Hector Quemada

Assessment of risk of insect-resistant transgenic crops to nontarget arthropods

An international initiative is developing a scientifically rigorous approach to evaluate the potential risks to nontarget arthropods (NTAs) posed by insect-resistant, genetically modified (IRGM) crops. It adapts the tiered approach to risk assessment that is used internationally within regulatory toxicology and environmental sciences. The approach focuses on the formulation and testing of clearly stated risk hypotheses, making maximum use of available data and using formal decision guidelines to progress between testing stages (or tiers). It is intended to provide guidance to regulatory agencies that are currently developing their own NTA risk assessment guidelines for IRGM crops and to help harmonize regulatory requirements between different countries and different regions of the world.

How Governmental Regulation Can Help or Hinder the Integration of Bt Crops within IPM Programs

Regulatory risk assessments are an important part of the introduction of insect-resistant genetically modified (GM) crops (e.g., Bacillus thuringiensis [Bt] crops) into the environment to ensure the safe use of such products. In doing so, the regulatory assessment process can be clearly beneficial to integrated pest management (IPM) programs. In general, the regulatory framework for insect-resistant GM crops includes an assessment of the following: effects of the insecticidal trait on non-target organisms, other potential adverse environmental impacts, evolution of resistance to target pests, and environmental and agronomic benefits of the insecticidal trait. Each country’s regulatory system is dependent on the overall environmental risk management goals, relevant and available risk information, scientific capacity, and the available financial resources. A number of regulatory activities can help to ensure that new products such as Bt crops fit well within IPM programs: (1) evaluation of the environmental safety of new products, and their ability to enhance IPM; (2) encouragement of the adoption of new technologies with improved environmental safety profiles; (3) adoption of an expedited regulatory review system; and (4) encouragement and appropriate oversight of sustainable use of such products. Governmental regulation of insect-resistant GM crops can also hinder IPM programs by creating significant barriers to the adoption of such technologies. Such barriers include: (1) absence of functioning regulatory systems in many developing countries; (2) meeting the obligations and understanding the various interpretations of international treaties, e.g., Cartagena Protocol on Biosafety; (3) lack of public sector research to generate data supporting the safety of these crops; and (4) regulatory costs involved in the development and commercialization of novel products for small market sectors. Ways in which regulatory data requirements can be globally harmonized need to be considered to decrease the regulatory barriers for insect-resistant GM crops and comparable technologies. International organizations can play a key role in rationalizing regulatory systems; however, public sector research will also be needed to make sure that the risk assessment process is scientifically sound and transparent.

Cantaloupe line CZW-30 containing coat protein genes of cucumber mosaic virus, zucchini yellow mosaic virus, and watermelon mosaic virus-2 is resistant to these three viruses in the field

Cantaloupe line CZW-30 containing coat protein gene constructs of cucumber mosaic cucumovirus (CMV), zucchini yellow mosaic potyvirus (ZYMV), and watermelon mosaic virus 2 potyvirus (WMV-2) was investigated in the field over two consecutive years for resistance to infections by CMV, ZYMV, and/or WMV-2. Resistance was evaluated under high disease pressure achieved by mechanical inoculations and/or natural challenge inoculations by indigenous aphid vectors. Across five different trials, homozygous plants were highly resistant in that they never developed systemic symptoms as did the nontransformed plants but showed few symptomatic leaves confined close to the vine tips. Hemizygous plants exhibited a significant delay (2–3 weeks) in the onset of disease compared to control plants but had systemic symptoms 9–10 weeks after transplanting to the field. Importantly, ELISA data revealed that transgenic plants reduced the incidence of mixed infections. Only 8% of the homozygous and 33% of the hemizygous plants were infected by two or three viruses while 99% of the nontransformed plants were mixed infected. This performance is of epidemiological significance. In addition, control plants were severely stunted (44% reduction in shoot length) and had poor fruit yield (62% loss) compared to transgenic plants, and most of their fruits (60%) were unmarketable. Remarkably, hemizygous plants yielded 7.4 times more marketable fruits than control plants, thus suggesting a potential commercial performance. This is the first report on extensive field trials designed to assess the resistance to mixed infection by CMV, ZYMV, and WMV-2, and to evaluate the yield of commercial quality cantaloupes that are genetically engineered.

Trace and traceability--a call for regulatory harmony.

975 and disrupt field research that they deem unacceptable. There are important lessons here. First, you don’t conciliate thugs by capitulating to them. Second, the problem would have been avoided entirely, had public policy been crafted intelligently in the first place. And third, when universities permit intimidation to compromise academic freedom and the safety of their faculty and students, they become part of the problem.

Diversity in Free-living Populations of Cucurbita pepo (Cucurbitaceae) as Assessed by Random Amplified Polymorphic DNA

Abstract One area of risk assessment for transgenic crops concerns cross-compatible wild and weedy relatives. In squash (Cucurbita pepo), free-living populations are diverse in their distributions, ecologies, histories, and genetic and phenotypic compositions. As part of the effort to understand this diversity, random amplified polymorphic DNA (RAPD) data were collected from 37 wild or weedy populations and 16 cultivars, which together represented all infraspecific taxa of C. pepo. Twenty-six primers yielded 70 scorable and variable markers. The presence/absence of bands for these markers produced a data matrix which was analyzed using cluster analysis. The analysis confirmed the relationships among infraspecific taxa that had been revealed, in part, in previous genetic analyses (e.g., isozymes, chloroplast DNA restriction-site mutations, inter simple sequence repeats). Also supported were findings of varying degrees of gene flow from cultivars into free-living populations. Some of the RAPD variation in subsp. ovifera var. ozarkana populations was found to be correlated with the distribution of the drainage systems along which these populations are dispersed. Finally, the RAPD results support the idea that transgenic gene flow experiments with free-living populations should consider using representatives from each of the three free-living taxa, as well as from genetically or ecologically distinct populations within these taxa. Communicating Editor: Aaron Liston

Calling the tunes on transgenic crops: the case for regulatory harmony

Genetically modified (GM) crops are now grown commercially in 23 countries, with another 29 granting approval for import and release into the environment. Despite the socio-economic and environmental benefits of the technology, further development is being hampered by differences in national regulatory frameworks relating to research, biosafety, and to the trade and use of GM crops. The biosafety regulations in different countries are based on five main international instruments that influence the development of national biosafety systems in terms of field trial permit requirements, risk assessment criteria, labeling, traceability, transparency, public awareness, post-monitoring and import regulations. The global harmonization of data collection, testing procedures and information exchange would help to remove artificial trade barriers, expedite the adoption of GM crops, foster technology transfer and protect developing countries from exploitation, instilling confidence and bringing the benefits of GM products to the consumer.

The origin and genetic affinities of wild populations of melon (Cucumis melo, Cucurbitaceae) in North America

Abstract. The origins of wild melon (Cucumis melo) populations in the New World have been in question since their initial description in the mid-nineteenth century by Charles Naudin. Typically, these populations have been assumed to represent escaped forms of cultivated vars. chito or dudaim, and have been labelled accordingly, or more rarely as var. agrestis. To clarify the origins of New World melons, North American, chito, and dudaim accessions were studied with respect to 45 quantitative and 10 qualitative morphological and physiological characters. Also collected were RAPD and SSR data for 42 North American populations, 10 cultivar accessions of vars. chito and dudaim, 10 other small-fruited Old World accessions, and 4 other varieties of C. melo – vars. conomon, flexuosus, inodorus, and cantalupensis. All data revealed that New World populations are distinct, and should be classified as ssp. agrestis var. texanus Naudin. This variety showed the greatest genetic affinities to var. chito and to cultivars from Eastern Asia, including var. conomon.

Plant biotechnology: the importance of being accurate

Barely a day seems to go by in the world of politics without a senior official needing to clarify an earlier statement that has been misconstrued or taken out of context, especially with an ever-vigilant media ready to jump on any perceived error or imperfection. But although politicians might often suffer under the burden of misinterpretation, they cannot really complain because they exploit the same phenomenon. The dissemination of information to the public is always loaded with spin, softening the impact of bad news and deflecting criticism using carefully crafted words, an effect magnified and exaggerated by the media obsession with sound bites.

Strategic environmental assessments for genetically modified organisms

Genetically modified crops appear to provide a promising option in finding sustainable solutions to end global hunger and poverty, but strategic decisions need to be made on how to spend limited agricultural research funds. Potentially, strategic environmental assessment (SEA) may be used as part of an environmental management system to introduce mainstreaming of environmental considerations in the policy research and priority-setting process of development organizations to help achieve international development goals. This paper sets out a possible biotechnology SEA process that integrates qualitative and quantitative assessments with a focus on risk assessment and management within the SEA and policy environmental assessment frameworks. It uses the International Association for Impact Assessment six performance criteria for SEAs: integration; sustainability; focus; accountability; participation; and iteration.

Rationalizing governance of genetically modified products in developing countries

137 as well. The main problem is that decisions in Europe are often made on political grounds, rather than on a scientific basis. These decisions then influence the way GM policy is formulated and implemented by national governments in many developing countries5. Indeed, the level of concern in much of South America is sufficiently strong that last August, the agriculture ministers from five major crop-producing countries signed a joint declaration that urged the EU (as well as China) to stop delaying GMO import authorizations6. In countries such as Brazil and India, public research and development of locally important GM crops is impeded by an overly stringent application of the precautionary principle. In India, for example, GM mustard, eggplant and chickpea have been entangled in one legal challenge after another and have faced very onerous regulatory measures over the past decade. Rather than creating greater confidence among consumers and farmers, this has contributed to widespread mistrust that continues to metastasize. One result is that risk-assessment decisions for new GM products in India have been repeatedly delayed. This pattern is repeated in many other developing countries that struggle to develop and deploy local GM products (Box 1). The inclusion of socioeconomic considerations in the Cartagena Protocol conflicts with the science-based approach enforced by the WTO. In particular, the ad hoc approach to taking into account socioeconomics, that is neither structured nor evidence-based, has contributed to a ‘go-slow approach’ in developing functional biosafety policy and limiting crop development in many developing countries for the benefit of the population especially countries in Africa. There has been limited progress in defining how socioeconomics should be used in the Cartagena Protocol. Lack of clear definitions and interpretations of socioeconomic considerations and difficulties in measuring unpredictable factors in ex ante studies continue to Rationalizing governance of genetically modified products in developing countries