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OECD Unique Identifier details

IR-ØØGR2E-5
Commodity: Rice
Traits: Rice with increased levels of provitamin A
Australia
Name of product applicant: International Rice Research Institute
Summary of application:

 


The International Rice Research Institute (IRRI) submitted an application to FSANZ to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) rice (Oryza sativa) line, GR2E, with OECD Unique Identifier IR-00GR2E-5 (herein referred to as GR2E). This rice line has been genetically modified to produce beta (β)-carotene (a form of provitamin A) in the endosperm of the rice grain.


 


This trait has been achieved through expression of a phytoene synthase protein (PSY1) encoded by a gene (Zmpsy1) from Zea mays (corn) and a carotene desaturase protein (CRTI) encoded by a gene (crtI) from the bacterium Pantoea ananatis. These two proteins, normally absent in rice endosperm, supply the necessary intermediaries to support a functional β-carotene biosynthetic pathway. When ingested, β-carotene is an effective source of vitamin A. The name ‘Golden Rice’ has been used to describe a number of versions of rice containing these two proteins (not necessarily from the same genes as used in GR2E).


 


The Applicant states the intended purpose of GR2E is to complement existing vitamin A deficiency control efforts by supplying up to 30–50 percent of the estimated average requirement for vitamin A for preschool age children and pregnant or lactating mothers in high-risk countries, including Bangladesh, Indonesia, and the Philippines.


 


GR2E also contains the bacterial phosphomannose isomerase (pmi) gene, which is derived from Escherichia coli strain K-12. Expression of the PMI protein in cells allows growth on mannose as a carbon source. This was used as a selectable marker to assist with identification of transformed rice cells in the early stages of selection. The PMI protein has been previously assessed by FSANZ in four corn applications - A564 (FSANZ 2006), A580 (FSANZ 2008b), A1001 (FSANZ 2008a), A1060 (FSANZ 2012).


 


GR2E was developed from a specific rice cultivar (see Section 2.1 below). Countries that wish to adopt the Golden Rice technology are free to introduce the GR2E event into preferred varieties that suit the local environment and meet certain humanitarian use criteria. Rice containing the GR2E event is not intended for commercialisation (either growing or intentional sale in the food supply) in Australia or New Zealand but it is possible it could inadvertently enter the food supply via exports from countries that may supply significant quantities of milled rice to Australia/New Zealand.


 


 


 


 

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Date of authorization: 22/02/2018
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):
Please kindly refer to the attachments.
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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: A1138 – Food derived from provitamin A rice line GR2E
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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.

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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)

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)

Canada
Name of product applicant: International Rice Research Institute
Summary of application:

The International Rice Research Institute (IRRI) has developed a genetically modified rice event (GR2E) using recombinant-DNA techniques that is biofortified with provitamin A.  GR2E rice will be grown commercially in major rice-producing regions, primarily in Asia.  The main intended market for this product is in countries such as Bangladesh and the Philippines where diets are typically low in vitamin A.  Intrinsic food supplementation could be a useful tool for alleviating vitamin A deficiency (VAD) in children, a known and preventable cause of blindness.  The IRRI has indicated that this product is not intended to be sold in Canada.

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Date of authorization: 16/03/2018
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the decision document weblink.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision
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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.

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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

New Zealand
Name of product applicant: International Rice Research Institute
Summary of application:

Application A1138 was submitted by IRRI on 16 November 2016. It seeks a variation to Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) rice (Oryza sativa) line, GR2E. This rice line has been genetically modified to produce beta (β)-carotene (the predominant form of provitamin A) and, to a lesser extent, the two other forms of provitamin A (α-carotene and β-cryptoxanthin) in the endosperm of the rice grain. This trait has been achieved through expression of a phytoene synthase protein (PSY1) encoded by a gene (Zmpsy1) from Zea mays (corn) and a carotene desaturase protein (CRTI) encoded by a gene (crtI) from the bacterium Pantoea ananatis. These two proteins, normally absent in rice endosperm, supply the necessary intermediates to support a functional β-carotene biosynthetic pathway. The collective name ‘Golden Rice’ has been used to describe a number of versions of rice containing these two proteins (not necessarily from the same genes as used in GR2E).


GR2E also contains the bacterial phosphomannose isomerase (PMI) gene which is derived from Escherichia coli strain K-12. Expression of the PMI protein in cells allows growth on mannose as a carbon source. This was used as a selectable marker to assist with identification of transformed rice cells in the early stages of selection. The PMI protein has been previously assessed by FSANZ in four corn applications – A564 (FSANZ 2006), A580 (FSANZ 2008a), A1001 (FSANZ 2008b) and A1060 (FSANZ 2012).

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Date of authorization: 06/06/2018
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):
In conducting a safety assessment of food derived from GR2E, a number of criteria have been addressed including: a characterisation of the transferred gene sequences, their origin, function and stability in the rice genome; the changes at the level of DNA and protein in the whole food; compositional analyses and evaluation of intended and unintended changes. No potential public health and safety concerns have been identified in the assessment of GR2E. On the basis of the data provided in the present Application, and other available information, food derived from GR2E is considered to be as safe for human consumption as food derived from conventional rice varieties.
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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: A1138 – Food derived from Provitamin A Rice Line GR2E
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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:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
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:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Philippines
Name of product applicant: Philippine Rice Research Institute (PhilRice) and International Rice Research Institute (IRRI)
Summary of application:

On February 28, 2017, Philippine Rice Research Institute (PhilRice) and International Rice Research Institute (IRRI) submitted GR2E Rice application for direct use as food and feed, or for processing to the Bureau of Plant Industry (BPI) under the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016. After reviewing the accomplished biosafety forms and socio-economic, ethical and cultural questionnaire, and supporting documents submitted by the applicant, the assessors namely: Scientific and Technical Review Panel (STRP), BPI- Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry (BAI), concurred that GR2E Rice is as safe for human food and animal feed as its conventional counterpart.

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Date of authorization: 10/12/2019
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 ZmPSY1 Protein Pepsin was used in a standardized digestion model. It was reported that the in vitro pepsin digestibility of ZmPSY1 protein was investigated by Oliva (2016) by incubating purified ZmPSY1 protein for 0, 0.5, 1, 2, 5, 10, 20, 10 and 60 minutes at 370C in the presence of simulated gastric fluid (SGF) pH 1.2 containing pepsin. Following exposure to SGF containing pepsin for 30 seconds, the earliest time point sampled during digestion, no intact ZmPSY1 protein (ca. 42 kDa) was evident as assessed by either SDS-PAGE or western immunoblot analysis. Low molecular weight degradation products were visible in samples removed up to two minutes of digestion, but not at later time points, and these were not detected in the western blot. On the other hand, thermal stability was measured by measuring enzymatic activity. Data showed that after heat treatment at 42 degrees C, activity of ZMPSY1 was at 50%, while preincubation at 50 degrees C for 15 minutes completely inactivated phytoene synthase. The methods used to measure the effect of temperature on enzyme activity were sufficient to show that temperatures lower than those used for cooking rice can inactivate phytoene synthase. For amino acid comparison, the ZmPSY1 protein (with and without the transit peptide) did not show a match at an E (0) lower than 1x10-5, and as such does not show similarity to known toxins. Furthermore, the acute oral gavage study was not performed for ZmPSY1 protein. According to the STRP, reason presented by applicant is acceptable in consideration of the evidence presented showing safety of ZmPSY1; that there is no toxin/allergen homology, it had high digestibility and underwent heat inactivation. CRTI protein The STRP reported that the in vitro pepsin digestibility of CRTI was investigated by Oliva and Cueto (2016) by incubating purified CRTI protein for 0, 0.5, 1, 2, 5, 10, 20, 10 and 60 minutes at 370C in the presence of simulated gastric fluid (SGF) pH 1.2 containing pepsin. CRTI protein was rapidly and completely digested when incubated in SGF containing pepsin. Following 30 seconds of incubation, the earliest time point sampled during digestion, no intact CRTI protein was evident as assessed by either SDS-PAGE or western immunoblot analysis. These data support the conclusion that CRTI protein will be readily digested as conventional dietary protein in a typical mammalian gastric environment, and there would not be a concern of increased potential allergenicity or toxicity due to stability of the CRTI protein in pepsin. CRTI activity was lost by 50% following 15 minutes incubation at 510C. Activity was totally lost when CRTI was incubated at 55 degrees for 15 minutes. Enzyme activity was measured using spectrophotometric assay. It was reported that the CRTI protein was shown to share homology with 3 known toxins from snake venom. However, there was limited sequence homology with these snake venom proteins. The similarities were at the N-terminal motifs, which is not considered as structural alert for sequence similarity. Acute oral gavage was performed for CRTI in mice. The study done by Mukerji (2016) evaluated the acute toxicity of the test substance, CRTI protein, in Crl:CD1 (ICR) mice following oral exposure at 100 mg/kg (administered in a split dose over a period of approximately 4 hours). All animals survived to scheduled euthanasia. There were no clinical abnormalities or overall (test day 1-15) losses in body weight among any of the animals tested. Gross findings were limited to a discolored tooth in one animal, which was considered non-specific. Under the conditions of this study, oral administration of CRTI protein to male and female mice at 100 mg/kg did not result in mortality or other evidence of acute oral toxicity, based on evaluation of body weight, clinical signs, and gross pathology. Therefore, an LD50 was not determined. PMI protein Pepsin was used in the digestibility study of PMI protein. The susceptibility of PMI to proteolytic degradation in simulated mammalian gastric fluid was evaluated using SDS PAGE and Western blot analysis. The results showed that PMI was readily degraded with no intact protein or degradation fragments detected following digestion for one minute. The heat stability of PMI protein was also evaluated by measuring enzymatic activity following pre-incubation for 30 min at 25-95 C. PMI enzymatic activity was below limits of quantification following pre-incubation at 65°Celsius and above. For amino acid sequence comparison, the STRP reported that no homologies were found with known/putative toxins using BLASTP. Moreover, Korgaonkar in 2009 performed single-dose oral (gavage) toxicity study using test substance PMI-0105, containing the active ingredient phosphomannose isomerase protein (89.5% purity w/w), which was administered as a single oral gavage dose to groups of five male and five female Crl:CD-1(ICR) mice at 0 or 2000 mg active ingredient/ kg body weight. All animals survived the 14-day observation period following dosing, up until the scheduled necropsy. There were no test substance-related clinical observations. There were no test substance-related effects on body weight or weight gain, food consumption or hematology parameters. There were no macroscopic or microscopic findings that were attributable to the test substance (Korgaonkar, 2009). Higher urea nitrogen levels (males only), slightly higher alkaline phosphatase levels (males only) and slightly higher alanine aminotransferase levels (females only) were noted in the 2000 mg/kg group compared with the control group, and were considered test substancerelated. However, these changes in serum chemistry parameters were considered nonadverse as there were no histopathological correlates and the group mean values were within WIL Historical control ranges (Version 2.5), except for one male mouse which had urea nitrogen levels exceeding the historical control range (Korgaonkar, 2009). Statistically significantly lower testicular and epididymal weights in males and slightly higher adrenal weights in females were noted in the 2000 mg/kg group compared with the control group, and were considered test substance-related. However, there were no distinct microscopic changes in these organs, and the organ weights were within the WIL Historical control ranges (Version 2.6), suggesting that organ weight alterations probably represented physiologic responses of a non-adverse nature (Kargaonkar, 2009). The assessors agreed with the applicant that the ZmPSY1, CRTI, and PMI proteins are independently expressed. Functional activity of both the ZmPSY1 and CRTI proteins is evidenced by the accumulation of b-carotene in GR2E rice endosperm, which would not occur if either of these proteins was inactive. Functional expression of the PMI protein was evidenced by the ability to select transformed plantlets in tissue culture on media containing only mannose as a carbon source. In addition, ZmPSY1 and CRTI are expressed in plastids while PMI is expressed in the cytoplasm. Only the ZmPSY1 and CRT1 enzymes interact in a metabolic pathway. Their sequential activities complete the carotenoid biosynthetic pathway in the GR2E rice endosperm. The condensation of two molecules of geranylgeranyl diphosphate to yield the first carotenoid C40 15-cis-phytoene, is catalyzed by ZmPSY1. CRT1 catalyzes consecutive modifications of phytoene, including desaturation and isomerization to form all-trans-lycopene. The endogenous rice B-cyclase enzyme is responsible for production of B-carotene from all-trans-lycopene. ALLERGENICITY ASSESSMENT ZmPSY1 Protein Pepsin in SGF was used and phytoene synthase was found to be digested with T50 of less than 30 seconds. In addition, data presented shows that phytoene synthase was inactivated by heat, with T50 of 51°C. No amino acid homology with known allergens were found in allergen database. It was reported that the expression of the ZmPSY1 proteins in event GR2E is driven by the endosperm-specific rice GluA-2 promoter and measurable concentrations of this protein were found in all grain developmental stages but not in stem tissue (straw). The highest concentration was measured in samples of dough-stage grain (BBCH 85) ranging between ca. 308-359 ng/g. Across the four locations and two growing seasons, the highest concentration for ZmPSY1 measured in samples of mature grain was 245 ng/g FWT. Total protein intake in grain was 8.1% DB; moisture content was 12.26%. Therefore, ZmPSY1 was 0.00034% of total protein. Serum screening was not performed since the introduced gene product was found to be not a major allergen. CRTI Protein Digestibility study used pepsin in simulated gastric fluid. Results showed that T50 was less than 30 secs, and no fragments were observed after exposure to pepsin in SGF. The thermal stability of the phytoene desaturase (CRTI) protein was evaluated by measuring enzymatic activity using a spectrophotometric assay to monitor the conversion of liposomeincorporated 15-cis-phytoene to all-trans-lycopene. Samples of microbial-expressed CRTI protein were subjected to heat treatment over a temperature incubation range of ca 30-600C for 15 minutes, following which enzyme activity was measured at 370C in the presence of 7µM phytoene, 150 µM Flavin adenine dinucleotide (FAD), 50 mM Tris-HCl pH8.0, and 200 mM NaCl. Under conditions of this study, the CRTI enzyme lost half of its activity when preincubated at ca. 510C for 15 minutes and was completely inactivated following pre-incubation at 550C for 15 minutes. The temperatures required to completely inactivate the CRTI enzyme were significantly lower than temperatures normally employed during cooking or processing, and it is therefore expected that dietary exposure to functional CRTI will be negligible (Schaub and Beyer, 2016). The 492 amino acid sequence encoded by the CRTI gene was compared to a peer reviewed database of 1956 known and putative allergen and celiac protein sequences found in FARRP16 dataset at University of Nebraska. No identity matches of >35 % over 80 residues were observed and no matches of eight contiguous identical amino acids. It was reported that CRTI was 0.00004% of total protein. Computed from 0.03 ug/gFWT of CRTI in mature grain, Total Protein content in grain was 8.1% DB, moisture content was 12.26%. PMI Protein The assessors reported that the digestibility study used pepsin in simulated gastric fluid. Results showed that T50 was less than 30 seconds, and no fragments of PMI were observed after exposure to pepsin in SGF. Furthermore, no significant sequence similarity between any 80 amino acid peptide of the PMI amino acid sequence and any entry in the FARRP AllergenOnline database (2010). Further investigation was done by using sensitive serum screening methodology. No cross reactivity between PMI and the serum from the single individual known to have demonstrated IgE-mediated allergy to this specific a-paravalbumin was found. The patient’s serum did not recognize any portion of the PMI protein as an allergenic epitope. Thus, the sequence identity between PMI an a-paravalbumin from Rana species CH2001 is not biologically meaningful and has no implications for the potential allergenicity of PMI. NUTRITIONAL DATA For the proximate and fibre analysis of straw, the assessors found scientific evidence that there were no statistically significant differences in proximates and fibre between samples of straw obtained from GR2E and control PSB Rc82 rice. Furthermore, the mean values for all proximates and fibre in rice straw were similar to the range reported in literature with the exception of moisture content, which is dependent on the extent of drying straw following harvest. On the other hand, comparison of proximates and fibre in grain (paddy) samples derived from GR2E and control PSB Rc82 rice grown during the rainy season resulted in no statistically significant differences in ash, crude fat, crude protein, carbohydrate, amylose, moisture, acid detergent fiber (ADF), neutral detergent fiber (NDF), and total dietary fiber (TDF). Although there was a statistically significant difference in the mean concentration of crude fibre between samples of GR2E and PSB Rc82 rice grain, the difference was relatively small (10.5 percent) and unlikely to be biologically meaningful. Some of the parameters like crude fat, acid detergent fiber, neutral detergent fiber and starch were not within the literature values; however, for these values, there were no statistically significant differences between GR2E rice and control PSB Rc82 rice. For the proximate and mineral analysis of bran, no statistically significant differences were noted for any of the measured parameters between bran samples derived from GR2E and control PSB Rc82 rice grain. The measured values for the analytes were within the respective ranges reported in the literature except for crude fat and phosphorus which were slightly higher in both GR2E and control PSB Rc82rice. For the analysis of minerals in straw, the assessors confirmed that there were no statistically significant differences in concentrations of calcium and phosphorus measured in samples of GR2E and control PSB Rc82 rice straw across locations and growing seasons. Calcium and phosphorus levels in straw samples of GR2E and PSB Rc82 were within range reported in the literature. Moreover, comparison of the mineral composition in samples of GR2E and control PSB Rc82 rice grain did not reveal any statistically significant differences in the concentrations of any measured analytes. The mean concentrations of each of the minerals measured in samples from GR2E and control PSB Rc82 rice grain were within the ranges reported in the literature. A comparison of amino acid composition of event GR2E and control PSB Rc82 rice (grown during the rainy and dry season) grain showed no statistical differences in the concentrations of any amino acids between samples of Gr2E and PSB Rc82. The mean concentrations of each of the amino acids except tryptophan (lower but not statistically different) in samples from GR2E and PSB Rc82 rice were within the ranges of literature values. In addition, samples of event GR2E and control PSB Rc82 rice grain were analyzed for concentrations of the water-soluble B vitamins (thiamine, riboflavin, niacin, pantothenic acid, pyridoxine, and folic acid), β-carotene, and α-tocopherol (Vitamin E). Except for B-carotene which was intended to be elevated in GR2E rice, there were no statistically significant differences noted in the concentrations of any measured vitamins between GR2E and control PSB Rc82 rice. Comparison with a range of values from the literature showed that GR2E had detectable and high values for β- carotene. All other vitamins were within the published range of values. For the analysis of fatty acids in grain, it was reported that the only statistically significant different observed between GR2E and control PSB Rc82 rice samples was in the concentration of stearic (C18:0) acid which was ~ 6.5% higher for GR2E rice. The data for the grain fatty acids from GR2E were within the range reported in the literature. Analysis of anti-nutrients present in grain were also conducted. The assessors have confirmed that there were no statistically significant differences in the concentrations of phytic acid or in levels of trypsin inhibitor between samples of GR2E and PSB Rc82 control rice. On the other hand, data on levels of phytic acid and trypsin inhibitor in conventional rice grain are limited or non-existent. Mean concentrations of phytic acid in grain samples from GR2E and control PSB Rc82 rice were both slightly outside the range reported from the ILSI Crop Composition Database, but were not significantly different. The assessors concurred with the applicant stating that the trypsin inhibitor is affected by heat and activity is expected to be significantly reduced following cooking. On the other hand, concentrations of phytic acid in rice may be reduced up to 82 percent when rice is cooked after steeping in excess water and then the excess water discarded, or up to 31 percent when rice is cooked without excess water removal. Reductions in phytic acid content of approximately 54 percent following boiling have also been reported. Moreover, the assessors reported that rice event GR2E was developed through the use of recombinant-DNA techniques to express elevated levels of provitamin A (mainly β-carotene in the rice endosperm, which is converted in the body to vitamin A). Vitamin A is required for normal functioning of the visual system, maintenance of cell function for growth, epithelial integrity, production of red blood cells, immunity and reproduction. Vitamin is an essential nutrient in humans that cannot be synthesized de novo in the body, so it must be obtained through the diet. It is a natural component of certain food crops with a history of long use for its beta -carotene nutrient content, such as those found in raw carrots that contain 82.9 ug beta-carotene/ g carrot. The applicant presented data on results of studies wherein different amounts of β-carotene were taken for several years. The conclusion was that there was no toxic effect of the prolonged uptake of β-carotene. In addition, data shows that the amount of β-carotene in GR2E is 7.31 ug/g. It was reported that there are no adverse effects when β-carotene is taken in excess of average consumption and below 15 mg per day. STRP RECOMMENDATION The assessors found scientific evidence that the regulated article applied for human food and/or animal feed use is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health.
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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:
Upload:
Authorization expiration date (a blank field means there is no expiration date) December 9, 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
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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.

 

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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

United States of America
Name of product applicant: International Rice Research Institute
Summary of application:

Rice
Submission Date: Nov 14, 2016
Developer Name: International Rice Research Institute
Developer Contact Information: DAPO Box 7777
Metro Manila 1301
PHILIPPINES


Trait 1 Added Protein or DNA: Phytoene synthase
Source: Zea mays
Intended Effect: Converts geranylgeranyl diphosphate to phytoene


Trait 2 Added Protein or DNA: Carotene desaturase I
Source: Pantoea ananatis
Intended Effect: Converts phytoene to lycopene


Trait 3 Added Protein or DNA: phosphomannose isomerase
Source: Escherichia coli
Intended Effect: selectable marker for transformation


Event Designation: GR2E

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Date of authorization: 24/05/2018
Scope of authorization: Food and feed
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Food and Drug Administration
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Jason Dietz
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5100 Paint Branch Parkway, College Park MD 20740
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240-402-2282
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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.

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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:

Food and Drug Administration ([email protected]); Environmental Protection Agency