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Date:

December 11, 2001

Subject:

Supreme Court Ruling Aids Biotech; Managing IPR; Patent

 

Today in AgBioView

* Biotechnology in International Trade: What Does the Future?
* Supreme Court Decision on J.E.M. Ag Supply, vs. Pioneer Hi-Bred Int'l
* Patent Ruling Aids Seed Biotech Firms: Courts
* Managing IPR in a Knowledge-based Economy - Bioinformatics & Public Policy
* An Intellectual Property Clearinghouse for AgBiotech
* Guidelines on Science and Health Communication
* Gene Flow Among Maize Landraces, Improved Maize Varieties, and Teosinte
- Implications for Transgenic Maize
* Mexico Investigating Transgenic Corn

Biotechnology in International Trade: What Does the Future?

Tuesday, January 08, 2002; 9:30-11:00 am, Washington DC (Hemisphere Suite A, Ronald Reagan International Trade Center, 13th and Pennsylvania Avenue)

http://www.wita.org/content.cfm?L1=4&QA=136 (Source: karen@kcegroup.com)

Some define biotechnology as the use of modern scientific techniques, including genetic engineering, to improve or modify plants, animals, and microorganisms. They feel that by using advanced scientific methods biotechnology can provide unique opportunities to increase the quantity, quality, and reliability of a food supply. Please join us for a WITA breakfast on Tuesday, January 8th, 2002 where we will hear the US government's perspective on this controversial issue.

Speaker: Alan P. Larson, Under Sec for Econ, Business, and Ag Affairs, US Department of State

Check-in begins at 9:00am. Spaces are limited, so please reserve a space in advance but no later than 5:00pm 1/7/02 by registering and submitting payment. Due to building security, please bring a photo ID! Cancellations not received 48 hours in advance will be billed to cover costs. All Non-members: $35;; WITA Members who are US government employees, full-time students, or unemployed: $10; All other WITA members: $20

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From: "Kershen, Drew L"
Subject: Supreme Court Decision on J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc.

On Monday, December 10, 2001, the Supreme Court of the United States ruled 6-2 that "Newly developed plant breeds fall within the subject matter of Section 101 of the Patent Laws, and neither the Plant Patent Act nor the Plant Variety Protection Act limits the scope of Section 101's coverage." Consequently, the court upheld Pioneer Hi-Bred's patents in corn.

For those who want to view the full opinion in .pdf format, http://www.supremecourtus.gov .Go to Opinions, Latest Slip Opinions, look for the J.E.M. name. The full opinion, including a concurring opinion and a dissenting opinion, prints to 33 pages on my printer.

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Patent Ruling Aids Seed Biotech Firms Courts

- Melinda Fulmer, Los Angeles Times, Dec 11, 2001

In a victory for companies that develop genetically modified plants, the U.S. Supreme Court ruled Monday that seeds and seed-grown plants can be patented.

The 6-2 ruling, which upheld a court of appeals decision, strengthens the intellectual property rights of the nation's largest seed biotechnology companies. If these protections had been struck down, companies such as DuPont, Monsanto Co. and Sygenta would have seen hundreds of patents invalidated or restricted, giving other companies and farmers access to their technology without having to pay for it. "We have spent hundreds of millions, if not billions, to bring forth our products, some biotech solutions, some not," said Monsanto spokeswoman Lori Fisher. The court "clearly wanted to protect the rights of investors."

With biotechnology advancing at a rapid pace, the ruling sends a signal that the nation's highest court is taking a tough stance on intellectual property rights in every industry, said analyst Donald Carlson of J.P. Morgan.

The U.S. Patent Office has granted patents to plants for 16 years. To date, more than 1,800 patents have been issued for plants and plant parts. J.E.M. Ag Supply, an Iowa seed firm, brought the legal challenge after it was sued for patent infringement by DuPont's Pioneer Hi-Bred unit for reselling 17 patented varieties of its corn. J.E.M. had argued that because hybrids are not mentioned in the Plant Protection Act, these products are regulated by the Plant Variety Protection Act of 1970, a less restrictive certificate program administered by the Department of Agriculture.

Putting regulation under that program would have hurt biotech companies because it would not have allowed Pioneer and other seed companies to collect licensing fees for seeds used in research or for seeds that farmers collected from their fields and replanted. Justices struck down J.E.M.'s argument, saying that because seed-grown plants qualify for the less-restrictive USDA certificate program doesn't mean they can't be patented.

"Denying patent protection simply because such coverage was thought technologically infeasible in the 1930s, however, would be inconsistent with the forward-looking perspective of the utility patent statute," said Justice Clarence Thomas, writing for the court's majority. But critics say the ruling perpetuates a system that slows the pace and diversity of research and punishes farmers by driving up costs.

But biotechnology proponents claim that protecting the profits of these firms ensures that new, more efficient varieties of plants will keep coming to market. Intellectual property rights are every bit as important to the seed industry as they are to the software industry," said analyst Donald Carlson of J.P. Morgan in New York. "If your competitor can quickly [come out with a new product] by stealing your germ plasm, your advantage in the marketplace is substantially diminished." "Intellectual property rights are every bit as important to the seed industry as they are to the software industry."

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Managing IPR in a Knowledge-based Economy - Bioinformatics and the Influence of Public Policy

- Forwarded by: Mark.Cantley@cec.eu.int

The report described below is announced on the opening page of the website describing the European Union's "Quality-of-Life" 2.4 Billion R&D programme:
http://www.cordis.lu/life/home.html and more permanently at
http://www.cordis.lu/life/src/pub_qol.htm

THE REPORT CAN BE ACCESSED DIRECTLY BY: ftp://ftp.cordis.lu/pub/life/docs/ipr_bioinf.pdf

"Workshop report on Managing IPR in a knowledge-based economy - Bioinformatics and the influence of public policy", based upon a Workshop held in Brussels, Belgium, on 11-12 September 2001

The workshop participants concluded that research and innovation in bioinformatics in Europe are functioning well at present, but there are a number of structural problems and changes in progress. These problems, which directly involve links between intellectual property rights (IPR) and public policy, threaten the long term future of European capabilities in this field.

The strengths of the current situation in Europe include: publicly available bioinformatics databases, a range of institutional research programmes; a wide mixture of funding sources. However, there are problem areas, which include include: underfunding in the EU; structural obstacles to public funding of database maintenance causing inappropriate IPR protection; lack of awareness among academics that IPR can be used strategically for knowledge management at all stages of research and innovation; economic vulnerability of European bioinformatics companies; escalation of costs due to royalty and license fee stacking; fragmented national and EU funding policies which are tied to non-optimised IPR rules; lack of coherent policies to deal with the very rapid growth rate of primary data.

To deal with these problems, guidelines to research organisations are proposed, including: - appropriate use of IPR protection to achieve strategic institutional objectives; - awareness training; - strategic university management of database IPR; - international collaboration agreements allowing for diverse IPR systems; - need for database publishing guidelines; - a variety of database access mechanisms; - support of both publicly available and privately controlled databases. Also, policy recommendations for governments and funding organisations include: - Databases and analysis software need to be regarded as research infrastructures; - Information services, including access to IPR protected databases, should be recognised as legitimate research costs; - Database and software definition and protection within IPR legislation needs to be relevant to bioinformatics research; - Government IPR regulations and legislation and funding should be reviewed to see if they are encouraging research to remain in the EU;

All involved sectors strongly support a comprehensive and up-to-date publicly-available and free set of bioinformatics data, while recognizing the need of large pharma companies to access to a mixture of high quality public and private databases and tools; Public policy has a key role in the whole life-cycle of databases, and in identifying best practices; - While maintaining a strong public sector, public funding and IPR rules should also encourage collaborations, especially public/private ones, that mobilise resources and support innovation; - The value of health informatics databases as a research resource should be considered.

Contact: Frederick Marcus, Research Directorate General, European Commission mailing address: EUROPEAN COMMISSION (SDME 1/44), B-1049 Brussels, Belgium e-mail: Frederick.Marcus@cec.eu.int

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An Intellectual Property Clearinghouse for Agricultural Biotechnology

Gregory Graff & David Zilberman, Nature Biotechnology, Dec 2001 Vol 9 No 12; p 1179-1180

Combining the best features of IP informatics services and online patent exchanges in an industry-specific collective rights organization could free up agricultural research by creating paths through the growing thickets of competing property claims.

The granting of intellectual property (IP) rights by governments over the components of life helps to provide a practical compromise between the public and private economic forces that drive agricultural biotechnology research. However, the effectiveness of a patent system turns on two factors: (1) the definition of what is patentable, to demarcate what may be claimed as private property and what should be left in the public domain; and (2) the mechanism to trade in patent rights, to efficiently move those rights to those able to create value with the technology while fairly compensating the inventors.

As agricultural knowledge and genetic resources are being staked out in the current fray of agbiotech patenting, their common-pool (interdependent or complementary) nature is being lost in the subdivision among multiple private property claims, thus diminishing the public benefits that would otherwise arise from the unrestricted flow of information and biological materials. In addition, difficulties in negotiating and managing access to needed IP sap the power of private incentives to innovate. The cumulative result is a dampening of research and innovation productivity known as "the tragedy of the anticommons"1. Particularly as agricultural research becomes increasingly complex, it depends more and more on access to knowledge and biological materials that have already been claimed as proprietary by others, and a thicket of blocking patents can choke the commercial "freedom-to-operate" of any resulting agricultural innovation.

Much of the critique of patent systems for engendering an intellectual anticommons has focused on the first factor—the scope or definition of what is patentable 2. However, by focusing on the second factor—the exchange of patent rights—significant improvements in freedom to operate can be achieved no matter what shape patent policies end up taking.

Accessing IP in a congested landscape: A company has limited options for pursuing freedom to operate within a congested IP landscape. It might be feasible to invent around another's proprietary technology, to license their technology, or to barter IP with them in cross-licensing, strategic collaboration, or conditional access agreements. In extreme cases, companies can obtain IP through buyouts or mergers. Today, even public sector institutions are developing IP management strategies.

Historically, when IP congestion has threatened the public good, governments have intervened by creating "collective rights organizations": mandating compulsory licensing of patents at established fees, creating and managing public patent pools, directly purchasing key enabling technology patents and placing them into the public domain, and even forcing mergers between firms holding mutually blocking IP3. Occasionally, private institutions or industry-led consortia have organized private patent pools—including small contract-based patent pools, large industry-wide patent pools, and technology standard-setting patent pools. However, patent pools can provide a pretext for unhealthy degrees of collaboration, and have mostly fallen out of fashion with antitrust authorities 4. A more sophisticated form of collective rights organization is the copyright royalty clearinghouse (such as ASCAP and BMI for music). Private collective rights organizations have been more economically efficient than government-invoked sol

An IP clearinghouse for agbiotech: The current IP congestion in agricultural biotechnology suggests that a multilateral collective rights organization—an "intellectual property clearinghouse"—could benefit all currently unsatisfied parties, in both the public and private sectors, in both the biotechnologically advanced industrial economies and the biodiversity-rich developing countries. The goal of such a clearinghouse would be to reduce transaction costs and other market failures that hinder the exchange of IP, creating pathways through the patent thicket and giving freedom to operate with proprietary biotechnologies.

The three essential functions of an IP clearinghouse are (1) the identification of all relevant IP claims over a technology and indication of the extent of availability for licensing; (2) matching buyers with sellers, with standardized yet flexible prices and terms of contract; and (3) monitoring and enforcement of contracts. One can envision multiple technology providers and users linked by a collective contractual commitment and supported by an independent professional staff and information network, quickly identifying relevant rights and technologies and readily fulfilling transactions.

The provision of information on relevant IP claims is aimed at overcoming imperfect information and information asymmetry, two barriers to fair trade in patented technologies. These barriers often take the form of ignorance about IP ownership and risks of infringement. Openly available, comprehensive, and up-to-date records describing what has been patented, by whom, and where, would allow research organizations to identify conflicts among claims already staked and unpatented frontiers of technology. Patent offices already provide free online databases5, but ideal IP information needs additional features to support decision-making: (1) user-friendly data structure and indexation to be easily navigated by non-IP professionals; (2) analytical tools to display the technological landscape, to characterize the differences and similarities among patented technologies, and the positions of different organizations in a technology; (3) analytical tools to chart or interpret patents' legal claims, to outline best app

Such capacities are more costly, but are already developed and marketed by private IP data providers (such as Derwent or Delphion), IP management system vendors (such as Aurigin Systems), and IP consultancies (such as Chi Research or Mogee Research).

The matching and price discovery function aims to reduce costs, risks, and strategic manipulation of transactions. A number of recently founded online patent and technology licensing services—such as The Patent and License Exchange (http://pl-x.com), http://Yet2.com, and TechEx—have pioneered information technology tools inspired by the Internet business-to-business (B2B) free-market efficiency model. However, these services are limited in their capacity to manage multiparty, multipatent transactions, nor have any achieved critical mass in the IP relevant to agricultural biotechnology.

An IP clearinghouse could bring these tools of IP information management and patent exchanges together, with some proposed features: (1) comprehensiveness and specificity to agriculture and its IP needs; (2) independence and neutrality, in order to maintain users' trust, to avoid conflicts of interest, and to promote healthy competition in the industry; (3) bundling of multiple complementary patents into "micropools" and offered under single contracts; and (4) provision of regulatory and biosafety information on new technologies, enabling product clearance matching with patents across countries.

Because IPR systems are different across nations and regions, clearance must be negotiated in each system separately. However, a clearinghouse need not be limited to one nation's IPR system and may be useful in facilitating the movement of technologies across IPR systems. As the World Trade Organization (WTO) TRIPS agreement begins to harmonize standards among these systems, the global clearing of IP will become easier.

Potential users: Those already actively patenting in agricultural biotechnology are the most likely initial participants, not only as the main suppliers, but also as the most active users of proprietary technologies (see Table 1). Leading multinationals have been changing their licensing policies in the last five years, recognizing that licensing can be more profitable than exclusive use (or neglect) of their inventions6. University offices of technology transfer (OTTs) operate under a mandate to spin out the fruits of university researchers' labor for commercialization and public use. With university technologies often in early stages of development, OTTs resort to offering exclusive rights even when they would prefer to make multiple licenses. A clearinghouse may help them to expand the utilization of university inventions. Smaller labs and biotechnology firms depend heavily on patent royalties and constantly seek better means to market their inventions. As they often hold just individual pieces of the la

Others who currently are not patenting but who would benefit from a better functioning IP market include farmers, agricultural co-ops and grower's associations, small seed enterprises and nurseries, as well as many universities, international agricultural research centers of the Consultative Group on International Agricultural Research (CGIAR), national agricultural research services (NARS) of developing countries, and agricultural development organizations. Not only would they find themselves much more able to in-license currently unavailable technologies at reasonable costs and on reasonable terms, but they would be encouraged to develop and in turn to out-license their own inventions for fair returns and on reasonable terms. These incentives would encourage the development of agricultural research capacity.

Steps forward: The value to society of more efficient IP exchange—getting good ideas deployed in their most valued applications—could be enormous. Where such mechanisms would be viable, competitive, and profitable, the economic rule of market efficiency would have us leave it to private enterprise to create them; however, if the likelihood of breaking even in the short term is insufficient to induce private investment, nonprofits or public agencies might consider investing in such mechanisms.

An active IP clearinghouse as a collective rights organization, using the available tools of the IP informatics service and the online patent exchange, could serve to level the playing field and free up agricultural research by creating paths through the growing thickets of competing property claims. It could reduce the drive for firms to consolidate in order to obtain complete in-house control of complementary technologies. It would enable companies to improve their product design, as their innovation would be less constrained by their current holdings of intellectual property. It could help to move appropriate technologies out into regional and applied agricultural research systems around the world and could provide incentives and means for current outside players to strengthen their agricultural research capacities. Finally, an IP clearinghouse could help agricultural research to find and maintain a healthy, dynamic balance between public and private forces, and grow along a more efficient, safe, and ben

A longer version of this article is available at http://www.cnr.berkeley.edu/csrd/technology/ipcmech/

REFERENCES
1. Heller, M. & Eisenberg, R. Science 280, 698-701 (1998).
2. Bobrow, M. & Thomas, S. Nature 409, 763-764 (2001).
3. Merges, R. Calif. Law Review 85, 1293 (1996).
4. Antitrust guidelines for the licensing of intellectual property. http://www.usdoj.gov:80/atr/public/guidelines/ipguide.htm
5. Intellectual property digital library. http://ipdl.wipo.int/
6. Rivette, K. & Kline, D. Harvard Business Review 54 (January 2000).
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Gregory Graff (e-mail: ggraff@are.berkeley.edu) is a graduate researcher and David Zilberman (e-mail: zilber@are.berkeley.edu) is a professor in the department of agricultural and resource economics, University of California, Berkeley, and a member of the Giannini Foundation.

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Guidelines on Science and Health Communication

- Social Issues Research Centre (UK) , http://www.sirc.org , December, 12, 2001

The Royal Society has now joined SIRC and the Royal Institution to produce a single set of guidelines on the reporting of science and health issues in the media. These replace the earlier SIRC / RI guidelines and the Royal Society's notes for journalists and editors.

The publication of a single document, of course, will not in itself lead to the eradication of the distortion and sensationalism which so often accompanies reporting of health and science issues. The spreading of unfounded anxieties, together with the generation of false optimism through talk of 'miracles' and 'breakthroughs', are entrenched media habits which may take some time to replace with more balanced and accurate coverage. At the same time we recognise that the sources of distortion and misrepresentation often lie within the science and health communities themselves and the manner in which they present their research to the public. It is for these reasons that a new charity has been established - The Health and Science Communication Trust (HCST). To read or download the full guidelines click

http://www.sirc.org/news/guidelines.shtml

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Gene Flow Among Maize Landraces, Improved Maize Varieties, and Teosinte: Implications for Transgenic Maize - Proceedings of a Forum:

http://www.cimmyt.org/ABC/Geneflow/geneflow_pdf_Engl/contents.htm

* Research on Gene Flow between Improved Maize and Landraces
* Regulation and Risk Assessment on Transgenic Maize in its Center of Origin
* Searching for a Balance: Environmental Concerns and Potential Benefits of Transgenic Crops in Centers of Origin and Diversity
* Evaluating the Risks of Transgene Flow from Crops to Wild Species
* The State of the Art in Maize Transformation
* Regulating Transgenic Plants: The Experience of USDA in Field Testing, Wide-Scale Production, and Assessment for Release in Centers of Origin
* Teosinte Distribution in Mexico
* Teosinte in Mexico: Personal Retrospective and Assessment
* Teosinte Distribution in Mexico
* Gene Flow Frequency and Intensity between Maize and Teosinte
* Cross Compatibility within the genus Zea
* Review of Introgression Between Maize and Teosinte
* Gene Flow from Improved Maize to Landraces
* Seed Exchange Among Farmers and Gene Flow Among Maize Varieties in Tradition Agricultural Systems

(The website has all papers listed above. Exec. summary appears below......CSP)
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Executive Summary: Gene Flow Among Maize Landraces, Improved Maize Varieties, and Teosinte

*Teosinte distribution in Mexico

The wild relatives of maize collectively referred to as teosinte are represented by annual and perennial diploid species (2n=20) and by a tetraploid species (2n=40). They are found within the tropical and subtropical areas of Mexico, Guatemala, Honduras, and Nicaragua as isolated populations of variable dimensions occupying from less than one square kilometer to several hundred square kilometers. The distibution of teosinte in Mexico extends from the southern part of the cultural region known as Arid America, in the Western Sierra Madre of the State of Chihuahua and the Guadiana Valley in Durango, to the Guatemalan border, including practically the entire western part of Mesoamerica. Exploration in Mexico and Guatemala has allowed researchers precisely to locate populations and races, as well as studying their taxonomy and ecological interactions. An estimated 80% of all teosinte populations have been identified, and germplasm samples are conserved in banks at research institutions such as INIFAP, CIMMYT, t

Changes in land use — especially increased grazing and urbanization — are the principal threats to teosinte. In recent decades there has been a drastic reduction in teosinte populations and the danger of extinction is real. In fact, transgenic maize may be considered a marginal threat, compared with the effects of urban growth.

Gene flow frequency and intensity between maize and teosinte
Hybrid plants and advanced generations of maize x teosinte crosses have been found with certain frequency in farmers’ fields. In spite of this, maize and teosinte have continuously coexisted as genetically separate entities, raising doubts about the degree of gene flow between them. Studies of the differences in general structure and position of maize and teosinte chromosome knobs have generally provided no evidence of introgression between the species. The results of the few studies that might seem to indicate introgression can also be explained by other factors. Also, it is possible that other regions of the genome not linked to the chromosome knobs could be exchanged between the two species at a higher frequency.

Regarding teosinte-maize exchanges, the free flow of genes may be modified by gametophytic
incompatibility controlled by an allelic series where fertilization is impeded due to either complete or partial incompatability. Complete incompatibility is demonstrated by either the non-functioning of some pollen genotypes on particular pistils or the exclusion by competition with pollen of other genotypes. Partial incompatibility is detected by differential pollen growth and the distorted recovery of alleles coupled to incompatibility genes. Both complete and partial incompatibility have been reported in Zea mays (includes maize and teosinte). Incompatibility serves as a stable isolating mechanism for species only if it is bilateral. The maize popcorn or Central plateau teosinte compatibility systems, acting individually constitute unilateral barriers with respect to other incompatibility alleles. Other factor such as time of flowering or human selection could contribute to bilateral isolation. It is also possible that compatibility factors act in pairs in sympatric populations. Further research is need

* Gene flow from improved maize to landraces

Landraces — native maize varieties — are planted on most maize land in Mexico, except for some exclusively hybrid-growing areas in the northern Pacific region.

The productivity of native maize varieties has been maintained in many regions through seed
exchanges. The movement of seed of native maize populations within and between farming
communities cultivating the same racial group of maize is dynamic. Farmers recognize several “classes” of maize in their communities and may exchange seed between the same extended family, or else they may acquire seed from nearby communities or from places hundreds of kilometers away to maintain the productivity of their crops. Traditional farmers in Mexico make no attempts to distance plantings of different classes of maize in their fields; for example white and blue grained maize might be planted in adjoining plots. Several studies document the effective fertilization by maize pollen from neighboring plots of plants located in the first 10 - 15 meters of another, contiguous plot. The introduction of new varieties plus the movement of pollen between adjacent plots means that farmer varieties are genetically dynamic and open to influence of maize introductions from other regions of Mexico.

Although information on genetic exchange between improved maize and native maize varieties is scarce, a few studies comparing native varieties collected at the same site over a significant time span show that their yield has increased over time. This can be attributed either to genetic gains from farmer selection or from the introgression of genes from improved maize.

* Regulation and risk assessment for the release of transgenic plants in centers of origin

The principal criterion for deciding whether or not to release transgenic plants in the center of origin for the corresponding crop is the tradeoff between the potential environmental problems and possible benefits from their release.

Field studies for some crops indicate a high probability of genetic exchange between cultivated plants and wild relatives and, at the very least, that crop x wild relative hybrids frequently appear in the field. Thus it is important to estimate the risk of introducing transgenic plants in areas where wild relatives exist. Two possible harmful consequences should be considered: 1) the creation of more persistent weeds and 2) the extinction of the wild species by way of hybridization.

Although there are no direct data on genetic exchanges between cultivated plants and wild relatives, at least two related and fundamental aspects are relevant: 1) the effect of transgenes on the survival of hybrid progeny and 2) the change in the adaptive value of the transgene in one plant species as opposed to another. Although it is not possible to anticipate all the consequences of a new technology, designing appropriate experiments to obtain solid data would enable scientifically-based decision-making to avoid the release of transgenic products considered improper for the environment and permit the timely release of others. In the United States several transgenic crops have been deregulated, including squash, which has wild relatives in the southern part of the country. The US regulatory system is based on the premise not of proving whether transgenic plants are safe but on the judgment of the regulatory agency that they are as safe as other varieties of plants. Under this construct, the decision to al
The principal criterion for deciding whether or not to release transgenic plants in the center of origin for the corresponding crop is the tradeoff between the potential environmental problems and possible benefits from their release.

Field studies for some crops indicate a high probability of genetic exchange between cultivated plants and wild relatives and, at the very least, that crop x wild relative hybrids frequently appear in the field. Thus it is important to estimate the risk of introducing transgenic plants in areas where wild relatives exist. Two possible harmful consequences should be considered: 1) the creation of more persistent weeds and 2) the extinction of the wild species by way of hybridization.

Although there are no direct data on genetic exchanges between cultivated plants and wild relatives, at least two related and fundamental aspects are relevant: 1) the effect of transgenes on the survival of hybrid progeny and 2) the change in the adaptive value of the transgene in one plant species as opposed to another. Although it is not possible to anticipate all the consequences of a new technology, designing appropriate experiments to obtain solid data would enable scientifically-based decision-making to avoid the release of transgenic products considered improper for the environment and permit the timely release of others. In the United States several transgenic crops have been deregulated, including squash, which has wild relatives in the southern part of the country. The US regulatory system is based on the premise not of proving whether transgenic plants are safe but on the judgment of the regulatory agency that they are as safe as other varieties of plants. Under this construct, the decision to al

* Conclusions and recommendations of discussion groups

* Group 1: Anticipated frequency of gene flow from transgenic maize to teosinte and landraces and its possible effect

Studies of introgression between maize and teosinte have been of three types: 1) morphological; 2) chromosomal (knobs and special chromosomes), and 3) molecular (isoenzymatic variation). Despite the lack of conclusive evidence regarding introgression between sympatric teosinte and maize, to establish a wide margin of safety, it was recommended that bi-directional introgression between maize and teosinte be taken as a given, even though this may occur at a low frequency.

Gene flow from transgenic maize to teosinte or maize landraces would be influenced by many factors — including the degree of crossing between transgenic maize and local teosinte or maize — relating to such considerations as isolation barriers, ploidy level and flowering dates, and policy and cultural factors which affect the promotion and acceptance of new varieties. It was thought that the probability of gene flow between transgenic maize and landraces is much higher than that between transgenic maize and teosinte.

Results of tests published to date involving transgenic maize varieties indicate that transgenes are sufficiently stable, segregate according to Mendel’s laws, and generally do not have pleiotropic nor epistatic effects. Nevertheless, given the significant differences between maize production and use in Mexico and the USA, forum participants recommended that carefully designed studies be conducted to obtain precise, quantitative information on gene flow between Zea species and varieties and to elucidate any possible effects — both favorable and unfavorable — from interactions between transgenes and “native” genes, before releasing transgenic maize for commercial use in Mexico.

It was recommended that areas of Mexico be assigned different risk levels for field tests involving transgenic maize. Risk zones were assigned on a scale of 0 to 3. Risk zone 0, where no risk exists, was decided to be inappropriate for Mexico at this time. Risk zones 1 - 3 were based on quantities of teosinte and native maizes in the respective areas. Risk zone 1 comprises areas where no teosinte is found and there is little use of native maize varieties; risk zone 2 includes areas where there is little teosinte and moderate to frequent plantings of native maizes; risk zone 3 includes the major areas of teosinte distribution where native maize varieties also predominate.

Certain complementary actions must be undertaken to protect and maintain maize and teosinte genetic diversity. With this aim, participants recommended 1) that the ex situ collection of maize germplasm in INIFAP be placed in proper long-term storage and 2) that a a national plant germplasm bank be constructed in Mexico to conserve representative samples of important agricultural native species. Ex situ samples of teosinte presently embody approximately 80% of teosinte diversity in Mexico. Prior to the commercial release of transgenic maize, collections are recommended to cover the remaining 20%. A program in collaboration with local institutions to monitor teosinte populations is also necessary, to salvage the knowledge of communities that are associated with the management of this germplasm.

The in situ conservation of certain types of teosinte is guaranteed by the existence and operation of the wild protected area in Manantlan, Jalisco, which has included within its programs the on-farm conservation of a Z. diploperennis population. As for the other teosinte populations, proposals similar to that of the Manantlan Biosphere Reserve must be considered. (This is one of the recomendations of this group. jash).

It is recommended that research and conservation priorities first target landraces and then teosinte, given that that transgenic flow would presumably occur in this order. It is recommended that conservation and characterization of maize and teosinte be started in zones close to settlements that have high demographic growth and in those that are subject to important ecological changes. It was considered that the release of transgenic maize involves risks, so a risk-benefits analysis is needed with special emphasis on possible effects on farmers of different socioeconomic levels.

* Group 2. Research in the area of risk, impact, and biosafety
The risks for landraces and teosinte from the introduction of transgenic maize are probably equivalent to the impact that different improved varieties and hybrids have had on native maize varieties. Notwithstanding, the effect of transgenes on teosinte cannot be anticipated or inferred until these transgenes are incorporated into its genome.

Transgenes that have been incorporated into maize may have pleiotropic effects on teosinte, which would imply the possibility of unexpected changes that might be beneficial for native maize varieties, but lethal or highly adverse for the reproductive capacity of teosinte. Therefore, it is recommended that research on maize -teosinte introgression focus on transgenes that are currently available or in advanced development, which include the following: a) the insecticide protein of the d-endotoxin gene of Bacillus thuringiensis; introgression of these genes into teosinte populations might contribute to the development of insect populations resistant to the toxin; b) resistance to herbicides might imply for teosinte populations two types of situations: 1) possible risk of elimination of teosinte populations due to application of herbicides that accompany the introduction of herbicide resistant transgenic varieties, or 2) an adaptive advantage conferred to teosinte by the introgression of the transgene, which w

In addition, research is needed to determine the frequencies of gene flow, the frequencies of introgression, and the effect of transgenes incorporated into teosinte. To evaluate the consequences of the introgression of transgenes to teosinte, three types of experiments are proposed. The first to measure the frequency of migration (m) of maize pollen to fertilize teosinte. The second to measure the fitness or selective coefficient (s) of maize -teosinte hybrids, independent of the selective coefficient of the transgene. The third would be to calculate the selective coefficient of the transgene in the hybrid. These are relevant parameters that may be used in models involving population genetics and risk analysis.

In the first two types of experiments transgenic plants would not be used, therefore these experiments could be carried out in situ. Experimental sites would be established in the teosinte macro-distribution regions, such as the Central Plateau, the Balsas and Chalco regions, with two repetitions per site. The use of co-dominant markers is recommended for the study of
experimental populations selected, and the size of the sample must be adequate to determine the biologicglly significant differences. In addition, it is suggested that comparison of fitness (s) of maize-teosinte hybrids, with and without incorporated transgenes, be carried out with maize that is otherwise isogenic.

* Group 3. Regulation and safety measures in transgenic maize tests
A consensus was reached that field tests with transgenic maize may be carried out in Mexico as long as proper measures are adopted to prevent gene flow to other Zea species. These measures will depend on the materials tested and the objectives of the trials, always taking into account that proposed safety measures are valid only for certain genes, localities, and times of the year.
Continuous follow-up of the tests is recommended, as well as maintaining a log of field activities, always at the disposal of members of the National Agricultural Biosafety Committee. Similarly, mechanisms of restricted access and strict oversight must be established over test sites to avoid the voluntary or involuntary exit of materials from these sites. It is recommended that a mechanism and a special body be created for follow-up and oversight during the experimentation and field testing phase with transgenic maize in Mexico. Trained individuals from research institutions and from independent non-governmental, professionally reliable agencies must participate.

Carefully controlled, properly conducted field tests of transgenic maize in Mexico should provide valuable information for future decisions on expanding field tests or on commercialization. It was felt that continually prohibiting the entire enterprise for lack of information would only cause a negative loop. An ideal testing site would be a semidesert area, such as the peninsula of Baja California, where there is no teosinte, there are virtually no landraces, and maize cultivation is not very important. In that region, isolation perhaps would not be necessary. In areas with a higher frequency of teosinte or landrace distribution, it would be necessary to adopt isolation measures at the experiment site. The most simple and direct, is detasseling the plants. Isolation of experiment fields is recommended. Adequate infrastructure and trained technicians to carry out these tasks properly and responsibly, would be an important component of test site evaluation.

To achieve isolation in farmers’ fields, it would be advisable to use combined physical and biological barriers of pollen containment, which may be the crop itself (in this case maize) or else sugarcane in tropical or subtropical regions. If the material utilized as a barrier is of the same species (in this case maize), neither the grain nor the stubble may be used for human or animal consumption. Grain produced from the barriers must be destroyed. Maize must not be planted at the test site in the cycle following the test. Furthermore, the field must be watered and cultivated to eliminate volunteer plants when the test cycle is over. Tests at sites distant from regions rich in landraces or teosinte may be impractical, so that it was suggested that distances of isolation between plots with transgenic and normal maize be on the order of 300 to 500 m, which are the distances used in hybrid seed production.

Field testing of transgenic maize in Mexico must be considered a special case and one of great importance. The critical questions for transgenic maize are not so much at the experimental stage, where conditions can be controlled, but at the stage of deciding to permit commercial release, when there can be no containment. Therefore, careful analysis of the consequences of deregulation is recommended. Educating the public to understand what is occurring with the introduction of transgenic material would be an important step in clarifying the decision-making process regarding deregulation.

It is recommended that research on gene flow and the analysis of biological risks derived from the use and release of transgenic plants be a coordinated, multi-institutional task. What is necessary is teamwork involving the participation of biotechnologists, ecologists, plant breeders, and other scientists who conduct research from diverse disciplines. release of transgenic plants in centers of origin

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From: MIKE BEYERSDORF,
RE: Pollan Strikes Again

Regarding Genetic Pollution:

>From a practical point of view, plant breeders are seldom interested in screening thousand of old varieties for the solution to today's problems because we now have the ability to harvest genes from myriad other species. Soon we'll have the ability to custom-build the genes we need. This discussion is akin to a lawsuit charging infringement of the vacuum tube patent.

Aloha from the desk of Mike Beyersdorf, Kihei, Hawaii Research Station

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Mexico Investigating Transgenic Corn

MEXICO: December 11, 2001

MEXICO CITY - The Mexican government is taking samples of corn from Puebla and Oaxaca states to check for genetically modified corn, forbidden as a commercial crop in Mexico since 1998.

Transgenic maize has been previously identified in Oaxaca, but not in its neighbor state of Puebla, raising the specter of broader contamination of native crops by modified pollen. "An exhaustive investigation is ongoing at different sites in Puebla and Oaxaca to collect representative samples from different corn parcels for molecular analysis to determine whether or not transgenics exist in those areas," the government said in a statement late on the weekend.

"This analysis will also allow for the definition of types of transgenics and evaluation of the risks and facilitate reaction to any eventuality," the Intersecretarial Commission for Biosecurity and Genetically Modified Organisms (CIBIOGEM) said in the statement. The CIBIOGEM investigation comes about two months after the Mexican environment ministry said there was evidence genetically modified corn was growing in the southern state of Oaxaca.

In late November scientists in the United States confirmed the reports and said that wild maize grown in a remote area of the state had been contaminated by genetically modified corn. Scientists were unsure how the contamination occurred, although some suggested it could have happened before the government banned the planting of transgenic maize.

The experts said it was unlikely that the contamination occurred by wind-blown corn pollen because the pollen is too heavy to be carried by air currents. Genetically modified foods are spliced with foreign genes to help plants resist drought or ward off pests. Proponents laud the foods' nutritive capacity, while detractors fear their potential impact on the environment.

The CIBIOGEM said in its statement that there is no scientific evidence that commercial genetically modified corn or its products harm human health. While the planting of transgenic maize has been forbidden in Mexico for three years now, it is still being imported from the United States.