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1 FOOD SAFETY ASSESSMENT OF AGRICULTURAL BIOTECHNOLOGY PRODUCTS Biosafety Technical Team for Food Safety 2019
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Page 1: FOOD SAFETY ASSESSMENT OF AGRICULTURAL BIOTECHNOLOGY PRODUCTScdast.unej.ac.id/.../Wien...GE-Products_compressed.pdf · AGRICULTURAL BIOTECHNOLOGY PRODUCTS Biosafety Technical Team

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FOOD SAFETY ASSESSMENT OF AGRICULTURAL BIOTECHNOLOGY

PRODUCTS

Biosafety Technical Team for Food Safety

2019

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Content

1. Introduction

2. GE Food Safety Assessment

3. Closing Remarks

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Genetically Engineered (GE) Food are foodprocessed or raw materials, food additives,and/or other materials produced from thegenetically engineered products.

Living modified organism means any livingorganism that possesses a novel combinationof genetic material obtained through the use ofmodern biotechnology

DEFINITION

1. INTRODUCTION

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Scope of GE Product

a. Animals and their products ;

b. Fishes and their products;

c. Plants and their products; and

d. Microorganisms and their products.

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Why do GE food need to be regulated?

• GE Food is a novel foods that is different fromconventional food (counterparts) because of thepresence of new genes that are inserted.

• The presence of these new genes can potentiallypose risks to human health, such as can causeallergies or be toxic.

• In addition, there are pro-contra issues in thecommunity regarding the safety of GE Foods.

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GE FOOD POLICY

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GE Food (both produced domestically and imported products)

A safety assessment must be carried out as a precautionary approach before it is

marketed in Indonesia

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Law of Republic Indonesia Number 18 of 2012 on Food . Law of Republic Indonesia Number 21 of 2004 on

Ratification Cartagene Protocol on Biosafety to TheConvention on Biological Diversity.

Government Regulation Number 21 of 2005 on Biosafetyof Genetically Modified Products.

Government Regulation Number 28 of 2004 on FoodSafety, Quality, and Nutrition.

Government Regulation Number 69 of 1999 on FoodLabels and Ads.

President Regulation Number 39 of 2010 on BiosafetyCommission of GE Products, and its amandement.

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Regulations

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President Decision Number 43/M of 2016 on Designationof Members of the Biosafety Commission for GeneticEngineering Products.

Indonesia Food and Drug Authority Regulation Number 6of 2018 on Food Control.

Decision of the Chair of the Biosafety Commission onGenetic Engineering Products (PRG KKH) No. KEP-06/KKH/04/2018 on Determination of Changes in the Memberof the Biosafety Technical Team

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Regulations

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Everyone who carry out Food Production process oractivity is prohibited from using raw materials, foodadditives and/or other materials produced by geneticallyengineered process that has not obtained food safetyapproval before their distribution

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The Food Safety Approval was obtainedafter a GE food safety assessment has beencarried out based on a written request to theHead of Indonesia Food and Drug Authority

2. GE FOOD SAFETY ASSESSMENT

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GE Food Safety Assessment Steps

Marketing Approval

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KKH PRG : Biosafety Commission for GE ProductsTTKH FS : Biosafety Technical Team for Food SafetyBKKH : Biosafety Clearing House

Applicant

Head of Indonesia FDA

TTKH FS

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3. Biosafety Technical Team for Food Safety

Conducting food safety assessment of GE food. Consists of experts from various disciplines from

government, university, research institute andcommunity/ NGO.

Coordinator: Indonesia FDA (Director ofProcessed Food Standardization)

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GE Food Safety Assessment

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1. Genetic Information

2. Food Safety Information

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Assessment includes :

1. Genetic Information

a. Description of the recombinant-

DNA

b. Description of Host and Its Use as

Food

c. Description of Donor Organism(s)

d. Description of Genetic

Modification(s)

e. Characterization of Genetic

Modification(s)

2. Food Safety Information

a. Substantial equivalence

b. Nutritional modification

c. Allergenicity

d. Toxicity

e. Other considerations

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Genetic Information

1. Description of the recombinant-DNA

A description of the recombinant-DNA being presented for safetyassessment should be provided. This description should identify theorganism, the transformation event(s) to be reviewed and the typeand purpose of the modification. This description should besufficient to aid in understanding the nature of the food beingsubmitted for safety assessment.

2. Description of Host and Its Use as Food

a. Common or usual name; scientific name; and, taxonomicclassification;

b. History of cultivation and development through breeding, inparticular identifying traits that may adversely impact on humanhealth;

c. Information on the host organism’s genotype and phenotyperelevant to its safety, including any known toxicity or allergenicity;and

d. History of safe use for consumption as food. 14

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Genetic Information (cont.)

3. Description of Donor Organism(s)

a. Common or usual name; scientific name; and, taxonomicclassification;

b. Information about the natural history as concerns food safety;c. Information on naturally occurring toxins, anti-nutrients and

allergens; for microorganisms, additional information onpathogenicity and the relationship to known pathogens;

d. Information on the past and present use, if any, in the food supplyand exposure route(s) other than intended food use (e.g. possiblepresence as contaminants).

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Genetic Information (cont.)

4. Description of Genetic Modifications

a. The description of the transformation process must include:

1) Information on the specific method used for the transformation (e.g.Agrobacterium-mediated transformation);

2) Information, if applicable, on the DNA used to modify the organism(e.g. helper plasmids), including the source (e.g. plant, microbial, viral,synthetic), identity and expected function in the organism; and

3) Intermediate host organisms including the organisms (e.g. bacteria)used to produce or process DNA for transformation of the hostorganism.

b. Information about donor DNA includes:

1) The characterization of all the genetic components including markergenes, regulatory and other elements affecting the function of theDNA;

2) The size and identity;3) The location and orientation of the sequence in the final vector/

construct; and4) The function of the genetic components. 16

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5. Genetic Modification CharacterizationIn order to provide clear understanding of the impact on the composition and safety of foods derived from recombinant-DNA, a comprehensive molecular and biochemical characterization of the genetic modification should be carried out.

Information should be provided on the DNA insertions into theorganism genome; this should include :a. The characterization and description of the inserted

genetic materials;b. The number of insertion sites;

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Genetic Information (cont.)

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5. Genetic Modification Characterization (cont.)c. the organisation of the inserted genetic material at each

insertion site including copy number and sequence data ofthe inserted material and of the surrounding region,sufficient to identify any substances expressed as aconsequence of the inserted material, or, where moreappropriate, other information such as analysis oftranscripts or expression products to identify any newsubstances that may be present in the food.

d. identification of any open reading frames within the insertedDNA or created by the insertions with contiguous organismgenomic DNA including those that could result in fusionproteins.

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Genetic Information (cont.)

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1. Substantial equivalence

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To find out whether GE Food is substantially commensurate withnon GE Food.

Determination of substantial equivalence of GE Food requiresconsideration of the characteristics of foodstuffs or processedproducts which include compositional analyses of key components,phenotype and metabolite properties and food processing factorswith conventionally obtained food.

Food Safety Information

Analysis of GE Food includes: proximate, ADF (acid detergent fiber),NDF (neutral detergent fiber), TDF (total dietary fiber), amino acids, fattyacids, minerals, vitamins, and GE Food anti-nutrition compared with nonGE Food.

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a. Bioinformatics AnalysisAnalysis of amino acid sequence similarity between the protein in theGE food and known proteins allergen.The analysis uses the BLASTP, FARRP and FASTA programs.

b. Protein Concentration AnalysisAnalysis of protein concentration on total food protein (b / b) usingmethods include ELISA, SDS PAGE, WESTERN BLOT.

c. Stabilitas Protein• In vitro digestibility test of GE Food Product proteins in simulated

gastric fluid (SGF) and intestine (SIF, simulated intestinal fluid)simulations.

• Heat Stability Test.

2. Allergenicity

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Food Safety Information (cont.)

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3. Toxicity

Food Safety Information (cont.)

• Studies of the toxicity at least include:

• acute toxicity, and/or• sub chronic

• Potential toxicity of non-protein substances that have not been safely consumed in food should be assessed on a case-by-case basis depending on the identity and biological function in theplant of the substance and dietary exposure. The type of studies to be performed may include studies on metabolism,toxicokinetics, sub-chronic toxicity, chronictoxicity/carcinogenicity, reproduction and development toxicity according to the traditional toxicological approach.

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2. Nutritional Modification

Animal feeding studies may be warranted for foods derived fromrecombinant-DNA if changes in the bioavailability of nutrients areexpected or if the composition is not comparable to conventionalfoods. Also, foods designed for health benefits may require specificnutritional, toxicological or other appropriate studies. If thecharacterization of the food indicates that the available data areinsufficient for a thorough safety assessment, properly designedanimal studies could be requested on the whole foods.

Food Safety Information (cont.)

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GE food products that has obtained a GE food certificate

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There are 30 GE food that have received

food safety agreements

GE corn products(12 commodities)

GE soybean products(9 commodities)

GE sugarcane products(3 commodities)

GE potato product(1 commodity)

GE raw material product(1 commodity)

A list of safe GE food can be found at:BKKH website (http://indonesiabch.or.id/?lang=en) and

dit. SPO subsite (http://standarpangan.pom.go.id/)

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1. Corn event MON 89034 (resistance to butterflies and mothspests )

2. Corn event NK 603 (resistance to glyphosate herbicide)3. Corn event GA 21 (resistance to glyphosate herbicide)4. Corn event MIR 162 (resistance to butterflies and moths

pests)5. Corn event Bt 11 (resistance to borer pest and glyphosate

herbicide)6. Corn event MIR 604 (resistance to beetles pest)7. Corn event 3272 (modified amylase enzyme to produce

ethanol)8. Corn event MON 87427 (resistance to glyphosate herbicide)

GE corn products

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9. Corn event MON 87460 (tolerance to cold/heat and drought stress andresistance to kanamycin and neomycin)

10. Corn event TC 1507 (resistance to butterflies and moths pests andglufosinate herbicide)

11. Corn event MON 810 (resistance to butterflies, moths, and borer pests)

12. Corn event MON 87411 (resistance to Western and Northern CornRootworm, and beetles pests, and glyphosate herbicide)

13. Corn event MON 88017 (resistance to beetles pest and glyphosateherbicide)

14. Corn event MZIR098 (resistance to Western and Northern Corn Rootworm,and beetles pests, and glufosinate herbicide)

15. Corn event 5307 (resistance to Western and Northern Corn Rootworm, andbeetles pests)

16. Corn event MZHG0JG (resistance to glufosinate and glyphosate herbicides)

GE corn products

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GE soybean products

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1. Soybean event GTS 40-3-2 (resistance to glyphosate herbicide)2. Soybean event MON 89788 (resistance to glyphosate herbicide)3. Soybean event MON 87701 (resistance to butterflies and moths

pest)4. Soybean event MON 87705 (change in fatty acids content and

resistance to glyphosate herbicide)5. Soybean event MON 87708 (resistance to Dicamba herbicide)6. Soybean event MON 87769 (change in stearidonic acid content)7. Soybean event SYHT0H2 (resistance to glufosinate herbicide

and mesotrione)8. Soybean event 305423 (contains high oleic acid and resistance

to sulfonylurea )9. Soybean event 87751 (resistance to butterflies and moths pest)

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GE sugarcane products

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1. Potato event SP951 (Resistance toPhytophthora infestans pests)

1. Sugarcane event NXI-1T (Tolerance to droughtstress)

2. Sugarcane event NXI-4T (Tolerance to droughtstress)

3. Sugarcane event NXI-6T (Tolerance to droughtstress)

GE potato products

1. Ice structuring protein (to make ice cream doesn'tmelt easily)

GE raw material product

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Closing Remarks

• The food safety assessment of GE Food isconducted by Biosafety Technical Team ofFood Safety based on principal of‘precautionary approach’.

• The data to be assessed includes: genetic andfood safety informations.

• The progress of innovations of science andtechnology on developing GE Food become achallenge in conducting food safetyassessment.

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