Results of a 13-week safety assurance study with rats fed grain from corn rootworm-protected, glyphosate-tolerant MON 88017 corn

Healy, Charles E.; Hammond, Bruce G.; Kirkpatrick, Jeannie B.

doi:10.1016/j.fct.2008.04.005

Cited by 38 publications

(15 citation statements)

References 19 publications

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“…There were no significant differences between the groups in terms of clinical observations, haematological parameters, biochemical markers and absolute or relative organ weights. Histopathology revealed a similar prevalence of anomalies among the three groups which are regarded as spontaneous, in agreement with data from previous feeding trials involving crops engineered for herbicide tolerance and pest resistance (Appenzeller et al, 2009;Hammond et al, 2004Hammond et al, , 2006Healy et al, 2008).…”

Section: Food Consumption (G)supporting

confidence: 88%

Mice fed on a diet enriched with genetically engineered multivitamin corn show no sub‐acute toxic effects and no sub‐chronic toxicity

Arjó¹,

Capell²,

Matías‐Guiu³

et al. 2012

Plant Biotechnology Journal

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SummaryMultivitamin corn is a novel genetically engineered variety that simultaneously produces high levels of b-carotene, ascorbate and folate, and therefore has the potential to address simultaneously multiple micronutrient deficiencies caused by the lack of vitamins A, B9 and C in developing country populations. As part of the development process for genetically engineered crops and following European Food Safety Authority (EFSA) recommendations, multivitamin corn must be tested in whole food ⁄ feed sub-chronic animal feeding studies to ensure there are no adverse effects, and potential allergens must be identified. We carried out a 28-day toxicity assessment in mice, which showed no short-term sub-acute evidence of dietrelated adverse health effects and no difference in clinical markers (food consumption, body weight, organ ⁄ tissue weight, haematological and biochemical blood parameters and histopathology) compared to mice fed on a control diet. A subsequent 90-day sub-chronic feeding study again showed no indications of toxicity compared to mice fed on control diets. Our data confirm that diets enriched with multivitamin corn have no adverse effects on mice, do not induce any clinical signs of toxicity and do not contain known allergens.

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Section: Food Consumption (G)supporting

confidence: 88%

Mice fed on a diet enriched with genetically engineered multivitamin corn show no sub‐acute toxic effects and no sub‐chronic toxicity

Arjó¹,

Capell²,

Matías‐Guiu³

et al. 2012

Plant Biotechnology Journal

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“…In the 90-day or 13-week feeding studies in rats, no statistical difference was uncovered in either the relative body and ovary weight of rats fed transgenic corns (Hammond et al, 2006;Healy et al, 2008), maize (MacKenzie et al, 2007;He et al, 2009;Appenzeller et al, 2009a and2009b), rice (Schroder et al, 2007) or soybeans (Appenzeller et al, 2008;Delaney et al, 2008b); and there were no histopathologic lesions in ovaries from rats fed DAS-59122-7 maize (Cry34Ab1 and Cry35Ab1 proteins; He et al, 2008). Furthermore, Malley et al (2007) reported higher mean uterus weight during the estrous stage of rats fed maize DAS-59122-7 (Cry34Ab1 and Cry35Ab1 proteins) or 5002B (commercial rodent diets) v. the 33R77 group (non-transgenic reference maize grain), 091 group (non-transgenic nearisogenic maize grain) or 5002A (commercial rodent diets); however, this might be due to the fact that the proportion of rats in proestrus and estrus in the 59122 and 5002B groups was greater than that in the 5002A, 091 and 33R77 maize grain groups, in which a greater proportion of rats were in metestrus and diestrus.…”

Section: Introductionmentioning

confidence: 94%

“…Long-term and multigenerational feeding studies Long-term feeding studies. In a 90-day or 13-weeks feeding studies on rats, several groups have reported that there were no effects on male reproductive organs such as testes, epididymides and prostate in rodents compared with rats receiving non-GM food in long-term study when the diet was treated with different GM foods (Hammond et al, 2006;MacKenzie et al, 2007;Schroder et al, 2007;Appenzeller et al, 2008Appenzeller et al, , 2009aAppenzeller et al, and 2009bDelaney et al, 2008b;Healy et al, 2008;He et al, 2008 and No apparent differences in percentages of testicular cell populations (haploid, diploid and tetraploid).…”

Section: Velimirov Et Al (2008)mentioning

confidence: 99%

Do genetically modified crops affect animal reproduction? A review of the ongoing debate

Zhang

Shi

2011

Animal

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In the past few years, genetically modified (GM) crops aimed at producing food/feed that became part of the regular agriculture in many areas of the world. However, we are uncertain whether GM food and feed can exert potential adverse effects on humans or animals. Of importance, the reproductive toxicology of GM crops has been studied using a number of methods, and by feeding GM crops to a number species of animals to ensure the safety assessment of GM food and feed. It appears that there are no adverse effects of GM crops on many species of animals in acute and short-term feeding studies, but serious debates of effects of long-term and multigenerational feeding studies remain. The aims of this review are to focus on the latest (last 3 to 4 years) findings and debates on reproduction of male and female animals after feeding daily diets containing the GM crops, and to present the possible mechanism(s) to explain their influences.

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“…Dietary incorporation of test crops at levels greater than 60% (w/w) have been achieved, although levels in the range of 30% (w/w) are more common ( Table 4 ). In some WF toxicity studies, two or more levels of test food have been incorporated into the diet with the goal of generating a “dose response” (Chen et al, 2003 ; Chukwudebe et al, 2012 ; EFSA, 2005a , b , c , 2007 , 2008a ; Hammond et al, 2004 , 2006a , b ; He et al, 2008 , 2009 ; Healy et al, 2008 ; Liu et al, 2012 ; Qi et al, 2012 ; Zhu et al, 2004 , 2013 ). When no effect is observed at any dose, the additional dose groups provide a further basis for evaluating and dismissing the inevitable random statistically significant findings.…”

Section: Basic Principles Of Toxicology Studies Applicable To Wf Studmentioning

confidence: 99%

The use of whole food animal studies in the safety assessment of genetically modified crops: Limitations and recommendations

Bartholomaeus

Parrott

Bondy

et al. 2013

Critical Reviews in Toxicology

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There is disagreement internationally across major regulatory jurisdictions on the relevance and utility of whole food (WF) toxicity studies on GM crops, with no harmonization of data or regulatory requirements. The scientific value, and therefore animal ethics, of WF studies on GM crops is a matter addressable from the wealth of data available on commercialized GM crops and WF studies on irradiated foods. We reviewed available GM crop WF studies and considered the extent to which they add to the information from agronomic and compositional analyses. No WF toxicity study was identified that convincingly demonstrated toxicological concern or that called into question the adequacy, sufficiency, and reliability of safety assessments based on crop molecular characterization, transgene source, agronomic characteristics, and/or compositional analysis of the GM crop and its near-isogenic line. Predictions of safety based on crop genetics and compositional analyses have provided complete concordance with the results of well-conducted animal testing. However, this concordance is primarily due to the improbability of de novo generation of toxic substances in crop plants using genetic engineering practices and due to the weakness of WF toxicity studies in general. Thus, based on the comparative robustness and reliability of compositional and agronomic considerations and on the absence of any scientific basis for a significant potential for de novo generation of toxicologically significant compositional alterations as a sole result of transgene insertion, the conclusion of this review is that WF animal toxicity studies are unnecessary and scientifically unjustifiable.

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Results of a 13-week safety assurance study with rats fed grain from corn rootworm-protected, glyphosate-tolerant MON 88017 corn

Cited by 38 publications

References 19 publications

Mice fed on a diet enriched with genetically engineered multivitamin corn show no sub‐acute toxic effects and no sub‐chronic toxicity

Mice fed on a diet enriched with genetically engineered multivitamin corn show no sub‐acute toxic effects and no sub‐chronic toxicity

Do genetically modified crops affect animal reproduction? A review of the ongoing debate

The use of whole food animal studies in the safety assessment of genetically modified crops: Limitations and recommendations

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