INFORMATION SYSTEMS FOR BIOTECHNOLOGY


August 2010
AGRICULTURAL AND ENVIRONMENTAL BIOTECHNOLOGY


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IN THIS ISSUE:


Sustainability of Glyphosate-based Weed Management: The Benchmark Study

Micheal Owen, Philip Dixon, David Shaw, Stephen Weller, Bryan Young, Robert Wilson, and David Jordan

Introduction
One key to improved global crop production efficiency is the effective management of weeds, which are ranked as the number one crop pest by a majority of farmers1. This is no great surprise, as weeds are constantly evolving within the man-caused agroecosystems by adapting to high selection pressures imposed by crop production practices and, importantly, developing resistance to herbicides. Genetically engineered (GE) herbicide resistant (HR) crops facilitate better weed management and thus improved yields and more efficient use of resources, while minimizing risks to the environment (e.g., soil erosion). Since the commercial introduction of glyphosate resistant (GR) crops in 1996, this technology has likely been the most rapidly-accepted agronomic production practice in the history of agriculture. Farmers in the United States plant an estimated 50% of the GE GR crops grown globally, and in 2009 the National Agricultural Statistics Service (NASS) reported that 85% of corn, 88% of upland cotton, and 91% of soybean hectares were planted to GE GR varieties. The rapid adoption of GE GR crops occurred because glyphosate controls most economically important weeds and simplifies weed management. The consistent and high level of weed control provided by glyphosate facilitated the widespread adoption of no-tillage systems that conserve soil and energy resources as well as improve time management efficiencies for farmers. However, the wide-spread adoption of GE GR crops, resulting in the grower decision to simplify weed management to the applications of glyphosate, imposed considerable selection pressure on weed communities. This pressure predictably resulted in weed population shifts, including the inevitable evolution of weeds with resistance to glyphosate2.

Benefits and risks associated with GE GR crops
The benefits and risks of the widespread adoption of GE GR crops on agroecosystems and for society has been a contentious topic of debate in scientific journals and the popular media. The complexity of assessing benefits and risks of GE GR crops is great, and often there is considerable variability, depending on the specific GE under assessment. Also adding to the complexity of assessing benefits and risks are the production practices utilized to cultivate the GE GR crop and the specific agroecosystem in which the crops are grown. Adopters of GE GR crops suggest that a major benefit has been the greatly reduced effort needed to implement a weed management system that significantly increases crop production. Simplicity of weed management strategies, improved time management, better success in conservation tillage systems, and crop safety are also noted as significant benefits of GE GR crops. Societal benefits reflect improved water quality and reduced soil erosion as a result of increased adoption of conservation tillage and the increased use of an herbicide (glyphosate) that is classified by the Environmental Protection Agency as being one of the safest herbicides available.

Risks attributed to the adoption of GE GR crops include the alleged displacement of small-farmers, food safety apprehensiveness, GE pollen movement to wild species, volunteer GE GR crops, and other issues. Several of these risks (i.e., GE pollen movement to wild species) are not a problem with the current suite of GE GR crops. Similarly, other issues are less clear. Often the published literature on the ecological, toxicological, and environmental risks of GE GR crop systems is contradictory. It is critically important to assess risks attributable to GE GR crops on solid, objective science.

However, one risk that is significant is the evolved resistance to glyphosate in weeds. Currently 19 weed species have evolved glyphosate-resistant populations globally and ten glyphosate-resistant weed species have been identified in the US, most of which evolved resistance to glyphosate in GE GR crop systems (Fig. 1)3. It is important to recognize that the impact of GE GR technology on weed communities and evolved resistance to glyphosate is not directly attributable to the use of a GE GR crop, but rather an indirect effect of the management of the GE GR crop system. A recently announced report by the National Research Council (The Impact of Genetically Engineered Crops on Farm Sustainability in the United States) (www.nationalacademies.org) addressed the complexity of the benefits and risks surrounding the adoption of GE GR crops. This report, based on an extensive review of the body of science available, concluded that evolved weed resistance to glyphosate, while not unique to GE GR crop systems, represents a significant problem for the sustainability of the technology and suggested that weed management programs must be diversified in order to maintain the benefits of the GE GR crop systems.

Figure 1.Number of weed species that have evolved resistance to glyphosate. Adapted from www.weedscience.org.

A multi-state, multi-year, field-scale study: THE BENCHMARK STUDY
A multi-state field-scale project is underway in the six states where the Benchmark Study Survey was conducted (Fig. 2)4. The Benchmark Study Survey represented an extensive telephone survey of more than 1000 growers from Illinois, Indiana, Iowa, Mississippi, Nebraska, and North Carolina to assess grower perceptions of GE GR technologies in corn, cotton, and soybean. While other studies, either with regard to scale or time, have been reported, the Benchmark Study is unique with regard to temporal, scale, geography, and crop systems. The agricultural, temporal, and geographical factors encompassed by the Benchmark Study will result in robust assessments of the sustainability of GE GR-based crop systems with a focus on weed management. The objective of the Benchmark Study is to compare growers’ weed management practices with stratagies recommended by university weed scientists and determine the relative sustainability GE GR crop systems with regard to economics and weed community shifts, including the evolution of GR weed populations.

Figure 2.Location of farms included in the Benchmark Study.

Approximately 150 growers in Illinois, Indiana, Iowa, Mississippi, Nebraska, and North Carolina were selected from respondents to a survey to participate in the Benchmark Study (Fig. 2)4. Growers provided a representative field of at least 10 ha, which was divided into near-equal halves. On one-half of the field, the grower continued using the current weed management program, typically multiple applications of glyphosate. On the other half, the grower used university-recommended herbicide resistance best management practices (HRBMP). HRBMP typically includes soil-applied herbicides that provide residual activity on important weeds in the field, and specifically those weeds that have demonstrated the ability to evolve resistance to glyphosate. Data and soil samples are being collected and include assessments of weed populations, weed species diversity, weed seedbank, crop yields, and economic returns.

Conclusions to date
When the Benchmark Study is completed, the resultant agronomic, economic, and ecological data will provide an excellent base upon which GE GR crop sustainability can be assessed. Preliminary results are favorable with regard to managing the potential evolution of GR weeds with diversifying tactics, while maintaining profitability of the GE GR system. The first publications describing the results from the Benchmark Study have been submitted for publication and will likely become available late in 2010. Importantly, the initial barriers that were encountered in the Benchmark Study—an inconsistent level of grower awareness of the potential risks to the sustainability of the GE GR crop systems attributable to evolved glyphosate resistance in weed populations, and a concern that the alternative weed management tactics (HRBMP) represented needless additional costs to weed management—have been addressed successfully.

However, changes have occurred since the initiation of the Benchmark Study, including an escalation the number of weeds with evolved resistance to glyphosate and the frequency of GR weed populations (Fig. 1)3. These changes reinforce the critical importance, addressed by the Benchmark Study, of performing comparisons of weed management tactics in GE GR crops. It is clear that grower awareness of GR weeds has increased dramatically since the initiation of the Benchmark Study5. Noteworthy is the observation from preliminary results that university-recommended HRBMP, while initially thought to be more costly by the growers participating in the Benchmark Study, has proven to provide more economic return on investment or is no more costly than grower weed management practices. Importantly, it is apparent from early Benchmark Study data that the adoption of HRBMP will delay and help manage evolved GR weed populations when compared with grower practices that emphasize simple and convenient tactics. Where growers persist in using simple tactics (i.e., glyphosate alone), it is inevitable that weed populations will ultimately evolve resistance to the tactic, often with consequences that are economically and environmentally difficult to overcome6.

When concluded, the Benchmark Study will provide invaluable data to describe sustainable and profitable weed management programs for GE GR crop systems designed to lower the potential risk of evolving weed resistance to glyphosate. This unique comprehensive study conducted in six states over five years in multiple cropping systems will provide a robust assessment of how growers utilized the GE GR technologies and will detail the implications that these decisions have on weed populations and the economics of crop production. Importantly, the results will detail how to sustainably and economically manage weeds at a scale that is applicable at the grower-level.

While most fields where GE GR crops are grown do not yet have GR weed populations, there is irrefutable evidence that the number of GR weed populations is increasing at an increasing rate3. Regardless, growers are still reticent to proactively adopt HRBMP. A greater educational emphasis on HRBMP in GE GR crops will help farmers effectively manage the evolution of GR weeds and optimize profitability of GE GR crops. The Benchmark Study will provide the basis for this educational process, thus preserving the sustainability of the globally-important GE GR crops. Regardless, the Benchmark Study must be supplemented with additional research into the specific resistance mechanisms to insure the continued development of scientifically-based management practices to support grower educational programs.

References

  1. Gibson KD, Johnson WG and Hillger DE. Farmer perceptions of problematic corn and soybean weeds in Indiana. Weed Technology; 19(4): 1065-1070 (2005).
  2. Owen MDK, Weed species shifts in glyphosate-resistant crops. Pest Management Science; 64:377-387 (2008).
  3. Heap I. The international survey of herbicide resistant weeds. Www.weedscience.com [accessed 06/11/10].
  4. Shaw DR, Givens WA, Farno LA, Gerard PD, Jordan D, Johnson WG, Weller SC, Young BG, Wilson RG and Owen MDK. Using a grower survey to assess the benefits and challenges of glyphosate-resistant cropping systems for weed management in U.S. corn, cotton, and soybean. Weed Technology; 23:134-149 (2009).
  5. Waltz E. Glyphosate resistance threatens Roundup hegemony. In Nature Biotechnology. Nature Publishing Group, pp. 537-538 (2010).
  6. Culpepper AS, Grey TL, Vencill WK, Kichler JM, Webster TM, Brown SM, York AC, Davis JW and Hanna WW. Glyphosate-resistant Palmer amaranth (Amaranthus palmeri) confirmed in Georgia. Weed Sci; 54:620-626 (2006).

Micheal DK Owen* and Philip M. Dixon
Iowa State University, Ames, IA 50011, USA

David R Shaw
Mississippi State University, Mississippi State, MS 39762, USA

Stephen C Weller
Purdue University, West Lafayette, IN 47907, USA

Bryan G Young
Southern Illinois University, Carbondale, IL 62901, USA

Robert G Wilson
University of Nebraska-Lincoln, Scotts Bluff, NE 69361, USA

David L Jordan
North Carolina State University, Raleigh, NC 27695, USA

Correspondence to: Micheal D. K. Owen, Agronomy Department, Iowa State University, 3218 Agronomy Hall, Ames, IA 50011, USA.
Email:
mdowen@iastate.edu


Post-market Monitoring of Bt Maize in the European Union

Ralf Wilhelm

Introduction
In the European Union, the commercial cultivation of crops derived from genetic engineering is still restricted to the starch-modified potato “Amflora” and maize expressing the insecticidal protein Cry1Ab from Bacillus thuringiensis (Bt maize). The cultivation of the genetically engineered (GE; i.e., “genetically modified” according to EC regulations) potato was approved recently, whereas Bt maize varieties have been commercially grown in some European countries since 1998. Cry1Ab confers resistance to lepidopteran pests. The main cropping areas are located in Spain. Very limited commercial cropping exists in a few other Member States (MS) of the European Communities (EC)1. Some MS banned the commercial cultivation of GE maize, invoking a “safeguard clause” in EC regulations that allows consideration of new scientific information on (severe) risks. Several national commissions for biosafety as well as the European Food Safety Authority (EFSA) re-evaluated these scientific data and did not find proof of a relevant risk2. However, a ban can only be lifted by a qualified majority decision of the Council of Ministers from the MS, which has not been achieved to date. The EC is currently discussing modifying the legislation to allow each MS to decide for itself whether cultivation of a GE crop is prohibited or which restrictions apply.

The commercial cultivation of GE crops in the EC has to be accompanied by post-market environmental monitoring (PMEM), which is considered a mandatory part of an overall risk management regime3. Notifiers (i.e., usually the company marketing a GE crop) must submit a monitoring plan for each transformation event to ensure the detection of adverse environmental effects possibly deriving from its cultivation. EC legislation addresses two general objectives of PMEM:

  • to determine whether and to what extent effects identified in a pre-market environmental risk assessment (ERA) may actually occur (case-specific monitoring; CSM); and
  • to detect adverse effects on the environment that have not been anticipated in the ERA (general surveillance, GS).
Although GS has to be conducted for each authorized GE crop, CSM may not be required if the ERA concludes there is an absence of risk or a negligible risk. Regulatory demands are still challenging the discussions on the operational implementation of PMEM. Several concepts have been proposed on how PMEM programs could be designed to meet the regulatory necessities4-6.

While the risk assessments published by EFSA for current Bt maize varieties reconsidered the “new scientific information” and did not indicate any particular risk, the extent and design of monitoring plans and reporting are still a subject of controversy among different EC regulatory bodies, national competent authorities, scientists, and the agricultural biotech industry.

Monitoring plans, trends and experiences
A EuropaBio working group is introducing a general format for the surveillance of GE crops cultivated in the EU7, which is an outgrowth of the activities of bioindustries to harmonize their PMEM approaches with regulatory demands. The format largely corresponds with the requirements put forth by the Decision of the European Commission8 for monitoring reports. The state-of-the art format of a GS plan may comprise the following elements:

  • farm questionnaires and/or other surveillance approaches
  • literature review
  • information for operators and farmers
  • alert “hot line”
  • integration of information from surveillance programs by third parties
Currently, the monitoring of Bt maize by notifiers/consent holders is based on a system of questionnaires and interviews with farmers who cultivate GE crops. It is a simple (and economical) method to utilize farmers’ first-hand observations and exploit their knowledge and experience9. The questions focus on the cultivation area and issues relevant to farmers, e.g., crop management, plant pest occurrences, etc. However, aspects of biodiversity are addressed only indirectly (e.g., tilling and rotation regimes) and may not be considered sufficiently. Therefore, additional sources of information may be useful. Farm questionnaires, literature review, information tools, and hotlines are already established tools. Nevertheless, the design, details, and reporting aspects are undergoing further discussion.

The integration of additional environmental surveillance programs into PMEM is as yet poorly realized, although such is suggested by the regulations and mentioned in monitoring plans by the applicants. This is due to problems caused by data quality, technical transfer, as well as inaccessibility of surveillance data owned by third parties. The integration of raw data from other programs seems widely impossible. A German research project10 suggests conducting an analysis of the reports published by other environmental surveillance programs for underlying system dynamics (background dynamics), for indications of impacts of GE crop releases, and/or for potential causes of reported trends or effects. The surveillance programs and reports should meet a set of criteria for quality assurance: e.g., transparent and scientifically sound data recording and analysis; surveys that include areas where the GE crop is being cultivated; and reports made publicly and regularly available. The evaluation approach was adopted by EuropaBio to reconsider a potential interchange of PMEM with other European environmental surveillance programs.

Recent monitoring plans do not foresee an extended CSM period, but applications for Bt maize propose an insect-resistance management plan that includes a monitoring regimen for Bt-resistant corn borers. There is an ongoing debate about whether and how to expand CSM and GS, especially to “non-target organisms” (NTO)11. The Cry1Ab protein is toxic to larvae of most Lepidoptera, and thereby it confers to Bt maize the resistance to targeted lepidopteran pests—European corn borer (Ostrinia nubilalis) and Mediterranean corn borer (Sesamia nonagrioides). All Bt maize varieties express Cry-protein in all parts of the plant—including pollen. The question arises whether other butterfly populations may be relevantly affected when their larvae are feeding on host plants covered with Bt-maize pollen at field margins. Although recent field trials do not reveal considerable effects, and modeling underlines these findings12, recording the abundance of butterfly populations (for CSM as well as further more detailed research) is frequently demanded13. In addition, other organisms (guilds) are suggested as bioindicators for GE crop monitoring (CSM or GS). Spain is the only Member State in the EU in which Bt maize has been cultivated at a reasonable commercial scale since 1998, 0.1 million ha in 20091. In the case of Spain, monitoring plans for Bt176 (1998 – 2005) and MON810 (initiated in 2003) have considered using CSM to detect the evolution of resistance in target insects and the potential effects on non-target arthropods. Summarizing the observations and experiences from Spain in an expert seminar on monitoring of Bt-maize, it was concluded that features related to the agro-ecological system rather than the Cry1Ab toxin were largely responsible for the composition of the aboveground arthropods and for the variation recorded within and between years14. Clear selection criteria for potential bioindicators as well as reflections on the information gain of data recordings are currently missing.

Future challenges
Pending applications for market releases of GE crops in Europe as well as international developments indicate that, in the future, additional transgenic events may occur in plants both singly and in combination (stacks) with other events. Current stacks contain multiple insect resistance genes and/or combinations of insect resistance and herbicide tolerance genes. Moreover, farmers will cultivate combinations of GE crops with single and stacked events in rotation regimes. Consequently, a mix of events will be present in a region at a time, and several notifiers will be responsible for monitoring the environmental impacts of their events/GE crops. In a recent workshop on PMEM (3/4 May 2010, JKI Quedlinburg, Germany) at our institute, participants concluded that it is necessary to harmonize monitoring methods for different events to enable consistent data collation and analysis for impact factors.

Disparate responsibilities and the limited feasibility of data exchange between different notifiers and surveillance programs are drawbacks of the given regulations and mode of operation. It has instead been proposed to establish a central reporting office for data collation and analysis15, and it is frequently demanded that PMEM be conducted by public or governmental institutions. PMEM in Spain is already partly initiated by the state, and some MS are considering specifically conducting GS. Nevertheless, an institutional and operational concept for the integration of large-scale data sets from various sources and dissemination of analysis outcomes for management are not available to date.

References

  1. James C. Global Status of Commercialized Biotech/GM Crops: 2009. ISAAA Brief No. 41. ISAAA: Ithaca, NY, (2009).
  2. EFSA. Scientific Opinion of the Panel on Genetically Modified Organisms Applications (EFSA-GMO-RXMON810) for renewal of authorization for the continued marketing of (1) existing food and food ingredients produced from genetically modified insect resistant maize MON810; (2) feed consisting of and/or containing maize MON810, including the use of seed for cultivation; and of (3) food and feed additives, and feed materials produced from maize MON810, all under Regulation (EC) No 1829/2003 from Monsanto. The EFSA Journal 1149, 1–84, (2009).
  3. The European Parliament and the Council. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, European Parliament and the Council of the European Union, Brussels. Official Journal of the European Communities L 106, 1–38, (2001).
  4. Sanvido O, Widmer F, Winzeler M, Bigler F. A conceptual framework for the design of environmental post-market monitoring of genetically modified plants. Environmental Biosafety Research 4, 13-27, (2005).
  5. ACRE. Guidance on best practice in the design of post-market monitoring plans in submission to the advisory committee on releases to the environment. Department for Environment, Food and Rural Affairs – Advisory Committee on Releases to the Environment, London, p 21, (2004).
  6. EFSA. Opinion of the scientific panel on genetically modified organisms on the post-market environmental monitoring (PMEM) of genetically modified plants. The EFSA Journal 319:1-27, (2006)
  7. Wandelt C, Alcalde E , Hayter K, Legris G, Patterson B, Tinland B, & Windels P. The EuropaBio approach to general surveillance for cultivation of GM crops. Available from Nature Precedings , http://dx.doi.org/10.1038/npre.2010.4451.1(2010)
  8. European Commission. Commission Decision of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (2009/770/EC). Official Journal of the European Communities L 275, 9–27, (2009)
  9. Schmidt K, Wilhelm R, Schmidtke J, Beißner L, Mönkemeyer W, Böttinger P, Sweet J & Schiemann J. Farm questionnaires for monitoring genetically modified crops: a case study using GM maize. Environmental Biosafety Research 7:163-179, (2008).
  10. Böttinger P & Schiemann J. Integration landwirtschaftlicher, ökologischer und biometrischer Aspekte zu einer praktikablen methodik der Flächenauswahl und datenerhebung für das Anbaubegleitende Monitoring. Funding Code: 0313286. http://edok01.tib.uni-hannover.de/edoks/e01fb10/625845692.pdf, (2009)
  11. de Jong T. General surveillance of genetically modified plants in the EC and the need for controls. J. Verbr. Lebensm. (2010) 5:181–183, (2010).
  12. Perry JN, Devos Y, Arpaia A, Bartsch D, Gathmann A, Hails RS, Kiss J, Lheureux K, Manachini B, Mestdagh S, Neemann G, Ortego F, Schiemann J, & Sweet JB. A mathematical model of exposure of non-target Lepidoptera to Bt-maize pollen expressing Cry1Ab within Europe. Proceedings of the Royal Society, series B, Biological Sciences, published online before print January 6, 2010, doi: 10.1098/rspb.2009.2091, (2010).
  13. Lang A & Otto M. A synthesis of laboratory and field studies on the effects of transgenic Bacillus thuringiensis (Bt) maize on non-target Lepidoptera. Entomologia Experimentalis et Applicata 135, 121–134, (2010).
  14. Wilhelm R, Sanvido O, Castanera P, Schmidt K & Schiemann J. Monitoring the commercial cultivation of Bt maize in Europe – conclusions and recommendations for future monitoring practice. Environmental Biosafety Research published online: 26 January 2010, doi: 10.1051/ebr/2009018, (2010).
  15. Schmidt K, Schiemann J & Wilhelm R. European-wide GMO-monitoring data management and analysis. J. Verbr. Lebensm. 2 (2007) Supplement 1, 11 – 15, (2007).

Dr Ralf Wilhelm
Institute for Biosafety of Genetically Modified Plants
Julius Kühn-Institute, Federal Research Centre for Cultivated Plants
Erwin-Baur-Str. 27, 06484 Quedlinburg, Germany
ralf.wilhelm@jki.bund.de


Genetically Engineered Alfalfa: OTAY! Or Not OTAY!

Phill Jones

The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) approved genetically engineered (GE) alfalfa in 2005. The US Food and Drug Administration gave it a thumbs up. Yet questions about GE alfalfa haunted courts and APHIS for about five years.

The controversy concerned the deregulation of two lines of GE alfalfa that tolerate the glyphosate herbicide, Roundup®. Benefits touted for Roundup Ready® alfalfa include high-quality weed-free hay, cost-effective weed control, and improved production efficiencies. A decrease in weed content should improve animal welfare by controlling the amount of poisonous weeds in alfalfa feed. Farmers have also reported increases in alfalfa yield with the Roundup Ready® crop.

The Western Organization of Resource Councils asserts that GE alfalfa poses a variety of harms. Since alfalfa is a cross-pollinating crop, the Council contended, GE DNA from Roundup Ready® alfalfa fields may contaminate fields of conventional alfalfa and alfalfa grown under organic conditions. About five percent of US-grown alfalfa is exported, and the presence of GE alfalfa could wreck organic alfalfa and conventional alfalfa export markets. Consumption of GE alfalfa also may harm birds, mammals, insects, and other beneficial organisms, the Council argued.

Alfalfa debate shifts from APHIS to Federal District Court
Monsanto Company owns the patent rights to Roundup Ready® alfalfa, and licenses the technology to Forage Genetics International, the exclusive developer of Roundup Ready® alfalfa seed. In May 2003, Monsanto and Forage Genetics submitted a petition to the USDA that requested nonregulated status for two Roundup Ready® alfalfa lines, J101 and J163. APHIS prepared an Environmental Assessment and accepted comments from the public about a draft EA. APHIS issued a Finding of No Significant Impact in June 2005. The agency saw no need to prepare an Environmental Impact Statement (EIS) and unconditionally deregulated the GE alfalfa. What about objectors’ fears of GE alfalfa contamination? APHIS concluded that it would be “up to the individual organic seed or hay grower to institute those procedures that will assure” that their crops will not include any GE alfalfa. By using reasonable quality control, the agency decided, “it is highly unlikely that the level of glyphosate tolerant alfalfa will exceed one percent in conventional alfalfa hay,” a degree of contamination that would not bar the product from the Japanese market.

In early 2006, the Center for Food Safety, several other nonprofit organizations, and alfalfa growers filed a lawsuit against the USDA in a California US District Court that challenged APHIS’ decision to deregulate the Roundup Ready® alfalfa lines. The plaintiffs alleged that the USDA’s deregulation of GE alfalfa violated the National Environmental Protection Act (NEPA), because cultivation of the GE alfalfa would pass on the glyphosate tolerance gene to conventional alfalfa, a significant environmental impact.

On February 13, 2007, Judge Charles R. Breyer held that APHIS had violated NEPA by deregulating Roundup Ready® alfalfa without first drafting an EIS. According to the judge, APHIS had effectively concluded that any environmental impact would be insignificant, because organic and conventional farmers bore the responsibility to prevent genetic contamination. Yet Judge Breyer could find no evidence that the agency had investigated if farmers could in fact protect their crops from genetic contamination.

As the court mulled over an appropriate remedy for the NEPA violation, Monsanto and Forage Genetics joined the case. In March, the judge issued a preliminary injunction order prohibiting all planting of Roundup Ready® alfalfa and all sales of Roundup Ready® alfalfa seed after March 30, 2007, pending the issuance of a permanent injunction. This order allowed farmers who had already purchased Roundup Ready® alfalfa seed to plant the seed. Farmers who had already planted Roundup Ready® alfalfa were not required to remove the plants, and were allowed to harvest, use, and sell Roundup Ready® alfalfa.

In April 2007, Judge Breyer held a hearing on the scope of permanent injunctive relief. The plaintiffs wanted to prevent all future planting of Roundup Ready® alfalfa, as well as the harvesting of any Roundup Ready® alfalfa seed already planted, pending the completion of an EIS and a new decision by APHIS on deregulation. The defendants requested that the GE alfalfa planting proceed under certain conditions, including the cultivation of GE alfalfa at suitable distances from other crops to minimize gene flow to non-genetically engineered alfalfa seeds. Both sides submitted a colossal amount of evidence, their experts disagreeing over practically every factual issue relating to possible environmental harm.

In May 2007, the district court judge vacated APHIS’ June 2005 regulation decision, ordered APHIS to prepare an EIS before the agency decided again about Monsanto’s deregulation petition, and issued a permanent injunction prohibiting the planting of any Roundup Ready® alfalfa in the United States after March 30, 2007, pending the government’s completion of the EIS and decision on the deregulation petition. Future harvesting or sale of about 260,000 acres of GE alfalfa already planted would be allowed under certain conditions. The judge instructed APHIS to issue an administrative order detailing mandatory practices for future harvesting or sale of GE alfalfa already planted. The judge ordered Forage Genetics to supply all known GE alfalfa seed production locations for public disclosure. Producers of conventional or organically-grown alfalfa could use this information to decide if they should test their crops for contamination. Later, the court restricted disclosure to farmers only.

The Supremes weigh in
In August 2007, the USDA, Forage Genetics, Monsanto, and a number of alfalfa growers filed an appeal with the Ninth US Circuit Court of Appeals in San Francisco. The defendants asserted that the injunction was too broad. They also argued that the district court should have held a further hearing before enjoining future planting, even though the judge had already held a hearing on the need for an EIS.

A three-judge panel heard the case in June of 2008, and issued a decision in September. Two of the three judges decided to uphold the ban on selling and planting of GE alfalfa seed, pending the completion of an EIS. The dissenting judge asserted that they should send the case back to the district court so that the court could conduct an evidentiary hearing on the merits and scope of the permanent injunction.

In December 2009, APHIS offered its draft EIS for public comment. The agency considered two alternatives in the draft EIS. It would either grant nonregulated status to the two lines of GE alfalfa, or maintain the status as regulated articles. APHIS analyzed the alternatives with regard to their potential impacts on gene flow between the GE alfalfa and conventional alfalfa, weed development, herbicide use, possible effects on conventional and organic alfalfa markets, human health and safety, effects on the physical environment, and other factors.

Meanwhile, Forage Genetics, Monsanto, and two alfalfa farmers appealed the latest court decision to the US Supreme Court. The Petitioners and the government did not dispute that APHIS’ deregulation decision violated NEPA. Rather, they argued that the lower courts failed to show a likelihood of irreparable harm to justify the issuance of the injunction. In January 2010, the Court agreed to review the ruling. Justice Stephen Breyer took no part in consideration of the petition; Judge Charles R. Breyer of the district court is his brother. The Court heard oral arguments in April, and issued its decision on June 21.

In a 7-1 ruling, the Court reversed the appellate court. First, the Court tackled the injunction that prevented APHIS from deregulating GE alfalfa pending completion of the EIS. “[T]he District Court barred the agency from pursuing any deregulation,” wrote Justice Alito, “no matter how limited the geographic area in which planting of [GE alfalfa] would be allowed, how great the isolation distances mandated between [GE alfalfa] fields and fields for growing non-genetically-engineered alfalfa, how stringent the regulations governing harvesting and distribution, how robust the enforcement mechanisms available at the time of the decision, and—consequently—no matter how small the risk that the planting authorized under such conditions would adversely affect the environment in general and respondents in particular.” Before a court grants a permanent injunction, a plaintiff must show that it has suffered an irreparable injury. Here, the plaintiffs cannot show that they will suffer irreparable injury if APHIS is allowed to proceed with any partial deregulation, the Court said, because if and when APHIS pursues a partial deregulation that arguably runs afoul of NEPA, the plaintiffs may file a new suit challenging the action. Also, a partial deregulation need not cause plaintiffs any injury at all. Depending upon APHIS’ conditions, the risk of gene flow could be virtually nonexistent.

The Court decided that the District Court also had erred in issuing the nationwide injunction against planting GE alfalfa. “[B]ecause it was inappropriate for the District Court to foreclose even the possibility of a partial and temporary deregulation,” Alito explained, “it necessarily follows that it was likewise inappropriate to enjoin any and all parties from acting in accordance with the terms of such a deregulation decision.”

Both sides of the dispute hailed the verdict as a victory. For now, APHIS can decide growing conditions for GE alfalfa pending completion of the EIS, which may issue in Spring 2011.

References

  1. APHIS (2010) Roundup Ready® Alfalfa. APHIS website. Available at: www.aphis.usda.gov/biotechnology/alfalfa.shtml.
  2. Monsanto et al. v. Geertson Seed Farms et al., 561 U. S. ____ (2010). Available at: http://www.supremecourt.gov/opinions/slipopinions.aspx.
  3. Hubbard, Kristina (2008). A Guide to Genetically Modified Alfalfa. Western Organization of Resource Councils. Available at: www.worc.org.
  4. Welker, Steve and Matt Fanta (December 18, 2009). Biotechnology and the Farmers’ Right to Choose. Available at: www.monsanto.com.

Phill Jones
Biotech-Writer.com
PhillJones@nasw.org


Recent News from Biotechnology in Food and Agriculture Organization of the United Nations (FAO)

ABDC-10 report in five languages
The FAO international technical conference on “Agricultural biotechnologies in developing countries: Options and opportunities in crops, forestry, livestock, fisheries and agro-industry to face the challenges of food insecurity and climate change” (ABDC-10) took place in Guadalajara, Mexico on 1-4 March 2010. ABDC-10 was hosted by the Government of Mexico and co-sponsored by the International Fund for Agricultural Development (IFAD). The Consultative Group on International Agricultural Research (CGIAR), the Global Forum on Agricultural Research (GFAR), the International Centre for Genetic Engineering and Biotechnology (ICGEB) and the World Bank were major partners. The conference report is now available in Arabic, Chinese, English, French and Spanish. Paragraphs 37-38 of the report contain the conference’s key conclusions. See http://www.fao.org/biotech/abdc/ or contact ABDC@fao.org for more information. Plenary presentations from IFAD, the CGIAR and the Secretariat of the International Treaty on Plant Genetic Resources for Food and Agriculture about relevant aspects of their work are also available from the same webpage.

FAO Biotechnology website – updates
Three main sections of the FAO biotechnology website have recently been updated. The first, on ‘FAO Documents’, provides an annotated list of freely-downloadable documents and now includes 210 web links to a wide range of articles, books, meeting reports, proceedings and studies published by FAO, or prepared in collaboration with FAO, over the last 13 years concerning agricultural biotechnologies. The second, on ‘Country policy documents’ provides an annotated list of freely-downloadable biotechnology policy documents from 18 FAO members. Most of the 25 documents are national policy documents, covering applications of biotechnology in food and agriculture as well as in other areas, such as pharmaceuticals, the environment and human health care. The third, on ‘Sectoral overviews’, provides an overview of the application of biotechnologies in the agro-industry, crop, fisheries and aquaculture, livestock and forestry sectors in developing countries. See http://www.fao.org/biotech/ (in Arabic, Chinese, English, French, Russian and Spanish) or contact biotech-website@fao.org with any comments.

Induced Plant Mutations in the Genomic Era
The book Induced Plant Mutations in the Genomics Era published by the Food and Agriculture Organization (FAO) is now available on online from the FAO website. The book is a 458-page compilation of papers presented at the August 2008 International Symposium on Induced Mutations in Plants in Vienna, Australia. Topics covered at the symposium and included in the book include induced mutations in food and agriculture; genetic diversity and crop domestication; abiotic stress tolerance and adaptation to climate change; crop quality and nutrition; seed and vegetatively propagated plants; gene discovery; and functional genomics. To download the book, see
http://www.fao.org/docrep/012/i0956e/i0956e00.htm

State of the World’s Animal Genetic Resources – Six languages and CD-ROM
In September 2007, FAO released “The State of the World’s Animal Genetic Resources for Food and Agriculture”, a comprehensive 511-page publication drawing on 169 Country Reports and a range of other sources to provide the first global assessment of animal genetic resources and their management. It also contains many sections indirectly or directly relevant to biotechnology, such as applications of molecular markers and reproductive technologies. The publication is now available in all six official FAO languages (Arabic, Chinese, English, French, Russian and Spanish). A 37-page summary version is also available in all FAO languages plus German, Japanese and Polish. In addition, a CD-ROM is available containing both the full and summary versions in all six FAO languages. See the full or summary versions at http://www.fao.org/docrep/010/a1250e/a1250e00.htm and http://www.fao.org/docrep/010/a1260e/a1260e00.htm respectively. To request the publication (or the CD-ROM), contact dad-is@fao.org providing your full postal address and indicating the version and language you wish to receive.

Source:
http://www.fao.org/biotech/index.asp?lang=en. Accessed July 28, 2010.


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