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OECD Unique Identifier details

DP-ØØ4114-3
Commodity: Corn / Maize
Traits: Herbicide tolerance,Insect resistance
European Union
Name of product applicant: Pioneer Overseas Corporation
Summary of application:

The genetically modified maize 4114 expresses the Cry1F (truncated version), Cry34Ab1 and Cry35Ab1 proteins providing protection against specific lepidopteran and coleopteran pests, and the PAT protein conferring tolerance to glufosinate-ammonium based herbicides.

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Date of authorization: 26/07/2019
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.): EU Register of authorised GMOs
Summary of the safety assessment (food safety):
Please see the EU relevant 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:
Method for detection: Event specific real-time quantitative PCR based method for detection of the genetically modified maize DP-ØØ4114-3. Reference material: ERM®-BF439 is accessible via the Joint Research Centre (JRC) of the European Commission. The relevant links are provided below.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Method for detection
Reference Material
Opinion of the European Food Safety Authority
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Authorization expiration date (a blank field means there is no expiration date) 28/07/2029
E-mail:
Organization/agency name (Full name):
European Union
Contact person name:
Alexandre Huchelmann
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
3222954092
Fax number:
Country introduction:

The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).

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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Australia
Name of product applicant: Pioneer Hi-Bred Australia Ltd
Summary of application:

Pioneer Hi-Bred Australia Ltd on behalf of Pioneer Hi-Bred International Inc has submitted, an application to FSANZ to vary Standard 1.5.2 – Food produced using Gene Technology – in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) corn line with OECD Unique Identifier DP-004114-3 (also referred to as line 4114). The corn has been modified to be tolerant to the herbicide glufosinate ammonium (glufosinate) and protected against lepidopteran insect pests, particularly European corn borer (Ostrinia nubilalis) and coleopteran insect pests, particularly western corn rootworm (Diabrotica virgifera virgifera).


Tolerance to glufosinate is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat gene derived from the common soil bacterium Streptomyces viridochromogenes. This protein has been considered in 19 previous FSANZ approvals and globally is represented in six major crop species and over 30 approved GM single plant events.


 


Protection against lepidopteran insect pests is conferred by the cry1F gene, which is a synthetic version of a gene from Bacillus thuringiensis var. aizawai, and encodes a truncated version of an insecticidal protein, Cry1F. Protection against coleopteran insect pests is conferred by two genes, cry34Ab1 and cry35Ab1 both from B. thuringiensis strain PS149B1 and encoding the insecticidal proteins Cry34Ab1 and Cry35Ab1. These proteins have both been considered previously by FSANZ.


 


Line 4114 is a molecular stack3 that, in terms of traits, is the equivalent of a breeding stack (known commercially as Herculex® XTRA) obtained by crossing two corn lines, DAS-01507-1 (line 1507) and DAS-59122-7 (line 59122). Food from both of these lines has been approved by FSANZ in applications A446 (FSANZ 2003) and A543 (FSANZ 2005) respectively and hence, food from the breeding stack is also approved to enter the Australian and New Zealand food supplies. The breeding stack was grown on approximately 10,000,000 ha in the U.S. in 2013.


 


Food from line 4114 requires a separate approval since it represents a unique molecular event although the expressed traits are the same as those already assessed by FSANZ. The purpose in developing the line 4114 molecular stack was to have all of the inserted genes on a single transformation construct integrated at a single genetic locus in the corn genome. Line 4114 therefore has an advantage over the breeding stack because having three linked traits at a single locus will simplify future breeding efforts. The Applicant has stated that line 4114 is not intended to be a stand-alone product and will be crossed by conventional breeding with other approved GM corn lines as well as conventional lines.


 


The Applicant indicates that any lines containing the DP-004114-3 event will be grown primarily in North America, and approval for cultivation in Australia or New Zealand is not currently being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.

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Date of authorization: 07/12/2015
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1106 – Food derived from Herbicide-tolerant & Insect-protected Corn Line 4114
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
[email protected]andards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2222
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

Useful links
Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.

No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.

Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given

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

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

Colombia
Name of product applicant: Dupont Colombia S.A
Summary of application:

Authorization of the genetically modified maize 4114 resistant to lepidoptera pest attack and tolerant to herbicides glyphosate and glufosinate

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Date of authorization: 27/01/2016
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):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization.
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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:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Japan
Name of product applicant: Du Pont K.K.
Summary of application:

4114 is genetically modified maize for insect-resistant and herbicide-tolerant, that insect resistance is conferred by the cry34Ab1, cry35Ab1 and cryIF genes from the common soil bacterium Bacillus thuringiensis, and glufosinate-ammonium herbicide tolerance through the pat gene from Streptomyces viridochromogenes.

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Date of authorization: 15/01/2015
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.): BCH Database
Summary of the safety assessment (food safety):
Please see the link 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: Food safety assessment performed by Food Safety Commission of Japan
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

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

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

Malaysia
Name of product applicant: Du Pont (Malaysia) Sdn. Bhd.
Summary of application:

Please refer to the decsion document of the National Biosafety Board

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Date of authorization: 14/12/2018
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Department of Biosafety Official Website
CBD Biosafety Clearing House
Malaysia Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to the Risk Assessment Report
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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:
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Department of Biosafety Ministry of Environment and Water Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia
Phone number:
+60388861153
Fax number:
+60388904935
Country introduction:

GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Department of Biosafety Malaysia, Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: [email protected] Url: www. biosafety.gov.my

 

Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
New Zealand
Name of product applicant: Pioneer Hi-Bred Australia Ltd
Summary of application:

Pioneer Hi-Bred Australia Ltd on behalf of Pioneer Hi-Bred International Inc has submitted, an application to FSANZ to vary Standard 1.5.2 – Food produced using Gene Technology – in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) corn line with OECD Unique Identifier DP-004114-3 (also referred to as line 4114). The corn has been modified to be tolerant to the herbicide glufosinate ammonium (glufosinate) and protected against lepidopteran insect pests, particularly European corn borer (Ostrinia nubilalis) and coleopteran insect pests, particularly western corn rootworm (Diabrotica virgifera virgifera).


Tolerance to glufosinate is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat gene derived from the common soil bacterium Streptomyces viridochromogenes. This protein has been considered in 19 previous FSANZ approvals and globally is represented in six major crop species and over 30 approved GM single plant events.


Protection against lepidopteran insect pests is conferred by the cry1F gene, which is a synthetic version of a gene from Bacillus thuringiensis var. aizawai, and encodes a truncated version of an insecticidal protein, Cry1F. Protection against coleopteran insect pests is conferred by two genes, cry34Ab1 andcry35Ab1 both from B. thuringiensis strain PS149B1 and encoding the insecticidal proteins Cry34Ab1 and Cry35Ab1. These proteins have both been considered previously by FSANZ.


Line 4114 is a molecular stack3 that, in terms of traits, is the equivalent of a breeding stack (known commercially as Herculex® XTRA) obtained by crossing two corn lines, DAS-01507-1 (line 1507) and DAS-59122-7 (line 59122). Food from both of these lines has been approved by FSANZ in applications A446 (FSANZ 2003) and A543 (FSANZ 2005) respectively and hence, food from the breeding stack is also approved to enter the Australian and New Zealand food supplies. The breeding stack was grown on approximately 10,000,000 ha in the U.S. in 2013.


Food from line 4114 requires a separate approval since it represents a unique molecular event although the expressed traits are the same as those already assessed by FSANZ. The purpose in developing the line 4114 molecular stack was to have all of the inserted genes on a single transformation construct integrated at a single genetic locus in the corn genome. Line 4114 therefore has an advantage over the breeding stack because having three linked traits at a single locus will simplify future breeding efforts. The Applicant has stated that line 4114 is not intended to be a stand-alone product and will be crossed by conventional breeding with other approved GM corn lines as well as conventional lines.


The Applicant indicates that any lines containing the DP-004114-3 event will be grown primarily in North America, and approval for cultivation in Australia or New Zealand is not currently being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.

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Date of authorization: 14/01/2016
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 line 4114, a number of criteria have been addressed including: a characterisation of the transferred gene sequences, their origin, function and stability in the corn 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 herbicide-tolerant and insect-protected corn line 4114. On the basis of the data provided in the present Application, and other available information, food derived from line 4114 is considered to be as safe for human consumption as food derived from conventional corn 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: A1106 – Food derived from Herbicide-tolerant & Insect-protected Corn Line 4114
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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)

Republic of Korea
Name of product applicant: DuPont (Korea) Inc.
Summary of application:

Glufosinate herbicide tolerance , Coleopteran insect resistance ,  Lepidopteran insect resistance

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Date of authorization: 10/10/2014
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the link below(in Korean).
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
United States of America
Name of product applicant: Pioneer Hi-Bred
Summary of application:

Corn
Trait 1 Added Protein or DNA: Cry1F
Source: Bacillus thuringiensis var aizawai
Intended Effect: Resistance to certain Lepidopteran and Coleopteran insects
Trait 2 Added Protein or DNA: Cry34Ab1 and Cry34Ab2 proteins
Source: Bacillus thuringiensis strain PS149B1
Intended Effect: Resistance to certain Lepidopteran and Coleopteran insects
Trait 3 Added Protein or DNA: pat gene encoding the phosphinothricin acetyl transferase (PAT) protein
Source: Streptomyces viridochromogenes
Intended Effect: Tolerance to glufosinate-ammonium herbicides
Event Designation: Event 4114

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Date of authorization: 07/06/2012
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):
Please consult the website links below.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
EPA Registered Plant Incorporated Protectants
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:

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

Useful links
Relevant documents
Stacked events:

Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized.  Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events.   

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

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