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At least 19 recordsLinked to original sources
PubMed2006

Evaluation of a non-targeted "omic" approach in the safety assessment of genetically modified plants.

Genetically modified plants must be approved before release in the European Union, and the approval is generally based upon a comparison of various characteristics between the transgenic plant and a conventional counterpart. As a case study, focusing on safety assessment of genetically modified plants, we here report the development and characterisation of six independently transformed ARABIDOPSIS THALIANA lines modified in the flavonoid biosynthesis. Analyses of integration events and comparative analysis for characterisation of the intended effects were performed by PCR, quantitative Real-time PCR, and High Performance Liquid Chromatography. Analysis by cDNA microarray was used as a non-targeted approach for the identification of potential unintended effects caused by the transformation. The results revealed that, although the transgenic lines possessed different types of integration events, no unintended effects were identified. However, we found that the majority of genes showing differential expression were identified as stress-related genes and that environmental conditions had a large impact on the expression of several genes, proteins, and metabolites. We suggest that the microarray approach has the potential to become a useful tool for screening of unintended effects, but state that it is crucial to have substantial information on the natural variation in traditional crops in order to be able to interpret "omics" data correctly within the framework of food safety assessment strategies of novel plant varieties, including genetically modified plant varieties.

Arabidopsis↗
PubMedDate not supplied

A conceptual framework for the design of environmental post-market monitoring of genetically modified plants.

Genetically modified plants (GMPs) may soon be cultivated commercially in several member countries of the European Union (EU). According to EU Directive 2001/18/EC, post-market monitoring (PMM) for commercial GMP cultivation must be implemented, in order to detect and prevent adverse effects on human health and the environment. However, no general PMM strategies for GMP cultivation have been established so far. We present a conceptual framework for the design of environmental PMM for GMP cultivation based on current EU legislation and common risk analysis procedures. We have established a comprehensive structure of the GMP approval process, consisting of pre-market risk assessment (PMRA) as well as PMM. Both programs can be distinguished conceptually due to principles inherent to risk analysis procedures. The design of PMM programs should take into account the knowledge gained during approval for commercialization of a specific GMP and the decisions made in the environmental risk assessments (ERAs). PMM is composed of case-specific monitoring (CSM) and general surveillance. CSM focuses on anticipated effects of a specific GMP. Selection of case-specific indicators for detection of ecological exposure and effects, as well as definition of effect sizes, are important for CSM. General surveillance is designed to detect unanticipated effects on general safeguard subjects, such as natural resources, which must not be adversely affected by human activities like GMP cultivation. We have identified clear conceptual differences between CSM and general surveillance, and propose to adopt separate frameworks when developing either of the two programs. Common to both programs is the need to put a value on possible ecological effects of GMP cultivation. The structure of PMM presented here will be of assistance to industry, researchers, and regulators, when assessing GMPs during commercialization.

Consumer Product Safety↗
PubMed2006

Quantification of cuticular permeability in genetically modified plants.

More and more studies on genetically modified plants are identifying parts of the genetic code with putative involvement in creating the cuticular barrier. Unfortunately, many of these studies suffer from the inadequacy of the chosen methods to quantify, in a reasonably unambiguous way, if and how the efficacy of the cuticular barrier is affected by the genetic change. A short overview of relevant findings is given and a more stringent experimental approach to quantifying effects on cuticular permeability in genetically modified plants proposed.

Biological Transport↗
PubMed2002

Transgenic, transplastomic and other genetically modified plants: a Canadian perspective.

Since the mid 1990s, genetically modified (GM) crops have been grown commercially in Canada on a scale that has increased steadily over the years. An intense debate ensued, as elsewhere, and many fears were expressed regarding not only the technology itself but some of the main GM crops being grown. It would seem appropriate at this time to examine how these novel crops compare to crops bred by more traditional means and what impacts these GM crops have had based on experience and not merely on conjecture. To begin, we will put things in a historical perspective and recall how domestication and conventional plant breeding have shaped the crops of today. Then, we will describe briefly the distinctive features of GM plants (obtained so far mainly by nuclear transgenesis) and how these novel crops are regulated in Canada. We will then give two examples of widely grown GM crops in Canada (insect-resistant corn and herbicide-tolerant canola) and examine the main questions that were raised as well as the actual impacts these crops have had on the farm. These examples will help us outline some of the limitations of the current generation of GM plants and, finally, we will try to get a glimpse of the future by examining some recent technical developments in the field of recombinant DNA technologies applied to plant breeding.

Agriculture↗
PubMed2005

Animal nutrition with feeds from genetically modified plants.

Plant breeders have made and will continue to make important contributions toward meeting the need for more and better feed and food. The use of new techniques to modify the genetic makeup of plants to improve their properties has led to a new generation of crops, grains and their by-products for feed. The use of ingredients and products from genetically modified plants (GMP) in animal nutrition properly raises many questions and issues, such as the role of a nutritional assessment of the modified feed or feed additive as part of safety assessment, the possible influence of genetically modified (GM) products on animal health and product quality and the persistence of the recombinant DNA and of the 'novel' protein in the digestive tract and tissues of food-producing animals. During the last few years many studies have determined the nutrient value of GM feeds compared to their conventional counterparts and some have additionally followed the fate of DNA and novel protein. The results available to date are reassuring and reveal no significant differences in the safety and nutritional value of feedstuffs containing material derived from the so-called 1st generation of genetically modified plants (those with unchanged gross composition) in comparison with non-GM varieties. In addition, no residues of recombinant DNA or novel proteins have been found in any organ or tissue samples obtained from animals fed with GMP. These results indicate that for compositionally equivalent GMP routine-feeding studies with target species generally add little to nutritional and safety assessment. However, the strategies devised for the nutritional and safety assessment of the 1st generation products will be much more difficult to apply to 2nd generation GMP in which significant changes in constituents have been deliberately introduced (e.g., increased fatty acids or amino acids content or a reduced concentration of undesirable constituents). It is suggested that studies made with animals will play a much more important role in insuring the safety of these 2nd generation constructs.

Animal Feed↗
PubMedDate not supplied

Are genetically modified plants useful and safe?

So far, plants have been genetically modified essentially to achieve resistance to herbicides, or to pathogens (mainly insects, or viruses), but resistance to abiotic stresses (such as cold, heat, drought, or salt) is also being studied. Genetically modified (GM) plants with improved nutritional qualities have more recently been developed, such as plants containing higher proportions of unsaturated fatty acids (omega-3 and omega-6) in their oil (to prevent cardio-vascular diseases), or containing beta-carotene as in the golden rice (to prevent vitamin A deficiency). Possible risks for human health (such as the production of allergenic proteins), or for the environment (such as the appearance of superweeds as a result from gene flow), should be carefully studied, and a science-based assessment of benefits vs. risks should be made on a case by case basis, both for GM plants and for plants obtained by conventional breeding methods.

Animals↗
PubMed2006

Presence of unintended Agrobacterium tumefaciens cloning vector sequences in genetically modified plants.

Agrobacterium transformation was used in the production of genetically modified plants from oilseed rape (Brassica napus) and tobacco (Nicotiana tabacum). After inoculation stop with the antibiotic timentin, a subsequent one-week treatment eliminated the vector bacterium from the oilseed rape plate explant cultures. From the tobacco, however, we recorded vector-derived signals one week after potting the regenerants in the greenhouse and still 10 weeks later. Genetically modified plants produced through Agrobacterium-transformation therefore cannot be guaranteed to be completely free of unintended vector sequences after antibiotic treatment.

Agrobacterium tumefaciens↗
PubMed2002

Hazard identification and risk assessment procedure for genetically modified plants in the field--GMHAZID.

The safe application of genetically modified organisms (GMOs) requires a risk assessment prior to their proposed use. Based on methods from the chemical industry, we developed a hazard identification procedure for the risk assessment of field tests with genetically modified plants. This risk assessment method, GMHAZID, is carried out in the form of guided brainstorm sessions. GMHAZID was tested with a case study for which a risk assessment had previously been made, and the results of the assessments were compared. The results showed that some new hazards potentially leading to uncontrolled spreading, in addition to those from the previous assessment, were identified using GMHAZID. GMHAZID also recognised some hazards leading to failures in the field experiments. We suggest that GMHAZID provides systematics, reliability, and transparency to the risk assessment procedure.

Environmental Monitoring↗
PubMedDate not supplied

A decade of European field trials with genetically modified plants.

This article analyzes the development of notifications of genetically modified plants field trials in the European Union from 1991 to 2001, based on the data collected at the European level in the Summary Notification Information Format database. During this time period, a total of 1687 field trial notifications were received. The number of field trial notifications dropped by 76% between 1998 and 2001, mainly due to the de facto moratorium in place since 1999. Input traits (77%) dominated the field trial notifications during the last decade, while output traits were relevant in only 18% of all notifications, with a decreasing relevance during the last six years. In particular, field trial notifications on molecular farming were almost absent in the EU. Large companies focused their field trials on crops with a high grown area in the European Union and resistance traits, while public institutions showed interest in a large diversity of plants and traits. Finally, some conclusions on future impacts of the results of the study are drawn in this article.

Agriculture↗
PubMed2004

[Genetically modified plants and food safety. State of the art and discussion in the European Union].

Placing genetically modified (GM) plants and derived products on the European Union's (EU) market has been regulated by a Community Directive since 1990. This directive was complemented by a regulation specific for genetically modified and other novel foods in 1997. Specific labelling requirements have been applicable for GM foods since 1998. The law requires a pre-market safety assessment for which criteria have been elaborated and continuously adapted in accordance with the state of the art by national and international bodies and organisations. Consequently, only genetically modified products that have been demonstrated to be as safe as their conventional counterparts can be commercialized. However, the poor acceptance of genetically modified foods has led to a de facto moratorium since 1998. It is based on the lack of a qualified majority of EU member states necessary for authorization to place genetically modified plants and derived foods on the market. New Community Regulations are intended to end this moratorium by providing a harmonized and transparent safety assessment, a centralised authorization procedure, extended labelling provisions and a traceability system for genetically modified organisms (GMO) and derived food and feed.

Consumer Product Safety↗
PubMed2003

In vivo studies on possible health consequences of genetically modified food and feed--with particular regard to ingredients consisting of genetically modified plant materials.

This synopsis reviews published in vivo studies on possible health consequences of genetically modified food and feed where the ingredients in question have consisted of genetically modified plant materials. The following, however, have not been taken into consideration:--ingredients consisting of genetically modified microorganisms or parts of animals/fish--ingredients produced by/from genetically modified organisms but without any DNA present--studies on consequences for the environment or biodiversity--in vitro studies or computer simulations. According to a Norwegian report "Gen-mat" (NOU 2000:29), and a more recent search in Medline and Citations Index, to our knowledge a total of ten studies have been published on the health effects of GM-foods and feeds. In this minireview the data made available in these published studies is discussed.

Animal Feed↗
PubMed2006

Loss and recovery of protein productivity in genetically modified plant cell lines.

This paper addresses the problem of decreasing protein expression levels in genetically modified plant cells. A modeling approach was used to explain the loss of productivity over successive generations. Using this model, productivity losses were simulated for two cell lines. Although the lines were relatively stable, the protein production level could decrease by more than 80% after a large number of generations. Motivated by this problem, a dispersion method was developed to isolate productive cells from existing cell suspensions. Dilution of transgenic cells in a feeder layer of nonproducing cells at a ratio of 1:1000 facilitated the recovery of distinct, separate daughter colonies. Applying this method, it was possible to recover high producing cell lines.

Cell Line↗
PubMed2004

Gaps, inexperience, inconsistencies, and overlaps: crisis in the regulation of genetically modified plants and animals.

The regulation of genetically modified products pursuant to statutes enacted decades prior to the advent of biotechnology has created a regulatory system that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured and inefficient--transgenic plants and animals are governed by at least twelve different statutes and five different agencies or services. The deficiencies resulting from this piecemeal approach to regulation unnecessarily expose society and the environment to adverse risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary increases in the cost of and delay in the development and commercialization of new biotechnology products. These deficiencies also increase the risk of further unnecessary biotechnology scares, which may cause public overreaction against biotechnology products, preventing the maximization of social welfare. With science and society poised to soar from first-generation biotechnology (focused on crops modified for agricultural benefit), to next-generation developments (including transgenic fish, insects, and livestock, and pharmaceutical-producing and industrial compound-producing plants and animals), it is necessary to establish a comprehensive, efficient, and scientifically rigorous regulatory system. This Article details how to achieve such a result through fixing the deficiencies in, and risks created by, the current regulatory structure. Ignoring many details, the solutions can be summarized in two categories. First, statutory and regulatory gaps that are identified must be closed with new legislation and regulation. Second, regulation of genetically modified products must be shifted from a haphazard model based on statutes not intended to cover biotechnology to a system based upon agency expertise in handling particular types of risks.

Animals↗
PubMed2004

Biopharmaceuticals derived from genetically modified plants.

Modern biotechnology has resulted in a resurgence of interest in the production of new therapeutic agents using botanical sources. With nearly 500 biotechnology products approved or in development globally, and with production capacity limited, the need for efficient means of therapeutic protein production is apparent. Through genetic engineering, plants can now be used to produce pharmacologically active proteins, including mammalian antibodies, blood product substitutes, vaccines, hormones, cytokines, and a variety of other therapeutic agents. Efficient biopharmaceutical production in plants involves the proper selection of host plant and gene expression system, including a decision as to whether a food crop or a non-food crop is more appropriate. Product safety issues relevant to patients, pharmaceutical workers, and the general public must be addressed, and proper regulation and regulatory oversight must be in place prior to commercial plant-based biopharmaceutical production. Plant production of pharmaceuticals holds great potential, and may become an important production system for a variety of new biopharmaceutical products.

Antibodies↗
PubMed2001

Genetically modified plants and human health risks: Can additional research reduce uncertainties and increase public confidence?

So long as the risks to human health from transgenic plants remain potential rather than actual, and, in any event, appear lower than those from traditional plant breeding, hazard assessment need not be extensive. However, in view of current public attitudes to transgenic plants, it is necessary that those tests that are required, be based on logic, on sound science, and in accordance with the best scientific methodology. This is particularly the case with testing for food allergenicity. Current testing is largely indirect and based on comparisons with other known food allergens. Development of direct tests that involve interaction between the actual transgenic protein in question and the immune system is essential if confidence in the regulatory system is to be restored.

Food Hypersensitivity↗