No country for new seeds: food and environmental security implications of Mexico's intended ban on GM crops.

An intended generalized ban on the "introduction and use of transgenic seeds" has been announced by the Mexican government, which, unlike the other agricultural programs under this administration, lacks a budget and rules of operation. In this policy brief we consider scenarios of implementing such an intended ban, de-regulating the use of genetically modified crops, or an intermediate scenario under the existing biosafety regulations. We recommend maintaining the status quo given its potential contributions to food and environmental security, in addition to a better economic outlook. However, a greater impulse needs to be given by the federal government to foment the domestic development of GM crops that are pertinent for Mexican agri-food needs, in addition to funding the development and implementation of various agro-ecological practices that increase biodiversity in food production units.

A research program for the socioeconomic impacts of gene editing regulation.

Gene editing technologies are a group of recent innovations in plant breeding using molecular biology, which have in common the capability of introducing a site-directed mutation or deletion in the genome. The first cases of crops improved with these technologies are approaching the market; this has raised an international debate regarding if they should be regulated as genetically modified crops or just as another form of mutagenesis under conventional breeding. This dilemma for policymakers not only entails issues pertaining safety information and legal/regulatory definitions. It also demands borrowing tools developed in the field of social studies of science and technology, as an additional basis for sound decision making.

A future scenario of the global regulatory landscape regarding genome-edited crops.

The global agricultural landscape regarding the commercial cultivation of genetically modified (GM) crops is mosaic. Meanwhile, a new plant breeding technique, genome editing is expected to make genetic engineering-mediated crop breeding more socially acceptable because it can be used to develop crop varieties without introducing transgenes, which have hampered the regulatory review and public acceptance of GM crops. The present study revealed that product- and process-based concepts have been implemented to regulate GM crops in 30 countries. Moreover, this study analyzed the regulatory responses to genome-edited crops in the USA, Argentina, Sweden and New Zealand. The findings suggested that countries will likely be divided in their policies on genome-edited crops: Some will deregulate transgene-free crops, while others will regulate all types of crops that have been modified by genome editing. These implications are discussed from the viewpoint of public acceptance.

Development of a construct-based risk assessment framework for genetic engineered crops.

Experience gained in the risk assessment (RA) of genetically engineered (GE) crops since their first experimental introductions in the early nineties, has increased the level of familiarity with these breeding methodologies and has motivated several agencies and expert groups worldwide to revisit the scientific criteria underlying the RA process. Along these lines, the need to engage in a scientific discussion for the case of GE crops transformed with similar constructs was recently identified in Argentina. In response to this need, the Argentine branch of the International Life Sciences Institute (ILSI Argentina) convened a tripartite working group to discuss a science-based evaluation approach for transformation events developed with genetic constructs which are identical or similar to those used in previously evaluated or approved GE crops. This discussion considered new transformation events within the same or different species and covered both environmental and food safety aspects. A construct similarity concept was defined, considering the biological function of the introduced genes. Factors like environmental and dietary exposure, familiarity with both the crop and the trait as well as the crop biology, were identified as key to inform a construct-based RA process.

Potential adoption and management of insect-resistant potato in Peru, and implications for genetically engineered potato.

This paper analyzes some important issues surrounding possible deployment of genetically engineered (GE) insect-resistant potato in Peru, based on a large farmer survey held in Peru in 2003. We found that the formal seed system plays a limited role compared with the informal seed system, especially for smallholder farmers. Although 97% of smallholder farmers would buy seed of an insect-resistant variety, a majority would buy it only once every 2 to 4 years. Survey data show that farmers would be willing to pay a premium of 50% on seed cost for insect resistant varieties. Paying price premiums of 25% to 50%, farmers would still increase their net income, assuming insect resistance is high and pesticide use will be strongly reduced. Of all farmers, 55% indicated preference for insect-resistant potato in varieties other than their current varieties. The survey indicates that smallholder farmers are interested to experiment with new varieties and have a positive perception of improved varieties. Based on these findings, and considering the difficulties implementing existing biosafety regulatory systems such as those in place in the U.S. and E.U., we propose to develop a variety-based segregation system to separate GE from conventionally bred potatoes. In such a system, which would embrace the spread of GE potatoes through informal seed systems, only a limited number of sterile varieties would be introduced that are easily distinguishable from conventional varieties.

Environmental biosafety and transgenic potato in a centre of diversity for this crop.

The Nuffield Council on Bioethics suggests that introgression of genetic material into related species in centres of crop biodiversity is an insufficient justification to bar the use of genetically modified crops in the developing world. They consider that a precautionary approach to forgo the possible benefits invokes the fallacy of thinking that doing nothing is itself without risk to the poor. Here we report findings relevant to this and other aspects of environmental biosafety for genetically modified potato in its main centre of biodiversity, the central Andes. We studied genetically modified potato clones that provide resistance to nematodes, principal pests of Andean potato crops. We show that there is no harm to many non-target organisms, but gene flow occurs to wild relatives growing near potato crops. If stable introgression were to result, the fitness of these wild species could be altered. We therefore transformed the male sterile cultivar Revolucion to provide a genetically modified nematode-resistant potato to evaluate the benefits that this provides until the possibility of stable introgression to wild relatives is determined. Thus, scientific progress is possible without compromise to the precautionary principle.

Labeling to manage marketing of GM foods.

Biotechnology has the potential to introduce new food safety risks, liabilities and benefits, and although privately managed supply chains (involving proactive management of the production of branded products) are effective at providing, managing and communicating adequate information about products with well understood risks, products with uncertain risks pose a greater challenge. The demand for increased product information regarding genetically modified content, in particular, places new constraints on food supply chains, frequently resulting in communication failures. Here we assess and reject mandatory labeling as an appropriate response.

Legal and regulatory concerns about transgenic plants in Brazil.

Brazil has a biosafety law that was approved in 1995. This law provides for a horizontal type of regulation that coordinates other existing regulatory frameworks in the areas of agriculture, health and environment. Various federal government departments are responsible for implementing the law. The National Technical Biosafety Commission is the national competent authority on biosafety with overall responsibility. In the case of Bt plants or any insecticidal organism, the Agrochemical Law also applies and authorization for laboratory, greenhouse and field studies must be obtained from the Plant Protection Secretariat, the Brazilian Institute of Environment and the National Agency of Health. Furthermore, the National Environmental Council must issue a license for commercialization of any GMO. There is pressure needed for capacity building and to harmonize the regulatory and administrative frameworks among the different federal departments involved. Some perspectives and challenges for the commercial registration of transgenic crops are discussed.

Manual de biossegurança / Biosafety manual

Abordando tópicos como os aspectos que visam à segurança daqueles que trabalham em laboratórios, o manuseio e o descarte de resíduos e produtos químicos, o risco de câncer na atividade laboratorial, além de levantar questões quanto à legislação e qualidade total pertinentes ao tema, este livro torna-se um manual indispensável para todos os laboratórios de pesquisa, de ensino ou de rotina, que trabalham com produtos químicos, material biológico, medicamentos, cosméticos e correlatos, radioisótopos e organismos geneticamente modificados.