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OECD Unique Identifier details

ACS-GMØØ5-3
Commodity: Soyabean / Soybeans
Traits: Glufosinate tolerance
Australia
Name of product applicant: Bayer CropScience Pty Ltd
Summary of application:
The GM soybean variety is known commercially as LibertyLink soybeans. Bayer CropScience is seeking approval for two lines; line A2704-12 and line A5547-127. Only line A2704-12 is intended for commercialisation at this stage.

Soybean lines A2704-12 and A5547-127 have been genetically modified to be tolerant to the herbicide glufosinate ammonium. Glufosinate ammonium (also referred to as
phosphinothricin) is a non-selective, contact herbicide that provides effective post-emergence control of many broadleaf and grassy weeds. The mode of action of the herbicide is to inhibit the enzyme glutamine synthetase, an essential enzyme involved with ammonium accumulation and nitrogen metabolism in plants. The inhibition of glutamine synthetase results in an over accumulation of ammonia in the plant, which leads to cell death. Tolerance to glufosinate ammonium is conferred though the expression in the plant of the enzyme phosphinothricin acetyltransferase (PAT), encoded by the pat gene from the soil bacteria Streptomyces viridochromogenes. The production of PAT by soybean lines A2704-12 and A5547-127 enables the post emergence use of glufosinate ammonium herbicides without risk
of damaging the crop. The applicant has stated that development of GM glufosinate
ammonium tolerant soybeans will provide a selective use for glufosinate ammonium, creating a valuable new weed management tool for soybean producers.

Soybean lines A2704-12 and A5547-127 have been developed for cultivation in the major soybean producing countries of the world. The applicant has indicated that at present they have no plans to develop glufosinate ammonium tolerant soybeans for cropping in either Australia or New Zealand. Food from soybean lines A2704-12 and A5547-127 will therefore be entering the Australian and New Zealand food supply as imported, processed, food products only.

There are three major food products derived from soybeans – seeds, oil and meal. Whole soybeans are used to produce soy sprouts, baked soybeans, roasted soybeans, full fat soy flour and the traditional soy foods such as miso, tofu, soy sauce and soymilk. Soybean oil has many food uses including in cooking oils, mayonnaise, margarine, salad dressings, sandwich spreads, and shortenings. Soybeans are also processed into lecithin, an emulsifying agent (food additive) found in a wide variety of foods. Finished food products containing soybean ingredients therefore include beer, noodles, breads, flours, sausage casings, pastries, crackers, meat substitutes, milk substitutes and confectionery among other things.

Soybean lines A2704-12 and A5547-127 will be used in conventional breeding programs to produce soybean hybrids tolerant to glufosinate ammonium. LibertyLink soybeans have been cleared for food use in the United States, Canada, Japan, South Africa (A2704-12 only) and Russia.
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Date of authorization: 29/04/2004
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment:
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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 A481 - 'LibertyLink' Glufosinate-ammonium Tolerant Soybean A2704-12 A5547-127
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Authorization expiration date:
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:
Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
Useful links
Relevant documents
Stacked events:
FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
Brazil
Name of product applicant: Bayer S.A
Summary of application:
commercial release of genetically modified gluphosinate ammonium tolerant soybean, as well as all progenies coming from transformation event A5547-127 and its derivatives through crossing of non-transgenic soybean lineages and populations with lineages carrying event A5547-127
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Date of authorization: 11/02/2010
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Center for environmental Risk Assessment
Summary of the safety assessment:
LL Soybean was developed through a specific genetic modification by inserting in the plant the pat gene responsible for synthesizing enzyme phosphinothricin N-acetyltransferase (PAT), which catalyzes conversion of L-phosphinothricin (gluphosinate ammonium) into non-toxic products, inactivating the active ingredient and this way granting the plant the attribute of tolerance to the herbicide. Gene pat used was a modified version of a gene isolated from a soil-natural bacterium, Streptomyces viridochromogenes, and was inserted in the plant cells through a transformation process via biobalistics. The modification introduced in the pat gene was one of reducing, via site-directed mutagenesis, the content of G:C bases (frequent in bacteria genomes, yet atypical in plant genomes). The modifications conducted failed to modify the original sequence of PAT protein amino acids. The genetic elements present in the insert were the pat gene, the promoter 35S derived from Cauliflower Mosaic Virus (CaMV), and the ƒÒ-Lactamase selection marker gene (ƒÒla) coming from Escherichia coli, which grants resistance to the antibiotic ampicilin. Plasmid vector used to replicate the insert was pB2/35SAcK derived from plasmid pUC19. The plasmid vector was linearized prior to the transformation process in order to deactivate gene ƒÒla coding sequence. Southern blot analyses showed that the LL Soybean genome contains one single copy of gene pat, which is flanked by fragments of gene ƒÒla. The PAT protein was the only exogenous protein to be expressed in the transgenic event. Amounts of PAT protein produced in different tissues of LL Soybean were assayed using the immunologic test ELISA and the results were 0.017% in leaves and 0.003% in hay and grain, against total protein in related tissues. Thus, the PAT protein was detected in low level in plant tissues assayed and, as expected, no amount was detected in refined oil. Besides, the protein is rapidly degraded in gastric and intestinal fluids, with great susceptibility to digestion and denaturation. The safe history of LL Soybean cultivation in the United States (since 1998), Canada (2000) and Japan (2006) grants the product a strong evidence of environment safety. To these results one shall aggregate assessments conducted by international organizations, as well as data supplied by applicant showing that the event fails to present any harmful effect to the environment and non-target organisms and fails to possess any characteristic that may grant adaptive advantages. Available information indicates that there is substantial equivalence, that is to say, transgenic plants of LL Soybean are not fundamentally different from the non-transformed soybean genotypes, except for the gluphosinate ammonium tolerance. Regarding horizontal gene flow, it is practically impossible, since there are no feral kindred of soybean in the Brazilian territory. Besides, soybean is an autogamous plant, which makes the vertical gene flow very difficult. Although the issue is beyond the scope of CTNBio, it is worth stressing that gluphosinate ammonium is a non-systemic and non-selective herbicide, used mainly in the control of invading plants in post-emergence, both of large leave and narrow leave invaders, and is registered, approved and free to be marketed in Brazil by the Ministry of Agriculture and Supply (MAPA), IBAMA and the Ministry of Health, used in Brazil and several other countries to control pest plants, either with or without farming of transgenic plants resistant to the herbicide. The herbicide wide use worldwide is due to its biodegradability, low residual activity and low toxicity to humans, animals and other organisms of the food chain. For the foregoing, the conclusion is that farming and consumption of Liberty Link Soybean (LL Soybean event A5547-127) is neither a potential cause of significant degradation of the environment nor of risks to human and animal health. For the reasons above, there are no restrictions to the use of this soybean and its derivatives. Applicant shall conduct the post-commercial release monitoring pursuant to CTNBio Ruling Resolution nº 5. As established in Article 1 of Law nº 11,460, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous and conservation unit areas”. CTNBio analyzed the reports submitted by applicant as well as the independent scientific literature. Under Article 14 of Law nº 11,105/05, CTNBio held that the request complies with applicable rules and legislation in effect aimed at securing biosafety of the environment, agriculture, human and animal health and concludes that Liberty Link Soybean is substantially equivalent to conventional soybean, being therefore its consumption safe for human and animal health. Regarding the environment, CTNBio concluded that farming of Liberty Link Soybean is not potentially a cause of significant degradation of the environment, keeping with the biota a relation identical to that of conventional soybean.   CTNBio TECHNICAL OPINION I. Identification of GMO Name of GMO: Genetically modified soybean tolerant to gluphosinate ammonium – Liberty Link Soybean, Event A5547-127. Applicant: Bayer S.A. Species: Glycine Max Inserted Characteristics: Tolerance to gluphosinate ammonium. Method of insertion: Particle acceleration method (Biobalistics) Proposed use: Farming, production of grain, human and animal consumption of the product and its derivatives. II. General Information Soybean is a predominantly autogamous plant, whose crossed pollination rate is as low as 1.0%. Soybean cross pollination rate in an environment such as the Brazilian cerrado (Abud et al., 2003) is about 0.45% at a distance of 0.5 m; 0.14% at 1.0 m and detectable absence at a distance of 6.5 m. Soybean is an exotic species with no feral kindred sexually compatible in Brazil. Therefore, crossed pollination with feral species in the natural environment may not occur in the national territory. Soybean is a domesticated species that depends highly on the human species for its survival. Therefore, there are no scientific reasons to foresee survival of plants derived from lineage A5547-127 outside farm environments. Besides, in absence of selective pressure (use of herbicide), expression of the inserted gene fails to grant any adaptive advantage. Around the world, the area farmed with herbicide tolerant soybean in 2008 was about 65.9 million hectares. Since 1998, genetically modified soybean tolerant to glyphosate herbicide (Roundup Ready – Monsanto) is extensively cultivated in Brazil. About 65% of the soybean produced in Brazil during 2008 was RR® transgenic, representing 21.9 million hectares (ISI, 2008). Until now no report of harmful effect of this GMP to the environment due to gene flow has come to light. However, the massive use of the same type of herbicide crop after crop, as in the case of glyphosate, accelerates appearance of invading plants naturally resistant to such herbicide (Owen, 2008). In this case, the possibility of using varieties of genetically modified soybean that are tolerant to another herbicide, such as the gluphosinate ammonium, may be an important tool to help manage invaders, making possible to increase longevity of such technologies. Soybean plants of event A5547-127 are sensitive to other herbicides, such as glyphosate, indicating the substrate specificity of protein PAT and showing that the plants of this event may be managed by the techniques usually employed in the field to eradicate undesirable plants. Herbicide gluphosinate ammonium is rapidly degraded in the soil by action of microorganisms using this molecule as a source of nitrogen, releasing CO2 and phosphorus. Soils maintained in laboratory conditions demonstrated that at a temperature of 20 ºC gluphosinate has a half-life of 10 days (Smith, 1988; OECD, 2002). According to Hoerlein (1994), this synthetic phosphinothricin (gluphosinate ammonium) is not toxic to fungi, nematodes and insects. III. Description of the GMO and Proteins Expressed Event A5547-127, styled LibertyLink Soybean, presents gene pat derived from Streptomyces viridochromogenes that grants tolerance to herbicide gluphosinate ammonium. This exogenous gene codes for enzyme phosphinothricin N-acetyltransferase (PAT protein) that promotes inactivation of the herbicide. Gene pat was replicated using plasmid pB2/35Sack and the nucleotide sequence was inserted in the soybean genome by particle acceleration technique. The plasmid displayed gene pat, promoter and terminator 35S (derived from Cauliflower Mosaic Virus (CaMV) and marker gene ƒÒla (resistance to antibiotic ampicilin). Gene ƒÒla (ƒÒ-lactamase derived from Escherichia coli) that is present in the plasmid vector, was fragmented by restriction enzyme prior to the event insertion. Hybridizations of Southern blots and amplifications by chain reaction of DNA-polymerase were presented to demonstrate integration of the exogenous DNA fragment to the plant genome, the number of gene copies, presence or absence of other DNA elements and location of transgene parts. The results submitted indicate that event A5547-127 has a single copy of gene pat in orientation 5’„_3’. The event has a gene ƒÒla fragment copy of the 3’end and a copy of the 5’end. However, ƒÒla fragments are unable to reconstitute the gene for they are invertedly oriented, making its expression impossible. The construct inserted in the soybean genome fails to present sequences associated to mobility in the genome. The characteristic of resistance to the gluphosinate ammonium herbicide followed the Mendelian way in the event, regarding generations assayed by applicant, indicating genetic stability of the insert. Enzyme PAT is the only protein expressed by the transgene; it has 183 amino acids and molecular weight of 22 kDa. Event A5547-127 plants display PAT protein in concentrations of 26.22 ƒÝg/g in leaves, 13.85 ƒÝg/g in stalks, 3.6 ƒÝg/g in roots (Annex 11) and 9.0 ƒÝg/g in seeds (Annex 32) (AgBios, 2009). During the event A5547-127 transformation, three new junctions, originating eight ORFs (open reading frames), were created. Based on bioinformatics analyses, the likelihood that a new protein expression created because of DNA insertion in event A5547-127 is very low for ORF-1, ORF-2, ORF-3, 0RF-4, ORF-6, ORF-7 and ORF-8. However, ORF-5 has all the regulating elements needed to initiate transcription and translation, though in non-optimal form and spacing, and one may not exclude the fact that it may lead to expression of a freshly created protein (Annex 35). Northern blot analyses were conducted for A5547-127 soybean to demonstrate expression of gene pat introduced and to assay absence of a putative cryptic gene expression coming from different junction regions. The study characterized the presence of gene pat mRNA in all tissues tested. Downstream cryptic expression on junctions II and III were noticed in transgenic samples only, though no cryptic expression has been found in non-transgenic samples. However it is not likely that a fresh protein, in addition to PAT, is translated in such transcriptions (Annex 36). Comparisons of event A5547-127 with its non-transgenic isoline A5547-127 showed that there are no differences regarding allergenic potential. In this assay, slight differences were found in some nutritional components. However, the variations were within the range normally found in conventional soybean lineages (FSANZ – Food Standards Australia and New Zealand, 2003), and resulted in no risks. Gluphosinate ammonium (synthetic phosphinotricin) acts through controlling invading plants by inhibiting enzyme glutamine synthetase. The enzyme is responsible for incorporating ammonia to glutamic acid, forming glutamine. Inhibition of glutamine synthase promotes both a reduction in the levels of glutamine and collection of ammonium in plant tissues, leading the plant to death. Glutamine synthetase is a protein produced by the cell nucleus that catalyzes formation of L-glutamine in the cytoplasm and predominantly in chloroplasts. The reaction is the main route of ammonium assimilation in plants. Gluphosinate ammonium is racemic, where the L-isomer has the function of inhibiting glutamine synthetase. The L-isomer has a structure similar to that of L-glutamate, leading to inhibition of glutamine synthetase by competition. However, ammonium collection is not directly responsible for the gluphosinate toxic effect. Gluphosinate indirectly inhibits the photochemical phase of photosynthesis, blocking the electron transportation chain, leading to disorganization of thylakoid membranes (Tan et al., 2006). Protein PAT is able to inactivate gluphosinate through acetylation, by converting gluphosinate into N-acetyl-L-gluphosinate, which is atoxic. The rapid activity of PAT enzyme either eliminates or reduces the odds of gluphosinate to inhibit glutamine synthetase. Up to now, no occurrence of this protein has been identified in any plant. However, experiments have shown that some plants display reduced ability to naturally detoxify gluphosinate through deamination reactions, as it is the case for soybean, wheat, maize, tobacco, alfafa and carrot (Dropege-Laser et al., 1994), resulting an atoxic composite (4-methylphosphinic-2-oxo-butanoic acid, PPO). This natural inactivation route is quite slow, leading the plant to death prior to complete gluphosinate detoxification. Presence of exogenous PAT protein inactivates gluphosinate in a fast way, leading to increased tolerance to the herbicide (OECD, 2002). Up to now, there is no record of invading plants naturally tolerant to gluphosinate. IV. Aspects Related to Human and Animal Health World production of soybean is about 200 million tons, and the grain is used as edible oil, animal ration, foodstuff component to humans, besides being input for meal, soap, cosmetics, resins, paint, solvents and biodiesel. Due to presence of anti-nutrients, such as stachyose, rafinose, trypsin and lectin inhibitors, soybean shall be submitted to a thermal process before being used for consumption. PAT protein is degraded by animal gastric fluid and by artificial gastric fluid similar to that of humans, weakening its physic-chemical characteristics after oral exposure. Therefore it is not expected that the protein may be wholly absorbed, being thereby impossible for it to cause adverse or toxic effects. Innocuity of transformation by gene pat is warranted by works developed by different research groups. A detailed study on PAT protein innocuity was conducted focusing structural assay, search for glycosylation sites, thermal stability and in vitro digestibility. Protein expressed by pat gene was analyzed and the conclusion was that it is safe for use in plant modification regarding all aspects investigated (Hérouet et al., 2004). Results of such study enable inferring that protein PAT fails to display any characteristics of allergenicity to sensitized individuals, either by direct action or by cross-reaction with other allergenic molecules. Allergens originated in foodstuffs are generally resistant to heat, acid and proteases, may be glycosylated and are present in high concentration. The protein analyzed is readily digested by gastric juices, is not glycosylated and exposure to heat leads to protein bioactivity loss. In order to ensure safety of LibertyLink® soybean in animal food, Bayer and other research institutions demonstrated that the genetically modified soybean by introduction of the pat gene: 1. Has a bromatological composition similar to its unmodified parental; 2. Fails to present any adverse effect to mammals, even when intravenously administered in high doses; 3. Protein PAT has no homology with allergenic or toxic proteins; 4. Protein PAT fails to present any glycosylation site; 5. Protein PAT is not structurally unstable in acid environments; 6. Protein PAT has substrate-specific activity. The search for PAT protein glycosylation sites, thermal stability, in vitro digestibility and allergenicity is fully described in studies conducted by applicant and other laboratories, upon applicant’s request, and is available in the Annexes of the proceedings. Composition analyses were comparatively conducted in genetically modified plants and its respective conventional analogues (control lineages), which had been developed in similar environmental conditions to avoid possible variations in composition that are unrelated to genetic modifications. Thus, different parameters were assayed for Event A5547-127 and for the unmodified conventional lineage. Chart 3 of the topic “Assessment of Risk to Human and Animal Health” describes the analyzed groups and respective components, for instance: centesimal composition: humidity, gross fat, proteins, ashes, among others; minerals and vitamins: Ca, P, K, B1 vitamins, vitamin B2, vitamin E, folic acid, among others. The similarity noticed for average values of analyzed composts indicates that the genetic modification resulting from insertion of pat gene to Event A5547-127 failed to affect any other metabolic function that might result in changed percentage of nutritional chemical components. Effects on growth and mortality of chicken (Gallus gallus domesticus) brought by food containing or not the GM soybean were measured in an experiment with 240 birds. The birds were fed with ration containing 18,25% of soybean during the first seventeen days of life. During this growth phase and after slaughtering the chicken, several parameters compiled in Table 13 were analyzed. Results showed that there was no significant change in analyzed zootechnical characteristics as well as in other parameters studied. Assessment of PAT protein cumulative toxicity was conducted in Wistar rats. Rat groups (10 animals) were fed on different concentrations of PAT protein, from zero to 50,000 ppm. The results showed no clinical effects as a result of the treatments and parameters, such as body weight, were not affected. The full details of the study are in the Annexes to the proceedings. Information and studies submitted, besides all other works in the literature (see references below) establish the safety of LibertyLink® soybean Event A5547-127. This variant shows low risk to human and animal health and has no risk of changing into a plant pest. Gene insertion failed to change plant composition and nutritive value. It was verified that PAT protein poses no significant risk to human and environmental health according to acute oral toxicity and in vitro digestibility studies. Studies showed absence of toxicity in rats and birds fed on PAT protein. Gene pat introduced in soybean has no similarity to known allergens; PAT protein does not share any immunologically significant sequence of amino acids with known allergens. These results, coupled with the rapid rupture of the protein in digestive conditions, confirm that protein PAT shall not pose significant allergenic risk. PAT protein may be widely found in nature, has a safe use history and well known action mechanism. In September, 2007, the European Food Safety Authority (EFSA) issued a positive opinion on LL soybean. LL soybean was approved in the United States, Canada for food and farming; LL soybean is approved for import by Australia, Japan, Mexico, New Zealand, Taiwan and South Africa and approved as foodstuff in Russia. V. Environmental Aspects Gluphosinate ammonium (GA) is a synthetic compound correspondent to phosphinothricin, which is naturally produced by some soil microorganisms and is regularly registered and traded in Brazil under the brand FINALE. Other commercial names (LIBERTY, BASTA, IGNITE) are internationally used. GA biodegradability is one of the main characteristics of the product, in addition to its low toxicity on fowl, insects, earthworms and bees; it is a non-mutagenic non-carcinogenic product with low risk of leaving residuals in soil and water given its low half-life. GA has a broad range and is a fast acting herbicide on monocotyledon and dicotyledon plants, controlling plants from its emergence in soil to more advanced stages. GA activity on the target-plant is exclusive and specific (inhibition of glutamine synthetase enzyme), acting in a way to minimize appearance of resistant plant pest populations. Plants derived from Event A5547-127 display the same agronomic behavior and adaptability than the conventional lineage, with no changes on the traits that regulate the species survival and reproduction. Comparative analyses of morphologic, phenotypic and agronomic characteristics enable a conclusion that none of such variables was changed by the genetic modification of the Event A5547-127. There are no records of traits that may grant either selective advantage or atypical behavior to the species. PAT protein, product of expression of the gene inserted in the Event, displays some characteristics in risk assessment, such as: (i) lack of homology with allergenic protein, toxin or antinutrients; (ii) lack of glycosilation site (that is present in a number of allergenic components); (iii) the protein is unstable in acid environments; (iv) the protein is rapidly degraded and denatured in gastric and intestinal fluids of mammals; (v) the protein has substrate-specific activity (acts solely on gluphosinate); and (vi) the protein failed to display any adverse effect in mammals, even when administered pure, in high doses, in the vein. According to applicant, possible effects to relevant indicator organisms in experiments conducted in the United States and Porto Rico, with visual observations during the evolutionary cycle to assess occurrence of atypical plants or plants that respond differently to biotic pressure, suggested that insertion of the pat gene has failed to influence susceptibility/influence to pests and diseases of lineages derived from A5547-127, even when they are subject to different environmental conditions. Studies conducted in the cities of Paulínia and São Gabriel do Oeste revealed no anomaly in terms of insect and fungus occurrence and anomalies related to plant physiology. Safety to environment aspects, analyzed in local field studies, demonstrated that the lineage originated from Event A5547-127 displays the same agronomic behavior and adaptability of the conventional lineage, with no changes on the species survival and reproduction regulating characteristics. Comparative analyses of morphologic, phenotypic and agronomic characteristics enabled a conclusion that none of such variables was changed as a result of the Event genetic modification. According to applicant, no traits that could grant selective advantage to the GM soybean or atypical behavior to the species were recorded. During post-harvest monitoring, carried out in experimental areas, few remaining soybean plants were recorded, and were easily eliminated. This is evidence that the GMP does not remain in the farming environment without human intervention, nor displays traits that make it more aggressive or invading on the ecosystem than its conventional parental lineage, according to applicant. Event A5547-127 is already commercially released in Mexico (2003), United States of America (1998) and Japan (2006). Taking into account internationally accepted criteria in the process of analyzing genetically modified plant risks, one may conclude that Event A5547-127 is as safe as its conventional equivalent. VI. Restrictions to the use of GMO and its derivatives According to Article 1 of Law no. 11,460, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous and conservation unit areas”. Soybean is an exotic species in Brazil and there are no feral kindred able to cross and generate offspring. Gene flow among soybean plants is already studied in tropical conditions. Soybean is an autogamic species displaying full flowers, with crossed pollination rates ranging from 0.5% to 1% according to place and type of cultivar; gene flow may occur at no more than eight meters. After ten years of use in different countries, no problem has been recorded as affecting human and animal health or the environment that may be attributable to transgenic soybeans. It shall be stressed that lack of negative results in farming transgenic plants is no guaranty that such results may not occur. Zero risk coupled with absolute safety do not exist in the biological world, although there is a host of reliable scientific information and a history of safe use of transgenic variety in agriculture. Therefore, applicant shall carry out post-commercial release monitoring under the provisions of CTNBio Ruling Resolution nº 5 and according to this Technical Opinion. Proceedings nº 01200.003881/2008-92, Event A5547-127, submits a monitoring plan for Liberty Link soybean. The company intends to establish two areas (with about 2 ha of area each) in the States of Paraná, Rio Grande do Sul and Mato Grosso, totaling six experimental areas for data collection and observation. Each experimental area shall contain two genotypes (LibertyLink and Conventional soybean). Each genotype shall occupy an area or 0.24 ha. The area shall include four repetitions of each genotype, totaling 0.96 ha/genotype. An isolation of 8m is intended around the experimental area. Monitoring shall take five years, with yearly reports. Parameters to be analyzed by applicant: • Plant nutritional state and sanity; • Chemical attributes of the soil related to fertility (including pH, Al, P, K, Re, Mn); • Community assessment of invading plants and development of resistance to the herbicide ammonium gluphosinate; • Soil microbiota assessment (protozoan, mycorrhiza, microbian biomass, soil respirometry). This intended monitoring shall be modified to include the parameter to be assessed: flow of ammonium gluphosinate resistance gene to other soybean plants; Assessing occurrence of ammonium gluphosinate pat gene flow to other soybean plants in areas of commercial farming. VII. Considerations on particulars of different regions of the country (assistance to monitoring bodies): As established in Article 1 of Law nº 11,460, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous and conservation unit areas”. VIII. Conclusion Whereas: • Soybean is a domesticated species, highly dependent from the human species for its survival and, therefore, there are no scientific reasons to foresee survival of plants derived from lineage A5547-127 outside farming environments; • Soybean is an exotic species, with no sexually compatible feral kindred in Brazil and crossed pollination with wild species in the natural environment may not occur in the Brazilian territory; • Herbicide gluphosinate is rapidly degraded in soil by action of microorganisms that use this molecule as a nitrogen source, producing CO2 and phosphorus; • Ammonium gluphosinate (AM) is a synthetic compound corresponding to phosphinothricin, produced in nature by some soil microorganisms; • Protein PAT has homology to no allergenic or toxic protein; • Protein PAT fails to display significant risk for human and animal health and to the environment according to oral acute toxicity and in vitro digestibility studies; • Studies showed absence of toxicity in rats and birds fed on PAT protein; • Gene pat introduced in soybean has no similarity with known allergens; • Protein PAT fails to share immunologically significant sequences of amino acids with known allergens; • Foods based on soybean derived from Event A5547-127 show compositional/nutritional equivalence to products coming from non-modified soybean varieties; • Environmental safety aspects were analyzed in local field studies where it was shown that the lineage coming from Event A5547-127 displays the same agronomic behavior and adaptability of the conventional lineage, with no change on characteristics that regulate the species’ survival and reproduction. For the foregoing and taking into consideration internationally accepted criteria in the process of risk analysis for genetically modified raw materials, one may conclude that LibertyLink Soybean is as safe as its conventional equivalents. According to Article 14 of Law 11,105/05, CTNBio held that the request complies with the rules and laws in effect aimed at securing biosafety of the environment, agriculture, human and animal health, and concluded that LibertyLink Soybean is equivalent to conventional soybean, and its consumption safe for human and animal health. Regarding the environment, CTNBio held that LibertyLink Soybean is not a potential cause of significant degradation of the environment, keeping with the biota a relation identical to that of the conventional soybean.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Molecular Traditional Methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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Authorization expiration date: Not Applicable
E-mail:
gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
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Stacked events:
At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)
Canada
Name of product applicant: Bayer CropScience Canada
Summary of application:
The soybean lines A2704-12 and A5547-127 were developed through a specific genetic modification to be tolerant to glufosinate ammonium. The soybean plants have been transformed with a bacterial gene, phosphinothricin -N-acetyltransferase (PAT), that confers resistance to the glufosinate ammonium herbicides. The soybeans will be used in the same food applications as conventional soybeans.

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Date of authorization: 20/11/2000
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment:
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
Malaysia
Name of product applicant: Bayer Co. (Malaysia) Sdn. Bhd.
Summary of application:
Please refer to uploaded document.
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Date of authorization: 28/03/2012
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): 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: Bayer CropScience Inc
Summary of application:
Bayer CropScience Inc. has developed Soybean A2704-12 that contains the pat gene from Streptomyces viridochromogenes. The pat gene encodes the phosphinothricin acetyltransferase (PAT) enzyme, which confers tolerance to glufosinate ammonium herbicides. AgrEvo first provided some background information on the new soybean varieties (derived from events A2704-12 and A5547-127) on March 21, 1998. The food and feed uses of this new soybean variety are no different than those varieties currently in the market.
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Date of authorization: 23/01/2009
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Soybean A2704-12 has been evaluated according to safety assessment by concerned agencies of the Department of Agriculture, such as the Bureau of Animal Industry (BAI) for feed safety, and Bureau of Fisheries and Product Standards (BAFPS) for food safety, and a Scientific Technical Review Panel (STRP) members. The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological and nutritional issues associated with the modified soybean The petitioner/applicant published the Public Information Sheet (PIS) of the said application in two widely circulated newspapers to solicit comments from the public. During the 30-day posting period, the Bureau of Plant Industry (BPI) received no comment on the petition. The STRP and agencies’ assessment and review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Thelma L. Soriano
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:
The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community. The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power. The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment. The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.
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Relevant documents
Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
United States of America
Name of product applicant: AgrEvo
Summary of application:
Soybean
Trait 1 Added Protein: Phosphinothricin acetyltransferase (PAT)
Source: Streptomyces viridochromogenes
Intended Effect: Tolerance to the herbicide glufosinate-ammonium
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Date of authorization: 15/05/1998
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
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