NBIAP NEWS REPORT 
                             June  1,  1993 
                                     
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REGULATORY UPDATE 
 
NOTIFICATION PROCEDURE FOR SIX TRANSGENIC CROPS IN EFFECT 
The USDA's Animal and Plant Health Inspection Service (APHIS) is
issuing a "User's Guide for Submitting Notifications" under the 
new rule that went into effect on April 30, 1993. The six
eligible crops are transgenic corn, cotton, potato, tobacco,
tomato and soybeans.
 
Some 52 field test permit applications which were pending with 
APHIS on 30 April have been approved for notification by APHIS 
These field tests can now go forward under the Notification 
rule without a permit.  Henceforth, notification letters must be
submitted 30 days before a planned introduction. APHIS must
approve or disapprove within that period.
 
The User's Guide contains sample Interstate Movement and Release
Notification, Release Notification, Interstate  Movement 
Notification and Importation Notification Letters.  It also 
contains instructions for submitting Confidential Business 
Information, Procedures for CBI Authorization by States, and 
comments on meeting the performance standards in 7 CFR 340. (c). 
 
In addition to calling for the standard information about the 
applicant, the duration of the introduction must be stated in the
Notification letter.  For release, the duration may be multi-year
and should be from the time of planting through the time of 
destruction of the final crop.  Each notification should refer to
only one recipient plant species such as corn or potatoes.  
Different cultivars may be submitted under the same notification. 

With respect to the Regulated Article (genetically modified 
plant), information requested includes designation of the 
transformed line, the category of modification, the phenotype and
genotype of each tranformant line, and a brief summary of the 
elements in the constructs and the organisms from which they were
derived. 

In general, a separate notification should be submitted for each
category/phenotype combination.  The method of transformation for
each transformed line should also be specified. The notification
must also contain a signed and dated  certification that the
regulated article will be introduced in accordance with the
eligibility criteria and the performance standards set forth in
the rule. 
 
The Notification Guidelines provide examples of protocols to be
followed to meet performance standards for shipping and 
planting transgenic corn, cotton, potato, tobacco, tomato and 
soybean plants.  The Guidelines point out that performance 
standards may be met by many protocols that are designed to meet
the needs of the individual circumstances.  It is suggested that
researchers seek additional guidance for individual circumstances
by consulting APHIS reports of workshops on safeguards for 
transgenic corn and potatoes; and consulting appropriate 
breeder's literature and breeder's practice on ensuring genetic 
isolation. 
 
For copies of the "User's Guide" contact:   
Arnold Foudin, PhD., Deputy Director Biotechnology Permits, 
Biotechnology, Biologics and Environmental Protection (BBEP), 
Room 850, Federal Bldg. 6505 Belcrest Road,  
Hyattsville, Md  20782.  Telephone:  301-436-7612. 
 
AGRICULTURAL BIOTECHNOLOGY RESEARCH ADVISORY COMMITTEE (ABRAC)
MEETING 
On June 29-30, 1993, the ABRAC will meet in the Board of 
Directors Room, Conference and Education Facility, North Carolina
Biotechnology Center, 15 T.W. Alexander Drive, Research Triangle
Park, North Carolina  27709-3547. 
 
The purpose of ABRAC is to review matters pertaining to 
agricultural biotechnology research and to develop advice for the
Secretary of Agriculture through the Assistant Secretary for 
Science and Education with respect to policies, programs, 
operations and activities associated with the conduct of 
agricultural biotechnology. 
 
Items to be considered at this meeting include activities of 
subcommittees working on transgenic animals, aquatic
biotechnology and environmental safety, and societal impacts of
food and agricultural biotechnology. 
 
For more information, contact Drs. Alvin Young or Daniel Jones,
Office of  Agricultural Biotechnology, Cooperative State Research
Service (CSRS), USDA, Room 1001, Rosslyn Plaza E, 14th Street and
Independence Ave., SW, Washington, DC  20520-2200.  Telephone 
703-235-4419. 
 
ARE COLLEGES OF AGRICULTURE IRRELEVANT? 
"For more than a century, the land-grant colleges of agriculture
helped ensure a bountiful food supply for the United States.  Now
the colleges' well-being and even survival are threatened." 
So began an article by James H. Meyer, Chancellor Emeritus of the
University of California at Davis in the Policy Forum section of
Science, 14 May 1993, pp. 881 and 1007.  

Entitled "The Stalemate in Food and Agricultural Research,
Teaching and Extension," Chancellor Meyer continued by pointing 
out that, in general, colleges of agriculture have stuck with
their agrarian tradition and have had difficulty adjusting to
changing social conditions, to modern urban and consumer
interests, and to the increasing interdependence of rural, urban,
and global communities. Because of this, the American public has
come to classify colleges of agriculture as irrelevant. 
 
The author notes that as early as 1966 a need to broaden the 
missions of colleges of agriculture was recognized by leaders 
from land grant universities.  Some progress was made in the 
intervening years in broadening the missions of teaching and 
extension.  However, in research, the traditional farm oriented 
view prevailed.  The major challenge was the "development of an 
agriculture that is economically viable, internationally 
competitive, and environmentally sensitive.  The relevance of 
agricultural research to social and environmental issues 
pertinent to human health and welfare was deemed less significant
than direct agricultural concerns." 
 
While some institutions have succeeded in adapting, many
colleges of agriculture are baffled by efforts to identify 
and address the challenges they confront.  Faculty may have 
developed an insular mentality, being apart rather than blending
with the mainstream of intellectual life of their institutions. 
The need for interdisciplinary, interdepartmental, and 
multidisciplinary research has increased to such an extent that a
new type of organization may be required. 
 
Chancellor Meyer poses the question, "if change is essential in 
order for land-grant colleges to remain relevant, from what 
institutions should leadership emanate?" 
 
Leaders of land-grant universities surveyed in 1992 downplayed 
the importance of federal government leadership and felt that 
leadership should come from within their own colleges.  Their 
viewpoint suggests that the time has come for colleges of 
agriculture to reduce their dependence on the U.S. Department of
Agriculture and other national organizations and to seize the 
opportunity to develop pertinent and rational missions that 
reflect their own teaching, research, and extension programs.  
"To achieve the desired results, ongoing consultation with urban,
environmental and consumer groups, in addition to the 
agricultural community, must be utilized.  Attention should focus
on the general topic of the human food and fiber system from 
production through consumption. Environmental quality ought to be
an integrating theme throughout, but each college should find its
own way to contribute, in keeping with its own regional 
circumstances." 
 
In sum, according to Chancellor Meyer, colleges of agriculture 
will need help in escaping from old ideas, which means escaping 
from old organizations built on the past.  A new sponsoring 
organization is needed to aid in this effort.  With a new 
intellectual foundation, and the future firmly in mind, then and
only then should a new national organization be instituted. 
 

The following article is excerpted from an article of the same
title which appeared in "Nature" for 6 May 1993, written by John
Maddox.

THE DARK SIDE OF MOLECULAR BIOLOGY 
The season of celebration of the fortieth anniversary of Watson 
and Crick's account of the structure of DNA, now past its peak, 
has been conducted with great restraint. 
 
Indeed, the research community's self-restraint may have been 
carried too far.  It has mostly been left to outsiders to remark
that knowledge of the structure of DNA has made possible and has
enforced a change of thinking about the nature of living things. 

Perhaps the most telling lesson of the past forty years has been
the recognition that very different forms of life are built 
around essentially similar molecular mechanisms.  All species are
discovered to have more in common with each other than their 
differences would suggest. 
 
The potential benefits are also huge.  A proper understanding of
the history of the surface of the earth is not the least of them. 
But it is also probably the case that, in molecular biology, the
gap between basic research and its application is smaller than in
any other field of technology.  That is why the imaginative 
imitation of life processes will bring great benefits to our 
successor generations. 
 
Two other features of this anniversary have not been 
sufficiently remarked upon.  One is the speed with which the 
revolution in biology has been effected.  It has also been 
remarkable that people who had not been born in 1953 have been 
conspicuous at the anniversary celebration.  That is not so much
a sign that molecular biology is a young person's game, but 
rather proof of how great a magnet for young people's enthusiasm
the structure of DNA has proved to be. 
 
So what can be amiss with a torrent of intellectual change as 
imaginative and potentially as beneficent as that represented by
the present condition of molecular biology? 
 
First, there is a somewhat technical point.  For all its 
success, molecular biology is still preoccupied with 
enumeration - the enumeration of the molecular components of 
cells and of the distinctive organisms to which they belong.  
This is the spirit in which people are now collecting the details
of new genes, and of new nucleotide sequences to go with them; 
new proteins and their amino-acid sequences; and novel membrane 
protein molecules, channels or receptors as they may be. 

That given that only forty years have passed, may be forgivable.
It is less easily defendable that the practitioners appear to 
think less deeply about the meaning of the present abundance of 
data than is the case in many other fields of science. 
 
The explanation of the unreflective state of molecular biology 
is easily accounted for by its third contemporary characteristic: 
competitiveness.  There can never have been a field of research 
in which the likelihood that people would make similar 
discoveries almost simultaneously has been as great.  The anxiety
to publish quickly, if unreflectively, is reinforced by the 
reward system in research, which links the award of research 
grants and promotion to people's publication records.  This is an
old diagnosis of other ills, of course, but it adds both tension
and anxiety to a field of science that would be different and 
perhaps even more fun, otherwise. 

ISSUES OF SAFETY IMPEDE DEVELOPMENT OF BIOPESTICIDES AND 
BIOREMEDIATION 
Concerns over the release into the environment of genetically
modified microorganisms remain a major obstacle to the use of
bioremediation and biopesticides. 
 
The Environmental Protection Agency (EPA) assesses safety risk in
terms of hazard-times-exposure and will only approve a release if
it can be shown that the risk is acceptable.  To do this, a great
deal of data is required to demonstrate that the risk is 
acceptable.  To date, EPA hasn't been able to define what those 
data should be. 
 
This lack of standards has hampered research in bioremediation
and biopesticide development. Current research emphasis is on the
use of natural organisms and bioreactors in which the
microorganisms are contained.  

One company, GX BioSystems Inc. is working on programmed killing
systems that eliminate microorganisms once they have done their
job.  The modified microorganisms are killed using lethal genes 
that are controlled by specific factors either present or absent
in the environment.  The company, for example, has developed an
organism that degrades toluene and dies after the toluene
concentration falls below a certain level.  Survival rates of
only one organisms out of 100 million have been documented, 
significantly reducing the risk of persistence in the environment
of the engineered microbe. 

In the meantime, DuPont Corporation has used natural soil 
bacteria to destroy chlorinated hydrocarbons in contaminated 
groundwater. TCE (trichloroethylene), a widely used degreaser and
a highly toxic carcinogen, is the most commonly encountered
pollutant at EPA Superfund sites across the country.
Unfortunately, there are no known bacteria that will use TCE as
their food source.  Bacteria to be deployed for bioremediation of
TCE must be fed on something else - toluene, phenol, methane or
ammonia.  One approach currently explored by Environgen Inc.
takes a structural gene from, for example, Pseudomonas mendicina,
removes the regulatory control and puts it into a host vector
system, allowing it to turn the gene on or off.  The genetically
engineered bacteria then produce a TCE-degrading enzyme while
being fed on glucose. 

The EPA views bioremediation as a technology with tremendous
potential for environmental improvement.  However, before this
potential can be realized, gaps in scientific knowledge must be
closed and more field experience and data acquired. 
(From The Bioremediation Report, April, 1993) 
 
CHEMICAL RESISTANCE GENES IN INSECTS IDENTIFIED 
Dr. Michael Rose, Associate Professor of Entomology at North 
Carolina State University, has identified the genes in 
cockroaches, tobacco aphids, tobacco budworms and Colorado potato
beetles which enable the insects to develop resistance to 
insecticides.  The resistance genes allow insects to alter the 
chemical makeup of an insecticide. 
 
In addition to helping researchers develop products to circumvent
insects' resistance ability, the resistance genes may have a 
future in bioremediation. Professor Rose has inserted the
resistance genes into bacteria where they continued to function
normally.  The next step could be to tailor bacteria specifically
to degrade a particular pesticide in soil or toxic byproducts
from manufacturing processes.  There are limits to the number of
chemicals that specific insect genes can degrade, but it appears
that a range of chemicals could be controlled.  Work is
continuing to identify more resistance genes in other insects. 
(From Biotech Daily, May 10, 1993) 
 
(The foregoing was compiled by Jay H. Blowers)

RESEARCH UPDATE - ANIMALS AND ANIMAL HEALTH
J. Glenn Songer, PhD, University of Arizona

BIOTECHNOLOGY IN PREVENTION AND CONTROL OF TROPICAL DISEASES
The  application of biotechnology to problems relating to
production of food animals in developing nations, particularly in
the tropics, has many potential benefits.  Among these are the
worldwide protection of livestock by combatting exotic diseases
in their countries of origin and the enhancement of food
production to lessen hunger and malnutrition.  Increased
productivity will come through improvements in basic nutrition,
breeding and efficiency of reproduction, and in methods for
diagnosis and prevention of disease.  For example, a recombinant,
vaccinia-virus based vaccine has been developed for prevention of
rinderpest, a fatal disease of cattle that occurs widely in Asia
and Africa (Yilma T.  1992.  The role of biotechnology in
tropical diseases.  In Williams JC, KM Kocan, and EPJ Gibbs, eds. 
Tropical Veterinary Medicine: Current Issues and Perspectives. 
Ann NY Acad Sci 653: 1-5).  Rinderpest is an acute viral disease,
in which affected animals develop hemorrhagic inflammation and
necrosis of the intestinal tract, with bloody diarrhea, rapid
weight loss, and death.  

Although there is an effective, tissue-culture prepared vaccine
for rinderpest, there are many problems with its production and
use in the field, including transport, lack of refrigeration, and
lack of a simple system for administration.  The recombinant
product, on the other hand, can be freeze-dried, abating problems
with transportation and handling, and can be administered
effectively to scarified skin.  The vaccinia virus strain used to
prepare the vaccine is attenuated, in part by natural means and
also by inactivation of the viral thymidine kinase gene by
genetic engineering methods.  Vaccination of cattle with this
recombinant vaccine results in a high level of immunity,
affording protection against test inoculations of 1000 times the
lethal dose of rinderpest virus.  The methods for field
production and administration of the vaccine are similar to those
developed and refined during the worldwide campaign to eradicate
smallpox.  The results of this work are encouraging, both in the
promise for control of rinderpest and in the suggestion that
other diseases can be attacked by similar methods.

APPLICATION OF BIOTECHNOLOGY TO CONTROL OF TICKBORNE DISEASES
New molecular diagnostic methods are having an impact on the
study of tickborne hemoparasitic diseases, including
anaplasmosis, bovine babesiosis, cowdriosis, and theileriosis
(Stiller D.  1992.  Biotechnology: A new approach to the
diagnosis and control of tick-borne hemoparasitic diseases.  In
Williams JC, KM Kocan, and EPJ Gibbs, eds.  Tropical Veterinary
Medicine: Current Issues and Perspectives.  Ann NY Acad Sci 653:
19-25).  In many cases, these parasites can now be identified in
either the animal host or the arthropod vector, by use of DNA
probes.  

To be truly effective, these probes must be sensitive (detecting
the parasite even when present in small numbers) and specific
(distinguishing between the parasite of interest and other,
perhaps closely-related, organisms).  Use of the polymerase chain
reaction can yield added sensitivity, in that target DNA
sequences can be amplified many thousands of times.  The
potential importance of such tools should not be underestimated,
in that they may allow the determination of numbers of parasites
present in infected ticks and animal hosts.  In fact, it may even
be possible, through use of DNA probes and examination of
restriction fragment length polymorphisms, to readily identify
ticks to the species level.  This, and perhaps other information
derived through use of these tools, will allow redefinition of
the epidemiology of at least some tickborne diseases and, as a
consequence, the formulation of more effective means for their
control.

In related work, scientists at Washington State University and
the Kimron Veterinary Institute in Bet Dagan, Israel, are
applying molecular methods to prevention of hemoparasitic
diseases.  Drs. Guy Palmer and T.F. McElwain at WSU and E. Pipano
and V. Shkap in Israel (along with other collaborators at both
institutions) are involved in projects on babesiosis and
anaplasmosis, both of which are aimed at development of a subunit
vaccine based on recombinant DNA methodology.

INCREASED USE OF NUCLEIC ACID PROBES IN AQUATIC BACTERIOLOGY
A recent report details the application of nucleic acid probes to
detection of pathogens in aquatic systems, particularly as this
pertains to diagnosis of disease in aquatic animals and to
recognition of points where human pathogens are concentrated in
these animals or in their environments (Vivar‚s CP and J-L
Guesdon.  1992.  Nucleic acid probes in aquatic bacteriology. 
Aquaculture 107: 147-154).  These methods have been used for
comparison of different strains of pathogenic bacteria from fish
(Cytophaga psychrophila from rainbow trout) and to identify
serovars of Yersinia ruckeri.  Classification of vibrios from the
marine environment as Vibrio vulnificus, and detection of
Edwardsiella ictaluri in channel catfish, have also been
accomplished by hybridization-based methods.  Use of unique
sequences in the 16S ribosomal RNAs of fish pathogens to detect
these organisms has also been successful, specifically in the
case of Vibrio anguillarum.  Application of this technology to
protection of human health from pathogens that may accumulate in
the aquatic environment are highlighted by the use of specific
probes to detect the gene for cholera toxin in isolates of Vibrio
cholerae.  Similar applications have been made in studies of
Salmonella sp., and detection of the development of mercury
tolerance in aquatic microorganisms has also been accomplished.

SIMPLIFIED DIAGNOSIS OF FREEMARTINISM IN CATTLE
In cattle, nearly all female calves having a male twin, referred
to as freemartins, are infertile.  Traditionally diagnosed by
culturing white blood cells and examining them for sex chromosome
chimerism, a polymerase chain reaction (PCR)-based method has
been developed to allow rapid, simple, and sensitive detection of
the XX and XY white cells in peripheral blood (Schellander K, J
Peli, TA Taha, E Kopp and B Mayr.  1992.  Diagnosis of bovine
freemartinism by the polymerase chain reaction method.  Animal
Genetics 23: 549-551).  The ZFY/ZFX fragment, from male and
female DNA on the X and Y chromosomes, is amplified and the PCR
product is digested with a restriction enzyme.  Difference in the
fragments generated by this digestion allow distinction between
the sexes.  Cells containing the Y chromosome can be detected in
a population consisting largely of female cells.  

DETECTION OF MYCOPLASMA IOWAE INFECTIONS 
Mycoplasma iowae is a significant cause of embryo mortality in
turkeys; it is transmitted transovarially by carriers which are
often asymptomatic. Loss of as little as three-to-five percent of
a hatch can be economically crippling to a producer.  Joint
studies conducted by researchers in the US (Drs. Mark Jackwood
and Stan Kleven of the University of Georgia) and Israel (Dr. S.
Levisohn of the Kimron Veterinary Institute, Bet Dagan) may
produce diagnostic methods which will allow control of the
disease by elimination of carrier birds.  The cooperative
approach will include development of methods for detection of
antimycoplasmal antibodies in infected birds, using specific
antigens purified from M. iowae; the workers are at present
evaluating various easily-obtained samples (including egg yolk)
for usefulness as diagnostic specimens.  A second approach to
detection of M. iowae is the use of a PCR-based method.  A two-
tiered system may be the most useful, in which breeder flocks are
cleared of disease through diagnosis by the PCR-based method and
are then monitored regularly by the less-expensive serologic
method (BARD Newsletter 12: 2-3, 1992).  
 

AGRICULTURAL BIOTECHNOLOGY NOTES  
Mark D. Dibner, Ph.D., Director, Institute for Biotechnology
Information, North Carolina Biotechnology Center

In a review of the literature related to commercial biotechnology
in agriculture and the environment, two interesting articles 
deserve mention. (numbers in parentheses refer to the article
number in the literature database {Door 6} on the NBIAP bulletin
board).  The first article describes how the United States is
helping to fund the Vavilov Plant Industry Institute, a seed bank
said to represent more than 10 percent of the earth's cultivated
plant life.  Due to budget crises in the Soviet Union, this
Institute was in dire financial straits, but USDA has implemented
a rescue plan of some $1.5 million, much of which will come from
the U.S. Agency for International Development.  The plan calls
for support of modernizing the Institute's ability to track data
(with 10 new personal computers and a USDA computer specialist). 
With this support, the valuable resources of the Vavilov
Institute are now likely to be preserved. (8271).

Another article points to the importance of agricultural
biotechnology to put food on tables in developing countries. 
Populations in these countries make up 70% of the Earth's
population, but this will grow to 90% within a generation. 
According to the World Bank, food production in these countries
will need to double in the next 25 years.  The funding for
research, development and its implementation in agricultural
biotechnology will need to come from government and private
foundations, such as the U.S. Agency for International
Development.  In the last 10 years, the World Bank and other
groups have spent $180 million towards this end, and, since 1985,
the Rockefeller Foundation has added another $50 million.  This
has allowed countries such as Thailand and the People's Republic
of China to make advances in developing new strains of rice.  The
next step is transferral of the technology from R&D to the market
and thus to the people. (8252) 

FORUM 
On the eve of 'Jurassic Park' many in the industry are waiting
for the other shoe to drop.  Jurassic Park is not the first major
motion picture to involve biotechnology or have biotechnology
gone astray.  It will easily be the most publicized film of this
type, though.  Based upon a novel of the same title by Michael
Crichton, the premise of the book and movie is that dinosaur DNA
extracted from mesozoic era insects which had bitten the animals
and then were entombed in amber, can be used to recreate living
dinosaurs for a modern day theme park.

A recent assessment by the communications group of the IBA
concluded that the movie will be viewed not as a genetic
engineering picture, but as a picture about dinosaurs.  Indeed,
Michael Crichton, Jurassic Park's Author, has been quoted as
saying, "People will not come away from the movie of 'Jurassic
Park' with a fear of biotechnology.  They will have a fear of
dinosaurs."  Jurassic Park will likely be viewed as
entertainment. 

Still, we have to wait and see.  Much has already been written
about the movie and its potential effects on the biotechnology
industry as evidenced by articles in the Wall St. Journal
(2/10/93), The NY Times (5/11/93) and many industry dailies,
weeklies and monthlies.  The headline of the NY Times article,
"Scientists Fret About 'Jurassic Park' Message," is particularly
revealing.     

Our message should be a recognition that the American public is
undereducated about biotechnology.  And ignorance about a subject
can lead to unsubstantiated fears.  Recently, in a class of 33
MBA students at Duke University, less than one-third of the
students felt they knew the meaning of recombinant DNA or genetic
engineering;  half of these 10 worked in the biotechnology,
pharmaceutical or related fields.  If these results are any
indication, only 20% of MBA students had picked up an
understanding of the meaning of biotechnology.    

Public education about new technology is essential if we are
going to combat irrational fears that could be spawned by a movie
about dinosaurs.  Only recently has the biotechnology industry
alerted itself to the fact that it must improve public
understanding and perception of biotechnology.  The recently
merged Biotechnology Industry Organization (BIO) has vowed
increased spending on these activities and a focus on its
education committee activities. 


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