MON810 Research Articles

Scientific opinion on a request from the European Commission related to the safeguard clause notified by Greece on genetically modified maize MON 810 according to Article 23 of Directive 2001/18/EC

Following a request of the European Commission, the European Food Safety Authority’s Panel on Genetically Modified Organisms (EFSA GMO Panel) evaluated the documentation submitted by Greece in support of its request for the prohibition of the placing on the market of the genetically modified maize MON 810 according to Article 23 of Directive 2001/18/EC. The EFSA GMO Panel notes that the majority of the publications referred to by Greece were already addressed by the EFSA GMO Panel in previous scientific outputs on maize MON 810 or other related insect-resistant genetically modified maize transformation events. In the remaining evidence provided by Greece, the EFSA GMO Panel could not identify any new data subject to scientific scrutiny or scientific information that would invalidate its previous risk assessments of maize MON 810. With regard to issues related to management and monitoring of maize MON 810, the EFSA GMO Panel refers to its recent recommendations for management and monitoring measures of maize MON 810. In conclusion, the EFSA GMO Panel considers that, based on the documentation submitted by Greece, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of a safeguard clause under Article 23 of Directive 2001/18/EC and that would invalidate the GMO Panel’s previous risk assessments of maize MON 810.

Assessment of fitness costs in Cry3Bb1‐resistant and susceptible western corn rootworm (Coleoptera: Chrysomelidae) laboratory colonies

Abstract Maize production in the United States is dominated by plants genetically modified with transgenes from Bacillus thuringiensis (Bt). Cry3Bb delta endotoxins expressed by Bt maize specifically target corn rootworms (genus Diabrotica) and have proven highly efficacious. However, development of resistance to Bt maize, especially among western corn rootworm (Diabrotica virgifera virgifera) populations, poses a significant threat to the future viability of this pest control biotechnology. The structured refuge insect resistance management (IRM) strategy implemented in the United States for Bt maize adopts a conservative approach to managing resistance by assuming no fitness costs of Bt resistance, even though these trade‐offs strongly influence the dynamics of Bt resistance within numerous agricultural pest species. To investigate the effects of Bt resistance on fitness components of western corn rootworm, we compared survivorship, fecundity and viability of five Bt‐resistant laboratory lines reared on MON863 (YieldGard Rootworm), a Bt maize product that expresses Cry3Bb1 delta endotoxin, and on its non‐transgenic isoline. Analysis of performance on the isoline maize demonstrated no fitness costs associated with Bt resistance. In fact, resistant lines emerged approximately 2–3 days earlier than control lines when reared on both MON863 and the isoline, indicating that selection for Bt resistance resulted in a general increase in the rate of larval development. In addition, resistant lines reared on Bt maize displayed higher fecundity than those reared on the isoline, which may have significant management implications. These data will be valuable for formulating improved IRM strategies for a principal agricultural pest of maize.

Incidence of Pollen from Genetically Modified Plants in Bee Products - A Review

Bees collect nectar, pollen and resins to produce honey. Pollen, which is present naturally in honey, is the main responsible for the presence of genetically modified (GM) material in honey. GM plants produce pollen containing transgenic DNA, nectar containing novel proteins or resins that bees may consume. Today there is an in creasing interest in natural food products, free of any contaminant, knowing that GM plants are grown in higher quantities every year. With GM plants, there is a possibility that transgenic DNA may be p resent in the plant parts and secretions collected by bees. Romania is one of the countries that grow GM maize (MON810) and is also a honey exporting country. For this reason it is necessary to develop different complementary analysis techniques to determine the presence of GM material in different bee products, so the export market will not suffer from the rejection of honey which is found to have traces of GM material in the composition.

Application (Reference EFSA-GMO-CZ-2006-33) for the placing on themarket of the insect-resistant and glyphosate-tolerant genetically modifiedmaize MON 88017 x MON 810, for food and feed uses, import andprocessing under Regulation (EC) No 1829/2003 from Monsanto

Application (Reference EFSA-GMO-CZ-2006-33) for the placing on themarket of the insect-resistant and glyphosate-tolerant genetically modifiedmaize MON 88017 x MON 810, for food and feed uses, import andprocessing under Regulation (EC) No 1829/2003 from Monsanto

Request from the European Commission related to the safeguard clause invoked by Austria on maize lines MON863 according to Article 23 of Directive 2001/18/EC

Request from the European Commission related to the safeguard clause invoked by Austria on maize lines MON863 according to Article 23 of Directive 2001/18/EC

The In Vivo Digestive Fate of the Cry3Bb1 Protein in Laying Hens Fed Diets Containing MON 863 Corn

Two trials were conducted to assess the fate of the Cry3Bb1 protein from YieldGard rootworm corn (MON 863) when fed to laying hens. In the first trial, 2 diets, 1 formulated with MON 863 and 1 with conventional corn, were fed to laying hens (12 replicate cages with 4 hens/cage per treatment) for 8 wk. Daily feed intake (FI), egg production (EP), and BW were measured. Prestudy fecal samples, wk 4 and 8 egg and fecal samples, and hepatic and pectoralis tissue samples were collected from 12 killed hens and were tested for the Cry3Bb1 protein. Corn source had no significant effects on FI, EP, or BW. Feces from hens fed diets containing MON 863 were positive for the Cry3Bb1 protein or proteolytic fragments (1.5 to 4.0 ppm fecal dry matter). The Cry3Bb1 protein could not be determined in eggs due to the presence of an interfering substance in all test and control eggs. No Cry3Bb1 protein was detected in hepatic and pectoralis tissue. In the second trial, the same test and control diets were fed to 12 hens each. Six hens/treatment were sampled after 7 and 28 d. Samples included blood, feces, and digesta (crop, small and large intestine, and ceca). The Cry3Bb1 protein could not be determined in blood due to the presence of an interfering substance in all test and control blood samples. The Cry3Bb1 protein or partially digested fragments, or both, were found in the digesta sampled from all sections of the digestive tract. About 98 to >99% of the dietary Cry3Bb1 protein was digested. Overall, MON 863, when fed to laying hens, had no significant effects on FI, EP, or BW. The Cry3Bb1 protein was extensively digested, similar to that of other dietary proteins, and was not detected in hepatic or muscle tissue.

Responses of transgenic maize hybrids to variant western corn rootworm larval injury

Abstract: In 2005 and 2006, transgenic insecticidal maize hybrids (YieldGard Rootworm, MON 863, Cry3Bb1, Vector ZMIR 13L) were evaluated for their ability to limit root injury caused by western corn rootworm (Diabrotica virgifera virgifera LeConte) larval feeding. Hybrids in each year of the experiment were planted in plots that had been devoted to a trap crop (late‐planted maize interplanted with pumpkins) the previous growing season. All maize hybrids were provided by Monsanto Company and the genetic backgrounds remain unknown to the investigators. In 2005, the experiment was conducted in Urbana, Illinois. Urbana is located in east central Illinois, an area of the state in which a variant of the western corn rootworm has overcome the pest management benefits of crop rotation. Variation in root injury was noted across the maize hybrids in 2005 and the level of pruning increased from 20 July to 9 August for most hybrids. In 2006, the experiment was conducted in two locations, Monmouth and Urbana, Illinois. Monmouth is located in north‐western Illinois and is within an area of the state in which densities of the variant of the western corn rootworm are lower than in east‐central Illinois. In 2006, variation in root protection was again observed across the maize hybrids. Root injury differences among the hybrids were more prominent at the Urbana site. Similar to the previous year, root injury increased from the third week in July to the first week of August at both locations with this increase most noticeable at the Urbana location. We hypothesize that the variant western corn rootworm may be able to inflict more root injury to these transgenic insecticidal maize hybrids than the non‐variant population of this species.

Effect of Corn Hybrids Expressing the Coleopteran-Specific Cry3Bb1 Protein for Corn Rootworm Control on Aboveground Insect Predators

Field and laboratory studies were conducted to determine the effect of transgenic Bacillus thuringiensis (Bt) corn, Zea mays L. (YieldGard Rootworm), expressing the Cry3Bb1 protein on aboveground nontarget insect predators (minute pirate bug, ladybird beetles, and carabids). Visual counts of adult and immature Orius insidiosus (Say), Coleomegilla maculata (DeGeer), Hippodamia convergens Gurin-Meneville, and Scymnus spp. occurring in Bt corn and its non-Bt isoline were made at Manhattan, KS, in 2002 and at Manhattan and Scandia, KS, in 2003. No significant differences were found between the Bt corn and non-Bt isoline plots in the abundance (number per plant) of O. insidiosus, C. maculata, H. convergens, and Scymnus spp. Field predation on Ostrinia nubilalis (Hübner) (Lepidoptera: Crambidae) egg masses was also observed during the silking stage of corn at Manhattan and Scandia in 2003. No significant differences were observed among treatments in predation rate for predators with chewing versus sucking mouthparts. Two laboratory studies determined the effect of Cry3Bb1 protein expressed in Bt corn pollen on C. maculata and carabids. The larvae of C. maculata were reared on Bt pollen, non-Bt pollen, or greenbugs, Schizaphis graminum (Rondani). The duration of larval and pupal stages, developmental time from egg hatch to adult emergence, percentage of survival, and elytra length were compared among treatments. There were no significant differences in developmental time of larvae fed pollen or greenbugs during their first two instars. However, significantly prolonged development of the third (1 d) and fourth instars (2 d) was observed for larvae fed greenbugs only. Total time for larval development was significantly longer for larvae that fed on greenbugs versus larvae fed on pollen. No significant differences were observed among treatments in the percentage of larvae that pupated or pupal stage duration. Larvae that fed on greenbugs had higher pupal and adult weights compared with pollen-fed larvae. However, pupal and adult weights did not vary between the Bt and non-Bt pollen treatments. No significant differences occurred in longevity and elytra length of beetles among all treatments. Two carabid species, Harpalus caliginosus F. and Harpalus pensylvanicus DeGeer, were reared on moistened dog food sprinkled with Bt or non-Bt corn pollen. No significant differences in mortality of H. caliginosus and H. pensylvanicus were detected among any of the treatments. There was no significant effect of Bt pollen on fecundity and egg viability of H. caliginosus. Our studies showed that YieldGard Rootworm had no effect on the selected coleopteran predators; therefore, this Bt corn hybrid could be used in an integrated pest management system.

Results of a 90-day safety assurance study with rats fed grain from corn rootworm-protected corn

The results of a 90-day rat feeding study with YieldGard ® (YieldGard Rootworm Corn is a registered trademark of Monsanto Technology, LLC.) Rootworm corn (MON 863) grain that is protected against feeding damage caused by corn rootworm larvae are presented. Corn rootworm-protection was accomplished through the introduction of a cry3Bb1 coding sequence into the corn genome for in planta production of a modified Cry3Bb1 protein from Bacillus thuringiensis. Grain from MON 863 and its near isogenic control were separately formulated into rodent diets at levels of 11% and 33% (w/w) by Purina Mills, Inc. Additionally, six groups of rats were fed diets containing grain from different conventional (non-biotechnology-derived) reference varieties. The responses of rats fed diets containing MON 863 were compared to those of rats fed grain from conventional corn varieties. All diets were nutritionally balanced and conformed to Purina Mills, Inc. specifications for Certified LabDiet 5002. There were a total of 400 rats in the study divided into 10 groups of 20 rats/sex/group. Overall health, body weight gain, food consumption, clinical pathology parameters (hematology, blood chemistry, urinalysis), organ weights, gross and microscopic appearance of tissues were comparable between groups fed diets containing MON 863 and conventional corn varieties. This study complements extensive agronomic, compositional and farm animal feeding studies with MON 863 grain, confirming that it is as safe and nutritious as existing conventional corn varieties.

Performance of growing-finishing pigs fed diets containing YieldGard Rootworm corn (MON 863), a nontransgenic genetically similar corn, or conventional corn hybrids

Two studies were conducted at two locations to evaluate growth performance and carcass characteristics of growing-finishing pigs fed diets containing either YieldGard Rootworm corn (MON 863), a non-transgenic genetically similar corn (RX670), or two conventional nontransgenic corn hybrids (DK647 and RX740). A randomized complete block design with a 2 x 4 factorial arrangement of treatments (two genders and four corn hybrids) was used. Study 1 used 72 barrows and 72 gilts (progeny of Danbred sires x [Danbred x NE White line] dams grown from 22.7 to 117.0 kg BW). Pigs were housed in a modified open-front building in single-gender groups of six (six pens per dietary treatment). Study 2 used 80 barrows and 80 gilts (progeny of PIC 337 sires x C22 dams) grown from 29.5 to 114.9 kg BW. Pigs were housed in an environmentally controlled finishing building in single-gender groups of five (eight pens per dietary treatment). The test corns were included at a fixed proportion of the diet in both studies. Animals had ad libitum access to feed and water. Pigs were slaughtered at the end of the growth period using standard procedures, and carcass measurements were taken. There were no diet x gender interactions for growth performance or carcass measurements in either study. In both studies, overall ADG, ADFI, and G:F were not affected by corn hybrid. There was no effect of corn hybrid on carcass or LM quality measurements in Study 1. In Study 2, LM protein content was less (P< 0.05) for pigs fed RX740 compared with those fed either MON 863 or RX670; however, there was no effect of corn hybrid on other LM composition measures or on quality traits. In both studies, differences between barrows and gilts for growth and carcass traits were similar to previous research. These results suggest that the YieldGard Rootworm corn (MON 863) results in equivalent growth performance and carcass quality to nontransgenic corn hybrids in growing-finishing pigs.

Effect ofBtCorn Expressing the Cry3Bb1 Toxin on Western Corn Rootworm (Coleoptera: Chrysomelidae) Biology

In Kansas, the western corn rootworm, Diabrotica virgifera virgifera LeConte (Coleoptera: Chrysomelidae), is one of the most economically important pests of corn. Crop losses and control costs attributed to Diabrotica spp. reach $1 billion annually in the U.S. Recently, Bt corn hybrids resistant to western corn rootworm larval damage have been field-tested for rootworm control. This study evaluated the effect of a specific Bt corn (YieldGard Rootworm®) for corn rootworm control on larval survival. Elytra length, fecundity, percent egg hatch, and longevity of adult D. v. virgifera that survived exposure to Bt corn in the larval stage were also evaluated. Two groups of D. v. virgifera adults were assessed. One group had emerged from Bt and non-Bt corn roots; the other group was obtained from a colony with no larval exposure to Bt corn and fed Bt or non-Bt corn silk and ears. Bt corn significantly reduced the number of D. v. virgifera beetles emerging from corn roots. In general, Bt corn had no significant effect on longevity, elytra length, and female fecundity of D. v. virgifera beetles emerging from Bt corn plants. Bt corn had no significant effect on longevity and female fecundity of D. v. virgifera beetles feeding only as adults on Bt corn silk and ears. In general, Bt corn had no effect on number of D. v. virgifera beetles feeding in the field on corn silk and on silk damage caused by adults. Generally, the results of this study demonstrated that Bt corn (MON 863) expressing the Cry3Bb1 toxin was extremely effective in reducing damage caused by D. v. virgifera larvae and had no significant effects on the longevity of beetles emerging from YieldGard Rootworm® corn.

Use of transgenic plants to measure insect herbivore movement.

Use of ingested transgenic corn tissue as a marker for measuring movement of adult Diabrotica virgifera virgifera (LeConte) (Coleoptera: Chrysomelidae; western corn rootworm) was investigated. Laboratory observations of beetles feeding on corn foliage, pollen, silks, or soybean foliage provided background on feeding patterns. The interval between food consumption and its appearance in feces (gut passage time) ranged from 102.7 +/- 11 min for soybean foliage to 56.7 +/- 2.9 min for corn silks. In a laboratory assay, protein expression tests identified the presence of Cry3Bb1 protein inside 50% of adult D. virgifera for up to 16 h after they had last consumed Cry3Bb1 protein-expressing corn silks from 'YieldGard Rootworm' corn plants (Monsanto Co.). Cry3Bb1 protein could not be detected by 32 h postfeeding. The proportion of Cry3Bb1 protein-positive beetles declined linearly with increasing time since feeding on 'YieldGard Rootworm' tissue. Approximately 20% of adult D. virgifera collected near 'YieldGard Rootworm' corn plots tested positive for Cry3Bb1 protein, indicating 'YieldGard Rootworm' tissue consumption within the last 16-32 h. Based on a 16- to 32-h postfeeding detection interval for Cry3Bb1 protein and the distance between 'YieldGard Rootworm' sources and sites where Cry3Bb1-positive insects were collected, 85.3% of males and females moved < or = 4.6-9.1 m/d through R2-R3 stage corn. Among Cry3Bb1-positive adults that left corn and were captured in an adjacent soybean field, 86.4% of males and 93.1% of females moved < or = 4.6-9.1 m/d through soybean. Detection of transgenic plant tissues in mobile insect herbivores is a novel application of biotechnology to the study of insect movement.

Use of Transgenic Plants to Measure Insect Herbivore Movement

Use of ingested transgenic corn tissue as a marker for measuring movement of adult Diabrotica virgifera virgifera (LeConte) (Coleoptera: Chrysomelidae; western corn rootworm) was investigated. Laboratory observations of beetles feeding on corn foliage, pollen, silks, or soybean foliage provided background on feeding patterns. The interval between food consumption and its appearance in feces (gut passage time) ranged from 102.7 ± 11 min for soybean foliage to 56.7 ± 2.9 min for corn silks. In a laboratory assay, protein expression tests identified the presence of Cry3Bb1 protein inside 50% of adult D. virgifera for up to 16 h after they had last consumed Cry3Bb1 protein-expressing corn silks from ‘YieldGard Rootworm’ corn plants (Monsanto Co.). Cry3Bb1 protein could not be detected by 32 h postfeeding. The proportion of Cry3Bb1 protein-positive beetles declined linearly with increasing time since feeding on ‘YieldGard Rootworm’ tissue. Approximately 20% of adult D. virgifera collected near ’YieldGard Rootworm’ corn plots tested positive for Cry3Bb1 protein, indicating ‘YieldGard Rootworm’ tissue consumption within the last 16–32 h. Based on a 16- to 32-h postfeeding detection interval for Cry3Bb1 protein and the distance between ‘YieldGard Rootworm’ sources and sites where Cry3Bb1-positive insects were collected, 85.3% of males and females moved ≤4.6–9.1 m/d through R2-R3 stage corn. Among Cry3Bb1-positive adults that left corn and were captured in an adjacent soybean field, 86.4% of males and 93.1% of females moved ≤4.6–9.1 m/d through soybean. Detection of transgenic plant tissues in mobile insect herbivores is a novel application of biotechnology to the study of insect movement.

Comparison of broiler performance when fed diets containing grain from YieldGard Rootworm (MON863), YieldGard Plus (MON810 × MON863), nontransgenic control, or commercial reference corn hybrids

Two 42-d experiments compared the nutritional value of YieldGard Rootworm corn (MON863; experiment 1) and YieldGard Plus corn (MON810 × MON863; experiment 2) to their respective nontransgenic controls and 6 commercial reference corn hybrids when fed to growing broilers. For each experiment, a randomized complete block design was used with 8 dietary treatments in each of 5 replicated blocks of pens. In experiment 1, no differences among diets were observed (P > 0.05) for final live weights and feed conversion. Broilers fed diets containing MON863 corn had adjusted feed conversion similar to the nontransgenic control and the population of control and commercial diets. On a weight basis, there were no differences among diets for chill, fat pad, and thigh, drum, and wing weights. Differences (P < 0.05) between MON863 and commercial corn diets were noted for breast meat, chill and thigh, drum, and wing weights on a percentage of weight basis. No differences were observed (P > 0.05) in the percentage of moisture, protein, and fat in breast meat or thigh meat across treatment diets. In experiment 2, there were no significant differences among diets for all broiler performance and carcass parameters evaluated. Broilers overall performed consistently and had similar carcass yields and meat compositions when fed diets containing MON863 corn or MON810 × MON863 corn as compared with their respective nontransgenic control and commercial diets, supporting a conclusion of similar feeding values among diets.

EPA APPROVES NEW MONSANTO CORN

EPA HAS APPROVED MONSANto's genetically engineered corn, designed to ward off the corn rootworm by producing a Bacillus thuringiensis (Bt) insecticidal protein. Approved just in time for the 2003 planting season, Monsanto's YieldGard Rootworm corn protects against a widespread and destructive pest that causes an estimated $800 million in lost revenue and $200 million in treatment costs annually for the U.S.'s largest crop. EPA believes the corn can help reduce reliance on millions of pounds of organophosphate and pyrethroid insecticides. EPAhas put this newproduct through a rigorous, science-based review process, including extensive public comment and independent scientific peer review, to ensure that it is safe for human health and the environment, EPA Assistant Administrator Stephen L.Johnson says. The agency will require that corn farmers plant 20% of their acreage with nonengineered corn as an insect refuge to prevent the development of Bt resistance. However, the environmental benefit from less pes...