Assessment of potential adjuvanticity of Cry proteins

Joshi, Saurabh S.; Barnett, Brian W.; Doerrer, Nancy G.; Glenn, Kevin C.; Herman, Rod A.; Hérouet-Guicheney, Corinne; Hunst, Penny; Kough, John; Ladics, Gregory S.; McClain, Scott; Papineni, Sabitha; Poulsen, Lars K.; Rascle, Jean-Baptiste; Tao, Ailin; Ree, Ronald van; Ward, Jason; Bowman, Christal C.

doi:10.1016/j.yrtph.2016.04.005

Cited by 12 publications

(8 citation statements)

References 78 publications

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“…Joshi et al also discussed literature concerning potential adjuvanticity of the Cry proteins 187 . In summary, this review reports that studies done to assess the immunomodulatory potential of Cry1Ac have major flaws in the design that preclude valid interpretation.…”

Section: Despite These Clear Results Other Studies Highlight Differementioning

confidence: 99%

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Parenti

Santoro

Río

et al. 2019

EFSA Supporting Publications

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Based on the risk assessment of genetically modified plants, according to Implementing Regulation (EU) No 503/201321 "In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants". To further investigate the topic, an EFSA procurement was launched requesting a comprehensive literature review and critically appraisal on adjuvanticity and immunogenicity of proteins. A systematic literature search and critical review was performed, identifying 299 relevant publications. From the evaluation of the relevant literature emerged that: i) a clear classification of adjuvant and immunogens of proteins cannot be done; ii) structural features able to modulate adjuvanticity and immunogenicity are mainly ascribed to therapeutic proteins and in the context of allergenicity and cross-reactivity; iii) factors affecting the propensity of a protein to stimulate immune response are aggregation, thermal processing, digestion, food matrix, among others; iv) different proteins are described to have immunomodulatory effects; v) risk assessment of adjuvant and immunogenic behaviour of proteins requires specific methodologies that can be adapted from other fields; vi) adjuvanticity and immunogenicity of Cry proteins in certain experimental conditions seems plausible but due to low dosage, oral route of administration, food and feed processing and digestion, it is unlikely to emerge as a safety issue in food and feed; vii) eliciting an immune response is a very complex matter as the body responds to immune offence by inducing many processes. Based on these considerations, it is expected that the availability of new humanized animal models and the possibility to deploy artificial intelligent systems on the vastity of human data will become a general direction aiming to help answering specific questions relating to the immune systems, including the adjuvanticity and immunogenicity of food/feed proteins.

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Section: Despite These Clear Results Other Studies Highlight Differementioning

confidence: 99%

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Parenti

Santoro

Río

et al. 2019

EFSA Supporting Publications

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“…5 In the case of event MIR604, a single nucleotide difference was identified in the non-coding region of the insert as compared with the sequence originally reported in 2005. 5 In the case of event MIR604, a single nucleotide difference was identified in the non-coding region of the insert as compared with the sequence originally reported in 2005.…”

Section: Updated Information On Single Eventsmentioning

confidence: 88%

“…For events MIR604 and GA21, updated nucleotide sequence information was received. 5 In the case of event MIR604, a single nucleotide difference was identified in the non-coding region of the insert as compared with the sequence originally reported in 2005. Further analyses demonstrated that this nucleotide difference had already been present in the original material used for the risk assessment of maize MIR604.…”

Section: Updated Information On Single Eventsmentioning

confidence: 88%

Scientific Opinion on an application by Syngenta (EFSA‐GMO‐DE‐2011‐99) for the placing on the market of maize Bt11 × 59122 × MIR604 × 1507 × GA21 and twenty subcombinations, which have not been authorised previously independently of their origin, for food and feed uses, import and processing under Regulation (EC) No 1829/2003

2016

EFS2

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In this opinion, the EFSA GMO Panel assesses the five-event stack maize and 20 of its subcombinations independently of their origin. The EFSA GMO Panel has previously assessed the five single events that are combined to produce this five-event stack maize Bt11 9 59122 9 MIR604 9 1507 9 GA21 and did not identify safety concerns. No new data on the single events, leading to a modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the five-event stack maize did not give rise to safety concerns and there is no reason to expect interactions between the single events impacting on the food and feed safety of the five-event stack maize. Considering the scope of the application (no cultivation), routes of exposure and limited exposure levels, the Panel concludes that this five-event stack maize would not raise safety concerns in the event of accidental release of viable grains into the environment. The EFSA GMO Panel concludes that the fiveevent stack maize is as safe and as nutritious as its conventional counterpart in the context of its scope. For the 20 subcombinations, the EFSA GMO Panel followed a weight-of-evidence approach, and concluded that they are expected to be as safe as the five-event stack maize. No specific data were submitted for the subcombinations included in the scope of this application that could be produced by conventional crossing through targeted breeding approaches. In order to reduce the consequent uncertainties and to confirm assumptions made for their assessment, the EFSA GMO Panel considers that the applicant should provide relevant information, if these subcombinations were to be created via targeted breeding approaches and imported into the EU in the future. In this case, this information should focus on expression levels of the newly expressed proteins. A minority opinion expressed by an EFSA GMO Panel member is appended to this opinion.

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“…After receiving application EFSA- GMO-DE-2010-86 and in accordance with Articles 5(2)(b) and 17(2) (b) of Regulation (EC) No 1829/2003, EFSA informed Member States and the European Commission, and made the summary of the application available to the public on the EFSA website. 2 EFSA initiated a formal review of the application to check compliance with the requirements laid down in Articles 5 (3) and 17 (3) The scope defined by the applicant at the time of submission was 'all food and feed products containing, consisting or produced from Bt11 9 MIR162 9 1507 9 GA21 maize including products from inbreds and hybrids obtained by conventional breeding of this stacked maize product. The application also covers the import and industrial processing of Bt11 9 MIR162 9 1507 9 GA21 maize for all potential uses as any other maize.'…”

Section: Discussionmentioning

confidence: 99%

“…In giving its scientific opinion to the European Commission, the Member States and the applicant, and in accordance with Articles 6(1) and 18(1) of Regulation (EC) No 1829/2003(European Commission, 2003, EFSA has endeavoured to respect a time limit of 6 months from the acknowledgement of the valid application. As additional information was requested by the GMO Panel, the time limit of 6 months was extended accordingly, in line with Articles 6(1), 6(2), 18(1) and 18 (2) of Regulation (EC) No 1829/2003. According to Regulation (EC) No 1829/2003(European Commission, 2003, this scientific opinion is to be seen as the report requested under Articles 6(6) and 18(6) of that Regulation and thus will be part of the EFSA overall opinion in accordance with Articles 6(5) and 18(5).…”

Section: Introductionmentioning

confidence: 99%

Assessment of genetically modified maize Bt11 x MIR162 x 1507 x GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2010‐86)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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In this opinion, the GMO Panel assessed the four‐event stack maize Bt11 × MIR162 × 1507 × GA21 and three of its subcombinations, independently of their origin. The GMO Panel previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four‐event stack maize did not give rise to food/feed safety issues. Based on the nutritional assessment of the compositional characteristics of maize Bt11 × MIR162 × 1507 × GA21, foods and feeds derived from the genetically modified (GM) maize are expected to have the same nutritional impact as those derived from non‐GM maize varieties. In the case of accidental release of viable grains of maize Bt11 × MIR162 × 1507 × GA21 into the environment, this would not raise environmental safety concerns. The GMO Panel concludes that maize Bt11 × MIR162 × 1507 × GA21 is nutritionally equivalent to and as safe as its non‐GM comparator in the context of the scope of this application. For the three subcombinations included in the scope, for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11 × MIR162 × 1507 × GA21 and its subcombinations. A minority opinion expressed by a GMO Panel member is appended to this opinion.

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Assessment of potential adjuvanticity of Cry proteins

Cited by 12 publications

References 78 publications

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Assessment of genetically modified maize Bt11 x MIR162 x 1507 x GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2010‐86)

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