| Commodity: |
Canola / Oilseed rape / Rape Seed |
| Traits: |
Glyphosate tolerance |
| Name of product applicant: |
Pioneer Hi-Bred Australia Pty Ltd |
| Summary of application: |
Canola line 73496 (OECD Unique Identifier DP-073496-4) has been genetically modified (GM) for tolerance to glyphosate, a broad spectrum herbicide used to control broadleaf weeds from pre-emergence to seven days pre-harvest. The Applicant claims herbicide-tolerant canola varieties have been useful in the management of weeds in canola crops, and their use reduces the overall volume of herbicides applied to the crop for weed control. From an agronomic perspective, the lack of competition with weeds for soil nutrients and moisture can also mean higher crop yields.
Tolerance to glyphosate in canola 73496 is achieved through constitutive expression of GAT4621 (glyphosate acetyltransferase), an enzyme that catalyses the acetylation of glyphosate, rendering it non-phytotoxic. The gat4621 gene is a variant of three gat genes isolated from the common soil bacterium Bacillus licheniformis. The GAT4621 protein has been assessed previously by FSANZ in dual herbicide-tolerant corn line DP-98140-6 (approved in 2010) and herbicide-tolerant soybean line DP-356043-5 (approved in 2009), therefore is not new to the food supply.
The Applicant intends to market canola line 73496 under the trade name Optimum GLY™ Canola to Australian growers as an alternative to currently available commercialised canola varieties. There are no plans to grow this canola variety in New Zealand.
Canola is a high value crop grown for its seeds which are used as a source of vegetable oil for human consumption, and canola meal (dry matter after oil extraction) as a high protein livestock feed supplement.
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| Date of authorization: |
15/05/2014 |
| 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
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| Summary of the safety assessment (food safety): |
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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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
A1089 - Food derived from Herbicide-tolerant Canola Line DP-073496-4
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E-mail:
Organization/agency name (Full name): Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address: Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number: +61 2 6271 2222
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 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island. 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)
No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.
No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.
Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given 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)
| Name of product applicant: |
Du Pont K.K. |
| Summary of application: |
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| Date of authorization: |
15/12/2014 |
| 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.): |
BCH Database
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| Summary of the safety assessment (food safety): |
Please see the links below (in Japanese). |
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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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Food
Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Feed
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E-mail:
Organization/agency name (Full name): Food Safety Commission Secretariat,Cabinet Office,
Contact person name: Kojiro Yokonuma
Website:
Physical full address: Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number: 81 3 6234 1122
Fax number: 81 3 3584 7392
Country introduction: Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Du Pont Production Agriscience (M) Sdn. Bhd. |
| Summary of application: |
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| Date of authorization: |
22/05/2018 |
| 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.): |
Department of Biosafety Malaysia
CBD Biosafety Clearing House
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| Summary of the safety assessment (food safety): |
Please refer to the Risk Assessment Report |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
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E-mail:
Organization/agency name (Full name): Department of Biosafety Malaysia
Contact person name: Dr. Anita Anthonysamy
Website:
Physical full address: Department of Biosafety,
Ministry of Natural Resources, Environment and Climate Change
Level 4, Block F11, Complex F
Lebuh Perdana Timur, Precinct 1
62000 Putrajaya, Malaysia
Phone number: +60380917322
Fax number: +60380917371
Country introduction: GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Department of Biosafety, Ministry of Natural Resources, Environment and Climate Change Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia. Email: [email protected]. Url: www. biosafety.gov.my
Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
| Name of product applicant: |
Pioneer Hi-Bred Philippines, Inc. |
| Summary of application: |
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| Date of authorization: |
22/08/2019 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Toxicological Assessment and Allergenicity Assessment
The safety assessment of novel protein, GAT4621, includes digestibility, heat inactivation, oral toxicity and amino acid sequence comparison studies to determine its potential to cause toxicity or allergenicity to hu mans (Pioneer, 2017).
Digestibility study using Simulated Gastric Fluid (SGF) with pepsin demonstrated that GAT4621 protein is rapidly degraded in simulated gastric fluid (SGF) with pepsin within 0.5 minutes with two low molecular weight bands visible through the two (2) minute time point in SGF (Pioneer, 2017). GAT4621 protein was readily digested in two (2) minutes upon incubation with simulated intestinal fluid (SIF) with pancreatin with no remaining bands detected. The same was observed in western blot analysis with pancreatinin (Pioneer, 2017).
Heat stability of GAT4621 was evaluated through monitoring the band intensity and enzymatic activity of the protein upon subject to varying temperatures (Pioneer, 2017). The stability of band intensity of GAT4621 upon incubation at 100°C for 30 minutes was determined through western blot analysis. Results showed a significant decrease in the band intensity of GAT4621 upon incubation at 100°C for 30 minutes. In terms of enzymatic activity, heat stability of GAT4621 protein upon incubation at temperatures ranging from 30-60°C for 15 minutes was determined using a continuous absorbance spectrophotometric enzyme activity assay. Results showed that GAT4621 protein was essentially inactivated upon incubation at above 53°C for 15 minutes.
Amino acid sequence comparison was conducted using techniques such as homology search using BLASTp program, a search for continuous, identical stretches of 8 amino acid residues in length, and an identity search using the FASTA35 alignment algorithm to search for alignments of 80 residues or longer possessing a sequence identity of 35%. Results showed that GAT4621 protein has no homology to any known toxins or allergens. (Pioneer, 2017).
The acute oral toxicity study indicated that administration of 2000 mg/kg GAT4621 protein to 5 male and 5 female mice did not resulted to mortality, treatment-related clinical observations of toxicity, gross lesions at necropsy body weight losses, change in food consumption, and macroscopic changes at necropsy. The No Observed Effect Level (NOEL) for GAT4621 protein is 2000 mg/kg body weight (Pioneer, 2017).
The GAT4621 proteins used for the toxicological and allergenicity studies was obtained from Escherichia coli and were found biochemically and functionally equivalent to GAT4621 expressed in DP73496 (Pioneer, 2017). Equivalency was determined through SDS-PAGE analysis which indicated the comparable molecular weight, western blot analysis which confirmed the immunoreactivity of plant-produced and E. coli-produced GAT4621, glycosylation analysis which indicated the absence of glycosylation of both test proteins and N -terminal amino acid sequence analysis and MALDI-MS analysis of tryptic peptides which showed sequence equivalency.
A computation of the percent total protein based on the data on the mean concentration of GAT4621 in DP73496 seed (6.2 ng/mg tissue dry weight) and the average crude protein content of DP73496 seeds (25.90/o) on a dry weight basis was provided by the developer (Pioneer, 2017). According to Martin-Hernandez et al. (2008), the human exposure to canola is limited primarily to the consumption of refined canola oil. Considering the total protein content of canola oil which is 0.2 µg/g, this indicates that for every tablespoon of DP73496 canola oil, the dietary exposure to GAT4621 protein would be 0.000056 µg.
Results of the toxicological and allergenicity assessment indicate that GAT4621 protein being expressed in DP73496 is not toxic or allergenic to humans (Pioneer, 2017).
Nutritional Data
Compositional analysis indicated the nutritional data of DP73496 in comparison with the non-transgenic canola, tolerance interval derived from range of commercial varieties and range of literature values (Pioneer, 2017; OECD, 2011). The trials were conducted six (6) sites in United States (Washington and North Dakota) and Canada (Saskatoon and Manitoba) under same environmental conditions. Results of the analysis indicated that there is no differences in the proximate, fiber, mineral, amino acid, fatty acid, vitamins, anti-nutrient, secondary metabolite, free amino acid and acetylated amino acid levels of DP73496 canola and the commercial canola varieties that can be considered biologically relevant. |
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| Authorization expiration date (a blank field means there is no expiration date) |
August 21, 2024 |
E-mail:
Organization/agency name (Full name): Bureau of Plant Industry
Contact person name: Geronima P. Eusebio
Website:
Physical full address: San Andres St., Malate, Manila
Phone number: 632 404 0409 loc 203
Fax number:
Country introduction: In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the 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), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.
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.
Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:
A full risk assessnent as to food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:
(a) genetic engineering, or
(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.
Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:
For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.
Notificatlon Requirement for Plant Products Carrying Stacked Genes
All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.
The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing. 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
| Name of product applicant: |
DuPont (Korea) Inc. |
| Summary of application: |
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| Date of authorization: |
02/04/2015 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Please see the link below(in Korean).
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E-mail:
Organization/agency name (Full name): Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address: Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number: 82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
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