| Commodity: |
Alfalfa / Lucerne |
| Traits: |
Glyphosate tolerance |
| Name of product applicant: |
INDEAR S.A. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
29/01/2019 |
| 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.): |
|
| Summary of the safety assessment (food safety): |
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. • It is concluded that alfalfa MON-ØØ163-7 is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties. |
| 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: |
GMO approvals in Argentina
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministerio de Agroindustria
Contact person name: Andrés Maggi
Website:
Physical full address: Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number: 54 11 5222 5986
Fax number:
Country introduction: In Argentina, the food and feed 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). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms. Useful links
Relevant documents
Stacked events: Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always 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)
https://www.argentina.gob.ar/senasa
https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia
| Name of product applicant: |
Monsanto Australia Ltd |
| Summary of application: |
Two distinct lines of glyphosate-tolerant lucerne, J101 and J163, have been developed using the same transgene (cp4 epsps). Each line has a separate insertion event at different, independently segregating loci. These two events were then combined through conventional breeding methods to optimise the number of plants carrying at least one copy of the gene conferring herbicide tolerance. Glyphosate-tolerant lucerne populations will contain a mixture of plants containing transformation event J101, J163 and both J101 x J163 due to the genetics of lucerne breeding.
Lucerne is an autotetraploid plant that is propagated by outcrossing and is adversely affected by inbreeding. Because of this, lucerne varieties are comprised of heterogeneous populations of lucerne breeding lines. In order to develop lucerne varieties displaying high trait purity while minimising inbreeding depression, a conventional breeding method has been developed that relies on glyphosate-tolerant plants carrying different, independently segregating transgenic events. The two independent events are subsequently combined via traditional F1 crossing between two non-related plants that each contains one of the independent events resulting in populations with more than 95% trait purity.
The glyphosate tolerance trait in lucerne lines J101 and J163 is due to the expression of the bacterial enzyme 5-enolpyruvyl-3-shikimate phosphate synthase (EPSPS) from
Agrobacterium sp. strain CP4. The EPSPS enzyme is present in all plants, bacteria and fungi and is essential for aromatic amino acid biosynthesis. The normal mode of action of glyphosate is to bind to the endogenous plant EPSPS, blocking its enzymatic activity which subsequently leads to the death of the plant. The bacterial EPSPS enzyme has a lower binding affinity for glyphosate, and therefore expression of CP4 EPSPS in the plant allows continuedproduction of aromatic amino acids in the presence of the herbicide.
Lucerne has a long history of use as animal forage and feed, both in grazing systems and as hay processed from cut and dried swards. Glyphosate-tolerant lucerne will enable the use of herbicides to provide effective weed control during forage and seed production. As weed infestations are a major limiting factor in the production of high-quality forage, superior weed control is expected to improve forage quality and allow higher yields. Availability of weed control at early, pre-plant, pre-emergence, and post-emergence timings will allow greater success in stand establishment and longer stand life.
In Australia and New Zealand, food uses of lucerne are referred to as alfalfa. There is a long history of food use of alfalfa, primarily as sprouted seeds and in alfalfa teas. Alfalfa would be expected to be consumed in minor quantities and on an occasional basis. |
| Upload: |
|
| Date of authorization: |
15/02/2007 |
| 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 (food safety): |
|
| 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: |
Application A575 - Food derived from Glyphosate- tolerant lucerne J101and J163
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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: |
Monsanto Canada |
| Summary of application: |
Monsanto has developed alfalfa (Medicago sativa L.) lines based upon transformation events J101 and J163. Alfalfa varieties containing these events express the CP4 5-enolpyruvylshikimate-3-phosphate (cp4-epsps) gene which confers tolerance to glyphosate herbicides (trade name, Roundup®). Health Canada has previously indicated no objection to the sale of glyphosate tolerant corn (NK603, Mon 802, Mon 832), cotton (1445), canola (GT 200, GT 73) and soybean (GTS 40-3-2) lines for human food applications in Canada. Like alfalfa events J101 and J163 these lines express the CP4 EPSPS enzyme which confers tolerance to glyphosate herbicides
The safety assessment performed by Food Directorate evaluators was conducted according to Health Canada's Guidelines for the Safety Assessment of Novel Foods. The assessment considered: how alfalfa events J101 and J163 were developed; how the composition and nutritional quality of alfalfa varieties containing these events compare to non-modified alfalfa varieties; and what the potential is for alfalfa derived from lines containing these events 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 alfalfa lines containing events J101 and J163 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
the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism" |
| Upload: |
|
| Date of authorization: |
28/07/2005 |
| 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.): |
BioTrack Product Database
|
| Summary of the safety assessment (food safety): |
Please see decision document weblinks |
| 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: |
Novel Foods Decision
Novel Feeds Decision
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Health Canada
Contact person name: Neil Strand
Website:
Physical full address: 251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number: 613-946-1317
Fax number:
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.
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 guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) 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: Neil Strand, Section Head of Novel Foods
| Name of product applicant: |
Monsanto Japan Ltd. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
14/10/2005 |
| 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.): |
OECD BioTrack Product Database
|
| Summary of the safety assessment (food safety): |
Please see the links below (in Japanese). |
| 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 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
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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: |
Monsanto Malaysia Sdn. Bhd. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
13/06/2022 |
| 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
|
| Summary of the safety assessment (food safety): |
Please refer to the Risk Assessment Report. |
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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: |
Monsanto Australia Ltd |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
11/05/2007 |
| 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 (food safety): |
FSANZ has completed a comprehensive safety assessment of food derived from glyphosate tolerant lucerne J101 and J163, as required under Standard 1.5.2 in the Code. The assessment included consideration of (i) the genetic modification to the plant; (ii) the potential toxicity and allergenicity of the novel protein; and (iii) the composition of glyphosate-tolerant lucerne J101 and J163 compared with that of conventional lucerne.
The assessment of this Application identified no public health and safety concerns. On the basis of the available evidence, including detailed studies provided by the Applicant, food derived from glyphosate-tolerant lucerne J101 and J163 is considered as safe and wholesome as food derived from other commercial lucerne varieties. |
| 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: |
Application A575 - Food derived from Glyphosate- tolerant lucerne J101and J163
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Ministry for Primary Industries
Contact person name: john vandenbeuken
Website:
Physical full address: Pastoral House, 25 The Terrace, Wellington, 6012
Phone number: 0298942581
Fax number:
Country introduction: New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint 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. 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:
| Name of product applicant: |
Monsanto Philippines, Inc. |
| Summary of application: |
|
| Upload: |
|
| 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.): |
|
| Summary of the safety assessment (food safety): |
Toxicological Assessment
Simulated gastric fluid (SGF) that contains a new formulation of pepsin was used to assess the
susceptibility of the CP4 EPSPS protein to proteolytic digestion in vitro. SDS-PAGE, western blot
analysis and EPSPS enzymatic activity assay were used to observe the digestibility of the E.coli –
produced CP4 EPSPS. SDS-PAGE staining method showed that at least 98% of the mature CP4 EPSPS
was digested in SGF within 15 seconds. No degenerative bands due to digestions were observed.
Western blot analysis confirmed that greater than 95% of the mature CP4 EPSPS was digested in SGF
within 15 seconds. Enzyme activity assay demonstrated that CP4 EPSPS activity was reduced by
>90% within 15 seconds of incubation in SGF.
In additon, the effect of heat treatment on CP4 EPSPS protein was determined using a functional
assay to assess the impact of temperature on activity and using SDS-PAGE to assess the impact of
temperature on protein integrity. The analysis showed no significant change in band intensity of the
CP4 EPSPS protein due heat treatment.
Furthermore, no biologically relevant structural similarities were observed between the CP4 EPSPS
protein and pharmacologically active proteins (including protein toxins) that are known to cause
adverse health effects in humans or animals, as shown by the bioinformatic analyses performed.
Meanwhile, an acute oral toxicity study was conducted with E. coli-produced CP4 EPSPS protein.
The E. coli-produced CP4 EPSPS protein has been shown to be equivalent to the plant-produced CP4
EPSPS present in J163. The NOEL for oral toxicity of the CP4 EPSPS in mice was 572 mg/kg. No
significant differences in body weight, cumulative body weight, or food consumption between the
vehicle or bovine serum albumin protein control groups and the CP4 EPSPS-treated groups were
observed.
The test protein was produced by Escherichia coli. Chemical and functional equivalence of the CP4
EPSPS produced by E. coli and the CP4 EPSPS produced in alfalfa J163 was demonstrated using five
methods namely, N-terminal sequencing, MALDI-TOF MS analysis, Western blot analysis and
immunoreactivity, SDS-PAGE, functional activity, and glycosylation analysis.
Allergenicity Assessment
A bioinformatic assessment of the CP4 EPSPS protein, using the allergen and public domain protein
sequences databases, has been performed and demonstrates the absence of sequence similarity to
proteins known to pose human health risks. No immunologically relevant sequences (eight
contiguous amino acid identities) were detected when the amino acid sequence of the CP4 EPSPS
protein was compared to the ALLERGEN3 sequence database.
In addition, the glycosylation analysis showed that the plant-produced CP4 EPSPS protein is not
glycosylated and is equivalent to that of the E. coli -produced CP4 EPSPS protein. The apparent
molecular weight of the plant-produced CP4 EPSPS protein was 43.3 kDa. Since this protein
migrated with an identical molecular weight as that of the E. coli reference standard, it was
concluded that this protein was the plant-produced CP4 EPSPS.
On the other hand, the overall mean CP4 EPSPS protein level in forage collected over two seasons is
270 g/g fresh weight, the CP4 EPSPS protein would represent approximately 0.52 percent of the
total protein in J163. This calculation was based on total protein levels of 5.2 % for fresh alfalfa
forage (Duke, 1981). Thus, the CP4 EPSPS protein represents a very small portion of the total protein
in the forage of J163
Nutritional Data
The forage samples used in compositional analyses were taken from plants grown in 2001 at five
replicated field sites across the alfalfa-producing regions of the United States (California, Illinois,
New York, Washington, and Wisconsin). Plots were established using plants that were reared in a
greenhouse and transplanted to the field. A randomized complete block design with four replicates
per treatment was used at each location. The treatments were: a) non-transgenic conventional
alfalfa; b) Roundup Ready J163 alfalfa were simplex (single copy, singe event); c) a synthetic
population of Roundup Ready alfalfa (Syn 1) that contained a combination of J101 and J163,
generated through conventional breeding (J101 x J163). Plots containing Roundup Ready alfalfa
were treated with a Roundup agricultural herbicide at expected commercial treatment rates.
Proximates include protein, fat, ash, and moisture. No significant difference was found in alfalfa J163,
J101 x J163 and the conventional alfalfa.
Meanwhile, six statistically significant differences observed between the J163 and nontransgenic
control: cystine, histidine, lysine, tyrosine, acid detergent fiber, and neutral detergent fiber.
However, the mean values of all nutrients analyzed were within the 99% tolerance interval
developed from the conventional alfalfa varieties grown at the same locations. Therefore, it is
unlikely that these differences are biologically significant.
Furthermore, lignin levels were measured in alfalfa forage produced by alfalfa plants containing J163
and in control and conventional alfalfa varieties. The values were significantly greater in J163 (18 %
increase) compared to the control, but were within the 99% tolerance interval established using
data derived from the conventional varieties. Therefore, it is concluded that lignin level in Roundup
Ready alfalfa is comparable to lignin levels in conventional alfalfa.
Recommendation
Find scientific evidence that the regulated article applied for human food and animal feed use is as
safe as its conventional counterpart and shall not pose any significant risk to human and animal
health |
| 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: |
|
| Upload: |
|
| 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: |
Monsanto Korea Ltd. |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
20/10/2017 |
| 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 (food safety): |
Please see the link below(in Korean). |
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
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:
| Name of product applicant: |
Monsanto |
| Summary of application: |
|
| Upload: |
|
| Date of authorization: |
21/03/2012 |
| Scope of authorization: |
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 (food safety): |
Alfalfa J101 (MON-00101-8) and J163 (MON-00163-7) have been genetically modified to tolerate the herbicide glyphosate through the transfer of the cp4 epsps gene (derived from Agrobacterium sp. strain CP4) to a alfalfa clone, R2336. Two different cp4 epsps insertion events, known as J101 and J163, were selected and combined through a conventional breeding process. Glyphosate-tolerant alfalfa plants may contain transformation event J101, J163 or both J101 and J163. The cp4 epsps gene encodes a version of the enzyme 5-enolpyruvyl-3-shikimatephosphate synthase (CP4 EPSPS) that continues to function in the biochemical pathway producing aromatic amino acids in a plant that has been applied with glyphosate. Molecular analyses showed that the transferred genes are stably integrated into the plant genome as single copies at different insertion sites, and are inherited in subsequent generations according to the patterns of inheritance. CP4 EPSPS protein is not toxic and does not have the potential to be allergenic in humans. Compositional analyses showed that forage from J101 and J163 is considered to be compositionally similar to forage from the control and commercially available alfalfa varieties. J101 and J163 are considered as substantially equivalent to their non-GM counterparts. |
| 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: |
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
Organization/agency name (Full name): Singapore Food Agency (SFA)
Contact person name: Dr Tan Yong Quan
Website:
Physical full address: 52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number: (65)68052750
Fax number:
Country introduction: The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food. SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption. The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Singapore Food Agency (SFA)
| Name of product applicant: |
Monsanto Company and Forage Genetics |
| Summary of application: |
Alfalfa
Trait 1 Added Protein: 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS)
Source: Agrobacterium sp. strain CP4
Intended Effect: Tolerance to the herbicide glyphosate
|
| Upload: |
|
| Date of authorization: |
10/12/2004 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
|
| Summary of the safety assessment (food safety): |
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
|
| Upload: |
|
| Authorization expiration date (a blank field means there is no expiration date) |
|
E-mail:
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: Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized. Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
|
|
