| Commodity: |
Potatoes |
| Traits: |
Reduced levels of arginine and reducing sugars, reduced black spot bruising,Resistance to late blight |
| Name of product applicant: |
SPS International Inc |
| Summary of application: |
FSANZ has received an Application from SPS International Inc (SPS), a subsidiary of J.R. Simplot Company (USA), to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code). The variation is to add food derived from six genetically modified (GM) potato lines from the Simplot Innate brand. These lines and their OECD Unique Identifiers are outlined in Table 1.
Table 1: Summary of the potato lines reviewed in this assessment
Parent variety
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Russet Burbank
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Ranger Russet
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Atlantic
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Transformation Step 1 (parent + plasmid pSIM1278)
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Line
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E56
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F10
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J3
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OECD Unique Identifier
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SPS-ØØE56-7
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SPS-ØØF10-7
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SPS-ØØØJ3-4
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Transformation Step 2 (event 1 + plasmid pSIM1678)
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Line
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W8
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X17
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Y9
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OECD Unique Identifier
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SPS-ØØØW8-4
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SPS-ØØX17-5
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SPS-ØØØY9-7
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Three potato lines (E56, F10 and J3) have been genetically modified using RNA interference (RNAi) to suppress the expression of four native potato genes. No new proteins are expressed and these lines are similar to line E12 that was assessed in Application A1128 (FSANZ 2016). The aims of the genetic modifications were to:
(i) reduce the production of acrylamide caused by cooking (frying, roasting and baking)
(ii) reduce the incidence of black spot formation in raw tubers caused by bruising or cutting to enable a decrease in food wastage.
The genes targeted by RNAi to reduce the production of acrylamide during cooking include asparagine synthetase-1 (Asn1), water dikinase (R1) and phosphorylase-L (PhL). Acrylamide, a known carcinogen, has been shown to form in high carbohydrate-rich foods such as potatoes, when they are fried, roasted or baked between 120-200°C. The acrylamide forms when the amino acid asparagine reacts with reducing sugars such as glucose and fructose by the Maillard reaction. By inhibiting the enzyme Asn1, there will be a reduction in the concentration of free asparagine in the potato. Combining this with the inhibition of R1 and PhL, which should lead to a reduction in the breakdown of starch into glucose, there will be a reduced potential for the derived food to produce acrylamide when cooked above 120°C.
The gene targeted by RNAi to reduce black spot formation is polyphenol oxidase-5 (Ppo5). The PPO enzyme converts colourless polyphenols in the plant tissue to coloured quinones, which further react to produce dark melanin pigments. This discoloration results in reduced organoleptic properties, associated with increased food wastage.
A second transformation was carried out on E56, F10 and J3 to produce lines W8, X17 and Y9 respectively. The aims of the second round of transformations were to: (i) reduce sucrose hydrolysis leading to less reducing sugars thus further decreasing the acrylamide potential of the potato; and (ii) protect the plant from infection by the same late blight fungus (Phytophthora infestans) that was responsible for the Great Potato Famine in Ireland in the 1840’s.
In order to further reduce the acrylamide potential of the potato, RNAi was used to target the gene for vacuolar invertase (VInv). The expressed invertase converts stored sucrose into glucose and fructose, particularly on the outer edge of the potatoes, which has been associated with darkening on the ends of French fries and crisps. The activity of this enzyme also increases with decreasing temperature, leading to an increase in reducing sugar formation at the cold temperatures normally used for storage of potatoes The gene added for protection against late blight is the late blight resistance gene (Rpi-vnt1) from the related potato species Solanum venturii. The resulting VNT1 resistance protein allows the plant to detect the presence of the infecting organism P. infestans, leading to the induction of the plant’s immune response and elimination of the fungus. This novel protein does not have a pesticidal mode of action.
The main objective of the application is to obtain food safety approval for trade purposes, as the Applicant has indicated none of these potato lines are currently intended to be grown in Australia or New Zealand but their processed products may enter the local food market through imports. At this stage, the initial lines (E56, F10 and J3) have limited food use and E56 in particular has not yet been commercialised. The second generation lines W8, X17 and Y9 are considered to have greater commercial potential. |
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| Date of authorization: |
07/12/2017 |
| 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
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| Summary of the safety assessment (food safety): |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
A1139 – Food derived from Potato Lines F10, J3, W8, X17 & Y9
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E-mail:
Organization/agency name (Full name): Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address: Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number: +61 2 6271 2222
Fax number: +61 2 6271 2278
Country introduction: Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island. Useful links
Relevant documents
Stacked events: FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.
No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.
Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
| Name of product applicant: |
J.R. Simplot Company |
| Summary of application: |
J.R. Simplot Company has developed three genetically modified potato events (i.e., 1 Russet Burbank variety, 1 Ranger Russet variety, and 1 Atlantic variety, respectively) using recombinant DNA techniques. These potato events exhibit reduced levels of free asparagine in tubers, as well as lower levels of reducing sugars (i.e., glucose and fructose) in tubers. The reduction in asparagine alone significantly decreases acrylamide formation in tubers when subjected to various forms of thermal processing (e.g., baking, frying, etc.) however lower levels of reducing sugars further decreases acrylamide formation and limit heat-induced browning. These potato events also exhibit reduced expression of polyphenol oxidase 5 enzyme (Ppo5), resulting in a decreased incidence of black spot bruising in tubers. Lastly, these potato events express a resistance protein (R-protein) found in wild Solanum species Solanum venturii and Solanum phureja (VNT1). The VNT1 protein enables the potato plant to detect an effector protein, Avr-Vnt1, which is produced by Phytopthora infestans; an oomycete that causes late blight in potatoes. Detection of the effector protein allows the potato plant to initiate its native immune response to resist infection by P. infestans.
With the exception of late blight resistance, the other novel traits (i.e. reduced asparagine levels, lower levels of reducing sugars, and reduced black spot bruising) are achieved through the transcription of inverted repeat sequences containing small fragments of DNA from five different endogenous genes (i.e., Asn1, Ppo5, PhL, R1, and VInv), which results in the reduced level of mRNA transcripts (and subsequently expressed proteins) for those same genes using the RNA interference (RNAi) pathway. As mentioned above, the late blight resistance trait is achieved through the expression of the VNT1 protein.
Simplot Innate® potato events Gen2-W8, Gen2-X17, and Gen2-Y9 are considered by their developer to be ‘Generation 2.0’ plants. The first generation of Simplot Innate® potato events (i.e., Gen1-E12, Gen1-F10, Gen1-J3, Gen1-J55, and Gen1-V11) exhibit lower levels of reducing sugars, have lower potential to form acrylamide during heat processing, and exhibit resistance to black spot bruising. The second generation of Simplot Innate® potato events possess all the same traits as their Generation 1.0 predecessors, while also exhibiting resistance to late blight disease. |
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| Date of authorization: |
28/07/2017 |
| 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
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| 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Novel Foods Decision Document
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Health Canada
Contact person name: Neil Strand
Website:
Physical full address: 251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number: 613-946-1317
Fax number:
Country introduction: Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.
The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.
Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances. Useful links
Relevant documents
Stacked events: Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.
Feed: Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Neil Strand, Section Head of Novel Foods
| Name of product applicant: |
J.R. Simplot Company |
| Summary of application: |
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| Date of authorization: |
12/11/2019 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Please see the links below. |
| Upload: |
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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: |
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| 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) |
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E-mail:
Organization/agency name (Full name): Food Safety Commission Secretariat,Cabinet Office,
Contact person name: Kojiro Yokonuma
Website:
Physical full address: Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number: 81 3 6234 1122
Fax number: 81 3 3584 7392
Country introduction: Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
SPS International Inc. (Malaysia branch) |
| Summary of application: |
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| Upload: |
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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 Malaysia
CBD Biosafety Clearing House
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| Summary of the safety assessment (food safety): |
Please refer to the Risk Assessment Report |
| Upload: |
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| 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) |
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E-mail:
Organization/agency name (Full name): Department of Biosafety Malaysia
Contact person name: Dr. Anita Anthonysamy
Website:
Physical full address: Department of Biosafety,
Ministry of Natural Resources, Environment and Climate Change
Level 4, Block F11, Complex F
Lebuh Perdana Timur, Precinct 1
62000 Putrajaya, Malaysia
Phone number: +60380917322
Fax number: +60380917371
Country introduction: GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Department of Biosafety, Ministry of Natural Resources, Environment and Climate Change Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia. Email: [email protected]. Url: www. biosafety.gov.my
Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
| Name of product applicant: |
SPS International Inc |
| Summary of application: |
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| Upload: |
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| Date of authorization: |
21/02/2018 |
| 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
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| Summary of the safety assessment (food safety): |
No potential public health and safety concerns have been identified in the assessment of
lines F10, J3, W8, X17 and Y9. On the basis of the data provided in the present Application, and other available information, food derived from F10, J3, W8, X17 and Y9 is considered to be as safe for human consumption as food derived from conventional potato 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: |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
A1139 – Food derived from Potato Lines F10, J3, W8, X17 & Y9
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Ministry for Primary Industries
Contact person name: john vandenbeuken
Website:
Physical full address: Pastoral House, 25 The Terrace, Wellington, 6012
Phone number: 0298942581
Fax number:
Country introduction: New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. Useful links
Relevant documents
Stacked events: FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5) Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
SPS International Inc |
| Summary of application: |
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| Upload: |
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| Date of authorization: |
29/03/2019 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Potato Y9 (SPS-ØØØY9-7) was generated using a two-step transformation process. J3 (SPS-ØØØJ3-4) was first generated from the transformation of Atlantic variety. The line has reduced blackspot bruising and reduced acrylamide potential. In the second step, J3 was retransformed, generating Y9 (SPS-ØØØY9-7). The second generation line is resistant to foliar late blight and exhibit further reduction of acrylamide potential. RNA interference (RNAi) was used to suppress the expression of genes associated with (1) conversion of storage carbohydrates such as starch and sucrose into the reducing sugars, glucose and fructose (phosphorylase L, water dikinase R1 and vacuolar invertase); (2) regulating the levels of the amino acid asparagine (asparagine synthetase); and (3) enzymatic browning, which in potatoes is referred to as blackspot bruising (polyphenol oxidase 5). The Rpi-vnt1 gene was also introduced to provide protection against foliar late blight. The DNA, which includes the native sequences covering the promoter, Rpi-vnt1 gene and terminator, was derived from the related species S. venturii. The resulting novel protein mediates the plant’s immune response to the pathogen. Molecular characterisation of potato line Y9 and the progenitor line J3 showed that a single insertion has occurred with each transformation step and each location has been identified. In every potato line, a fully intact insert containing the expression cassettes has been integrated. Only the required sequences have been inserted into the modified potatoes. DNA analyses of Y9 plants generated from two successive rounds of clonal propagation have confirmed that the inserted DNA was stably incorporated. Y9 plants exhibited the desired traits. Tubers from Y9 are compositionally similar to tubers from conventional potato varieties. Y9 is considered as safe as food derived from conventional potato varieties. |
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Singapore Food Agency (SFA)
Contact person name: Dr Tan Yong Quan
Website:
Physical full address: 52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number: (65)68052750
Fax number:
Country introduction: The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food. SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption. The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork. Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Singapore Food Agency (SFA)
| Name of product applicant: |
J.R. Simplot Company |
| Summary of application: |
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| Upload: |
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| Date of authorization: |
24/02/2017 |
| Scope of authorization: |
Food and feed |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
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| Summary of the safety assessment (food safety): |
Please consult the website links below. |
| Upload: |
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| 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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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:
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