Food safety and quality
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OECD Unique Identifier details

ACS-OSØØ2-5
Commodity: Rice
Traits: Glufosinate tolerance
Australia
Name of product applicant: Bayer CropScience Pty Ltd
Summary of application:
Glufosinate ammonium (also referred to as phosphinothricin, L-PPT) is a non-selective,
contact herbicide that provides post-emergence control of many broadleaf and grassy weeds.
LLRICE62 is tolerant to glufosinate-ammonium through the expression in the plant of the bacterial enzyme phosphinothricin acetyl transferase (PAT) encoded by the bar gene from the soil bacterium Streptomyces hygroscopicus. The PAT enzyme chemically inactivates the herbicide. Expression of this enzyme in LLRICE62 therefore enables the use of glufosinate ammonium herbicides on post-emergence weeds, without adverse effects to the crop.
Glufosinate-ammonium is currently registered in Australia under the commercial name of Basta for non-selective uses, or Finale for turf and home garden uses, and as Buster in New Zealand.
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Date of authorization: 09/10/2008
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):
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Application A589 - Food derived from glufosinate ammonium-tolerant rice LLRICE62
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 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: Bayer CropScience Canada
Summary of application:
Bayer CropScience has developed rice (O. sativa) lines based upon transformation event LibertyLink® rice 62 (LLRICE62). Rice varieties containing this event express the bar gene which confers tolerance to glufosinate-ammonium herbicides (trade name, Liberty®). Health Canada has previously indicated no objection to the sale of glufosinate tolerant corn(DLL25 and DBT418) and cotton (LLCotton25) lines for human food applications in Canada. Like rice event LLRICE62, these lines express the bar gene which confers tolerance to glufosinate ammonium.

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 rice event LLRICE62 was developed; how the composition and nutritional quality of grain derived from rice varieties containing this event compare to grain of non-modified rice varieties; and what the potential is for grain derived from lines containing this event to be toxic or cause allergic reactions.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). Foods derived from rice lines containing event LLRICE62 are considered novel foods under the following part of the definition of novel foods: "c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

i.the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism"
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Date of authorization: 07/06/2006
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): 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
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Neil.Strand@hc-sc.gc.ca
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

Mexico
Name of product applicant: Bayer de México, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 45


Rice
Trait 1 Added Protein: Phosphinothricin acetyltransferase (PAT)
Source: Streptomyces hygroscopicus
Intended Effect: Tolerance to the herbicide glufosinate-ammonium

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Date of authorization: 28/03/2007
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.):
Summary of the safety assessment (food safety):
UI OECD: ACS-OSØØ2-5 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
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:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: ralatorre@cofepris.gob.mx%20

New Zealand
Name of product applicant: Bayer CropScience Pty Ltd
Summary of application:

Glufosinate ammonium (also referred to as phosphinothricin, L-PPT) is a non-selective,
contact herbicide that provides post-emergence control of many broadleaf and grassy weeds.
LLRICE62 is tolerant to glufosinate-ammonium through the expression in the plant of the bacterial enzyme phosphinothricin acetyl transferase (PAT) encoded by the bar gene from the soil bacterium Streptomyces hygroscopicus. The PAT enzyme chemically inactivates the herbicide. Expression of this enzyme in LLRICE62 therefore enables the use of glufosinate ammonium herbicides on post-emergence weeds, without adverse effects to the crop.
Glufosinate-ammonium is currently registered in Australia under the commercial name of Basta for non-selective uses, or Finale for turf and home garden uses, and as Buster in New Zealand.

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Date of authorization: 05/03/2009
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 glufosinate ammonium-tolerant rice LLRICE62, 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 LLRICE62 compared with that of conventional rice varieties. 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 glufosinate ammonium-tolerant rice LLRICE62 is considered as safe and wholesome as food derived from other commercial 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: Application A589 - Food derived from glufosinate ammonium-tolerant rice LLRICE62
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
andrew.pearson@mpi.govt.nz
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Andrew Pearson
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448942535
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: Bayer Crop Science
Summary of application:
Bayer CropScience, Inc. has developed a rice event with tolerance to glufosinate ammonium herbicide. The event, designated as LLRICE62, was developed to impart novel tolerance to the herbicide glufosinate ammonium which allows for the control or suppression of weeds in rice production.
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Date of authorization: 16/05/2012
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Bayer CropScience, Inc. submitted an application to the Bureau of Plant Industry (BPI) requesting a biosafety permit for direct use as food and feed or for processing under A.O. #8 for LLRICE62 which has been genetically modified for herbicide tolerance. Bayer CropScience, Inc. has provided information on the safe history of use of the crop, the source of the donor gene, the molecular characterization of the LLRICE62 event, the stability of the inserted genetic elements, characterization and expression levels of the PAT protein, safety of the PAT protein including absence of any allergenicity or toxicity characteristics, the nutrient composition of forage and grain as well as processed fractions, and overall food and feed safety of plants containing the LLRICE62 event and products derived from them. Relevant scientific publications were also supplied. The LLRICE62 event has been evaluated according to BPI’s safety assessment procedures carried out by the relevant agencies of the Department of Agriculture: Bureau of Animal Industry (BAI), Bureau of Agriculture Fisheries and Product Standards (BAFPS) and Scientific Technical Review Panel (STRP) members. The process involved an intensive analysis of the nature of the genetic modification with a consideration of general safety issues, and the toxicological and nutritional characteristics of the LLRICE62 event. The petitioner/applicant published the said application in two (2) widely circulated newspapers for public comments/review. BPI did not receive any comments during the 30-day comment period in regards to the LLRICE62 application for direct use as food and feed or for processing. However, outside of this comment period, the BPI received several documents opposing LLRICE62. These were forwarded to the applicant, and to the concerned STRP members who found that the proponent had fully evaluated and demonstrated the safety of the PAT protein in accordance with the internationally accepted criteria set out in the Codex Alimentarius Commission Guideline (Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants, CAC/GL 45-2003). In 2007, a case was filed by Greenpeace against the DA entitled “Declaration of Unconstitutionality of DA Administrative Order No. 8, Prohibition, Mandamus Injunction and Temporary restraining Order (TRO)”. On August 16, 2010, the Clerk of the Court of Appeals issued certification that an entry of judgment for the case had been made, and recorded in the book of entries of judgment the decision rendered by the Court of Appeals dated November 4, 2009 that has become final and executory. In view of the Court of Appeals decision dissolving the writ of preliminary injunction issued by the Regional Trial Court on Bayer’s LLRICE62 application, it is the DA Legal Division’s opinion that there is no more legal impediment to BPI processing Bayer’s LLRICE62 application. Review of the results of evaluation by the BPI Biotech Core Team completed the approval process.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Ma. Lorelie U. Agbagala
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 202
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.

 

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Relevant documents
Stacked events:

Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.

 

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

Russian Federation
Name of product applicant: Bayer CropScience LP
Summary of application:

There were submitted (1) data enabling to identify the matter of research (species, variety, and the transformation event); (2) data on the initial parental organism and the donor organism for introduced genetic sequences;  (3) data on the genetic modification method, genetic construction, and the level of gene expression; (4) data on identification of GM rice line LL62 (identification methods, protocol of analysis, description of primers, reference materials); (5) data on registration of the GM line  in other countries and the results of safety assessment which conducted for registration purposes of GMO in other countries.

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Date of authorization: 15/10/2003
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.):
Summary of the safety assessment (food safety):
By all examined parameters, the data of the complex safety assessment of transgenic rice line LLRICE62 tolerant to glufosinate ammonium attest to the absence of any toxic, genotoxic, immunomodulating, or allergenic effects of this rice line. By biochemical composition, the transgenic rice line LLRICE62 was identical to conventional rice. Based on results of these studies, the Ministry of Health of the Russian Federation (Department of State Sanitation and Epidemiological Inspectorate) granted the Registration Certificate, which allows the transgenic rice line LLRICE62 to be used in the food industry and placed on the market without restrictions. More information is on P. 272-289 of monograph ”Genetically Modified Food Sources. Safety Assessment and Control”, published by Elsevier Inc. Academic Press in 2013, the uploaded file.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
tnv@ion.ru
Organization/agency name (Full name):
FSBI «Institute of Nutrition» RAMS
Contact person name:
Nadezhda Tyshko
Website:
Physical full address:
109240, Russia, Moscow, Ustinsky Proezd, 2/14
Phone number:
+7(495)698-53-64
Fax number:
Country introduction:

The development of the GMO safety assessment currently used in the Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers. GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 2.3.2.2306-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”. According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following: ■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level. ■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products. ■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies. ■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food). The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc.

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Stacked events:

Russia follows the national Methodical Guidelines  2.3.2.3388-16 “Medical and biological safety assessment of genetically modified stack events of plant origin ”

Our position regarding GM stacks registration is very close to the EU approach.

 

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Federal Research Centre of nutrition and biotechnology Viktor A. Tutelyan Ustinsky proezd, 2/14 109240 Moscow, RUSSIA E-mail: tutelyan@ion.ru Tel.:+7 495 698-53-60

United States of America
Name of product applicant: AVentis Crop Science
Summary of application:
Rice
Trait 1 Added Protein: Phosphinothricin acetyltransferase (PAT)
Source: Streptomyces hygroscopicus
Intended Effect: Tolerance to the herbicide glufosinate-ammonium
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Date of authorization: 31/08/2000
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please consult the FDA website links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:

The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.

Useful links
Relevant documents
Stacked events:

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 (premarkt@fda.hhs.gov); Environmental Protection Agency