NBIAP NEWS REPORT July 1, 1993 FDA SEEKS ADDITIONAL COMMENTS ON LABELING ISSUES ARISING FROM GENETICALLY ENGINEERED FOODS July 27 is the deadline for submitting data and other information to the Food and Drug Administration concerning how foods derived from genetically engineered plants should be labeled. Such submissions were invited by the FDA in an announcement in the April 28 issues of the Federal Register, Vol. 58, No. 80, pp. 25837-25843. Written comments should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857. For information contact: James Maryanski, Center for Food Safety and Applied Nutrition (HFS-13), Food and Drug Administration, 200 C Street SW, Washington, DC 20204, telephone 202-205-4359. RISK ASSESSMENT RESEARCH GRANTS PROGRAM June 14 was the closing date for submission of proposals under the USDA's 1993 Risk Assessment Research Grants Program. Sixty research proposals were received and have been distributed for peer review. The Peer Review Panel will meet during the first week of August to select those proposals that will be recommended for funding. AN ECOLOGICAL APPROACH FOR DETERMINING THE RISK OF TRANSGENIC PLANTS In what could lead to a new method for determining the impact of transgenic plants on natural ecosystems, a group of British scientists has reported in the journal Nature on a unique three year study to test the invasive properties of oilseed rape, a plant from which canola oil is derived. Under the test protocol, the scientists sowed both genetically altered and unaltered seeds of oilseed rape in 12 natural habitats under a variety of ecological conditions in three widely separated areas of England and Scotland. Then, they compared their behavior for three growing seasons. Oilseed rape was chosen because it has wild relatives and its potential to colonize natural habitats has caused particular concern. In all, some 2,000 seeds were sown in the springs of 1990, 1991, and 1992. The sowing localities were in Cornwall in southwest England where winters are mild and the growing season starts early; in Berkshire in southeast England, where winters are cold and summers dry; and in Sutherland in northeast Scotland, where the growing season starts late and summer days are long. In each locality, four habitats typical of the region were selected for the test. Habitat conditions provided contrasts of sun and shade, wetness and dryness. In each habitat, seeds genetically modified with an antibiotic marker gene and for herbicide resistance and seeds which were unmodified were sown. Neither antibiotics nor herbicides were applied to the plots, since the purpose of the test was to determine if the process of genetic modification itself would give the plant an advantage. Within each habitat some sixteen different biological manipulations were carried out. They ranged from fencing to pesticide treatments. The object was to create growing conditions ranging from "extremely benign" to "extremely hostile" for both the modified and the unmodified plants. By measuring the germination rate of the seeds and the growth rate of the plants, the scientists found that under no set of conditions did the transgenic plants exhibit different rates of population growth from the unmodified ones. In short, genetic modification did not increase the invasive tendency of oilseed rape in any of the ecological characteristics measured. As Dr. Michael Crowley, one of the scientists who conducted the test, pointed out, the results are limited to the invasiveness of oilseed rape and cannot be extrapolated to apply to other crop species or genetic modifications. However, the test shows a way toward the development of testing procedures that can assess the ecological risks of any transgenic plant. Peter Kareiva, of the University of Washington, commented in Nature that the importance of the study comes not so much from its results, but from its scope and timeliness. The USDA has recently published guidelines for applications to deregulate transgenic plants. To accomplish this, firm evidence must be presented that the phenotype of the transgenic crop poses no greater risk than does the unmodified plant from which it is derived. The British study points to one possible way this can be realized. (Nature, June 17, 1993) HOW MUCH SCIENCE DO WE NEED? REPORT RECOMMENDS ALLOCATING FEDERAL R&D FUNDS IN SCIENCE ON BASIS OF COMPETITIVENESS OF FIELDS A committee of the National Academy of Sciences, the Institute of Medicine and the National Academy of Engineering has released a report titled, "Science, Technology, and the Federal Government: National Goals for a New Era" recommending that the federal government allocate its $70 billion science and technology research and development budget based upon evaluation of the competitiveness of the various science fields. Under the proposed system, a series of independent panels, staffed by experts in the fields of basic science would gauge where the U.S. stood compared with other countries. The panels could "judge where the most exciting and promising ideas were emerging, consider where the best new talent is located, and examine the comparative capabilities of research facilities or equipment," the report said. Competitive evaluations would also be made in the fields of applied technology. The competitiveness evaluations by the independent panels would be used either to increase or cut funds in the various areas. Overall, the report states that the U.S. should strive to remain "among the world leaders in all major areas of science," and be No. 1 in a selected number of fields. The U.S. should try to dominate those scientific fields that are important to such R&D intensive industries as microelectronics and biotechnology, according to the report. The report's recommendations are generally in line with the Clinton Administration view that the government should promote commercially useful technology and stay ahead of competitors. Dr. Phillip Griffiths, Chairman of the NAS Committee and Director of the Institute for Advanced Study at Princeton expressed the belief that the goal of being world leaders in several science areas and near the lead in all the major sciences, "in the short term could be met with current funding." The report is sure to provoke much positive and negative comment. (NY Times, June 22, 1993; Wall Street Journal) VIRTUAL REALITY AND BIOTECHNOLOGY To hasten the production of new drugs and therapies, biomedical researchers are utilizing computers in novel ways to replace lengthy biological experiments.A physicist at IBM has devised a system that uses chunks of computer code (automata) programmed to act like simple organisms. He's simulated some key parts of the human immune system in a mainframe computer so that immunologists can do more of their research with computer models. Some people call the computerized immune system "A-life" (artificial life). For the IBM A-life immune system, automata have been created that act like simple versions of the cells and molecules that help humans fight disease. The scale is, of course, far less elaborate than a real immune system and is only two dimensional. The National Institutes of Health is funding the IBM work and progress is being made on making movies of the model in action using a graphics computer. Meanwhile, scientists from Britain's York University and the drug firm Glaxo are developing a computer driven "virtual reality" technique for understanding the structure of molecules involved in disease and then designing drugs to block them. Wearing a headset with two tiny television screens giving a three dimensional effect, researchers have the illusion that they are actually working around inside a molecule. As they move, the computer redraws the image. A special glove can be used to reach out and grab parts of the molecule, twisting and flexing the structure to look at its makeup. However, the visualization is still relatively poor and present technology is being pushed to the limit. Computers are, and will continue to help in, keeping down the cost of developing new drugs. Computers produce relatively low- cost information that can help researchers decide whether or not to synthesize a compound. This information would otherwise require expensive laboratory research to obtain. (The foregoing was compiled by Jay H. Blowers.) IMPORTED BIOLOGICAL SPECIMENS NEED PERMITS TO ENTER THE UNITED STATES About 30 percent of all animal and plant material sent internationally to U.S. scientists is delayed or stopped because it lacks an import permit from the U.S. Department of Agriculture's Animal and Plant Health Inspection Service. "Scientists could spare themselves inconvenience and delays by applying in advance for import permits for materials of plant or animal origin," said Lonnie King, acting APHIS administrator. King said valuable or perishable specimens, cultures and tissues also could be expedited more easily through a U.S. Customs or USDA station if the proper USDA-APHIS import permit requirements are met in advance. Scientists intending to import animal or plant materials should contact the following permit units: -For the importation of biological materials of animal origin or derivation, contact the Import-Export Product Staff of APHIS' Veterinary Services program at (301) 436-7885. -For the importation of plant material or soil, contact the Permit Unit of APHIS' Plant Protection and Quarantine program at (301) 436-8645. -For the importation of genetically engineered plants or microorganisms, contact the Biotechnology Permit Staff of APHIS's Biotechnology, Biologics and Environmental Protection unit at (301) 436-7612. To write to any of the above offices, the address is USDA, APHIS, 6505 Belcrest Road, Hyattsville, Md. 20782. (Reprinted from APHIS News) NEWSLETTER UPDATE Freiberg Publishing invites readers to call for a free sample issue of the Biotech Reporter. Formerly Agbiotechnology News, the publication has been expanded to cover human medical, environmental, bioprocessing/food processing and related industries, as well as plant and animal areas. Freiberg Publishing has also started two additional newsletters, the Environmental Business Trendletter and the International Trade & Licensing Hot List. New technologies or tech transfer opportunities may be submitted to the Hot List by contacting Karol Wrage at 319-277-3599. For free samples of any of these publications, call 1-800-959- 3276 or fax 319-277-3783. RESEARCH UPDATE - ANIMALS AND ANIMAL HEALTH J. Glenn Songer, PhD, University of Arizona ANTIBODY TECHNOLOGY CONTINUES TO UNFOLD The introduction of monoclonal antibody technology in recent years led to rapid progress in many areas of scientific research and disease therapy. This progress has continued, and the time is drawing ever nearer when the production of monoclonal antibodies as recombinant gene products will become a practical reality. In the pharmaceutical field, the application of polymerase chain reaction (PCR) technology is allowing the development of therapeutics for use against a variety of medical conditions. There is particular hope for products that will be effective against viral infections such as human immunodeficiency virus, hepatitis B virus, herpes viruses, respiratory syncytial virus, parainfluenza viruses, cytomegalovirus, and rhinoviruses, and against systemic effects of infections by Gram-negative bacteria (Gram-negative sepsis). Recombinant monoclonal antibodies could also find use in modification of cellular responses (such as antibodies against cytokines for amelioration of the effects of acute inflammation). It is even conceptually possible to produce a molecule with multiple activities, one which can carry out several different "tasks." Antibody diversity in natural systems is based upon the variable region of the antibody molecule: a specific portion of an antigen, referred to as an epitope, is recognized by a specific variable region. With an understanding of the structure of a particular epitope, PCR can be employed to alter, or even construct from scratch, a gene giving rise to a recombinant monoclonal antibody -- actually a recombinant variable portion of an antibody -- with the characteristics necessary for specific interaction with the epitope of choice. The use of these variable portions of the antibody as a therapeutic has advantages over the use of intact monoclonal antibodies, in that they have a lesser tendency to give rise to a neutralizing immune response and are cleared from the body more rapidly. On the down side of this very promising field of endeavor are recent trials of monoclonal antibodies for therapy of Gram- negative sepsis: results have been disappointing, and have apparently had a strong negative impact on the fortunes of at least two biotechnology companies. A clinical trial of Centoxin (a monoclonal antibody directed against endotoxin, produced by Centocor, Malvern, PA) was halted in January because the death rate in a treatment group (a group of ill patients who did not have Gram-negative sepsis) was higher than in a control group. A large part of the potential significance of this finding is in the fact that treatment of patients suspected of having sepsis is often begun before a definitive diagnosis is made. Along with stopping the clinical trial, Centocor has removed Centoxin from the market in countries where it has been approved. Tests of another antisepsis product, Antril (developed to interfere with the activity of interleukin-1, and produced by Synergen, Boulder, CO) have also been disappointing. In the case of both Centocor and Synergen, these outcomes have been financially devastating, leading to drastic reductions in the value of company stock. DELIVERY OF FOREIGN ANTIGENS BY BACTERIA Delivery of a foreign antigen, or perhaps several antigens, by a bacterium has been proposed as a strategy for immunization of humans and domestic animals. Much research has been directed towards the development of mutant bacterial strains, called auxotrophs, which are unable to grow unless supplied with a particular nutrient (such as an amino acid). An example is the aro mutant strains of Salmonella sp., which cannot produce certain aromatic amino acids. The genes for important antigens - - which give rise to protective immune responses -- of pathogenic bacteria can be cloned and expressed in the Salmonella sp. nutritional mutants. When cultures of these recombinant mutants are introduced into a host (usually by the gastrointestinal route), multiplication is limited (due to lack of a readily available in vivo supply of the aromatic amino acid), but sufficient amounts of the protective antigen may be produced to yield a prophylactic immune response in the host. Recent work by scientists at a Melbourne laboratory of Australia's Commonwealth Scientific and Industrial Research Organization (CSIRO) has brought a new twist to the expression of foreign antigens in bacteria. Dr. Adrian Hodgson and co-workers produced a mutant of the bacterial pathogen of small ruminants, Corynebacterium pseudotuberculosis. The mutant is incapable of producing the organism's toxin and most important virulence factor, phospholipase D. When inoculated into sheep, this mutant establishes and multiplies briefly, but the infection quickly resolves. A large proportion of the sheep inoculated in this manner are immune to subsequent challenge with fully virulent strains of C. pseudotuberculosis. This is, in itself, an important advance, but further work has shown that this mutant may be useful in delivery of antigens for immunization against other infections, as well. Genes for protective antigens are cloned into a plasmid which is capable of replicating in C. pseudotuberculosis and then this recombinant plasmid is introduced into the mutant strain. Production of recombinant antigen has been demonstrated and trials are now underway to evaluate the usefulness of this technology in immunization of a variety of domestic animals. DEVELOPMENTS IN PRODUCTION AND USE OF TRANSGENIC ANIMALS Tissue plasminogen activator is a recent entry into the therapeutic regimen for victims of heart attacks. In many cases, this compound now replaces streptokinase (a natural product of bacteria of the genus Streptococcus) as a means for dissolving clots which occlude coronary arteries and often lead to death and degeneration of the surrounding cardiac muscle (referred to as myocardial infarction). In a new comparative study, recombinant tissue plasminogen activator (produced by Genentech) administered with intravenous anticoagulant reduced mortality in heart attack patients by nearly 15% over streptokinase and anticoagulant. A new development is the production of transgenic rabbits which express active tissue plasminogen activator in their milk. Although it remains a highly debatable topic, there is continued interest in DNA delivery by sperm cells. Use of DNA treated sperm for in vitro fertilization of mice has resulted in expression of foreign genes in a small proportion of offspring. The potential benefits of such technology are obvious and far- reaching. PUBLIC INTEREST IN BIOTECHNOLOGY INCREASES WITH SPOTLIGHTING OF FOOD SAFETY ISSUES Gerald Guest, former director of FDA's Center for Veterinary Medicine, spoke at the recent annual meeting of the Livestock Conservation Institute, pointing out that the future of drugs used in animal production -- and possibly in therapy -- may be modeled by experience with bovine somatotropin (BST). BST was deemed safe by the FDA, the American Health Institute, and the General Accounting Office. However, Jeremy Rifkin's "failed" lawsuit, which was based upon potential negative environmental impacts of BST, led to bans on this substance by Wisconsin, Vermont, and Minnesota. Dr. Guest stated that, in the future, there may be a public-mandated move away from use of drugs which are not for therapy but are rather used strictly to boost the economic value of a food animal or its products. UNCONVENTIONAL AGENTS OF HUMAN AND DOMESTIC ANIMAL DISEASE COMPLICATE PRODUCTION OF BIOTHERAPEUTICS The description and study over the past two decades of the agents of Creutzfeld-Jakob disease and Kuru in humans, and the continued study of bovine spongiform encephalopathy and scrapie in domestic ruminants, has led to interesting challenges for companies which manufacture biotherapeutic products of animal origin (Stiles GE. 1993. Unconventional viruses pose unique biotherapeutic production challenge. Genetic Engineering News 13: 7-8). The current putative problem with spongiform encephalopathy in British cattle has been well-publicized; less well-known are the reported possible contamination of human growth hormone with the agent of Creutzfeld-Jakob disease, and the apparent transfer of this agent from patient-to-patient as a result of failed sterilization of implements used during brain surgery. These disease-causing agents are not viruses, nor are they virus-like; the incubation period of the diseases they induce may be extended to months or years. No nucleic acids (DNA or RNA) are present, implying the direct reproduction of proteins, and the lack of immune response to infection greatly complicates diagnosis. Infection leads inescapably to death. The agents are highly resistant to inactivation by chemical or thermal means. These factors (low infectious dose, high attack and case fatality rates, resistance to traditional methods for sterilization) have led to extensive work to assess risks and to subsequently assure the quality of animal-derived biotherapeutic products. Validation of products has also necessitated work with animal models, since these agents cannot be cultivated in cell cultures. Overall, this promises to be a significant challenge to the industry for years to come, and solutions will come through work in the laboratory and on the farm, with changes in animal management practices. RESEARCH UPDATE - MICROBES AND PLANTS Charles Hagedorn, Ph.D., Virginia Polytechnic Institute & State University The recent report of plasmid DNA transfer between strains of fast-growing rhizobia in non-sterile soil has emphasized concerns over potential gene transfer from genetically engineered microorganisms to indigenous soil bacteria (Kinkle and Schmidt. 1991. Appl. Environ. Microbiol. 57:3264-3269). More recently, Kinkle et. al. (1993 Appl. Environ. Microbiol. 59:1762-1766) reported plasmid DNA transfer between slow-growing rhizobia in non-sterile soil, but not in plant nodules. In their report, the IncP plasmid r68.45, which carries several antibiotic resistance genes, and IncP plasmid pJP4, which contains genes for mercury resistance and 2,4-dichlorophenoxyacetic acid degradation, were evaluated for their ability to transfer to soil populations of rhizobia. Transfer of r68.45 was detected in nonsterile soil by using Bradyrhizobium japonicum USDA 123 as the plasmid donor and several Bradyrhizobium sp. strains as recipients. Plasmid transfer frequencies ranged up to 9.1 x 10-5 in soil amended with 0.1% soybean meal and were highest after 7 days with strain 3G4b4-RS as the recipient. Transconjugants were detected in 7 of 500 soybean nodules tested, but the absence of both parental strains in these nodules suggests that plasmid transfer had occurred in the soil, in the rhizosphere, or on the root surface. Transfer of degradative plasmid pJP4 was also evaluated in nonsterile soil by using B. japonicum USDA 438 as the plasmid donor and several Bradyrhizobium sp. strains as recipients. Plasmid pJP4 was transferred only when strains USDA 110-ARS and 3G4b4-RS were the recipients. The plasmid transfer frequency was highest for strain 3G4b4-RS (up to 7.4 x 10-6). Mercury additions to soil, ranging from 10 to 50 micrograms/gram of soil, did not affect population levels of parental strains or the plasmid transfer frequency. One of the major problems in research on the slow-growing rhizobia is the inability to readily differentiate between genetically related strains in the same serogroup cluster. Judd et. al. (1993 Appl. Environ. Microbiol. 59:1702-1708) demonstrated that repetitive extragenic palindromic [REP] and enterobacterial repetitive intergenic consensus [ERIC] sequences used in conjunction with the polymerase chain reaction technique (REP and ERIC PCR) provide an effective means of differentiating between and classifying genetically related Bradyrhizobium japonicum serocluster 123 strains. Analysis of REP and ERIC PCR- generated dendrograms indicated that this technique can effectively differentiate between closely related strains which were indistinguishable by other classification methods. To maximize the genomic differences detected by REP and ERIC PCR fingerprint patterns, the REP and the ERIC data sets were combined for statistical analyses. REP-plus-ERIC PCR fingerprints were also found to provide a method to differentiate between highly diverse strains of Bradyrhizobium spp., but they did not provide an effective means for classifying these strains because of the relatively low number of REP and ERIC consensus sequences found in some of the bradyrhizobia. Their results also suggest that there is a relationship between nodulation phenotypes and the distribution of REP and ERIC consensus sequences within the genomes of B. japonicum serogroup 123 and 127 strains. Results obtained by restriction fragment length polymorphism hybridization analyses were correlated with the phylogenetic classification of B. japonicum serocluster 123 strains obtained by using REP and ERIC PCR. Large areas of rangeland contain low pH soils that can reduce the productivity of forage legumes, such as subclover, that are acid tolerant and suitable for many rangeland conditions. Although acid tolerant rhizobial strains for subclover are relatively easy to isolate, these naturally occurring strains are usually of poor nitrogen-fixing effectiveness. An understanding of the genetics of acid tolerance may permit construction of superior strains effective at low pH levels. Chen et. al. (1993 Appl. Environ. Microbiol. 59:1798-1804) reported that acid-tolerant Rhizobium leguminosarum biovar trifolii ANU1173 was able to grow on laboratory media at a pH as low as 4.5. Transposon Tn5 mutagenesis was used to isolate mutants of strain ANU1173, which were unable to grow on media at a pH of less than 4.8. The acid-tolerant strain ANU1173 maintained a near-neutral intracellular pH when the external pH was as low as 4.5. In contrast, the acid-sensitive mutants AS25 and AS28 derived from ANU1173 had an acidic intracellular pH when the external pH was less than 5.5. The acid-sensitive R. leguminosarum biovar trifolii ANU794, which was comparatively more sensitive to low pH than mutants AS25 and AS28, showed a more acidic internal pH than the two mutants when the three strains were exposed to medium buffered at a pH of less than 5.5. The two acid-sensitive mutants had an increased membrane permeability to protons but did not change their proton extrusion activities. However, the acid-sensitive strain ANU794 exhibited both a higher membrane permeability to protons and a lower proton extrusion activity compared with the acid-tolerant strain ANU1173. DNA hybridization analysis showed that mutants AS25 and AS28 carried a single copy of Tn5 located in 13.7-kb (AS25) and 10.0-kb (AS28) EcoRI DNA fragments. The wild-type DNA sequences spanning the mutation sites of mutants AS25 and AS28 were cloned from genomic DNA of strain ANU1173. Transfer of these wild-type DNA sequences into corresponding Tn5-induced acid-sensitive mutants, respectively, restored the mutants to their acid tolerance phenotypes. Mapping studies showed that the AS25 locus was mapped to a 5.6-kb EcoRI-BamHI megaplasmid DNA fragment, while the AS28 locus was located in an 8.7-kb BG/II chromosomal DNA fragment. PATENT DEVELOPMENTS Virginia C. Bennett, Bell, Seltzer, Park & Gibson, Raleigh, NC A gene conferring male sterility in plants is disclosed in patent WO 9302197. This newly described DNA may optionally be coupled to a lytic enzyme gene which also confers male sterility. Disclosed in the patent are recombinant or isolated DNA encoding a callase (endo-1,3-beta-D-glucanase); antisense DNA encoding antisense RNA complementary to the newly described DNA; DNA encoding a ribozyme that cleaves RNA encoded by the new DNA; a microorganism host transfected or transformed with a vector containing the DNA; and a plant cell containing the new DNA. The DNA may also include a marker such as beta-glucuronidase, antibiotic resistance or herbicide resistance. Several recent patents disclose methods for producing transgenic plants. EP 522880 discloses a new nucleic acid isolate encoding flavonoid pathway enzymes which can be used to manipulate flower color. A method of producing a transgenic plant and the transgenic plant are also disclosed. EP 525508 discloses a method of combatting plant pathogens using a protein of Ustilago maydis (a fungus). Microorganisms and plants transformed with the DNA encoding the protein, and a method of producing a transgenic plant with disease resistance are also disclosed. WO 9301294 discloses DNA encoding the gene promoter for a subunit of glutathione-transferase, as well as a vector containing the DNA and a chemically switchable gene construct containing the DNA linked to foreign genes such that gene expression is controlled by the application of an exogenous inducer. US Patent No. 5,185,253 discloses a method for producing transgenic potato and tobacco plants resistant to infection by potato virus-x (PVX) and virus-Y (PVY). A double stranded DNA construct is inserted into the susceptible plant cell, where it encodes the coat proteins of PVX and PVY. Transformed plants capable of expressing the foreign coat protein genes are then regenerated from the transformed cells. The DNA construct contains a heterologous promoter, preferably a modified cauliflower-mosaic virus 35S promoter, joined to a structural gene encoding PVX and a second promoter joined to a structural gene encoding PVY. Alternatively, a single heterologous promoter may be joined to a fusion protein of the PVX and PVY genes. Two recent patents disclose recombinant vaccines useful against common fowl diseases. EP 522535 discloses a recombinant Marek-disease virus (MDV) obtained by the mutation of MDV with a plasmid. A multivalent live vaccine for birds and a vector for administration of a physiologically active substance to birds are also disclosed. WO 9301276 discloses a non-lymphoid continuous cell line capable of replicating Eimeria tenella. A recombinant antigen is produced by culturing the cell line, which is transfected with a recombinant DNA molecule capable of expressing the recombinant antigen. A vaccine comprising the antigen composition, for use in controlling fowl coccidiosis, is also disclosed. MORE JURASSIC PARK On the op-ed page of the New York Times for June 22, Carl Feldbaum, President of the Biotechnology Industry Organization (BIO), offers a good antidote by outlining the positive uses to which biotechnology is being put. Mr. Feldbaum points out that the industry has created 22 drugs to treat serious illnesses such as diabetes and heart disease and 130 new drugs are in the pipeline. Biotech companies are also working to produce more nutritious foods that will require less fertilizers, pesticides and herbicides. They are also working on genetically modified microorganisms that reduce toxic chemicals in the environment to biodegradable compounds. As Feldbaum notes, "the film does a disservice by leaving the impression that biotech research is done in a regulation-free world. In fact, the biotech industry acknowledges the need for responsible government regulation and companies work closely with government agencies to assure that regulation keeps pace with knowledge despite the fact that it's expensive and delays the availability of products. But the public has a right to know, to be reassured about safety and efficacy." PRINTED COPIES OF THE NEWS REPORT If you prefer the News Report in printed form, call Information Systems for Biotechnology at (703) 231-3747. Or, you may go to the Main Menu, leave a (C)omment for the SysOp giving us your address, and we will include you on the mailing list. **************************************************************** The material in this News Report is compiled by Information Systems for Biotechnology at the Virginia Polytechnic Institute and State University. It does not necessarily reflect the views of the U.S. Department of Agriculture. ****************************END*********************************