Genetically Engineered Crops' Authorizations in the US and the EU: a Struggle Against the Clock

The regulation of genetically engineered crops is important for society: ensuring their safety for humans and the environment. Their authorization starts with a scientific step and ends with a political step. Trends in the time taken for their authorization in the European Union are that they are decreasing, but in the United States there is a break in the overall trend: initially it decreased until 1998 after which it increased.

Regulating Genetically Modified Organisms in Ireland – Laissez faire approach?

This chapter examines the legal framework applicable to genetically modified organisms (GMOs) in Ireland, bearing in mind the limited presence of GMOs. As a member of the European Union (EU), a specific, process-based regime applies regarding the authorisation and regulation of GMOs. This is intended to ensure a high level of environmental and human health protection and also enable producer and consumer choice. This regime is highly harmonized, but allows some flexibility regarding its implementation and, soon, the potential to opt-out from cultivation in part or entirely. Although, Ireland has only legislated on the area to the extent and in the manner required by the EU, it may avail of the opt-out in future – understandable in light of the lack of any cultivation currently and the green image of Ireland.
Complementary horizontal legislation and common law principles, relevant to labelling and varying forms of liability, deal with most issues that might arise quite comprehensively. However, they are quite complicated, overlapping and untailored and it is worth considering whether specific legislation should be developed to deal with liability related to GMOs.
Overall, Ireland holds varying stances to different forms of GMOs, with the greatest acceptance and use of GM-feed for pragmatic reasons. It has not developed a specific Irish approach, copy-pasting EU legislation and relying upon existing law to deal with any issues. This is understandable in light of the high level of harmonization and limited presence of GMOs in Ireland, but nonetheless will need to be developed as the availability of GMOs increases.

Trends in Approval Times for Genetically Engineered Crops in the United States and the European Union

Genetically engineered (GE) crops are subject to regulatory oversight to ensure their safety for humans and the environment. Their approval in the European Union (EU) starts with an application in a given Member State followed by a scientific step (risk assessment), and ends with a political decision-making step (risk management); and in the United States (US) it starts with a scientific (field trial) step and ends with a ‘bureaucratic’ decision-making step. We investigated trends for the time taken for these steps and the overall time taken for approving GE crops in the US and the EU (traders in these commodities). Results show that from 1996-2015 the overall time trend for approval in the EU decreased and then flattened off, with an overall mean completion-time of 1,763 days. In the US in 1998 there was a break in the trend of the overall approval time: Initially, from 1988 until 1997 the trend decreased with a mean approval time of 1,321 days; from 1998-2015, the trend almost stagnated with a mean approval time of 2,467 days.

Economic impact of genetically modified cotton in India

This paper presents the results of a study aimed at measuring the economic impact of genetically modified cotton in Maharashtra State, India. It is the first study of its kind in India in that the data have been collected from farmers growing the crop under market conditions, rather than from trials. The research compares the performance of more than 9,000 Bt and non-Bt cotton farm plots in Maharashtra over the 2002 and 2003 growing seasons. Results show that Bt cotton varieties have had a significant positive impact on average yields and on the economic performance of cotton growers.

Farm-level economic performance of genetically modified cotton in Maharashtra, India

A study of the commercial growing of Bacillus flutringiensis (Bt) cotton in India, compares the performance of over 9,000 Bt and non-Bt cotton farm plots in Maharashtra over the 2002 and 2003 seasons. Results show that since their commercial release in 2002, Bt cotton varieties have had a significant positive impact on average yields and on the economic performance of cotton growers. Regional variation showed that, in a very few areas, not all farmers had benefited from increased performance of Bt varieties.

The economic impact of genetically modified cotton on South African smallholders: Yield, profit and health effects

Results of a large-scale survey of resource-poor smallholder cotton farmers in South Africa over three years conclusively show that adopters of Bt cotton have benefited in terms of higher yields, lower pesticide use, less labour for pesticide application and substantially higher gross margins per hectare. These benefits were clearly related to the technology, and not to preferential adoption by farmers who were already highly efficient. The smallest producers are shown to have benefited from adoption of the Bt variety as much as, if not more than, larger producers. Moreover, evidence from hospital records suggests a link between declining pesticide poisonings and adoption of the Bt variety.

Perceptions of the impacts of genetically modified cotton varieties: a case study of the cotton industry in Gujarat, India

The paper reports the findings of a study designed to consider the impact of the adoption of Bt cotton on markets, businesses, and institutional arrangements in India. Given that evidence to date suggests that widespread adoption of Bt cotton by farmers is likely to increase production, this study aims to assess possible implications for markets (access to inputs, prices of inputs and outputs, etc.) and local industries and to identify potential winners and losers. The results suggest that there are impacts on the cotton industry following from the release of Bt hybrids, and so far the impacts are most noticeable "upstream" (i.e., the input suppliers), where companies are rapidly moving away from the sale of bollworm insecticide and attempting to sell Bt seeds. Seed companies are looking for partnerships with Monsanto, the owner of the Bt gene. One reason that companies are keen to move away from insecticide is so they can avoid the need for credit supply to their customers. Seed purchase is not normally through credit, whereas insecticide purchase is. Issues for companies "downstream" (gins, textile manufacturers) relate more to the better quality of Bt cotton and the need for adequate segregation of Bt and non-Bt cotton.

Comparing the performance of official and unofficial genetically modified cotton in India

Genetically modified (GM) cotton was approved for commercial cultivation in 2002. Hybrids to date have carried the Bt (Bacillus thuringiensis) gene, which confers resistance to Lepidoptera and certain Coleoptera. As well as "official" Bt hybrids (i.e., those that have gone through a formal approval process), there are "unofficial" Bt hybrids produced without such approval. The owners of the official hybrids, Monsanto-Mahyco, claim that the unofficial hybrids are not as good and could even damage the perception of Bt cotton amongst farmers. Anti-GM groups claim that neither type of Bt hybrid provides either yield or economic advantages over non-Bt hybrids. This paper reports the first study of official versus unofficial versus non-Bt hybrids in India (622 farmers in Gujarat State) with the specific aim of comparing one hypothesized ranking in terms of gross margin of (a) official Bt hybrids, (b) unofficial Bt hybrids, and (c) non-Bt hybrids. Results suggest that the official Bt varieties (MECH 12 and MECH 162) significantly outperform the unofficial varieties in terms of gross margin. However, unofficial, locally produced Bt hybrids can also perform significantly better than non-Bt hybrids, although second-generation (F2) Bt seed appears to have no yield advantage compared to non-Bt hybrids but can save on insecticide use. The paper explores some of the implications of this ranking.

Environmental impact of genetically modified cotton in South Africa

This paper presents the results of a large-scale study designed to monitor the impact arising from the introduction of insect-resistant Bt cotton in the Makhathini Flats, Republic of South Africa. Bt cotton provides a degree of resistance to cotton bollworm complex (Lepidoptera). Data were collected on the use of insecticides (type and quantity) as well as the farm-level economics of production from over 2200 farmers in three growing seasons (1998/1999, 1999/2000 and 2000/2001). and the results are discussed within the context of environmental impact brought about by insecticide. Over the three seasons of the study it was clear that Bt cotton provided benefits in terms of higher yield and gross margin relative to farmers growing conventional (non-Bt) cotton, and the benefits were particularly apparent for the smallest producers. Bt growers also used significantly less insecticide than growers of non-Bt cotton. Once quantities of insecticide applied to Bt and non-Bt cotton were converted into a Biocide Index and an Environmental Impact Quotient (EIQ) in order to allow for differences in terms of toxicity and persistence in the environment, it was apparent that the growing of Bt had a less negative impact on the environment. While this points to beneficial impacts on agricultural sustainability there are wider concerns regarding the vulnerability of resource-poor farmers in an area with limited (as yet) marketing options for their product and options for livelihood diversification both within and outside agriculture. Cotton producers in Makhathini are vulnerable as they rely on just One company for inputs (including, credit) and for their market. While Bt cotton provides benefits it does not in itself address some of the structural limitations that farmers face. (c) 2006 Elsevier B.V. All rights reserved.

Isolating the 'farmer' effect as a component of the advantage of growing genetically modified varieties in developing countries: a Bt cotton case study from Jalgaon, India

The present paper explores the 'farmer' effect in economic advantages often claimed for Bt cotton varieties (those with the endotoxin gene from Bacillus thuringiensis conferring resistance to some insect pests) compared to non-Bt varieties. Critics claim that much of the yield advantage of Bt cotton could be due to the fact that farmers adopting the technology are in a better position to provide inputs and management and so much of any claimed Bt advantage is an artefact rather than reflecting a real advantage of the variety per se. The present paper provides an in-depth analysis of 63 non-adopting and 94 adopting households of Bt cotton in Jalgaon, Maharashtra State, India, spanning the seasons 2002 and 2003. Results suggest that Bt adopters are indeed different from non-adopters in a number of ways. Adopters appear to specialize more on cotton (at least in terms of the land area they devote to the crop), spend more money on irrigation and grow well-performing non-Bt varieties of cotton (Bunny). Taking gross margin as the basis for comparison, Bt plots had 2.5 times the gross margin of non-Bt plots in both seasons. If only adopters are considered then the gross margin advantage of Bt plots reduces to 1.6 times that of non-Bt plots. This is still a significant advantage and could well explain the popularity of Bt in Maharashtra. However, it is clear that great care needs to be taken with such comparative studies.

Genetically modified insect resistance in cotton: some farm level economic impacts in India

The paper explores the impact of insect-resistant Bacillus thuringiensis (Bt) cotton on costs and returns over the first two seasons of its commercial release in three sub-regions of Maharashtra State, India. It is the first such research conducted in India based on farmers' own practices rather than trial plots. Data were collected for a total of 7793 cotton plots in 2002 and 1577 plots in 2003. Results suggest that while the cost of cotton seed was much higher for farmers growing Bt cotton relative to those growing non-Bt cotton, the costs of bollworm spray were much lower. While Bt plots had greater costs (seed plus insecticide) than non-Bt plots, the yields and revenue from Bt plots were much higher than those of non-Bt plots (some 39% and 63% higher in 2002 and 2003, respectively). Overall, the gross margins of Bt plots were some 43% (2002) and 73% (2003) higher than those of non-Bt plots, although there was some variation between the three sub-regions of the state. The results suggest that Bt cotton has provided substantial benefits for farmers in India over the 2 years, but there are questions as to whether these benefits are sustainable. (c) 2004 Elsevier Ltd. All rights reserved.