Food safety and quality
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OECD Unique Identifier details

REN-ØØØ38-3
Commodity: Corn / Maize
Traits: Increased lysine content
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C.
Summary of application:
The maize event LY038 confers lysine high content to grain of the maize. This is obtained by presence of enzyme dihydrodipicolinate synthase (cDHDPS) in the germ, resulting in the accumulation of lysine in the grain. To express cDHDPS enzyme was introduced the bacterial gene cordapA from Corynebacterium glutamicum into the maize. To achieve the transformants, the particle acceleration method was utilized.
Regarding the genetic stability, the gene cordapA segregate according to the rules of inheritance of Mendel for a single genetic locus. The molecular analysis shows that the cordapA gene was integrated stabily.
DHDPS is the first enzyme in lysine pathway, catalyses the condensation of L-aspartate 4-semialdehyde and pyruvate to form 2,3-dihydrodipicolinate, that is converted to lysine through a series of subsequent enzymatic reactions. DHDPS is inhibited by product but the variant from Corynebacterium glutamicum (cDHDPS) on the contrary is not sensitive to inhibition by high concentrations of free lysine. Due to this, the grain that expresses cDHDPS accumulates more free lysine than conventional grains. Protein cDHDPS is mainly expressed in grains with a mean level of 41 ug/g of dry weight.
The compositional analysis was carried out with the comparison of 85 key components of forage (10) and grain (75). The result presents statistical differences between LY038 and the control in the amount of lysine, free lysine and saccharopine (the main associated catabolite). It was reported that mean content of free lysine in
LY038 ranged between 1254.9 and 1614.1 μg/g of dry weight while in the control it was from 17.4 to 44.5 μg/g of dry weight. Therefore LY038 are compositionally equivalent to conventional maize except for the intentional increased levels of free and total lysine in grain and the increased levels of lysine catabolites: saccharopine and α-aminoadipic acid. The levels of metabolites α-aminoadipic acid and saccharopine in LY038 are not harmful for human and animal health. Two 90 day feeding studies were performed with LY038 maize grain, one in broilers and the other in rats, and no unexpected effects were found. In conclusion, the LY038 grain and forage composition is equivalent to control and commercial maize except for the intentional modifications included.
The applicant has presented studies "in vitro" and "in vivo" with protein purified and characterized, where it has been demonstrated that:
(i) No toxicity was observed related to cDHDPS protein, after an acute toxicity study with the administration of the cDHDPS protein by oral gavage, the protein used was produced by E. coli, this protein demonstrated to be equivalent to the protein produced in LY038)
(ii) Rapid degradation in simulated gastric fluids,
(iii) Absence of significant homology of cDHDPS with proteins known as toxic or allergenic, and
(iv) Characteristics of cDHDPS protein do not coincide with the profile of known allergens.
With the information exposed and having into account the current scientific knowledge available there were no objections to approve the event LY038 for human and animal consumption.
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Date of authorization: 19/09/2007
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
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: Principles for the Assessment of Food and Feed derived from GMO in Argentina - Resolution Nº 412
Decision document of food/feed safety assessment of event LY038
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Authorization expiration date:
E-mail:
mjunco@senasa.gov.ar
Organization/agency name (Full name):
SENASA (National Service for Agrifood Health and Quality)
Contact person name:
Mariano Junco
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 4121 5276
Fax number:
54 11 4121 5258
Country introduction:
The food risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa), regulatory agency depending on the Ministery of Agriculture, Livestock and Fisheries. The Agrifood Quality Directorate of Senasa, is the area responsible for carrying out this task. It has an specific scientific team and the advise of a Technical Advisory Committee composed of experts from different scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.
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Relevant documents
Stacked events:
Argentina hasn't a specific authorization mechanism for food/feed safety assessment for stacked events. In principle, stacked events are assessed like another single event on a case-by-case basis.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
National Service for Agrifood Health and Quality (Senasa) (http://www.senasa.gov.ar)
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
LY038 corn produces grain with high levels of lysine that is intended to be used as animal feed. Conventional corn-soy based pig and chicken feeds are characteristically deficient in lysine and require the addition of supplemental lysine for optimal animal growth andperformance.

Corn line LY038 contains one novel gene, cordapA, from Corynebacterium glutamicum,
which encodes the enzyme dihydrodipicolinate synthase (DHDPS). This enzyme is involved in lysine biosynthesis. The bacterial DHDPS enzyme (cDHDPS), unlike the plant DHDPS enzyme, is not sensitive to lysine feedback inhibition, so lysine biosynthesis will continue in the presence of high levels of free lysine.
The nptII gene (an antibiotic resistance gene) was also transferred into LY038 corn, but then subsequently removed from the corn cells by recombination. No additional genes are present in LY038 corn.

The levels of free lysine in corn line LY038 are expected to be in the range of 1000 to 2500 parts per million (ppm) in the grain, compared to <100 ppm in conventional corn grain. The total lysine level in conventional corn, most of which is present as protein-incorporated lysine, typically ranges from 2500 to 2800 ppm on a dry weight basis. Therefore in LY038 corn the expected total lysine would range from 3500 ppm to 5300 ppm. The quantity of protein-incorporated lysine in corn line LY038 is expected to be the same as in conventional corn.

High lysine corn line LY038 is intended for use as animal feed and the Applicant does not intend to breed it into other types of corn such as sweet corn and popcorn. As LY038 will not be grown in Australia and New Zealand, the only source LY038 in our food supply would bein imported products. The types of food products that might contain corn line LY038 are: margarine, cooking oil and baking and frying fats; various sweeteners including high fructose, dextrose, and maltodextrins; corn grain used as an additive; flaking grits used almost exclusively in the manufacture of corn flakes; fine grits utilised by the snack, breakfast cereal and brewing industries; coarse grits eaten as a breakfast food; corn flour; dried-milled corn products used as a substrate for brewing beer; and corn grits and whole kernels used to produce many distilled hard liquors. Many of these products are highly refined (e.g. corn oil and corn syrup) and would be unlikely to contain increased levels of lysine.
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Date of authorization: 02/08/2007
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 A549 - Food derived from High Lysine Corn LY038
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Authorization expiration date:
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:
Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
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Relevant documents
Stacked events:
FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
Canada
Name of product applicant: Monsanto
Summary of application:
Monsanto Canada Inc. in collaboration with Renessen LLC developed a genetically modified corn with elevated levels of free lysine in grain.

Corn event LY038 was developed using recombinant DNA technology, resulting in the introduction of the bacterial gene cordapA from Corynebacterium glutamicum. This gene encodes the lysine-insensitive dihydrodipicolinate synthase (cDHDPS) enzyme. Dihydrodipicolinate synthase (DHDPS) is a regulatory enzyme in the lysine biosynthetic pathway and is the first and major rate-limiting enzyme for lysine biosynthesis in plants and bacteria. As the first committed enzyme in lysine biosynthesis, DHDPS is highly susceptible to lysine feedback inhibition, particularly DHDPS isolated from plants. Since the cDHDPS enzyme is less sensitive to lysine feedback inhibition, its expression in corn LY038 is expected to result in the elevated levels of free lysine in the plant when compared to conventional corn. The transcription of cordapA is under the control of the corn promoter globulin 1 (Glb1) which directs cDHDPS expression predominantly in the germ, resulting in accumulation of free lysine in this portion of the grain.

Currently, all commercially grown corn exhibiting the high lysine trait are derived by conventional breeding of corn mutants with reduced accumulation of lysine-poor zein seed storage proteins and increased accumulation of other storage proteins with higher lysine content in the endosperm portion of the grain. In contrast to the protein-bound lysine of such mutants, the elevated lysine content of corn LY038 is achieved by the accumulation of free lysine amino acids in the germ portion of the grain.

LY038 corn is intended for import to Canada from the US as a nutritionally enhanced livestock feed ingredient only. The use of LY038 corn grain in animal feeds provides an alternative to the direct addition of commercially available supplemental lysine sources in the form of lysine monohydrochloride or lysine sulphate, which are produced via fermentation by Corynebacterium glutamicum or Brevibacterium lactofermentum.

The safety assessment performed by Food Directorate evaluators was conducted according to Health Canada's Guidelines for the Safety Assessment of Novel Foods. Although not intended for human food use, the assessment was performed to account for potential accidental co-mingling of LY038 corn with conventional corn in the food supply. The assessment considered: how corn event LY038 was developed; how the composition and nutritional quality of corn grain derived from plants containing this event compare to non-modified corn; and what the potential is for food products derived from plants containing this event to be toxic or cause allergic reactions.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). Foods derived from corn lines containing event LY038 are considered novel foods under the following part of the definition of novel foods: "c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism".
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Date of authorization: 12/07/2006
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.):
Summary of the safety assessment:
See decision document weblinks on food and feed below
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Food Decision Document
Feeds Decision Document
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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.
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
United States of America
Name of product applicant: Monsanto Company
Summary of application:
Corn
Trait 1 Added Protein: Dihydrodipicolinate synthase (cDHDPS)
Source: Corynebacterium glutamicum
Intended Effect: Increased lysine level for use in animal feed
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Date of authorization: 05/10/2005
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.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: 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