In This Issue:
Insect Control in Agriculture: Report from the ESA Meeting
Inventors: Don't Trip over Electronic Timelines
Reflections on 1996
Towards the Development of Cold Tolerant Plants
Edible Plant Vaccines
Transgenic Arthropods: Current Status, Future Prospects
EPA Oversight of Plant-Pesticides
Requirements for Select Infectious and Toxic Agents
State Of the Industry
Trends in Potato Production: Impact of Transgenic Virus Resistance
Bt Cotton
Preliminary 1996 performance reports for commercial cotton and corn
varieties genetically engineered with Bt insect control genes were
positive. More than 1.8 million acres of cotton resistant to
bollworm, tobacco budworm and pink bollworm were planted in 1996.
From the outset, genetically engineered varieties were in high
demand from farmers willing to pay the $32/acre technology fee. As
much as 77% of the cotton acreage in Alabama was planted to Bt
varieties such as DeltaPine Land Company's NuCOTN lines. It was a
good year for cotton throughout most of the southern growing
regions. NuCOTN33B posted an 8-10% increase in yield over its
parental line, due to the combined effects of the Bt insect control
gene and the variety's improved agronomic performance.
As with other agricultural products, DeltaPine Land Co. is working with farmers to optimize performance. In some cases, growers are advised that transgenic technology may not be the most appropriate to their particular situation. In other cases, growers must deal with associated traits that affect harvestable yield. In cotton, for example, plants should not be too tall. The indeterminate growth pattern of parental line 33, however, shows up in NuCOTN33Bas a tendency to produce "buggy whip" shoots, which are excessively tall and have only a few bolls. The company will be advising farmers on management practices to control this undesirable trait.
The first year of introduction has also taught the company a basic lesson in technology adoption. After determining that half of their on-farm calls this season were due to farmers getting seed mixed up, DeltaPine Land Co. began color coding their cotton seeds so that farmers can better track which fields are planted to transgenic varieties. A company spokesman estimated that within five years, 80-90% of cotton seed planted in the U.S. will be transgenic.
Bt Corn
Did Bt corn resistant to European corn borer deliver on its
marketing promise? This year transgenic Northrup King lines
produced anywhere from five to twelve bushels per acre more than
unprotected varieties. The Bt gene itself does not confer a yield
advantage, rather it protects the crop's yield potential. In a year
of high insect pressure like 1996, farmers get a high benefit from
Bt varieties, but in a year of low insect pressure the yield
improvement over conventional varieties may only just cover the
added cost. Insect pressures cycle over time and geographical
areas. The U.S. corn belt is coming off two years of high European
corn borer pressure, so while Bt corn did well enough this year to
convince farmers to buy it next year, insect pressure is likely to
decline somewhat. Before they plant their 1997 crop, farmers will
try to predict how serious pest problems will be in the coming
season. Many are expected to decide to pay the $7.50 per acre
premium for Bt seed corn as a form of insurance against next year's
uncertain losses.
Engineered Baculoviruses
Insect-specific viruses are being engineered with a variety of
genes to make them more effective biocontrol agents. Genes encoding
diuretic hormone, juvenile hormone, Bt delta endotoxins, and mite
toxins are being added to baculoviruses to improve the killing
power of these viral insecticides.
This year's field tests of a baculovirus engineered with the AaIT gene encoding a scorpion toxin provide a glimpse at the environmental fate and genetic competitiveness of the recombinant virus. The tests evaluated the efficacy of genetically-altered viruses against lepidopteran species (cabbage looper and tobacco budworm) on tobacco, cotton and leafy vegetables. No difference was seen in the physical properties of transgenic versus non-transgenic strains; they were equally sensitive to rapid degradation in sunlight, slow degradation at temperatures above 85øF, and temperature/moisture interactions.
Tobacco budworm larvae killed by the AaIT strain harbored ten-fold fewer viral inclusion bodies than larvae killed by the non- engineered strain. This result was expected, since insertion of the toxin gene leads to faster death of the insect host, therefore fewer viral progeny are formed. In mixed infections established with a 9:1 ratio of transgenic to nontransgenic virus, the inserted gene could not be detected by the 6th generation due to reduced reproduction.
Use of engineered viral insecticides offers several environmental benefits. The virus serves as an efficient dose delivery system in that no toxin is applied to the crop, only the toxin gene. Only in suitable insect hosts is the toxin gene expressed; when just enough toxin is produced to kill the host, the system shuts down. The AaIT toxin binds with high affinity to insect neurons, thus death is due to disruption of the nervous system rather than from massive viral infection. While crude scorpion venom does have effects on spiders, crustaceans and mice, the purified AaIT toxin protein does not. The toxin has no affinity to mammalian neurons, and neither the toxin nor the recombinant virus has any clinical effect on nontarget insects, rodents and beneficial species. Eventually, these data may help support a food use registration for similar viral pesticides.
More Options
Ciba-Geigy is working with a new class of insect control proteins
produced by Bacillus thuringiensis. Unlike the sporulation-specific
delta endotoxins found as crystals in Bt spores, Vegetative
Insecticidal Proteins are produced during log phase of growth and
secreted. Like the endotoxins, these novel proteins target midgut
epithelial cells, however they have a different activity spectrum.
The effort to discover and develop a wider array of insect control
proteins has dual benefits. If successful, it sidesteps the
increasingly litigious battle over rights to the various Cry genes.
From an environmental perspective, in broadening the biological
arsenal used to control insects, the threat of pests becoming
resistant to a single over-used compound is lessened.
Pat Traynor
Information Systems for Biotechnology
traynor@nbiap.biochem.vt.edu
In patent law, prior art is the information used to judge whether an invention is both novel and nonobvious. In other words, prior art provides a standard to determine if an invention meets the legal requirements of a patentable invention. The policy behind the criteria of novelty and nonobviousness is that a patent should not remove something from the public domain that either exists as the claimed invention or exists as an obvious variation of the claimed invention. Consequently, an invention is not patentable if it was placed in the public domain before a "critical date." In the United States, the critical date is the date of invention under 35 U.S.C. Section 102(a), or one year before the patent application filing date under 35 U.S.C. Section 102(b).
The present test for determining whether any disclosure is prior art focuses on the accessibility of information rather than on the form of the disclosed information. The Court of Appeals for the Federal Circuit has stated that public accessibility is the "touchstone" in determining whether a reference constitutes a "printed publication" form of prior art (1). Therefore, the fact that a reference is printed electronically, rather than on paper, is relevant to the prior art determination only to the extent that publication in an electronic form may affect public availability. There is little doubt that information posted on a web site is "effectively part of the public domain, impossible to retrieve" (2).
The bottom line is that the description of an invention in an Internet electronic publication will initiate the countdown toward the one-year statutory bar to a U.S. patent. At the same time, patent rights outside the U.S. may be destroyed at the time that an invention is disclosed in an electronic publication before filing a patent application. This is so, because the one-year "grace period" for publication under 35 U.S.C. Section 102(b) is unique to U.S. patent practice.
It is not possible to overemphasize the importance of knowing the exact date that an article will be published on the Internet. Science, for example, posts information online on the same day that the corresponding paper version is mailed to print subscribers. This electronic publication advances the effective publication date of disclosure since, under U.S. patent law, a paper journal is effective as prior art on the date that it reaches the addressee, not on the date of mailing (3).
Other online journals publish abstracts or full texts of articles weeks before the publication date of the paper journal. Under an enlightened editorial policy, Blood Cells, Molecules & Diseases informs researchers in its "Instructions to Authors" about the relative timing of Internet and paper publication. The journal also includes the Internet posting date on each paper article as the official date of publication. According to Dr. Ernest Beutler, the editor-in-chief of Blood Cells, Molecules & Diseases, the reason that his journal "adopted the practice of accurately dating all of our articles is precisely to establish priorities both from the point of view of scientific credit and from the point of view of establishing a date of dissemination of the intellectual property" (4). Unfortunately, not all online journals advertise their relative dates of electronic and paper publication, and it may be necessary to contact the editorial office of a journal to discover its publication policies.
Another form of electronic publication that can destroy patent rights is a nucleotide or amino acid sequence stored in a publicly accessible database. In fact, public access of such information can predate both electronic and paper publications of the relevant research report. Examiners in the European Patent Office have routinely cited as prior art nucleotide and amino acid sequences obtained from electronic databases. During the past year, it became clear that U.S. Patent Office examiners have enthusiastically adopted this practice as well.
In sum, the important point is that under patent law, "publication" means that information becomes publicly accessible regardless of the form of the information. With this thought in mind, an inventor can provide current information to further open scientific communication, while maintaining a flow of funding.
References:
(1) In re Hall, 228 USPQ 453, 455 (Fed. Cir. 1986).
(2) Religious Technology Center v. Lerma, 908 F.Supp. 1362, 1368
(E.D.Va. 1995).
(3) Carella v. Starlight Archery, 231 USPQ 644, 647 (Fed. Cir.
1986).
(4) Personal communication.
Phill Jones
Foley & Lardner, Madison, Wisconsin
pjones@foleylaw.com
2. Consumer concern resurfaced over the transfer of an allergen from Brazil nut to soybeans, resulting from the transfer of a gene between the two crops. This result was announced in 1994, and Pioneer Hybrid stopped further development of that line of soybeans. That this case made news in 1996 demonstrates the durability of the issue of allergens and gene transfer. It also poses an interesting question: should transferred genes be from sources regarded as highly allergenic (such as legumes), moderately allergenic, or weakly allergenic? At first, the use of weakly allergenic donor organisms seems the wiser choice. Some would argue that using highly allergenic sources has an advantage in that the allergenicity of the engineered crop can be easily tested. The obvious response, however, is that the potential to transfer genes encoding allergenic proteins is a recognized factor to be evaluated long before consumers ever see the product. In fact, the topic is explicitly addressed in the FDA's policy on biotech foods.
3. Another example that all news is not necessarily new was the announcement that a marker gene introduced into canola was transferred by pollen to weedy relatives. The observation confirmed that genes flow between canola and weedy relatives, a fact previously established using conventional marker genes from canola. However, the perceived risk and tightness of scrutiny applied to crops genetically engineered with one or two transgenes continues to be greater than that associated with new cultivars developed by wide crosses within a genus using conventional means.
4. While 1996 was not the first season genetically engineered commodity crops such as corn, soybeans, potatoes, and cotton were commercially grown, it will be remembered as the year that the issue of fungibility and biotechnology hit international trade and politics. The term fungibility roughly means that equivalent items can be substituted or interchanged in fulfillment of a contract. Does a person who agrees to purchase a metric ton of soybeans retain the right to refuse a shipment if it contains some soybeans that are genetically engineered? In October, groups in Europe and North America announced a boycott against transgenic commodities. However, in mid December the European Union announced that it would accept genetically engineered corn; in April the EU had approved import of genetically engineered soybeans.
Tom Zinnen
Biotechnology Education
University of Wisconsin Biotechnology Center and UW-Extension
zinnen@macc.wisc.edu
Thomashow's strategy has been to understand the process whereby plants exposed to low, non-freezing temperatures somehow learn to put up with subsequent freezing temperatures. For instance, cold-acclimated rye plants can survive temperatures of up to -3°C. The underlying reasons for this phenomenon appear to be complex, but it is known that cold acclimation is controlled by many genes and that cell membranes are particularly vulnerable to cold damage. Thomashow and colleagues have isolated many genes that are turned on during cold acclimation in Arabidopsis. One such gene is COR15a, which is speculated to have a role in freezing tolerance.
The Michigan State group developed transgenic Arabidopsis plants expressing the COR15a gene in a constitutive manner. In normal plants this gene is turned on only through cold acclimation, while the transgenic plants showed COR15a gene product in both cold acclimated and non-acclimated plants. Chloroplasts in leaves of transgenic plants showed reduced damage to freezing temperatures compared to those from the control plants. Further, in collaboration with Peter Steponkus and colleagues at Cornell University, it was found that protoplasts isolated from transgenic plants survived better at sub-zero temperatures (18% better survival at -6.5°C) than the controls.
Although the COR15a gene produces a chloroplast-targeted protein, the results indicate that the expression of the gene may also affect other cellular functions including improving the cryostability of the plasma membrane. The COR15a gene enhanced the freezing tolerance of chloroplasts in engineered plants by almost 2°C which was nearly one-third of the increase seen due to cold-acclimation. While this might not appear to be a large increase, a 2°C improvement in freeze tolerance could potentially benefit certain crop plants.
According to Thomashow, there are many more COR genes known to scientists. If introduced together into a plant, even more dramatic cold tolerance, especially at the whole plant level, may be achieved. Ongoing research in the Michigan State lab is striving to understand more about the intricacies of plant gene expression in response to freezing temperatures. This knowledge may empower scientists to develop crop plants which can brave the cold.
Reference:
(1) Artus, N. N. et al. 1996. Proc. Natl. Acad. Sci. 93: 13404-13409.
C. S. Prakash
Center for Plant Biotechnology Research
Tuskegee University
prakash@acd.tusk.edu
To achieve the ambitious goal of expanding the number of vaccines used globally, simpler and more economical methods of delivering them are needed. Edible plant vaccines hold promise as ideal candidates. Production of vaccines in plants would eliminate the expenses associated with maintaining the cold chain, purchasing needles and syringes, and training personnel. Additionally, it would eliminate the risk of contamination by animal pathogens. Researchers at the Boyce Thompson Institute for Plant Research have successfully expressed the E. coli heat-labile enterotoxin B-subunit in potato tubers and the Norwalk virus capsid protein in tobacco and potato. Enterotoxigenic E. coli causes acute diarrhea and Norwalk virus causes acute gastroenteritis in humans. Feeding of raw potato tubers expressing these proteins to mice resulted in the production of specific serum and gut mucosal antibodies. These studies demonstrate the feasibility of using transgenic plants as a safe vaccine production and delivery system.
One important point to consider with this approach is that the plant must be eaten raw in order to be effective, since cooking would destroy the antigen. Potatoes, which are not generally eaten raw, thus serve only as a model transgenic system. Bananas have been proposed as a more real-world delivery system, since bananas are more palatable to children and are a staple of many diets. Another group at Thomas Jefferson University is similarly exploring the use of transgenic tomatoes as a delivery system for rabies vaccines. Clearly the next step in the development of this technology is to demonstrate in the vaccinated animal the induction of a protective immunological response upon challenge with the appropriate pathogen. If this proves successful, then the efficacy of the procedure should be ready for testing in human preclinical trials.
References:
(1)McGarvey, P.B., J. Hammond, M.M. Dienelt, D.C. Hooper, Z.F. Fu, B.
Dietzschold, H. Koprowski, and F.H. Michaels. 1995. Bio/Technology
13:1484-1487.
(2)Mason, H.S., J.M. Ball, J.J. Shi, X. Jiang, M.K. Estes, and C.J.
Arntzen. 1996. Proc. Natl. Acad. Sci. USA 93:5335-5340.
Eric A. Wong
Department of Animal and Poultry Sciences
Virginia Tech
ewong@mail.vt.edu
Delivery and recombination systems need to get DNA stably integrated into germ cells. Transgenic arthropods have been reported following the direct injection of DNA into the haemocoel of a reproductive female using transposable element-based integration vectors. Microinjection of eggs has had some success, but is not practical where the egg is very small or has a hard shell, or where the insect bears live young. Newer techniques make use of Sindbis virus vectors, or change insect phenotype through the genetic alteration of an insect symbiont. There are additional strategies being developed such as the use of modified retroviruses that are likely to be successful as well. Recognition of transformed individuals relies on the presence of screenable markers. Here the options are expected to increase beyond the currently available traits such as eye color or expression of green fluorescent protein.
The most important point to be made is that limited solutions to all of the problems associated with making transgenic arthropods have been found. Although a transformation system is not yet available, i.e. an efficient, robust, reproducible and relatively simple method, it is clear that this is now just a matter of time.
David Andow (University of Minnesota) observed that given the imminent arrival of transformation systems, it is prudent to begin considering how the risks of transgenic insects and their release into the environment might be assessed. Understanding how risk will be assessed, particularly by regulatory agencies, can serve to guide researchers in the early stages of designing field test experiments. A number of models of risk assessment were discussed and the underlying assumptions of each model were articulated. Perhaps the most workable model considers the specifics of each organism and each release on a case-by-case basis, allowing specific questions to be addressed.
The regulatory view was presented in a talk prepared by Orrey Young (USDA/APHIS Transgenic Arthropod Team) and given by Ralph Stoakes (USDA/APHIS/PPQ Western Region). Although transgenic arthropod technology is still in the early phases of development APHIS has been proactive in addressing the issue of release by establishing a team of scientists who are ready to review applications for permits to take transgenic arthropods out of the laboratory.
While the rules and regulations under which permits will be evaluated is mandated by law, the mechanism scientists must employ to complete and submit permit applications is determined by APHIS. The arthropod team has taken a relatively new approach to this process by employing the internet. All applications for the release of transgenic arthropods are posted on the internet and are available for public and scientific scrutiny (http://www.aphis.usda.gov/bbep/bp/arthropod/). Comments and evaluations, solicited and unsolicited, are also posted. One goal of the arthropod team is to promote an interactive relationship with the scientists developing and using this technology and at the same time provide those with a concern for this technology an opportunity to be part of the review process.
Gerald Franz (FAO/IAEA, Siebersdorf, Austria) discussed a classic system of genetic control, the Sterile Insect Technique (SIT). This methodology uses ionizing radiation to sterilize insects which are then released to breed with natural populations. SIT is currently being used to control Medfly in Guatemala, Argentina and the Los Angeles region; up to one billion sterile Medflies are released worldwide per week. Other insects, such as tsetse fly on the island of Zanzibar and the New World Screwworm in Mexico, are also being controlled effectively using this method.
Medfly SIT could be improved with certain genetic improvements in the released flies. One simple improvement would be the incorporation of a gene that would permit the unambiguous identification of release individuals from wild individuals. Another improvement would be the incorporation of a gene or genes that would permit the elimination of females from mass-reared populations. Transgenic Medflies have been created using a transposable element called Minos and the transposable element Hermes looks equally promising. We can now seriously consider the development of Medfly strains that have the genotypes and phenotypes desired.
Frank Collins (Centers for Disease Control and Prevention) described initiatives to genetically control disease transmission by altering mosquitos so that they can no longer act as malaria vectors. Conversion of a mosquito (Aedes aegypti) from being vector competent to being vector incompetent by expressing a transgene has been demonstrated recently by Olson et al. These investigators used a Sindbis virus based expression system to transiently express an antisense RNA that interfered with Dengue virus replication. Although not permanently transformed, insects with the antisense RNA were no longer capable of transmitting Dengue. The Hermes transposable element was shown to have some potential to function in mosquitos but it has not been used to create a transgenic insect as yet. Permanent germline transformation is still not possible.
Frank Richards (Yale University), who also is interested in converting disease vectors, rather than eradicating them, described a unique strategy for achieving this goal. His group works with a blood-sucking fly (Rhodnius prolixus) which harbors a bacterial symbiont in its gut and which vectors trypanosomes (Trypanosoma cruzi), parasitic flagellates that cause Chagas' disease. The bacterial symbiont has been successfully engineered to express cercropin A, a natural insect defense protein that makes pores in membranes. When flies are cured of the naturally occurring symbiont and their gut repopulated with the genetically engineered strain, the insects lose their ability to harbor trypanosomes. Richards described the development of a formulation of these genetically altered symbionts, called CRUZIGUARD, which can be applied to the walls of houses. The product is nearing the field trial stage.
In his closing remarks, David O'Brochta emphasized that the routine use of insect biotechnology is not far off. Much of the effort in the immediate future will be to determine which of the various transformation or modification systems being developed will be most appropriate for particular insects and applications. The problem of identifying transgenic insects is still a pressing problem that will receive considerable attention in the short term. In the longer term the technology will be used in ways that are analogous to its uses in plant and animal breeding. This will involve the genetic improvement of honeybees and silkworms, disease resistance and product improving modifications. Finally, transgenic insects will be used for gene farming in which they serve as bioreactors for producing products of commercial interest. Insects may have advantages over using large mammals or plants under some conditions.
Pat Traynor
Information Systems for Biotechnology
traynor@nbiap.biochem.vt.edu
David O'Brochta
Center for Agricultural Biotechnology
University of Maryland
obrochta@mbisgi.umd.edu
One example of the resultant problems is the citation of Northrup King (NK, now called Novartis Seeds) for violations of FIFRA with regard to handling of transgenic corn under an EPA experimental use permit (EUP). An EUP allows limited pesticide production for the purpose of data collection during the product development phase. The specific violations were for selling and distributing (EPA lingo for importing) an unregistered plant-pesticide; failure to file a Notice of Arrival; and failure to register production facilities. Since provisions in FIFRA allow fines to be assessed on a per shipment basis, the resultant fine levied against NK was relatively substantial. While the EPA press release (3) suggested that EPA's purpose in taking enforcement action against NK was to ensure "that pesticides produced under new technologies do not pose any environmental or health risks," the violations, according to Dea Zimmerman, EPA Region 5, were purely technical, resulting from missing paperwork.
Some of the events surrounding the violations clearly were unique to NK; it appears that no other companies have had similar problems. In anticipation that registration of their Bt corn product would be accomplished by March 1996, NK prepared for entry into the marketplace by producing large amounts of hybrid seed in Chile. Registration was delayed, however, and the shipments arrived without a Notice of Arrival in violation of FIFRA. EPA invented a process specifically for transgenic plant- pesticides, called Plant Propagation Registration, which allows companies to increase seed production in anticipation of registration. Presumably, the violation charged to NK would not have occurred if the company had followed this procedure.
In August, 1996, NK received registration of its new product, i.e., the insecticidal protein and the genetic material needed to produce it. The pesticide label, which normally appears on a pesticide container, will remain in the registration file rather than be printed on seed bags. Instead, NK is required as a condition of registration to attach to the bags of hybrid seed a tag which states:
The tag will also state that glufosinate ammonium is not registered nor recommended for use on the corn even though the transgenic seed produces a protein which increases its tolerance to the herbicide. With the registration now in place, NK can move hybrid seed without the restrictions which led to the violations.
Under the present interpretation of FIFRA, facilities where the initial plant transformation is performed and where seeds of the transgenic inbred line are processed are considered by EPA to be pesticide production facilities and must be registered as such. EPA considers the inbred corn as the means to transfer the active ingredient (defined as the insecticidal protein and the genetic material required to produce it) to the end product, hybrid seed. However, EPA will not require registration of those facilities where transgenic hybrid seed is produced from inbred lines. The transgenic hybrid seed itself is considered to be a "treated article", and therefore is exempt from FIFRA, analogous to treated fenceposts. This exemption spares growers of Bt-corn from being regulated as pesticide producers and puts the primary weight of regulatory compliance on the registrant.
According to Phil Hutton, an EPA Product Manager, it has been easier for developers of transgenic plant-pesticides to understand the regulations if they have experience dealing with traditional pesticides. EPA is preparing a workshop on oversight of transgenic plant-pesticides for the seed industry. The eventual publication of the new rule, which has again been delayed several months, will provide much needed guidance to industry.
References:
(1) 1986. The coordinated framework for regulation of
biotechnology. Federal Register 51:23302-23393.
(2) 1994. Plant-pesticides subject to the Federal Insecticide,
Fungicide, and Rodenticide Act and the Federal Food, Drug, and
Cosmetic Act; Proposed policy; Notice. Federal Register 59:60495-
60547.
(3) EPA Region 5 Press Release. Nov. 4, 1996. EPA nets $162,500
for pesticide violations; first action of its kind under
pesticide law. No.96-OPA255.
Jan Klein
WDATCP-ARM
kleinja@wheel.datcp.state.wi.us
According to the statement accompanying its publication, the rule was designed to:
The core of the new rule, Appendix A, lists the select agents which are subject to the reporting requirement: 13 viruses, 7 bacteria, 3 rickettsiae, 1 fungus, and twelve toxins. Included in the list of toxins are aflatoxins, botulinum toxins, and ricin. Also subject to the rule are genetic elements from the select agents that contain a nucleic acid sequence(s) which, if inserted into an appropriate host system, are reasonably believed capable of producing disease or toxicosis. Appendix A also specifies exemptions to the rule.
Commercial suppliers of these select agents, as well as government agencies, universities, research institutions, individuals, and private companies that transfer or obtain these agents must register with HSS or with an organization authorized by HSS. Certified clinical laboratories that utilize these agents for diagnostic, reference, verification, or proficiency testing purposes are exempt from this rule. The rule allows assessment of a fee to cover the costs of the registration service. The fee structure has not yet been established, but registration could cost more than $1000, especially if a facility inspection is done. An anticipated result of the new rule is that many facilities will remove from inventory those select agents for which there is no current use.
The final rule was published in the Federal Register, October 24, 1996 (Vol.61 no.207). To request a registration packet, fax your name and address to the Office of Health and Safety at (404)639- 3236. For additional information, contact Dr. Jonathan Y. Richmond, Director, Office of Health and Safety, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop FO5, Atlanta, GA 30333; (404)639-2453.
The section of the report dedicated to agbiotech begins, "For the agbiotech sector, the handwriting may be on the wall." This prediction is driven by several facts. First is the consolidation that has taken place within the agbiotech sector, including DowElanco's investment in Mycogen and Monsanto's equity stakes in DeKalb Genetics, Agracetus, and Calgene. E&Y notes that Calgene was the agbiotech industry's flagship company, and now an agrochemical giant, Monsanto, is the key agbiotech company.
E&Y also refers to lower returns on investment in the agbiotech sector versus biopharmaceuticals as another obstacle to growth. They argue that consumers are willing to pay more for novel biotherapies than for novel seeds, despite the high cost of development that agbiotech companies also face. Lower returns on investment make it more difficult for agbiotech firms to entice venture capital and public equity investors. With relatively few agbiotech start-ups in the wings, E&Y states, "many people are wondering if the US agbiotech game is better played by large chemical and agricultural companies with deep pockets" (1).
The report goes on to say that the overall biotech industry in the US is getting more concentrated in the health care and supplier sectors, although this is not the case in Europe where there is a much more even distribution of companies across areas including therapeutics, industrial supply, agbiotech, and others. The agbiotech sector also makes up a much larger percentage of the biotech industry in Canada, as well. Results from a separate survey recently undertaken by E&Y's Toronto office show strong growth in the Canadian agrifood sector, while the percentage of firms in the health care sector has decreased to 55% down from about 67% two years ago. This is in contrast to the health care sector in the United States, that accounts for 87 percent of the biotech industry (2).
References:
(1) K.B. Lee and G.S. Burrill. 1996. Biotech 97: Alignment, The Eleventh Industry Annual Report. Ernst & Young, Palo Alto, CA.
(2) S. Yanchinski. 1996. Number of Canadian Biotech Firms Doubles in Last Two Years, to 250. Genetic Engineering News, 16(21):44.
William O. Bullock
Institute for Biotechnology Information, LLC
Research Triangle Park, NC
http://www.biotechinfo.com
TRENDS IN POTATO PRODUCTION: IMPACT OF TRANSGENIC VIRUS RESISTANCE
The products of agricultural biotechnology are said to accelerate
existing trends in the agricultural marketplace. The best known
example of this phenomenon is Monsanto's recombinant bovine
somatotropin which was accused of bankrupting small dairy farms
even before the product was approved for commercial distribution.
Thomas German and Steven Slack (University of Wisconsin-Madison)
suggest that entry into the marketplace of transgenic virus
resistant (VR) potatoes may also accelerate existing trends in
potato production. NatureMark, a subsidiary of Monsanto, plans to
have two types of virus resistant potatoes approved for
commercialization in 1998, with seed available in limited
quantities in 1999. NewLeaf Plus is a Russet Burbank variety with
resistance to potato leaf roll virus (PLRV) and to Colorado potato
beetle; NewLeaf Y will have resistance to potato virus Y (PVY) in
addition to beetle protection and will be available in three
varieties, Russet Burbank, Russet Norkotah, and Shepody.
German and Slack believe that the introduction of VR potatoes will accelerate the trend within potato production toward fewer and larger farms. They further point out that since a large investment of capital, time and market development is required to bring transgenic plants into the marketplace, their introduction is likely to take place on a large scale primarily, but not exclusively, in the private sector. The authors also suggest that the new varieties may contribute to the current trend towards vertical integration as potato producers enter into direct or exclusive contracts with cultivar owners. The authors envision a production scheme in which "the producers of transgenic cultivars will generate seed for distribution to contract seed growers who have contracts with commercial producers that in turn will have contracts with processors or other end users (who may or may not be owned by the same corporations)."
Aggressive marketing will help recoup the investment, but will likely have the side effect of reducing the use of some less strongly supported public and minor use varieties, thereby increasing homogenization of the system. Varietal patents and variety protection are also being used increasingly to help defray costs of development for traditionally derived cultivars as well as for transgenics.
The rate and level of adoption of transgenic VR lines will affect their overall impact on the potato industry. An immediate benefit to growers will be the lowering of virus reservoirs within a field. Additionally, VR plants will, in effect, be more tolerant to the presence of aphids which are the natural insect vectors of PLRV and PVY. As a result, less pesticide will need to be applied. On the other side of the equation, though, a build up of aphid populations in potato fields will likely be a concern for adjacent non- transgenic crops. According to Jennifer Feldman of NatureMark, use of the transgenic varieties by growers will be carefully controlled in order to manage the potential for development of resistance; it would be counterproductive to flood the market.
The transgenic VR potato varieties fit well within the current system of seed certification which was developed early in the century. Seed certification insures potato seed quality by setting standards for varietal purity and tolerances for viruses and other diseases. A recent trend has been to reduce the number of generations prior to release of seed to the commercial grower, resulting generally in increased vigor and less yield loss due to disease. The current standard inspection process within seed certification programs is expected to provide monitoring of VR potatoes to eliminate off types and detect any breakdown of resistance. In summary, German and Slack conclude that the "most significant changes anticipated from this new technology will likely occur as a result of continued homogenization and specialization within the industry."
Jan Klein
DATCP-ARM
kleinja@wheel.datcp.state.wi.us
The material in this News Report is compiled by NBIAP's Information Systems for Biotechnology, a joint project of USDA/CSREES and the Virginia Polytechnic Institute and State University. It does not necessarily reflect the views of the U.S. Department of Agriculture or of Virginia Tech. The News Report may be freely photocopied or otherwise distributed without charge. P.L. Traynor, Editor.
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