intentional and non-intentional differences, taking into consideration: identity, source, transformation process, composition, effects of processing, characteristics of recombinant DNA (stability of insert; potential genic transfer); toxic, allergenic and other potential effects of the protein expressed by the transfene; and possible side effects of the new gene expression (interruption of metabolic pathways, interference with macro- and micronutrients). Validation of substantial equivalence is an important phase, yet it shall not be misinterpreted as assessment of food risk itself. In case there are any likelihood or risk, be it toxic or nutritional, the assessment shall proceed to attempt and establish its nature and severity, including the possible conduction of in vivo toxicological tests. The requirement of such tests for assessing the safety of the GMO or its derivatives shall be decided on a case-by-case basis. Especially in the case of new proteins, tests shall be performed when: (1) there is no detailed record of previous safe consumption of the GMO and its products, by humans or by animals raised for food; (2) available information on its safety is perceived as insufficient; (3) its biochemical and functional characterization was deemed insufficient: molecular weight, amino acid sequence, homology with proteins that cause adverse effects, subsidiary enzymes, stability during processing and storage, resistance to digestion, products from breaking, among others; (4) there is a possible interference of the new protein with metabolic and functional pathways or relevant structures; (5) there is the possibility that the transgenicity may trigger unexpected genetic changes in the transgenic plant (silencing or overexpression of endogenous genes); (6) the substantial equivalence analysis indicates dissimilarity with the original product with which the GMO was compared. Naturally, toxicity essays of the GMO with experimentation animals (repeated exposure, 28 or 90 days), implies appropriate strategies to harmonize the offer of test-materials to animals (form of presentation, dose levels, etc.). When the transgenic product is a modified protein, it may be isolated from the GMO itself or synthesized by microorganisms and offered to test-animals in this isolated form. In this latter case, the isolated protein shall keep biochemical and functional correspondence with the protein of the transgenic product. In very special situations, the test may be conducted with the whole food that, in this case shall be supplied in the same form and at least in the amount consumed by humans. Safety assessment of foods derived from genetically modified raw materials is based on risk analysis, a scientific methodology comprising the phases of assessment, risk management and risk communication. In the risk assessment phase, a quantitative and qualitative characterization is pursued of potential adverse effects, guided by the substantial equivalence standard, in order to identify any differences between the new food and its corresponding conventional food. In order to assess safety of a genetically modified alimentary raw material or its equivalence to the conventional food, it is recommended that four mail elements are analyzed in some depth: (1) parental variety, that is to say, the plant that originated the new genetically modified raw material; (2) transformation process, including full description of the construct used and resulting event; (3) product of the inserted gene and potential toxicity and allergenicity; and (4) composition of the new variety resulting from genetic transformation. The set of data of such analyses shall enable an identification and description of potential adverse effects associated to consumption of the new raw material, to be used as basis for the phases of risk management and communication. Z. mays is a well characterized species, with a solid record of safety for human consumption. In the proceedings, information comprising origin, domestication, taxonomy, reproduction and changes in its composition are mentioned(45), reflecting the high degree of knowledge about this species. Corn is used basically as a component of food by peoples through the whole world, and is one of the most important grains used in the production of animal food for being one of the most concentrated forms of energy, containing more energy able to be metabolized – or digestive nutrients – than any other grain. Corn plants and kernels are not considered toxic for humans, domestic animals or wild species. The cereal is at the base of nutrition for large groups of people in Latin America, Asia and Africa. In the United States and Japan, corn is generally used as food for animals. Corn is palatable, readily digested by humans and monogastric and ruminant animals and has a safe record of use as a human and animal food. GA21 corn was obtained by bombarding the plant material with particles covered with the genetic material of interest. Since this is a physical process of transference of DNA molecules, without intermediation of any biological agent and is performed in aseptic conditions, the likelihood that DNA molecules that are not in the genic construct present in the particles are transferred to the plant cells is practically negligible. No sequence induced in GA21 event or its donors are known as pathogenic for humans. EPSPS proteins are ubiquitous in nature and are naturally present in food derived from plant and microbial sources present in the normal diet of humans and animals(5, 13, 20). Chemical composition analysis of the variety obtained by genetic modification, mainly at the levels of its nutrients and any toxic components that may be present, aims at securing that this new variety is as safe and nutritive as its conventional equivalent. Therefore, the analysis verifies that the intentional effects of the modification did not affect negatively its security nor resulted in unintended effects. Presence and levels of natural constituents in human animal food were analyzed and compared with genetically unchanged contour lines and data from the literature(22). Bromatologic analyses and quantification of different nutritional components of corn kernels, such as carbohydrates, proteins, humidity, fat, ashes, starch, fibers, minerals, vitamins, amino acids, fatty acids, secondary metabolites and anti-nutrients(35). The analyses suggested that the measured levels of components have not changed more than the natural variation found in corn. No consistent pattern emerged that suggested significant biological changes in composition or nutritional value of the kernel or forage took place as a result of the transformation or expression of the mepsps transgene. The data corroborate the studies of Grant and his collaborators(19) who concluded that the use of corn for silage or kernel does not change the nutritional value of the food. Erickson et al.(14) verified the lack of change in nutritional value in cattle feeding. Similarly, studies carried out with birds in specific GMO diets did not reveal changes(42). As mentioned above, the mEPSPS enzyme amino acid sequence expressed in GA21 corn is identical to the conventional corn endogenous sequence. Analysis of amino acids inserted in mEPSPS enzyme fails to display homology with proteins toxic for mammas and it is not deemed to have any potential toxic for humans. Absence of toxicity was also verified in studies with animals using high doses of purified protein. Studies lasting 90 days in rodents did not indicate any change in the animals with doses up to 400mg/kg of CP4 EPSPS derived from Eschericha Coli. The protein is degraded in less than 15 seconds in the presence of pepsin and in 10 minutes in the presence of trypsin. Susceptibility of the mEPSPS protein to proteolytic degradation was assessed in simulated mammal gastric fluid containing pepsin. Protein mEPSPS obtained from E. coli and corn was rapidly degraded, and was not detected intact in a sample of reaction mixture in the first sampling interval (one minute). No immune-reactive fragment of mEPSPS could be detected after incubation for five minutes in mammal simulated gastric fluid(37). These data corroborate the EFSA(11) understanding, maintaining that there are no toxicity or allergenicity changes foreseeable by bioinformatics in studies of in vitro digestibility and in in vivo experimental studies. Toxicity of mEPSPS protein (83%p.p. pure) was assessed by forced oral intake in a single dose of 2,000mg/kg of body weight to CD-1 mice of both sexes. The dose was selected for it represents the borderline dose for this type of study. After fifteen days, the animals were sacrificed and submitted to full necropsy. There was no evidence of effects on food ingestion, body weight and weight gain, hematologic profile and histology of all organs that might be associated to exposure to GA21 corn. Some alterations recorded in serum biochemical tests were deemed inconsistent and not associated to exposure to transgenic corn(39). In another study, ALpk:APf SD male and female rats received GA21 corn in concentrations of 10% or 45% in their food. Selection of corn offer levels was made assuming that the lowest concentration (10%) represents a level “at least equivalent to the human chronic dietary intake of corn (3mg/kg/day”. The highest level (41.5%) was selected as “the highest attainable level without causing nutritional imbalance to animals.”(40). The control used was a corn negative for event GA21, supplied in the same concentrations. Experimental food was offered for ninety days, and at the end the animals were sacrificed and submitted to full necropsy. There was no evidence of effects in weight and body gain, food consumption, clinical condition and functional performance during the study, hematologic profile, organ weight and histology, as well as no records of changes to ophthalmoscopy and serum biochemistry of animals exposed to GA21 corn(40). In this context of GA21 toxic effect absence in both studies, it is important to emphasize that there was no record of homology in the amino acid sequence of corn 5-Enolpiruvylshikimate-3-Phosphate double mutated synthase protein (mEPSPS) with any other proteins already identified as toxic(36). The result corroborates the European Food Safety Authority (EFSA) conclusions(13) that the results of the studies fail to indicate occurrence of adverse effects in GA21 corn consumption. The mEPSPS enzyme expressed in event GA21 corn does not have the typical features of known allergenic substances, since the behavior of allergenic proteins in the digestive tract is well described(4, 7, 21). There are no homology regions when the introduced sequence is compared with sequences of known allergens. Besides, many food allergens are known for being stable when submitted to heat. Data collected evidenced that incubation for thirty days at 65ºC or 95ºC deactivated the mEPSPS specific enzymatic activity(38), indicating a extremely low likelihood that the whole protein might be absorbed through the bowel mucosa during consumption and establish immunochemical affinity for antibodies, including IgE antibodies, primarily responsible for allergic reactions(34). In addition, available data in the literature(44) indicate normal digestibility for transgenic corn varieties released for human consumption. Indeed, the mEPSPS enzyme is rapidly degraded by acid and enzymatic hydrolysis when exposed to fluids that are similar to gastric or intestinal fluids. For the foregoing, the likelihood of mEPSPS protein to interfere in metabolic or functional pathways or in relevant structures is negligible, in view of the plant morphology, its agronomic performance, biochemical composition, nutritive content and digestibility. Therefore, it is not foreseen that transgenic modification could cause unexpected genetic changes in the plant (silencing or overexpression of endogenous genes) and, in case such changes do occur, they will not imply adverse effects. According to data on GA21 corn nutritional and compositional equivalence as regards its isogenic conventional, no GA21 corn metabolite has potential to concentrate in the food chain, in addition of that already expected for the widely cultivated conventional corn. Studies on acute oral toxicity in mice conducted with mEPSPS protein indicated that the mEPSPS protein failed to have any acute toxic effect on the animals at the highest tested dose. No mortality associated to the test substance took place during the study and no clinic signal attributable to the test substance was observed(39). Besides, GA21 corn was already released for human and animal consumption in the United States, Japan, Canada, Argentina, Mexico, South Africa, Australia, New Zealand, Philippines, Thailand and China, and in some of these countries for over ten years, displaying a safe history of consumption without adverse effects scientifically proven(1). For the foregoing, one reaches a conclusion that there are not indications that consumption of GA21 corn or products derived from this event pose any risk to life and health of animals or humans, being as safe as the conventional corns commercialized in Brazil, and that the likelihood that it may harm human and animal health is negligible. V. Environmental aspects Corn is a monoic plant: a single individual contains male and female flowers located separately. Corn plants are crossed fecundation plants and largely pollinated with the help of wind, insects, gravity and others. The introduction of genic elements described above failed to change the reproductive characteristics of the plant. Therefore, the same likelihood of crossed fecundation existing between hybrids and lineages of conventional corn – non-genetically modified – will occur between event GA21 and other corn plants. Genic flow of corn may occur through transfer of pollen and dispersion of seeds. Dispersion of seeds is easily controlled, since domestication of corn eliminated the ancestor mechanisms of seed dispersion and pollen movement is the only effective means for genes escaping from corn plants. Corn is an annual and allogamous plant, predominantly pollinated by wind, and distances covered by pollen depend on the wind pattern, humidity and temperature. Corn pollen disperses freely near the area cultivated with this grass, and may reach the stigmas of the same or different genotypes and, under adequate conditions, starts its germination, originating the pollen tube that promotes fecundation of the ovule within an average period of 24 hours. Studies on corn pollen dispersion have been conducted, and some of them show that corn pollen may travel long distances. However, most of the pollen released is deposited near the culture, with a very low translocation rate to outside the source culture: over 95% of the pollen reaches distances within 60m from its source(32). The predominant pollinating agent in corn is the wind, and the distance that viable pollen may cover depends on wind patterns, humidity and temperature. Luna et. al.(26) assessed the isolation distance and control of pollen, and showed that crossed pollination took place within a maximum distance of 200 m and that no crossed pollination occurred in distances exceeding 300 m from the pollen sources, in conditions of absence of detasseling. The results indicate that pollen viability is maintained for two hours and that crossed pollination was not observed in distances exceeding 300m from the pollen source. Comparing concentrations at 1 m from the source culture with winds ranging from low to moderate, one estimates that about 2% of pollen are recorded at 60m, 1.1% at 200m and 0.75-0.5% at 500m from the source. Ten meters away from a field, the average number of pollen grains by unit of area is ten times less that the figure recorded at 1m from the border. Therefore, if the established distances of separation developed for corn seed production are observed, one expects that the transfer of pollen to adjacent varieties is minimized, being unlikely the presence of glyphosate tolerant genetic material. In Brazil there are not kindred corn species in natural distribution. However, the genic flow to local varieties of open pollination is possible, but poses the same risk as commercial genotypes available in the market. In the specific case of crossing between GA21 corn and local (creole) varieties there is no expected selective pressure from management by small farmers: the transgene shall not be incorporated to the genome of creole varieties because, in practice, the small farmer does not use herbicides. From the agronomic viewpoint, coexistence between conventional (improved or creole) corn and transgenic(8,28) cultivars is possible. Old communities and modern farmers have been able to easily live together with different corn cultivars, while keeping their genetic identities across time. The likelihood of a transgenic plant to change into a weed species, as well as the likelihood of a GA21 corn crossing with other corn plants and originate a weed is negligible, in view of the biologic characteristics of the species and the fact that corn does not survive well without human intervention, a result of a selection made along the plant evolution. Corn is the species reaching the highest degree of domestication among cultivated plants and lost its natural surviving characteristics as, for instance, the elimination of shucking. Therefore, corn is a plant unable to survive in natural conditions, without technical assistance. In this context, one expects the GA21 corn to display an environmental behavior similar to ordinary corn being therefore negligible the likelihood of changing into an invading plant or weed. The likelihood of the transgenic plant mepsps gene to pass to other organisms as, for instance, soil microorganisms is practically null(29,41). The epsps gene is common to plants, fungi and microorganisms, its occurrence is abundant in nature, and does not result in significant risk to the soil microbiota. In addition, there are is no evidence that plant genes have ever been transferred to bacteria under natural conditions. Glyphosate is an organic compound that does not affect the nervous system and is highly efficient in eliminating weeds, besides being held as little toxic (toxicological class IV). It is a large spectrum, non selective, herbicide that kills plants by inhibiting the 5-Enol-pyruvylshikimate-3-phosphate (EPSPS) synthase enzyme, important in the biosynthesis of aromatic amino acids. Glyphosate is registered with the Brazilian Ministry of Agriculture and Supply (MAPA), Ministry of the Environment (MMA) and has a monograph approved by the National Sanitary Surveillance Agency (ANVISA)(3). Use of the glyphosate herbicide in crops of GA21 corn shall observe the applicable rules as, for instance, Law no. 7,802, of July 11, 1989 (Pesticide Act). VI. Restrictions on the use of the GMO and its derivatives As established by Article 11 of Law no. 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” Studies submitted by applicant demonstrated that there is no significant difference between hybrids of corn derived from unmodified lineages and GA21 corn regarding agronomic characteristics, reproduction methods, dissemination and ability to survive. All evidence submitted in the proceedings and bibliographic references confirm the transgenic variety level of risk as equivalent to non transgenic ones regarding soil microflora, as well as other plants and human and animal health. Therefore, cultivation and consumption of GA21 corn are not potentially a source of significant degradation to the environment or of risks to human and animal health. For the above reasons, there is no restrictions to the use of such corn or its derivatives, except in places as mentioned by Law no. 11,460, of March 21, 2007. Vertical genic flow for local varieties (the so called creole corn) of open pollination is possible and poses the same risk caused by commercial genotypes available in the market (80% of conventional corn cultivated in Brazil comes from commercial seeds that have been genetically improved). Coexistence of conventional corn cultivars (either improved or creole) and transgenic corn cultivars is possible from the agronomic viewpoint(8,28) and shall comply with the provisions of CTNBio Regulating Resolution no. 4. After ten years of use in different countries, no problem has been detected for human or animal health or the environment that may be attributable to transgenic corns. It shall be emphasized that the lack of negative effects in cultivating transgenic corn plants is not a guaranty that such effects cannot occur. Zero risk and absolute safety do not exist in the biology world and, although there is a host of trustworthy scientific information and a safe history of use of ten years that enable us to affirm that GA21 corn is as safe as the conventional versions. Therefore, applicant shall conduct post-commercial release monitoring according to CTNBio Regulating Resolution no. 3. VII. Consideration on the particulars of different regions of the Country (Information to supervisory agencies) In Brazil, there are no kindred species of corn in natural distribution. VIII. Conclusion Considering that the corn (Zea mays) GA21 belongs to a well characterized species with a solid background of safety for human consumption and that the mepsps gene introduced in this variety codifies a protein that is ubiquitous in nature, present in plants, fungi and microorganisms participating in the alimentary diet of humans and animals. Considering that the genic construct used to insert the gene in corn resulted from the stable insertion of a functional copy of mepsps, which granted tolerance to the glyphosate herbicide. Considering that centesimal composition data failed to identify significant differences between the genetically modified and conventional varieties, suggesting nutritional equivalence between them. Considering, in addition, that: 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. The mEPSPS protein was detected in low levels in tissues analyzed and displayed great susceptibility to digestion in simulated gastric fluids, lacking acute toxicity in mammals and similarity with known allergens. 4. The genetic modification introduced in GA21 event did not result in important differences of chemical composition regarding nutrients, which are within the normal variation range found between conventional varieties. 5 The DNA molecule is a natural food component and there is no evidence that this molecule may have adverse effect to humans when ingested in food in acceptable amounts (no direct toxic effect). 6. There is no evidence that intact plant genes may be transferred and functionally integrated to the genome of human or other mammals exposed to this DNA or to food produced with such elements(15). 7. The applicant answered all questions stipulated by CTNBio Regulatory Instruction no. 20 and that no topic indicated that this corn may have adverse effect in human and animal food. 8. The likelihood of a transgenic plant to change into a weed species, as well as the crossing of GA21 corn with other corn plants originating a pest is negligible. 9. The mEPSPS protein is common to plants, fungi and microorganisms and the exposure of living organisms and the environment to this protein is an event that occurs abundantly in nature without resulting significant risk to soil microbiota. 10. The coexistence between cultivars of conventional corn (either cultivated or creole) and transgenic corn cultivars is possible from the agronomic viewpoint, under the provisions of CTNBio Regulatory Resolution no. 4. 11. Annex III of the Cartagena Protocol on Biosafety (Decree no. 5,705, of February 16, 2006) provides that risks associated to modified living organisms or to products derived therefrom, to wit, improved materials originated from a modified living organism containing new detectable combinations of replicable genetic material obtained by modern biotechnology shall be considered in the context of the risks posed by the unmodified receptors in kindred organisms in the probable receiving environment. 12. The worldwide use history of this transgenic variety points out to a host of trustworthy scientific information indicating that the variety is as safe to the environment and human and animal heath as the hybrid corn varieties that have been used. 13. After ten years of use in different countries, no problem was detected to human and animal health or the environment that may be attributable to transgenic corns. For the foregoing and considering the internationally accepted criteria in the process of analyzing the risk of genetically modified raw materials, one may reach a conclusion that GA21 corn is as safe as its conventional equivalent. CTNBio considers that the activity is not potentially a cause of significant degradation to the environment or aggravation to human and animal health. Use restrictions of the relevant GMO and its derivatives are determined by the provisions of Law no. 11,460, of March 21, 2007, CTNBio Regulating Resolution no. 03 and CTNBio Regulating Resolution no. 04. CTNBio analysis took into consideration opinions issued by the Commission members; ad hoc consultants; documents forwarded by applicant to the CTNBio Executive Secretariat; results of planned releases to the environment; lectures, texts and discussions of the public hearing held on 03.23.2007. Third party independent scientific studies and publications submitted by applicant were also taken into consideration and consulted. Under Annex I of Regulating Resolution no. 05, of March 12, 2008, applicant shall have a term of thirty (30) days from publication of this Technical Opinion to adapt its proposed post commercial release monitoring plan. IX. Mentioned bibliography 1. AGBIOS. 2008.Database product description: Information on GM Approved Products: GA21. http://www.agbios.com/dbase.php?action=Submit&evidx=1. 2. 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 to 07.20.2001 3. ANVISA. 2008. http://wsww.anvisa.gov.br/toxicologia/monografias/g01.pdf. 4. ASTWOOD, J.; LEACH, J.N.; FUCHS, R.L. 1996. Stability of food allergens to digestion in vitro. Nat. Biotech. 14: 1269-1273. 5. AUSTRALIA NEW ZEALAND FOOD AUTHORITY. 2001. Food derived from glyphosate-tolerant line corn GA21: a safety assessment. Technical Report Series nº 7, 25pp. 6. 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 dos recursos genéticos. Brasília: Paralelo 15, 167-172. 7. BANNON, G.A.; COCKRELL, G.; CONNAUGHTOH, C.; WEST, C.M.; HELM, R.; STANLEY, J.S.; KING, N.; RABJOHN, P.; SAMPSON, H.A.; BURKS, A.W. 2001. Engineering, characterization and in vitro efficiency of the major peanuts allergens for use in immunotherapy. Int. Arch. Allergy Immonol. 1241-3) 70-72. 8. BROOKES, G.; BARFOOT, P.; MELÉ, E.; MESSEGUER, J.; BÉNÉTRIX, F.; BLOC, D.; FOUEILLASAR, S.; FABIÉ, A.; POEYDOMENGE, C. 2004. Genetically modified maize: pollen movement and crop coexistence. Dorchester, UK: PG Economics, 20 pp. (www.pgeconomics.co.uk/pdf/Maizepollennov2004final.pdf) 9. CONAB. Milho total (1ª e 2ª safra) Brasil – Série histórica de area plantada: safra 1976-1977 a 2006-2007. http://www.conab.gov.br/conabweb/download/safra/MIlhoTotalSeriehist.xls 10. DEPICKER, A.; SATCHEL, S.; DHAESE, P.; ZAMBRISKY, P.; GOODMAN, H.M. 1982. Nopaline synthase: transcript mapping and DNA sequence. J. Mol. Appl. Gen. 1: 562-573. 11. EUROPEAN FOOD SAFETY AUTHORITY – EFSA. 2003. Opinion on the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Notification (Reference CE/ES/00/01) for the placing on the market of herbicide-tolerant genetically modified maize NK603, for import and processing, under Part C of Directive 2001/18/EC from Monsanto. The EFSA Journal 10: 1-13. 12. EUROPEAN FOOD SAFETY AUTHORITY – EFSA. 2003. Guidance document of the scientific panel on genetically modified organisms for risk assessment of genetically modified plants and derived food and feed. The EFSA Journal 99: 1-100. 13. EUROPEAN FOOD SAFETY AUTHORITY – EFSA. 2007a. Opinion of the Scientific Panel on Genetically Modified Organisms and applications (references EFSA-GMO-UK-2005-19 and EFSA-GMO-RX-GA21) for the placing on the market of glyphosate-tolerant genetically modified maize GA21, for food and feed uses, import ant processing and for renewal of the authorization of maize GA21 as existing product, both under Regulation (EC) no. 1829/2003 from Syngenta Seeds S.A.S. on behalf of Syngenta Crop Protection AG. The 1829/2003 from Syngenta Seeds S.A.S. on behalf of Syngenta Crop Protection AB. The EFSA Journal 541: 1-25. 14. ERICKSON, G.E.; ROBBINS, N.D.; SIMON, J.J.; BERGER, L.L.; KLOPFENSTEIN, T.J.; STANISIEWSKI, E.P.; HARTNELL, G.F. 2003. Effect of feeding glyphosate-tolerant (Round-up events GA21 or nk603) corn compared with reference hybrids on feedlot steer performance and carcass characteristics. J. Anim. Sci. 81: 2600-2608. 15. FAO/WHO – Food and Agriculture Organization of the United Nations / World Health Organization. 2000. Safety Aspects of Genetically Modified Foods of Plant Origin. Report of a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology, 29 May – 2 June 2000. World Health Organization, WHO Headquarters, Geneva, Switzerland. 35 pp. (http://www.who.int/foodsafety/publications/biotech/en/ecjune2000en.pdf) 16. FAO/WHO – Food and Agriculture Organization of the United Nations / World Health Organization. 2000a. Grassland Index. Zea mays L. (http://www.who.org/WAICENT/faoinfo/agricult/agp/agpc/doc/gbase/data/pf000342.htm) 17. 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, 57 pp. 18. FAO/WHO – Food and Agriculture Organization of the United Nations / World Health Organization. 2007. FAOSTAT; http://faostat.fao.org/site/34/default.aspx. 19. GRANT, R.J.; FANNING, K.C.; KLEINSCHMIT, D.; STANISIEWSKI E.P.; HARTNELL, G.F. 2003. Influence of Glyphosate-Tolerant (event nk603) and Corn Rootworm Protected (event MON863) Corn Silage and Grain on Feed Consumption and Milk Production in Holstein Cattle. J. Dairy Sci. 86: 1707-1715. 20. HEALTH CANADA. 1999. Glyphosate Tolerant Corn, GA21: novel food information -- food biotechnology. http://www.hc-sc.gc.ca/fn-an/gmf0-agm/appro/ofb-099-133-1-eng-php. 21. HILEMAN,R.D.; SILVANOVICH, A.; GOODMAN, R.E.; RICE, E.A.; HOLLESCHAK, G.; ASTWOOD, J.D.; HEFLE, S.L. 2002. Bioinformatic methods for allergenicity assessment using a comprehensive allergen database. Int. Arch. Allergy Immonol., 128, 280-291. 22. INTERNATIONAL LIFE SCIENCE INSTITUTE – ILSI. 2004. Nutritional and safety assessment of foods and feeds nutritionally improved through biotechnology. Compr. Rev. Food Sci. Saf.3:35-104. 23. KLEIN, T.M./ WOLF, E.D.; WU, R.; SANFORD, J.C. 1987. High velocity microprojectiles for delivering nucleic acids into living cells. Nature327: 70-73. 24. LEBRUN, M.; LEROUX, B.; SAILLAND, A. 1996. Chimeric gene for the transformation or plants. U.S. patent number 5,510,471. 25. LEBRUN, M.; SAILLAND, A.; FREYSSINET, G.; DEGRYSE, E. 2003. Muted 5 enolpyruvylshikimate-3-phosphate synthase, gene coding for said protein and transformed plants containing said gene. Bayer CropScience S.A. (Lyons, FR) Patent nº 6,556,587. 26. LUNA, S.V.; FIGUEROA, J.M.; BALTAZAR, M.B.; GOMEZ, L.R.; TOWNSEND, R.E.; SHOPER, J.B. 2001. Maize pollen longevity and distance isolation requirements for effective pollen control. Crop Sci. 41: 1551-1557. 27. MCLEROY, D.; ZHANG, W.; CAO, J.; WU, R. 1990. Isolation and efficient action promoter for use in rice transformation. Plant Cell2: 163-171. 28. MESSEGURE, 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 Biotechnology Journal, 4: 633-645. 29. NIELSEN, K.M.; BONES, A.M.; SMALLA, K.; VAN ELSAS, J.D. 1998. Horizontal gene transfer from transgenic plants to terrestrial bacteria – a rare event? FEMS Microbiology Reviews 22, 79-103. 30. ORGANIZATION FOR ECONOMICAL COOPERATION AND DEVELOPMENT – OECD. 2003. Considerations for the safety assessment of animal feedstuffs derived from genetically modified plants. Series on the Safety of Novel Foods and Feeds, nº 9. 46 pp. Available at: http://www.olis.oecd.org/olis/2003doc.nsf/LinkTo/NT0000426A/$FILE/JT00147696.PDF. 31. PATERNIANNI, E.; CAMPOS, M.S. 1999. Melhoramento do milho. In: BORÉM, A. (Ed.) Melhoramento de espécies cultivadas. Viçosa: UFV, p. 429-486. 32. RAYNOR, G.; OGDEN, E.C.; HAYES, J.V. 1972. Dispersion and deposition of corn pollen from experimental sources. Agron J. 64: 420-427. 33. SOCIETY OF TOXICOLOGY. 2003. The safety of genetically modified foods produced through biotechnology. Toxicol Sci 71: 2-8. 345. SYNGENTA SEEDS LTDA. Processo nº 01200.000062/2006-21 – Apêndice 3. Análise Western Blot de extratos de folhas de plantas de milho derivado do evento GA21 usando seis diferentes anticorpos policlonais anti-mEPSPS, p. 1833-1847. 35. SYNGENTA SEEDS LTDA. Processo 01200.000063/2006-21 – Apêndice 9. Análise da composição química do grão e da forragem do milho evento GA21 expressando a sintase do mutante duplo de milho 5-enopiruvinilshikimate-3-fosfato (mEPSPS). p. 2043-2014. 36. SYNGENTA SEEDS LTDA. Processo 01200.000062/2006-21 – Apêndice 11. Sintase 5-EnopiruvinilShikimate-3-Fosfato duplo mutante de milho (mEPSPS) expressa no milho geneticamente modificado evento GA21: avaliação da homologia da sequência de aminoácidos com toxinas conhecidas. p. 2123-2225. 37. SYNGENTA SEEDS LTDA. Processo 01200.000062/2006-21 – Apêndice 13. Digestibilidade in vitro da sintase 5-enolpiruvinilshikimate-3-fosfato (mEPSPS) das substâncias teste GA21-0104 e IPA21-0105 do milho duplo mutante sob condições gástricas simuladas de mamíferos. p. 2277-2295. 38. SYNGENTA SEEDS LTDA. Processo 01200.000062/2006-21 – Apêndice 14. Efeito da temperature na estabilidade da enzima dulo mutante de milho 5-enolpiruvinilshikimate-3-fosfato sintase (mEPSPS). p. 2296-2306. 39. SYNGENTA SEEDS LTDA. Processo 01200.000062/2006-21 – Apêndice 15. GA21-0104: Estudo de toxicidez por dose oral única em camundongo. p. 2309-2500. 40. SYNGENTA SEEDS LTDA. Processo 01200.000062/2006-21 – Apêndice 19. Grão de milho Evento GA21: Estudo de segurança de alimento integral em 90 dias em ratos. p. 2550-3917. 41. SIQUEIRA, J.O.; TRANNIN, I.C.B.; RAMALHO, M.A.P.; FONTES, E.M.G. 2004. Interferências no agrossistemas e riscos ambientais de culturas transgênicas tolerantes a herbicidas e protegidas contra insetos. Cadernos de Ciência e Tecnologia 21: 11-81. 42. TAYLOR, M.; HARTNELL, G.F.; RIORDAN, S.G.; NEMETH, M.A.; KARUNANANDAA, K.; GEORGE, B.; ASTWOOD, J.D. 2003. Comparison of broiler performance when fed diets containing grain from roundup ready (NK603), yieldgard x roundoup ready (MON810 x NK603), non-transgenic control, or commercial corn. Pout. Sci. 82: 443-453. 43. U.S. FOOD AND DRUG ADMINISTRATION – FDA. 2007. Toxicological principles for the safety assessment of food ingredients: Rek 2000. http://www.cfsan.fda.gov/~rek/red-toca.html. 44. WATANABE, E.; MARIN, V.A.; NUTIN, M.R. 2003. Avaliação da segurança alimentar. In: BORÉM, A.; GIUDICE, M.P.; COSTA, N.M.B. (Ed). Alimentos geneticamente modificados. Viçosa, Editora Folha de Viçosa, 302 pp. 45. WATSON, S.A.; RAMSTAD, P.E. 1987. Corn: chemistry and technology. St. Paul: American Association of Cereal Chemists, 1 ed. 604 pp. IX. Bibliography consulted 1. ALTIERI M. A. 2005. The myth of coexistence: Why transgenic crops are not compatible with agroecologically based systems of production. Bull. Sci. Technol. & Soc. 25: 361-371. 2. ASTWOOD, J.D.; FUCHS, R.L. 2001. Status and safety of biotech crops. In BAKER, D.R.; UMETSU, N.K. (editors) Agrochemical discovery: insect, weed and fungal control. Am.Chem. Soc Symp. Series: nº 774, p. 152-164. 3. AUMAITRE A. 2000. New feeds from genetically modified plants: substantial equivalence, nutritional equivalence, digestibility, and safety for animals and the food chain. Livestock Prod. Sci. 74: 223A. 4. DONKIN, S.S.; VELEZ, J.C.; TOTTEN, A.K.; STANISIEWSKI, E.P.; HARTNELL, G.F. 2003. Effects of feeding silage and grain from glyphosate-tolerant or insect-protected corn hybrids on feed intake, ruminal digestion and milk production in dairy cattle. J. Dairy Sci, 86: 1780-1788. 5. FOSBSCH, A.; SCHUBERT, D.; LECHTENBERG, B.; GILS, M.; SCHMIDT, R. 2003. A comprehensive characterization of single-copy T-DNA insertions in the Arabidopsis thaliana genome. Plant Mol. Biol. 52: 161-175. 6. GARCIA, M.A.; ALTIERI, M.A. 2005. Transgenic crops: implications for biodiversity and sustainable agriculture. Bull. Sci. Technol & Soc. 25: 335-353. 7. GRAEF, F.; STACHOW, U.; WERNER, A.; SCHÜTE, G. 2007. Agricultural practice changes with cultivating genetically modified herbicide-tolerant oilseed rape. Agricult. Syst. 94: 111-118. 8. HARRISON, L.A.; BAILEY, M.R.; NAYLOR, M.; REAM, J.; HAMMOND, B.; NIDA, D.L.; BURNETTE, B.; NICKSON, T.E.; MITSKY, T.; TAYLOR, M.L.; FUCHS, R.L.; PADGETTE, S.R. 1996. The expressed protein in glyphosate-tolerant soybean, 5-enolpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4, is rapidly digested in vitro and is not toxic to acutely gavaged mice. J. Nutr. 126: 728-740. 9. LADICS, G.R.; HOLSAPPLE, M.P.; ASTWOOD, J.D.; KIMBER, I.; KNIPELS, L.M.J.; HELM, R.; DONG, W. 2003. Workshop overview: approaches to the assessment of the allergenic potential of food from genetically modified crops. Toxicol. Sci. 73: 8-16. 10. LATHAM, J.R.; WILSON, A.K.; STENBRECHER, R.A. 2006. The mutational consequences of plant transformation. J. of Biomed. Biotech. 2006: 1-7. 11. MCCLELLAN, R.O. 1999. Human health risk assessment: an historical overview and alternative paths followed. Inhal. Toxicol. 11: 477-518. 12. ORGANIZATION FOR ECONOMICAL COOPERATION AND DEVELOPMENT – OECD. 2006. OECD Guidelines for the Testing of Chemicals. Section 4. Health effects. Joint Meeting of the Chemicals Committee and the Working Part on Chemicals, Pesticides and Biotechnology. OECD Environment, Health and Safety Publication. Organization for Economic Cooperation and Development. http://www.oecd.org. 13. RIAZ, T.; HOR, H.L.; KRISHNAN, A.; TANG, F.; LI, K.B. 2005. WebAllergen: a web server for predicting allergenic proteins. Bioinf. 21: 2570-2571. http://weballergen.bii.a-star.edu.sg/ 14. U.S. FOOD AND DRUG ADMINISTRATION – FDA. 2001. Toxicology testing hank: principles, applications, and data interpretation. Marcel Dekker, Inc. New York: 428 p. 15. U.S. FOOD AND DRUG ADMINISTRATION – FDA. 2006. Recommendations for the early food safety evaluation of new- pesticidal proteins produced by new plant varieties intended for food use. Center for Food Safety and Applied Nutrition. http://www.cfsan.fda.gov/~dms/bioprgu2.html. 16. U.S. NATIONAL RESEARCH COUNCIL. 1983. Risk Assessment in the Federal Government: managing the process. Commissionon Life Science. Committee on the Institutional Means for Assessment of Risks to Public Health. National Academy Press, Washington, DC: 1-8.
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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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gutemberg.sousa@mcti.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
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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:
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Canada
Name of product applicant: Monsanto Canada Inc.
Summary of application:
The GA21 line of corn (Zea mays L.) was developed through a specific genetic modification to be tolerant to glyphosate containing herbicides. The novel variety was developed from the inbred AT corn variety by insertion of an additional copy of the maize 5-enolypyruvylshikimate-3-phosphate synthase (EPSPS) encoding gene, which had been modified to be glyphosate tolerant. Glyphosate specifically binds to and inactivates EPSPS, which is involved in the biosynthesis of the aromatic amino acids tyrosine, phenylalanine and tryptophan. This enzyme is present in all plants, bacteria and fungi, but not in animals, which do not synthesize their own aromatic amino acids. Thus, EPSPS is normally present in food derived from plant and microbial sources. The modified corn line permits farmers to use glyphosate containing herbicides, such as Roundup®, for weed control in the cultivation of corn.

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Date of authorization: 13/05/1999
Scope of authorization: Food and feed
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Novel Feeds Decision
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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.
Useful links
Relevant documents
Stacked events:
Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

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

Genetically modified organism: MON-ØØØ21-9 (GA21)  line of maize (Zea mays L.); Exogenous gene: Maize 5-enolpyruvylshikimate-3-phosphate synthase (mepsps) gene was modified through site-directed mutagenesis;  Trait: Tolerance of glyphosate-containing herbicides; Transformation methods: Particle acceleration (biolistic) transformation; Safety level: Ⅰ

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Date of authorization: 20/02/2004
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. 869-12-2007: Detection of genetically modified plants and derived products Qualitative PCR method for herbicide-tolerant maize GA21 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: 20/2/2007
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
Philippines
Name of product applicant: Syngenta Philippines
Summary of application:
Syngenta developed a corn line tolerant to glyphosate containing herbicides. This corn line referred to in this document as Corn GA21, was developed to provide a weed management method to control yield losses from weeds.
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Date of authorization: 20/11/2008
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Corn GA21 has been evaluated according to the safety assessment by concerned agencies of the Department of Agriculture: [Bureau of Animal Industry (BAI) for feed safety, Bureau of Agriculture, Fisheries, and Product Standards (BAFPS) for food safety], and a Scientific Technical Review Panel (STRP). The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological issues and nutritional issues associated with the genetically modified corn The petitioner/applicant published the application for food and feed on 12 September 2008 (Manila Standard) and on 15 September 2008 (Manila Times) for public comment/review. BPI received no comment on the petition during the 30-day comment period. Review of results of evaluation by the Bureau of Plant Industry (BPI) Biotech Core Team, in consultation with Department of Agriculture - 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.
Useful links
Relevant documents
Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
United States of America
Name of product applicant: Monsanto Company
Summary of application:
Corn
Trait 1 Added Protein: Modified 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS)
Source: Zea mays
Intended Effect: Tolerance to the herbicide glyphosate
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Date of authorization: 13/02/1998
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Please consult the FDA website links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Authorization expiration date:
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:
The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food and Drug Administration (premarkt@fda.hhs.gov); Environmental Protection Agency