Accept and involve the public as a legitimate partner

Contrary to proponents' initial expectations, the public has not enthusiastically embraced agricultural biotechnology. In retrospect, it is not hard to see how this came about. In the beginning, most scientists and, to a greater extent, company executives assumed that the wonders of biotechnology were self-evident and that the benefits were almost unlimited. They were slow to recognize that the public was becoming increasingly alienated by decision makers who ignored the need for public input...

Acknowledgments

This workbook is a product of the Agricultural Biotechnology Support Project (ABSP), an international program funded by the U.S. Agency for International Development and based in the Institute for International Agriculture at Michigan State University. The workbook is a natural outgrowth of the many biosafety training activities ABSP has conducted over the past ten years in partner countries in Africa, Asia, and Latin America, and in regional programs reaching wider audiences. We are grateful...

Australia Office of the Gene Technology Regulator OGTR httpwwwhealthgovauogtr

The OGTR was established in 2000 to be responsible for a national scheme to regulate genetically modified organisms. The new Gene Technology Technical Advisory Committee will provide expert scientific advice on applications for contained research, field trials, and general releases involving GMOs. The scientific committee will also provide advice on other matters related to gene technology, GMOs, and GM products and on the need for, and proposed content of, policy principles, policy guidelines,...

Be honest frank and open

No single person has all the answers. Communicators build trust and credibility with their audience by acknowledging when questions go beyond their knowledge and offering to find the information and provide it later. Perceptions are extremely important if the communicator appears honest and sincere, what he or she says is perceived as honest and sincere. Because culture and personal values are ingrained within us, it is very difficult for any one individual to be totally without bias. Having...

Benefits of Iterative Processing

The iterative - regularly repeated - nature of risk assessment is fundamental to good assessment practice (Figure 2, page 28). The question-and-answer conversations inform applicants of regulatory concerns so that they may provide additional information, satisfy unintended omissions, and clarify language. Information gaps that become evident through the process draw attention to biosafety-related topics that need to be researched. Reviewers interact primarily with applicants during the review...

Biosafety Monitoring

May contribute knowledge and experience in the use of organisms with novel traits Ranges from simple observation to extensive research studies Can be the responsibility of the user or an independent authority, organization, or body Can be used to verify assumptions made in a risk assessment Should be used to evaluate whether risk-management measures used are appropriate and effective. United Nations Environment Programme (UNEP), 1996 ciples expected to be followed when developing a monitoring...

Biotechnology Advisory Center BAC Stockholm Environment Institute httpwwwseisebiotechbachtml

The BAC was established to help meet the challenge of biosafety capacity building in developing countries. The BAC's support consists of three components training, independent advice, and biosafety and biotechnology information exchange. The East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Policy Development (BIO-EARN) is the main activity at present. The principal objective of the BIO-EARN programme is to build national capacity and competence...

Brief Summary of Field Trials Undertaken

Six years of field trials have been undertaken in this country. The trial data have shown that gene transfer to local flora does not occur and have supported the claim that the herbicide-tolerant soy leads to increased production, decreased herbicide usage, decreased plant damage, and decreased soil erosion through the associated conservation tillage techniques. Table 1 shows results obtained in comparative trials with four GM soya varieties in three growing areas. In each area the suitable GM...

Codex Alimentarius httpwwwcodexalimentariusnet

The Codex Alimentarius, or the food code, has become the seminal global reference point for consumers, food producers and processors, national food control agencies, and the international food trade. Codex standards have become the benchmarks against which national food measures and regulations are evaluated. This site carries provisional agendas for forthcoming meetings and working papers and reports of Codex Meetings. Of particular interest is the Preliminary Report of the ad hoc...

Confinement

Confinement, or measures to keep experimental organisms within a zone having designated borders or limits, is the most common method for preventing or minimizing the unintentional spread of a GMO or its genetic material. Physical means to confine GM plants and plant parts include geographical or spatial isolation or use of structures such as fences, screens, mesh, and the like to keep animals out and prevent unauthorized harvest. In order to be considered an environmental risk, transgenic...

Context for Biosafety Review and Decision Making

Biosafety review the scientific evaluation of a GMO's potential effects on the environment and human and animal health is often seen as the single factor that determines whether or not a GMO or product is approved for testing or use. However, safety assessments are conducted within a larger context for decision making that includes national policies for agriculture, biotechnology, and biosafety (or lack thereof), international agreements, stakeholder interests, and public attitudes (see Figure...

Crossability of Sunflower

Cultivated sunflower crosses readily with wild and weedy forms of H. annuus, which are common in many areas. Insect-aided pollination is the predominant method by which a high degree of cross-pollination takes place in sunflowers. Cultivated sunflowers are potentially capable of crossing with many other species of Helianthus, and naturally occurring hybrid swarms are known in North America. Interspecific hybridization involving H. annuus as one of the parents has been conducted for many years...

Decision Documents

Biosafety decisions typically are recorded in some form of decision document. The documents present key findings of the biosafety review committee and of other parties providing information and advice that collectively form the basis for a final decision to use, or not, a particular GMO in a specified way. Decision documents prepared by biosafety committees serve to communicate their science-based findings to regulators, applicants, stakeholders, and interested parties. Such reports will Note...

Description of Any Product Derived from the Plant

Soya is used in about 1,600 processed food products as a filler and as a source of healthy, affordable protein. Processing and cooking denatures the foreign DNA and foreign gene product. In the absence of local labeling guidelines for GM foods, food processors have been asked to label all foods containing detectable foreign protein as genetically modified. This will probably require the labeling of milled, unprocessed soya meal, but no other products in the processing line. Soya seed is...

Environmental Biosafety Journal httpwwwedpsciencesorgebr

Environmental Biosafety Research (EBR) is a new interdisciplinary, international journal that publishes the results of research related to science-based risk-assessment of GMOs. Included are peer-reviewed original research papers and review articles, as well as scientific correspondence on all types of GMOs, including plants, animals, and microbes. The scope of material encompasses ecological studies of the impact of novel organisms studies of their interactions with pests and pathogens food-...

Environmental Impact and Protection

Soya has been grown in this country for 15 years with no adverse impact on the environment. Soya is neither weedy nor invasive. The GM soya is not going to change this pattern. GM soya is no more likely to escape into the environment than conventional soya varieties. Any selective advantage conferred on GM soya by the Gox gene is only effective when the Roundup Ready herbicide is used. Thus, the selective advantage is confined to agricultural areas and can be quickly reversed by other...

European Federation of Biotechnology EFB Agri Biotechnology Europe httpwwwagbiotechorg

The EFB is an association of European scientific and technological societies in biotechnology together with universities, scientific institutes, companies, biotechnology associations, and individual members. Their mission is . . . to promote the safe, sustainable, and beneficial use of Nature's resources in the life sciences and technologies to facilitate exchange of people and ideas and to contribute to a better understanding and perception of biotechnology by the general public in Europe.

Experimentation

When field testing of genetically modified microorganisms first began in the United States, assumptions regarding monitoring needs led to ill-conceived and expensive protocols. Perhaps because little experience and no experimental evidence were available to draw upon, unproven methods were often chosen. During the course of field testing, it was discovered that these monitoring procedures were inadequate (i.e., inappropriately timed, provided poorly discriminated detection, or Figure 3....

Feedback Mechanisms

Field trials of GM varieties are carried out to collect data of commercial and biosafety importance. Feedback, in the form of data and information derived from prior GMO releases, helps support subsequent biosafety committee deliberations, particularly in the early phase of biosafety implementation. Feedback mechanisms can also provide information that may help improve procedures for future field tests. Extensive plantings of commercial GM crops provide unique conditions that may also result in...

Food Future Genetically Modified Crops and the Environment United Kingdom httpwwwfoodfutureorguk

The Food and Drink Federation's Food Future program aims to improve public understanding of genetic modification. The program has initiated wider discussion of the technology - the perceived benefits and disadvantages as well as the ethical and moral concerns. The site provides consumers with facts and figures about GM crops so that they can make informed decisions about what they buy. The site has informative sections on the benefits, risks, and regulation of GM crops in the United Kingdom.

Food Products Unit FPU httpfoodjrcit

The FPU of the European Commission's Joint Research Council works in two main areas activities within the field of food safety and quality, and issues on genetically modified organisms. The unit's main clients and partners are the European Com mission Directorates involved in establishing legislation related to food and feed. Other aspects of the unit's work are harmonization of analytical procedures in order to produce reliable data for risk assessment, detection of fraud, and monitoring of...

Foreign Genes and Gene Products

The soya varieties all contain the same gene construct. The Gox gene is from Streptomyces and codes for a single protein that inactivates the active compound in glyphosate herbicides. The protein lies behind a CAMV 35S promoter that expresses the gene in all plant tissues at all growth stages. Foreign protein levels in seed are between 8 to 20 ng per g dry weight. This is very low and is undetectable under some growing conditions. The DNA and the protein from the Gox gene are quickly digested...

Full details are required about the manner in which the trial release of the GMO is to be undertaken

The bananas will be planted at the Tropical Agriculture Institute's research facility, which is surrounded by a fence to minimize pilfering. Access to the trial site will require a key and will be by authorized personnel only. A sign on the fence will have a skull and crossbones and say, Test bananas, not for human consumption. The trial site is within the grounds of the institute, on a southwest slope. Water drains from the site to the dam. The institute is surrounded by subtropical vegetation...

Furnish a description of the genetic and resultant phenotypic modifications of the GMO This should include the origin

Map of the omega cassette that was used to disable virulence in Ralstonia hrp target sequence for crossover insertion into the Ralstonia virulence region Map of the omega cassette that was used to disable virulence in Ralstonia Gene insertion was used to knock out the virulence gene in the wild type strain. The inserted DNA, the omega cassette on plasmid pKhrp42a, consisted of a kanamycin resistance gene (npt II) flanked by short segments of the hrp gene hrp target sequence for crossover...

Gene Flow

The possibility that genes introduced by genetic engineering may escape (be transferred via pollen) to wild or weedy related species growing nearby is often cited as one of the major risks of GMOs. Gene flow between crops and the wild species from which they were derived, however, is a well-documented natural phenomenon. Over the course of evolution, familiar crop species - wheat, potatoes, corn, canola, and numerous others - were modified from their original form because of hybridization with...

General Release

These imports will not be used for planting, but only for food and feed processing. The seed will be milled and is not expected to escape into the local environment. We propose to import the commodity maize using the conditions devised for phytosanitary containment. The seed will be offloaded into sealed containers, shipped to the nearest mill, and milled immediately. No storage of seed will be allowed. The milled maize is nonliving and will not grow and reproduce when released into the food...

Genetic resources eg susceptibility of economically important species to herbicides pesticides etc

Bt is unlikely to affect genetic resources in the area because the only insects that are affected are lepidopterans that eat parts of the plant. The poor natural germination of cotton seed and the absence of wild relatives will ensure that the genetic modification has no negative impact on the environment. 4.9 Will the trial release have any unlikely but possible impacts 4.10 What will be the consequences if the organism remains in the environment beyond the planned period 4.11 Has a trial...

Genetics of Cotton

At least seven genomes, designated A, B, C, D, E, F, and G, are found in the genus. Diploid species (2n 26) are found on all continents, and a few are of some agricultural importance. The A genome is restricted in diploids to two species (G. arboreum and G. herbaceum) of the Old World. The D genome is restricted in diploids to some species of the New World, such as G. thurberi. By far the most important agricultural cottons are G. hirsutum and G.barbadense. These are both allotetraploids of New...

Httpwwwagbiosafetyunledu

A source of scientific, regulatory, and educational materials relevant to crop biotechnology and the current debate on the genetic modification of food. The site offers up-to-date information on current issues in biotechnology and food safety and a searchable database of safety information on GM crops that have received regulatory approval in Canada, the United States, and elsewhere. It provides educational resources and lesson plans on crop biotechnology for both consumers and educators and...

Httpwwwcheckbiotechorg

The aim of this site, sponsored by Syngenta, is to provide trustworthy and up-to-date information on agricultural biotechnology and thereby to contribute to an open debate. The collection of documents gives an overview of ongoing discussions in agricultural biotechnology. The information provided comes from different sources and thus may not always reflect the opinion of the sponsor. This site will be useful for people with a special interest in the field of ag-biotech and GM-food, primarily...

Httpwwwcidharvardeducidbiotech

This site includes background papers and a forum to promote exchange of views on topical issues related to biotechnology and development. These include the evolution of the biotechnology industry biotechnology in international trade intellectual property rights in biotechnology biotechnology and international relations bio-prospecting biotechnology in developing countries environmental aspects of biotechnology biotechnology and human health and ethics, social values, and biotechnology.

Httpwwweuropabioorg

EuropaBio, the European Association for Bioindustries, represents nearly forty member compa- nies operating worldwide and eighteen national biotechnology associations. This site features an Info Kit with nineteen modules on topics including an introduction to biotchnology, environmental effects and food safety of GM crops, and frequently raised arguments against biotechnology, commercial GM crops, industrial biotechnology, and others. It also carries the latest news reports and information on...

HttpwwwoecdorgENhome0ENhome528nodirectoratenonono27FFhtml

BioTrack Online was created in 1995 as a pioneer site at the Organization for Economic Cooperation and Development (OECD) in the field of the safety in biotechnology. This site focuses on information related to the regulatory oversight of products of biotechnology. BioTrack Online currently includes information related to major legislative developments in OECD member countries (including details of the relevant regulatory authorities) an online database of products of biotechnology as well as...

Human and Animal Health

The Gox protein has been tested in human and animal health trials by three independent teams. No evidence of toxicity or allergenicity has been found. A nationwide French study in 1998, to investigate increasing reports of allergenicity to soya, found that the increase correlated with increased consumption of soya and improved allergenicity testing procedures, not with the advent of GM soya as had been hypothesized. The researchers reported that GM soya is the only soya that is tested for...

Imperfect Knowledge

Findings based on scientific data are often limited by incomplete or missing information. It is not uncommon for biosafety committees to raise questions for which experimental data are lacking. Their deliberations must accommodate this inherent limitation of risk assessment. Otherwise, a circular argument results if all questions must be answered before approving a field test, and if the answers can be found only by conducting field tests, then no approvals can be granted. Part of the solution...

Information and Access

Scientific biosafety review teams require a significant amount of information and data on which to base their recommendations. The greater the degree of confidence sought, or the lower the tolerance for an erroneous finding, the more information needed. Much of the necessary information may be supplied with the application. However, a predetermined set of questions may not elicit all that is necessary and sufficient to complete an informed risk assessment. Where gaps exist, or if supporting or...

Instructions

NOTE Each group first should establish terms of reference with regard to the purpose and scope of its work as a biosafety review committee (15 minutes). See pages 11-15 of Part One of this workbook for further details on terms of reference. A. Read the case-study application proposing release of a GMO to the environment. For the purpose of these exercises, assume that data referred to in the text, but not found in the case document, were submitted with the application. B. Evaluate the proposal...

International Agreements

The Cartagena Protocol on Biosafety (CPB) is a legally binding international agreement negotiated under the auspices of the 1992 Convention on Biological Diversity. Its primary aim is to protect biodiversity by ensuring the safe and responsible development, handling, use, transfer and release of any Living Modified Organism. The protocol addresses transboundary movement of living GMOs it also applies to the use or trade of products derived from GMOs, such as grain processed into meal or flour,...

International Centre for Genetic Engineering and Biotechnology ICGEB httpwwwicgebtriesteitbsafesrv

The Biosafety Unit of the ICGEB is dedicated to biosafety and risk assessment for the environmental release of genetically modified organisms. It offers information on biosafety concerns, upcoming meetings and training courses, and a regularly updated index of selected scientific articles published on biosafety and risk assessment from 1990 onward. This site also carries an outstanding collection of links to databases on GMO releases, scientific bibliographies, decision support systems,...

International Service for the Acquisition of Agribiotech Applications ISAAA httpwwwisaaaorg

The primary site describes ISAAA's activities and initiatives in biosafety, food safety, intellectual property, and technology transfer. The Global Knowledge Center on Crop Biotechnology section is organized into several main areas. Global Network provides a status of biotechnology in the developing countries of Asia, South America, and Africa. Crop Biotech Update is a weekly summary of world developments in agricultural biotechnology for developing countries. Separate pages cover GM products...

Introduction

As we stated at the beginning, biotechnology is a complex topic it is a proposition with high stakes and has passionate proponents and opponents. Risk-assessment and risk-management procedures intended to identify and minimize potential negative effects on human health and the environment are key elements in making technical decisions to use, or not use, a product of biotechnology. However, just as a three-legged stool will not stand with only two legs, the public will not accept biotechnology...

Listen to your audience

People attending any kind of discussion forum generally want to either learn more about the subject, express their opinion, or both. Effective communicators make it a point to find out what their audience wants to know and are prepared to pro vide that information. They give people an opportunity to speak without being judged and pay attention to what is said. Experts in conflict management stress that making the effort to hear someone's concerns and showing that they have been heard and...

Modes of Gene Escape

Genetic material of G. hirsutum may escape from a test area by vegetative material, by seed, or by pollen. Propagation by vegetative material is not a common method of reproduction of cotton. Physical safeguards that inhibit the movement of vegetative material from the area should be adequate to prevent gene movement by this means. Movement of seed from the test area can likewise be inhibited by adequate physical safeguards. Movement of genetic material by pollen is possible only to those...

Modes of Gene Movement

Genes may move out of the test areas by pollen or by seed. Because insect-vectored sunflower pollen may readily transfer genes to wild, weedy, or cultivated H. annuus, or other Helianthus spp. outside test areas, some means, such as flower removal, caging, etc., must be used to prevent such movement. Spatial isolation may not be realistic for some test sites. Seeds may serve as a means of movement either by bird dissemination, or simply by falling to the ground. Some means, almost certainly...

Monitoring

Monitoring in biotechnology has different meanings and interpretations depending on individual perspectives or circumstances. In one sense, monitoring is the measuring and comparison of new plant varieties for relative performance and is a normal component of all stages of research and development. However, with the emergence of modern biotechnology, speculation about potential harm from GMOs introduced into the environment has shifted the focus of monitoring to following the fate of these...

Monitoring Categories

Gather basic scientific information Test pre-release assumptions Improve experimental design Product development marketing Incremental dissemination dispersal When the first field tests of GMOs took place, it was not clear what should be monitored, why, or for how long. Monitoring objectives and methodologies were conceived and implemented with no precedent to follow and often resulted in unusable data or no data at all. Subsequently, methods and sampling designs have been refocused through...

Morphology and Reproduction

Maize is a tall, robust, monoecious annual with overlapping sheaths and broad, conspicuously distichous blades staminate spikelets in numerous long spike-like racemes forming large spreading terminal panicles (tassels) pistillate inflorescence in the axils of the leaves, the spikelets in 8-16 (30) rows, on a thickened, almost woody axis (cob), the whole enclosed in numerous large foliaceous bracts or spathes, the long styles (silk) protruding from the summit as a mass of silky threads grains at...

Morphology and Sexual Reproduction

The soybean plant is a branched, non-frost-tolerant annual about one meter above ground level and two meters below ground level. The stem tissues are mostly primary, although the basal and more mature portions of the stems develop secondary vascular tissues during later development. This woody development is in accord with the derivation of soybean from tree ancestors in the rosewood tribe, Dalbergieae. The nodulated root system is intermediate between a taproot type and a diffuse type. The...

National Policy

A strong national policy environment for agriculture, new technologies, resource conservation, and related areas will foster the adoption of appropriate GM technologies. Coherent policies promote development of an implementable regulatory system for biosafety and guide its coordination with related regulatory mechanisms (e.g., phytosanitary requirements, seed registration, etc.). They provide a basis for accommodating the differing interests of ministries of agriculture, health, science and...

Objectives of Risk Communication

Communication, not science, is the heart of risk communication. Regardless of subject matter and level of risk - whether reporting an outbreak of a devastating animal disease, announcing a GM crop field test, or talking to people living near a chemical spill - risk communication seeks to Better educate the public about risks, risk assessment, and risk management Better inform the public about specific risks and about actions taken to alleviate them Improve communicators' understanding of public...

Personnel

Sound biosafety reviews require the expertise of scientists knowledgeable about the organisms, the introduced traits, and the environment into which specific GMOs will be released. The scope of disciplines relevant to biotechnology and biosafety is extensive. Some countries, such as the Philippines and China, have a large pool of qualified life scientists and thus are capable of securing the necessary expertise. Many others lack sufficient scientific capacity and will find it difficult, if not...

Pollination of Cotton

Gossypium hirsutum is generally self-pollinating, but in the presence of suitable insect pollinators can exhibit cross-pollination. Bumble bees (Bombus spp.), Melissodes bees, and honey bees (Apis mellifera) are the primary pollinators. Concentration of suitable pollinators varies from location to location and by season and is considerably suppressed by insecticide use. If suitable bee pollinators are present, distribution of pollen decreases considerably with increasing distance. In an...

Pollination of Maize

Studies of pollination of maize have mostly centered on the needs of hybrid seed production. This production involves the development and maintenance of inbred lines and the subsequent crosses to produce commercial seed. In the former, self-pollination is mandatory. In the latter, cross-pollination is mandatory. Mechanisms have been developed to ensure each kind of pollination. Breeder seed is usually derived from self-pollinated seed at the F8 to F10 generation of inbreeding. A high degree of...

Provide information through credible sources

People tend to pay attention to information coming from sources they trust. To a public hearing inconsistent and conflicting information about controversial issues, who the messenger is may be as important as the message. The public is not a homogeneous entity but rather a collection of numerous groups whose priorities and concerns are highly variable. To whom do different constituent groups turn for information Who is viewed as a credible spokesperson In some countries, government authorities...

Reproduction of Sunflower

Flowers are borne on a fairly standard Asteraceae capitulum of 700-8,000 individual florets. Disk flowers are perfect ray flowers are sterile with a rudimentary pistil. Disk flowers within a single capitultum open centripetally for a period of 5-10 days or more each capitulum may have, depending on timing, a central portion of unopened buds, surrounded by a ring of florets with exposed stamens, another ring of florets with exposed stigmas, and finally a ring of pollinated florets. On the...

Risk Assessment

Risk assessment is inherently the most critical component of biosafety implementation. Those who make determinations of the relative safety of a biotechnology product and its use will be well served to master an understanding of the approaches that have been used for assessment of environmental risk and the reality of what an assessment may or may not do. With some grasp of the basics, better choices of personnel, education, and training needs may be brought to the formation of biosafety...

Risk Communication in Practice

Provide clear and accurate information. In communicating about biotechnology to a nontechnical audience, information needs to be translated into everyday language. Explanations using ordinary words can help the public gain more realistic ideas about the technology - what it is, what benefits it offers, what concerns it raises - and how it is being used. For instance, the subject of DNA can be introduced with an analogy to videotape both are linear and carry information that must be decoded....

Risk Assessment Research

Biosafety reviewers often face uncertainty when certain data needed for a complete evaluation are missing. Risk-assessment research is designed to provide information and generate data that fill in knowledge gaps and expand basic understanding of crop biology, agricultural ecosystems, and the ecological interactions of crop plants and their environment. High-priority topics for risk-assessment research are often identified in the course of biosafety reviews. They may take the form of questions...

Scaleup

The risk assessor needs to be aware of the spatial and temporal scale of GMO introductions. Questions may change as the size of the area being planted changes. For example, some questions pertaining to commercial-scale release cannot be answered by data from small-scale field tests (e.g., probability of gene transfer). Low-probability events are more likely to occur when large numbers of plants are cultivated. Differences in scale may have profound effects on the ability to provide meaningful...

Seed Dispersal

The marketed seed will be labeled as genetically modified and all growers will receive information on the technology and how to implement revised herbicide treatment and conservation tillage procedures. The plant is spread by seed dispersal and the seeds are viable. However, studies around soya fields show that there is little dispersal beyond the planted area and no evidence of roadside volunteers could be found. Soya is also controlled by three other registered herbicides in this country,...

Seed Dispersal in Sunflower

The subject of seed dispersal inevitably leads to birds. For several reasons, sunflower seed is very attractive to many birds. The seeds have high levels of protein and fat that are useful to growth, molt, fat storage, and energy needs of birds. The seeds mature during the postbreeding season of most birds, when their energy demands are greatest. In some parts of the world, birds have many years of co-evolution with sunflower. Although most of the seed is consumed by the birds and becomes...

Stakeholder Involvement

Stakeholders in biosafety decision making are those interested in or affected by decisions regarding the use of GMOs. In addition to scientists and research directors, the term encompasses farmers and farm organizations, environmental groups, local landowners, consumer organizations, industry and trade organizations, seed suppliers, national and local authorities, and the like. Stakeholders and decision makers share the common goal of using biotechnology and GM products in such a way as to...

Sunflower as a Crop

Sunflower, Helianthus annuus Linnaeus, is an annual row crop that is grown primarily for its edible oil. Other uses and byproducts include animal feed, human snacks, and various chemical and industrial products. The crop, and indeed the entire genus Helianthus, was unknown in the Old World until after Columbus. But it was grown by North American Indians for millennia throughout much of the United States and portions of Canada and Mexico. Sunflower subsequently spread to Europe for garden and...

Surveillance

Surveillance, the ongoing post-release observation of the organism to monitor its survival and dispersal or its environmental impact, is a form of monitoring appropriate when predetermined sampling regimes are impractical. However, devising a meaningful surveillance program presents difficulties when the environmental effects of a GMO release are only speculative. Furthermore, the large distances (e.g., kilometers) and long time intervals (e.g., years) associated with monitoring, for example,...

Table 2 Quantitative PCR determinations of Gm Dna as a percentage of soya food products

PRODUCT NEGATIVE* < 0.5 0.5 < x < 2 > 2 Soya flour 0 0 17.9 82.1 Soya grist 0 8.75 74.0 17.25 Soya Composed food 92.0 8.0 0 0 A comparative study by 16 Swiss analytical laboratories averaging the data for two primers RR and 35S (Nat Biotech 17 1 137-1 138, 1999) * All negative controls were correctly detected by all laboratories.

Taxonomy of Maize

Zea is a genus of the family Gramineae (Poaceae), commonly known as the grass family. The genus consists of some four species Zea mays, cultivated maize and teosinte Zea diploperennis Iltis et al., diploperennial teosinte Zea luxurians Bird and Zea perennis Reeves et Mangelsd., perennial teosinte. Various of the species have been assigned to the segregate genus Euchlaena, which is not currently recognized, or have been divided into numerous small species within the genus Zea. The closest...

Taxonomy of Sunflower

Sunflower belongs to the genus Helianthus, a genus of 67 species, all native to the Americas. The genus consists of both annual and perennials some, such as H. annuus, are very common some, such as H. niveus (Bentham) Brandegee, are quite rare some are very weedy and some are grown as ornamentals. In addition to the sunflower, the Jerusalem artichoke, H. tuberosus Linnaeus, is grown for food. Taxonomists have repeatedly noted that the distinctiveness of the genus within the Asteraceae...

The extent to which it has been characterized

The Hepatitis B vaccine protein was cloned from the virus and inserted into a plasmid containing a tissue-specific promoter that only expresses the protein banana fruit. The plasmid also contains an herbicide-resistance marker gene. The plasmid was shot into banana tissue using a helium gun. Plantlets were regenerated from transformed cells of eight banana varieties. Stable transformants were selected over ten generations of plants regenerated in tissue culture. RR glyphosate herbicide...

The Monitoring Paradox

On one hand, new problems cannot be predicted and on the other hand if we can predict problems, they are not new. Wide-ranging, open-ended monitoring is probably the way to detect new or unique effects of genetic engineering. Yet such monitoring is expensive in time and money. It is also inefficient surely most studies will find nothing at great expense even if a previously unknown problem eventually turns up. It is helpful to decision makers and those who will be charged with the design and...

The Precautionary Principle as Stated in International Documents

Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. Rio Declaration on Environment and Development (Earth Summit), 1992, Principle 15 Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of potential adverse effects of a living modified organism on the conservation and sustainable use of...

The survival rates of the GMO in the spectrum of conditions that are likely to be found in the proposed release areas

The mutants survive for long periods in laboratory conditions. Experiments monitoring GMO survival in soil indicated that they decreased rapidly in the numbers of GMOs in the first week, but then a stabilizing of the population at very low counts (approximately 10-17) for the duration of the monitoring, which was six months. However, current control mechanisms indicate that wild type numbers decrease in fields not planted with potatoes. After two to three years, the numbers are low enough to...

Toxicity

There are some concerns regarding the safety of new proteins expressed in transgenic plants. Even low-level expression of a new transgene potentially may have an unintended, deleterious effect on other organisms including birds, insects, browsing animals, and soil organisms in the local environment. This is particularly the case when the protein has no prior history of being found in plants, or is not found at the levels expected in the GMO. Proteins intended to control specifically targeted...

Tracking

Tracking refers to monitoring the movement and dispersal of organisms and their genes over time. If crop plants do not survive well beyond cultivated fields, tracking is not necessary. But if cultivated plots of crop plants have close relatives growing nearby, outcrossing of the engineered genes may be a concern. It is commonly recognized by breeders and agronomists that natural mechanisms for such outcrossing do exist. However, it is only in certain cases that a biosafety concern is raised...

Trial Release Microorganisms Associated with Plants

5.1 What is the target species of plant 5.2 Is the organism able to establish itself on in nontarget species in the surrounding environment 5.3 To what extent does the organism survive and reproduce on in The GMO is a common pathogen of potatoes and survives effectively in potato fields. However, it decreases to nonpathogenic levels if the fields are not planted with potatoes for two to three years. 5.3.2 The rhizosphere of the target plant species 5.3.3 Other plant species in the test site...

Trial Release Microorganisms to Be Used for Modifying the Environment eg biological control pollution control

6.1 In the case of biological control organisms, what is the biological control target species 6.2 What direct effects do the unmodified and modified organisms have on The modified organism prevents or reduces colonization of plant by nonmodified organisms. 6.2.2 Nontarget species (including humans) The GMO is nonpathogenic, but the wild type causes bacterial wilt on potatoes. 6.2.3 Any plant or animal species being protected from the target species 6.3 What is known about the organism's...

Trial Release Vaccines

5.1 For human clinical trials, what arrangements are proposed to dispose of waste containing any vaccine organisms Clinical trials are not part of this application. They are already under way in Europe. 5.2 Will the subjects carry live vaccine organisms at the end of the trial If so 5.2.1 Will they be likely to disseminate the live vaccine organisms to the general population 5.3 On the basis of data obtained in contained experiments (please supply), what effects are expected when the vaccine...

Unepgef Biosafety Project httpwwwunepchbiosafety

The UNEP-GEF Biosafety Project is funded by the Global Environmental Facility and is based on its Initial Strategy for assisting countries to prepare for the entry into force of the Cartagena Protocol on Biosafety (GEF C.16 4). The main objectives of this strategy are to assist countries in the establishment of their national biosafety frameworks promote information sharing and collaboration, especially at the regional and subregional level and promote collaboration with other organizations to...

United Kingdom Advisory Committee on Releases to the Environment ACRE httpwwwdefragovukenvironmentacre

ACRE, a nondepartmental public body, advises the Department for Environment, Food and Rural Affairs on applications to field test or release for commercial use agricultural GMOs. The site has extensive background information on the release of GMOs in the European Union, lists of applications for experimental trials and to market GMOs, application formats for deliberate releases and marketing of higher plants and organisms other than higher plants, a statement on GM animals, and more. The...

Use of Expert Committees

Although not always required, expert committees offer an invaluable adjunct to risk assessors. They not only expand the pool of expertise brought to bear on specific issues, but also provide stimulating debate around the limitations of scientific data to arrive at conclusions and the uncertainties that must be considered. These advisory groups have been used successfully for many years. Already limited in the supply of national experts, developing countries with active biotechnology research...

Use of Prior Reviews

Applications for field tests or market releases in developing countries in many cases involve GMOs previously approved by national biosafety committees elsewhere in the world. The findings of these committees are a valuable resource because they can direct subsequent reviewers to specific areas of concern and indicate how these concerns might be addressed. Sharing documentation from prior reviews helps build familiarity with specific GM products, gives insight into management procedures,...

Weediness

The concept of weediness with its numerous characteristics contributing to complex and variable phenotypes is difficult to define. Weediness is not an inherent property of certain plant species, but rather is a judgment based on the time and circumstances in which the plant is growing in light of human preferences at that time and place. Thus the simplistic definition of a weed is a plant in a place where you don't want it. In cultivated fields, a GM crop may become an agricultural pest (weed)...

What data are available to suggest that the introduced genetic trait has no deleterious effect in the long term upon

No data are available to determine the long-term impact of this GM sunflower on other species. However, the modification is expected to have a positive benefit to the plant and a negative benefit to fungi in the sunflower fields. Whether the modification results in increased weediness of the crop will need to be assessed in field trials. These cannot be carried out until some data are available on the rate of gene spread to related species (this trial). The effect on fungal populations also...

What is the aim of the proposed trial release of the genetically modified organism GMO What are the benefits of this

The current vaccine for Hepatitis B is the same cloned viral protein, but delivery is in a pharmacological package designed for injection. Storage and hygiene of injected vaccines have been problematic in rural areas of developing countries where refrigeration and supplies are not readily available. In addition, injections cause significant trauma to children and adults. Packaging the vaccine protein in an edible fruit is a convenient, cost-effective, and humane way of ensuring that adequate...

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Degree of Monitoring Difficulty Expense Figure 4. Factors contributing to the intensity of monitoring. The degree of uncertainty and magnitude of potential adverse effects determine the intensity of a monitoring plan. naively conceived). The result was expensive monitoring schemes that produced little or no usable data. Research and field-testing experience led to the unfortunate conclusion that these early monitoring procedures would not answer the questions of concern. Experimenters and...

Financial Support

Biosafety systems impose financial costs for implementation and for compliance. Costs of establishing and operating a biosafety system include Education of policy makers and stakeholders Development and distribution of procedural information Administrative expenses of the biosafety review committee Salary and support for paid staff Pre-release site visits (if required) Inspections during and upon termination of the field-test release Documentation and record keeping In some countries,...

Taxonomy of Soybean Relatives

The soybean is a papilionoid legume (family Fabaceae, subfamily Faboideae), and a member of the tribe Phaseoleae, subtribe Glycininae. The sub-tribe to which soybean belongs consists of 16 genera, none of which, except soybean (Glycine) and kudzu (Pueraria), are commonly known outside of botanical science. The genus Glycine is unique within the subtribe on several morphological and chromosomal characters, and does not seem to bear an especially intimate relationship with any other genus in the...

Definitions of Risk Assessment

. . . the attempt to quantify the degree of hazard that might result from human activities an exercise that combines available data on . . . potency in causing adverse . . . effects with information about likely . . . exposure, and through the use of plausible assumptions, it generates an estimate of risk. . . . the scientific activity of evaluating the potential effects of an entity and its application in order to ascertain the likelihood that an adverse effect may occur, and to characterize...