Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and stability once placed into the crop genome. The safety of the proteins coded by the inserted DNA and potential effects on the crop are considered, and the purpose is to ensure that the transgenic novel proteins are safe from a toxicity, allergy, and environmental perspective. In addition, the grain that provides the processed food or animal feed is also tested to evaluate its nutritional content and identify unintended effects to the plant composition when warranted. To provide a platform for the safety assessment, the GM crop is compared to non-GM comparators in what is typically referred to as composition equivalence testing. New technologies, such as mass spectrometry and well-designed antibody-based methods, allow better analytical measurements of crop composition, including endogenous allergens. Many of the analytical methods and their intended uses are based on regulatory guidance documents, some of which are outlined in globally recognized documents such as Codex Alimentarius. In certain cases, animal models are recommended by some regulatory agencies in specific countries, but there is typically no hypothesis or justification of their use in testing the safety of GM crops. The quality and standardization of testing methods can be supported, in some cases, by employing good laboratory practices (GLP) and is recognized in China as important to ensure quality data. Although the number of recommended, in some cases, required methods for safety testing are increasing in some regulatory agencies, it should be noted that GM crops registered to date have been shown to be comparable to their nontransgenic counterparts and safe . The crops upon which GM development are based are generally considered safe.
Agriculture ; Animal Feed ; Animals ; Biotechnology ; China ; Consumer Product Safety ; Food, Genetically Modified ; Humans ; Models, Animal ; Plants, Genetically Modified ; Safety

With the research and development of genetically engineered animals (GEAs) in breeding of new variety, xenotransplantation, bioreactor and disease model, biosafety issues of GEAs have attracted widespread attentions worldwide. So far, governments and agencies have established corresponding laws and regulations to regulate research and application of GEAs or their derived products. We reviewed research contents, evaluated principles, policies and procedures for biosafety of GEAs, also enumerated upcoming approved products of GEAs. Finally, we suggested perspectives of research and application of GEAs or their derived products.
Agriculture ; economics ; legislation & jurisprudence ; Animals ; Animals, Genetically Modified ; genetics ; growth & development ; Biotechnology ; economics ; legislation & jurisprudence ; Food Safety ; Food, Genetically Modified ; economics ; standards ; Laboratories ; standards

PURPOSE: Serum screening test to detect specific immunoglobulin E (IgE) is an important step for the assessment of potential allergenicity of genetically modified (GM) food. The purpose of this study was to evaluate the usefulness of pooled serum for serum screening instead of individual serum. METHODS: Children with allergic disease were recruited and those who were sensitized to peanut or egg white were selected to obtain their sera. Sensitization to these foods was determined when the level of specific IgE was over 0.35 kU/L by ImmunoCAP. The patients were divided into subgroups according to their level of specific IgE. Raw proteins were extracted and immunoblot analysis was performed to compare the immunoreactivity between individual serum and pooled serum. RESULTS: Pooled serum from peanut-sensitized allergic children showed all the bands which were shown in immunoblot analysis by using individual serum and peanut protein extract. These findings were demonstrated both in pooled serum with low level of peanut-specific IgE and in those with high level of peanut-specific IgE. Likewise, there was no difference in the immunoreactivity between individual serum and pooled serum from egg white-sensitized allergic children. CONCLUSION: Pooled serum can be used as an alternative to individual serum for the serum screening in the allergenicity assessment of GM food.
Child ; Egg White ; Food, Genetically Modified ; Humans ; Immunoglobulin E ; Immunoglobulins ; Mass Screening ; Ovum ; Proteins

OBJECTIVETo compare the digestibility of main nutrients in genetically modified rice with double antisense starch-branching enzyme gene and parental rice.

METHODSSeven Wuzhishan healthy adult barrows were surgically fitted with a T-cannula at the terminal ileum. After surgery, seven pigs were randomly divided into two groups, and fed genetically modified rice and parental rice by a crossover model. Ileal digesta were collected for analysis of main nutrient digestibility.

RESULTSThe apparent digestibility levels of protein in genetically modified rice and parental rice were 69.50% ± 4.50%, 69.61% ± 8.40%, respectively (t = 0.01, P = 0.994); true digestibility levels of protein were 87.55% ± 4.95%, 87.64% ± 9.40%, respectively (t = 0.01, P = 0.994); fat digestibility levels were 72.86% ± 0.34%, 77.89% ± 13.09%, respectively (t = 0.95, P = 0.378); carbohydrate digestibility levels were 72.92% ± 7.43%, 92.35% ± 5.88%, respectively (t = 4.27, P = 0.005). The apparent and true digestibility of 17 amino acids had no significant difference in the two rice.

CONCLUSIONCarbohydrate digestibility in genetically modified rice was significantly lower than that in non-genetically modified rice, other main nutrients digestibility in the two rice have substantial equivalence.

1,4-alpha-Glucan Branching Enzyme ; metabolism ; Animals ; Carbohydrate Metabolism ; Digestion ; Food ; Ileum ; metabolism ; Intestinal Absorption ; Oryza ; chemistry ; Plants, Genetically Modified ; chemistry ; Starch ; metabolism ; Swine ; metabolism

PURPOSE: This study aimed to evaluate the potential allergenicity of genetically modified (GM) herbicide-resistant food by using the serum screenning test. METHODS: Children with allergic disease were recruited, and those who were sensitized to soybean, corn or peanut were selected to obtain their sera. Sensitization to these food allergens was determined when the level of specific IgE was over 0.35 kU/L using ImmunoCAP (Pharmacia, Uppsala, Sweden). Immunoblot analyses were performed for soybean (n=50), corn (n=50) and peanut (n=20). Newly inserted gene was sequenced and cloned from GM soy (Roundup Ready Soybean, Monsanto), GM corn (Bt 11, Syngenta) and GM canola (MS8/RF3 canola, Bayer CropScience). These proteins, such as CP4 EPSPS, PAT, and BAR, were expressed and purified for the serum screening test. RESULTS: Immunoblot analysis using CP4 EPSPS and sera from soybean-sensitized children showed no bands. Likewise, sera from corn-sensitized children and PAT did not demonstrate IgE binding in immunoblot analysis. In addition, there were no reactions between BAR and sera from peanut-sensitized patients. CONCLUSION: The serum screening test using sera from allergic children and newly inserted protein (CP4 EPSPS, PAT and BAR) in GM soybean, GM corn and GM canola failed to show IgE binding in immunoblot analysis. The results of this study suggest that these newly inserted proteins may not cause allergic disease. Further studies using more sera from allergic children are needed to conclude the safety of herbicide-resistant GM food.
Allergens ; Child ; Clone Cells ; Excitatory Postsynaptic Potentials ; Food, Genetically Modified ; Humans ; Immunoglobulin E ; Mass Screening ; Proteins ; Soybeans ; Zea mays

PURPOSES: The aim of this study was to clarify whether genetically modified organic (GMO) foods cause any allergic reactions in patients with food allergy, by means of their serum tests. In addition, it was also attempted to perform follow-up observation on targeting proteins contained in GMO food, using the serum of patients with food allergy, and to show the improvement for evaluating GMO food as allergens. METHODS: To identify the targeting proteins in GMO food and to evaluate their allergenic risks, several genes including CP4 EPSPS in genetically modified soybean, and Cry1f, Cry1Ab and Pat in genetically modified corn were cloned. The genes were transformed to synthesize proteins to induce protein expression of their target genes. The serums were divided allergy-positive and allergy-negative to soybean and corn, and SDS-PAGE and Western blotting were conducted, and finally allergenic risks were evaluated. RESULTS: This study showed that the allergenic risks of 4 targeting proteins were insignificant. Although some non-specific bands appeared, it was considered that they were not associated with allergenic risk as they often appeared in other proteins. Additionally, as a result of analyzing DNA sequences for each targeting protein with the intention of protein identification, they perfectly matched. CONCLUSION: As a way to evaluate the allergenic risk of GMO food, it is reasonable to use the purified serum proteins of allergic patients as performed in this study. However, this evaluation method is carefully applied to the future practice.
Base Sequence ; Blood Proteins ; Blotting, Western ; Clone Cells ; Electrophoresis, Polyacrylamide Gel ; Excitatory Postsynaptic Potentials ; Follow-Up Studies ; Food Hypersensitivity ; Food, Genetically Modified ; Food, Organic ; Humans ; Hypersensitivity ; Intention ; Proteins ; Soybeans ; Zea mays

This study explores the Chinese public's perceptions of, and attitudes to, agriculture and food applications of biotechnology; and investigates the effect of socio-demographic factors on attitudes. A questionnaire survey and interviews were used in an attempt to combine quantitative analysis with qualitative review. The main finding of this study is that the Chinese population has a superficial, optimistic attitude to agricultural biotechnology; and that, in accordance with public attitudes, a cautious policy, with obligatory labelling, should be adopted. The study reveals that education is the factor among socio-demographic variables with the strongest impact on public attitudes. Higher education leads to a more positive evaluation of GM (genetically modified) foods and applications of biotechnology with respect to usefulness, moral acceptability, and suitability for encouragement. In addition, public attitudinal differences depend significantly on area of residence. Compared with their more urban compatriots, members of the public in less developed areas of China have more optimistic attitudes, perceive more benefits, and are more risk tolerant in relation to GM foods and agricultural biotechnology. Finally we obtained a very high rate of "don't know" answers to our survey questions. This suggests that many people do not have settled attitudes, and correspondingly, that the overall public attitude to agricultural biotechnology and GM foods in China is at present somewhat unstable.
Adolescent ; Adult ; Aged ; Attitude ; Biotechnology ; China ; Consumer Product Safety ; Food Labeling ; Food, Genetically Modified ; Humans ; Interviews as Topic ; Middle Aged ; Public Opinion ; Rural Population ; Surveys and Questionnaires ; Urban Population

Genetically modified (GM) soybean (carrying the EPSPS transgene) is the most common GM food in Korea. In order to assess whether genetic modification increases the allergenic risk of soybeans, the allergenicity and IgE-reactive components of wild-type and GM soybean extracts were compared in allergic adults who had been sensitized to soybeans. We enrolled 1,716 adult allergy patients and 40 healthy, non-atopic controls. Skin prick tests and IgE enzyme linked immunosorbent assays (ELISAs) were performed using wild-type and GM soybean extracts, along with other common inhaled allergens. The specificities of serum IgE antibodies from allergic patients and the identities of the IgE-reactive components of the soybean extracts were compared using ELISA inhibition testing, 2-dimensional gel electrophoresis, and IgE immunoblotting. To evaluate the effects of digestive enzymes and heat treatment, the soybean extracts were heated or pre- incubated with or without simulated gastric and intestinal fluids. The IgE sensitization rates to wild-type and GM soybeans were identical (3.8% of allergic adults), and circulating IgE antibodies specific for the two extracts were comparable. The results of the ELISA inhibition test, SDS-PAGE, and IgE immunoblotting showed a similar composition of IgE-binding components within the wild-type and GM extracts, which was confirmed using two-dimensional gel electrophoresis, IgE immunoblotting, and amino acid sequencing. None of the subjects had a positive response to purified EPSPS protein in the skin prick test, ELISA, or IgE immunoblot analysis. These findings suggest that the IgE sensitization rate to GM soybean extracts is identical to that of wild-type soybean extracts in adult allergy patients. In addition, based on both in vivo and in vitro methods, the allergenicity of wild type and GM soybean extracts was identical.
Soybeans/*immunology ; Skin Tests ; Protein Structure, Tertiary ; *Plants, Genetically Modified ; Middle Aged ; Immunoglobulin E/blood/chemistry ; Immunoblotting ; Humans ; Food Hypersensitivity/etiology/*immunology ; Food/*adverse effects ; Enzyme-Linked Immunosorbent Assay ; Electrophoresis, Gel, Two-Dimensional ; *Crops, Agricultural ; Allergens/*immunology ; Adult ; Adolescent

OBJECTIVETo produce the monoclonal antibodies (mAbs) against hygromycin B phosphotransferase (HPT) and to develop immunoassay based on mAbs for biosafety assessment of HPT in genetically modified rice (GM rice).

METHODSBALB/c mice were immunized with purified recombinant 6His. HPT protein, and the conventional hybridoma technology was used to generate the monoclonal hybridoma cells. ELISA and Western blot were used to analyze the specificity of mAbs recognizing HPT and the cross reaction with other proteins. A double-Ab sandwich ELISA method was established to detect HPT expression level in the sck gene-modified rice plants.

RESULTSFour hybridomas, named F1, D4-2, D4-4, and D4-5, producing the mAbs against HPT were successfully obtained with the titer of ascetic mAbs ranging from 1x10(-4) to 1x10(-5). Identification of subclass showed that all the produced mAbs belonged to IgG1. Western blot showed specific binding reaction between the mAbs to the HPT proteins expressed in the GM rice. A double sandwich ELISA coated with anti-HPT polyclonal antibody was established with mAbs as sandwich antibody, which showed a sensitivity of 30ng/mL and did not crossreact with other proteins. The expression level of HPT in the leaves of sck-transformed lines was detected (80-150ng/mL). But HPT protein in the grain and seed of GM rice could not be detected using this ELISA assay.

CONCLUSIONAnti-HPT mAbs prepared herein have a high specificity and can be used for rapid assay of HPT antigen. The expression level of HPT in the GM rice grain and seed is lower than our ELISA detection limit.

Animals ; Antibodies, Monoclonal ; immunology ; isolation & purification ; Biomarkers ; analysis ; Blotting, Western ; Consumer Product Safety ; Enzyme-Linked Immunosorbent Assay ; Female ; Food, Genetically Modified ; standards ; Hybridomas ; Mice ; Mice, Inbred BALB C ; Oryza ; genetics ; metabolism ; Phosphotransferases (Alcohol Group Acceptor) ; analysis ; immunology ; metabolism ; Plants, Genetically Modified ; metabolism ; Rabbits

BACKGROUND: The aim of this study was to evaluate the prevalence of IgE sensitization and allergic risk of genetically modified (GM) potato compared with wild one in adult patients with various allergic diseases. METHODS: One thousand eight hundred eighty eight allergy patients visited Ajou University hospital and 38 healthy controls were enrolled. Skin prick tests were performed with wild and GM extracts. Phosphinothricin N-acetyltransferase (PAT) and neomycin phosphotransferase (NPT) gene was inserted in GM potato. Serum specific IgE level to the two potato extracts was measured by ELISA and their binding specificities were confirmed by ELISA inhibition test. IgE binding components in both wild and GM potato extracts were identified by SDS-PAGE and IgE-immunoblot. RESULTS: One hundred eight patients (5.7%) showed positive responses (A/H >or= 2+) on skin prick test to both wild and GM potatoes. Serum specific IgE was detectable in 50~88% among the positive reactors on skin prick test. ELISA inhibition tests showed similar inhibition pattern between wild and GM. Fourteen IgE binding components within wild potato and nine IgE binding components within GM potato with similar binding patterns, of which three major allergens in wild (26, 34, 45 kDa) and one (45 kDa) in GM one were noted.. CONCLUSIONS: The sensitization rates to wild and GM potato extracts were 5.7% respectively, in adult allergy patients and one common major allergen (45 kDa) was identified. It is speculated that genetic manipulation of the potato did not increase allergenic risk.
Adult* ; Allergens ; Electrophoresis, Polyacrylamide Gel ; Enzyme-Linked Immunosorbent Assay ; Food, Genetically Modified ; Humans ; Hypersensitivity* ; Immunization ; Immunoglobulin E* ; Kanamycin Kinase ; Prevalence ; Skin ; Solanum tuberosum*