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Originally Processed With FOIA(s):
FOIA Number:
2005-0336-F
2005-0336-F
FOIA
MARKER
This is not a textual record. This is used as an
administrative marker by the George Bush Presidential
Library Staff.
Record Group/Collection:
George H.W. Bush Presidential Records
Collection/Office of Origin:
Science and Technology Policy, Office of (OSTP)
Series:
Bromley, D. Allan, Files
Subseries:
General Science Files
OA/ID Number:
62038
Folder ID Number:
62038-006
Folder Title:
Life Sciences: General [2 of 7] [1992]
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"Document Control for Division of Life Sciences"
TYPE:
ACTION
DOCUMENT NUMBER: 9203561
ORIGINATOR: 02
STATUS I
DIRECTORATE STATUS C
FROM:
GALAS, David J.: U.S. DEPARTMENT OF ENERGY
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 12/04/92
SUBJECT: HE IS CONCERNED ABOUT THE DECISION WITHIN THE
DEPARTMENT OF COMMERCE THAT AFFECTS THE
BIOTECHNOLOGY RESEARCH BUDGET.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED: D.A. Henderson
ACTION
STAFF
REQUIRED: FOR DAB'S SIGNATURE
ACTION: Bromley Signature
SENDER'S DUE DATE:
OSTP DUE DATE:
12/23/92
STAFF DUE DATE
12/23/92
DATE COMPLETED:
DATE COMPLETED/DEPT: 12/30/92
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS: Per D.A. Henderson, no reply is necessary.
OSTP RECEIVED: 12/07/92
DEPT RECEIVED: 12/18/92
FILE: P-LIFE SCIENCES
CENTRAL FILES:
ARTMENT
OF
ENERGY STATES OF
Department of Energy
Washington, DC 20585
December 4, 1992
Dr. D. Allan Bromley
Director
Office of Science and Technology Policy
Washington, D.C. 20506
Dear Dr. Bromley:
I am writing to express my concern over a recent budget decision within the
Department of Commerce (DOC) that affects the biotechnology research budget.
It is reasonably clear that the Biotechnology Research Initiative will be
damaged by this decision, which is therefore of concern to you. It is
unclear to me what can be done at this point, but I thought it important to
raise the issue, and ask for your help and advice in moving towards a
solution.
The National Oceanic and Atmospheric Administration (NOAA) originally
proposed a major initiative in marine biotechnology for FY 1994, totaling
$10 million. The initiative came out of NOAA's National Sea Grant Office and
focusses on four issues:
0
development of industrial materials and processes,
0
development of aquacultural technology,
0
development and improvement of seafood technology, and
0
improvement of fisheries science and management.
These are all important issues and each promises to make the U.S. more
competitive in this important and rapidly growing area of biotechnology --
born in the U.S. and now being dominated by Scandinavia and Asia -- marine
biotechnology. This NOAA initiative is in the spirit of the Biotechnology
Research Initiative, and has been endorsed by the Biotechnology Research
Subcommittee (BRS) process.
As you recall, the BRS is currently conducting an outside review of the
Biotechnology Initiative. Based on the response to date, there is a strong
sense that we are about to miss a major area of opportunity by not adequately
supporting marine biotechnology research. Marine biotechnology is perceived
as a critical area by academia, industry, and other nations of the world.
The DOC has just recently made the decision to go with a partial version of
the NOAA initiative in marine biotechnology, at a reduced level of
$3 million, but to completely exclude Sea Grant from the funding. The impact
of the decision is to shift the funds to the National Marine Fisheries
Service where most of the new funds will be used to hire personnel working on
fisheries' issues. While I am sure these are significant issues, we cannot
consider this alternative as a valid part of the Biotechnology Initiative.
This decision does not seem to be in the spirit of the FCCSET process, and it
will not advance marine biotechnology research efforts.
The National Sea Grant College Program has been a lead agency in marine
biotechnology research since the early 1970's. All of their research support
goes to academic institutions and must be matched 50 percent with non-Federal
funds. I have to agree with the initial Sea Grant proposal that marine
biotechnology research would best be served by placing primary responsibility
for the marine biotechnology initiative in the DOC with Sea Grant.
I enclose a copy of the documents describing the initiative, and I would be
happy to discuss this matter with you further.
Sincerely,
David J. Galas
Associate Director for Health
and Environmental Research
Office of Energy Research
Enclosures
FY 1994 Budget Initiative
Marine Biotechnology
For
Economic Development
Develop Industrial Materials and Processes
Develop Aquacultural Technology
Develop and Improve Seafood Technology
Improve Fisheries Science and Management
National Oceanic and Atmospheric Administration
U.S. Department of Commerce
FY 1994 Budget Initiative
Marine Biotechnology
For
Economic Development
Develop Industrial Materials and Processes
Develop Aquacultural Technology
Develop and Improve Seafood Technology
Improve Fisheries Science and Management
National Oceanic and Atmospheric Administration
U.S. Department of Commerce
Overview of the Initiative
What are the Issues?
Industrial Products and Processes. The majority of plant and invertebrate phyla
on Earth are exclusively or predominantly marine. These plants and animals as
well as marine microorganisms often exhibit processes and produce substances
with no terrestrial counterparts. Some of these processes and materials are of
proven or potential importance in industry, but in general little is known about
them. Biopolymers, enzymes, hormones, pigments, pharmaceuticals, and
pesticides are among the chemical materials of interest. For example, annual
U.S. trade in marine algal polymers is over $200 million. Bioprocessing and
detoxification of effluents and waste materials are among the ways in which
the biochemistry of marine organisms, especially microorganisms, can be
exploited. The research community worldwide is recognizing the importance
of marine organisms as sources of models for industrial materials and new
approaches to industrial processing. Japan's aggressive program in marine
biotechnology has developed an algal strain that produces large amounts of an
industrial enzyme, superoxide dismutase. The annual international market for
this kind of enzyme is $700 million. A NOAA initiative in research will
contribute to the scientific basis and technology for new metabolic products of
commercial significance, for producing bio-materials in controlled systems, and
for using marine organisms or their components in industrial processing.
Aquacultural Technology. Foreign aquacultured products continue to invade
domestic markets and the annual U.S. deficit in seafood trade stands at $2.4
billion. Improved biological and engineering technology and fish strains
enhanced for culture in controlled systems will enable the United States to
improve its trade position in seafood, to protect fisheries through market
substitution of aquacultural products, and to enhance natural stocks with
hatchery-produced animals. International competition in this field is intense,
especially in Scandinavia and Asia. Aquaculture in China now provides 50% of
its aquatic protein. Norwegian salmon farming employs 100,000 people and
generates $750 million at the farm gate. NOAA research will provide
technology for regulating reproduction, growth and development of aquacultural
species; DNA technology for enhancing their growth characteristics; and
engineering technology for production in closed systems and at off-shore sites
in order to make the U.S. competitive in this growing field.
Seafood Technology. Seafood processors are facing increasingly stringent
requirements for managing wastes and effluents from their plants. These
requirements often exceed the ability of standard technology in the seafood
industry or require expensive modifications in these plants. Numerous plants
Marine Biotechnology
are closing rather than acceding to the requirements. Current technology
frequently allows seafood quality to deteriorate to undesirable leveis as it
moves from processor to consumer. Seafood contaminated with bacteria and
viruses moves in many marketing channels. Foreign and domestic seafood
processors, importers, and exporters perpetrate economic fraud by selling one
fish species as another. Current technology does not allow such substitutions
to be easily pinpointed. Advancements and applications in biotechnology are
needed through research for improving and assessing seafood quality and
safety, providing economic methods for recovering byproducts and treating
wastes and effluents in seafood processing, and preventing fraud in seafood
marketing.
Fisheries Science and Management. Many fish stocks are not managed
optimally in part because conventional meristic techniques are incapable of
identifying and separating regional fish stocks. In addition, the environmental
perturbations, including fishing, that regulate the size and rate of growth of
populations are poorly understood. Molecular technology has the potential to
provide methods for assessing genetic changes resulting from environmental
perturbations, including fishing; defining and assessing fish populations for
management purposes; and defining and sorting ecological parameters affecting
size of populations; and determining the degree of genetic diversity within
species groups.
What Actions are Proposed?
NOAA is proposing research and development of biotechnology that will
enhance economic development and fisheries management. Focused research
in the following seven categories will be conducted:
Molecular genetics and genetic diversity - identify unique genetic codes that
may form the basis for commercial technology; develop genetic engineering
technology for aquatic plants, animals, and microorganisms useful in
biotechnology, including aquaculture; determine diversity in fish stocks.
Growth and production of aquatic species - improve survival of commercial
species under controlled conditions, especially closed and off-shore aquacultural
systems; develop technology to prevent and treat diseases and to control and
synchronize reproductive and growth cycles.
Bio-organic chemistrv and pharmacology - identify novel marine substances as
models for new types of biopolymers, enzymes, pigments, pharmaceuticals,
hormones and pesticides; define related biosynthetic pathways; determine
natural function and mechanism of action of novel bioactive compounds; define
chemical and physical properties and develop production technology.
Cell culture, bioreaction, and bioprocessing - develop techniques for culturing
2
Marine Biotechnology
cells and tissues as a basis for mass production of useful natural chemicals;
develop technology for catalyzing industrial reactions and for producing
industrial materials; determine factors that control production of useful
metabolites.
Technology for seafood processing and other water-dependent industries -
develop new technology, biological processes, and by-products for controlling
wastes, detoxifying effluents, and reducing solutes in waste water; improve
technology for producing safe and high quality seafood.
Fish species and stocks improve fisheries management by developing better
tools for defining distinct fish populations and for assessing genetic changes in
stocks that result from environmental perturbations and heavy fishing.
Recruitment processes and ecological relationships - improve fisheries
management and yield forecasts by applying molecular techniques to defining
and sorting variables that control trophic structures and affect the size and
dynamics of fish populations.
What Will be the Impact on the Problem?
This program of research will make it possible to (1) rebuild fisheries and
make more resources available to the fishing industry by enhancing natural
stocks with hatchery produced animals and by substituting aquacultured
animals in the marketplace for those from over-fished stocks, (2) improve the
balance of trade in seafood by producing more product domestically through
aquaculture and by developing byproducts, (3) upgrade the seafood processing
industry by improving product quality and safety and through better
technology, and by better handling wastes and effluents, and (4) increase U.S.
competitiveness in high technology.
In regard to competitiveness, NOAA research has shown marine organisms to
be rich sources of anti-inflammatory metabolites, some of which are under
commercial development. The annual world-wide market for a new anti-
inflammatory drug has been estimated at $2 billion. Obviously, the potential
economic importance of even a single chemical product can be enormous. The
Japanese Ministry of International Trade and Industry (MITI) as part of its
emphasis on developing bio-industries also is emphasizing marine
biotechnology. One of the primary goals of this Japanese effort is the
"industrial utilization of marine organisms" and providing the basis for new
industries in the 21st century. This is being done in part through a new Marine
Biotechnology Institute whose objective is to be the first full-scale marine
biotechnology research and development base, not only nationally, but globally.
It is based on the premise that marine biotechnology is the "greatest remaining
technological and industrial frontier."
3
Marine Biotechnology
Why Now?
The United States, and NOAA, must make an immediate commitment to
advance state-of-the-art technology to ensure wise use and conservation of
living marine resources and competitiveness in the aquaculture and
biotechnology industries, and national health. The White House has identified
biotechnology as one of five topics of special focus for a proposed Presidential
budget initiative. The corresponding report of the Federal Coordinating
Council for Science, Engineering, and Technology, "Biotechnology for the
21st Century," identifies marine biotechnology as a topic for special
attention, and recognizes NOAA as a primary player in this field.
However, it shows the federal government's investment in marine
biotechnology to be quite low. For example, a report of the National Academy
of Sciences (in preparation) will recommend increased attention on research to
develop and improve aquaculture in closed systems and at offshore locations.
Living marine resources contribute significantly to the U.S. and world
economics, and they have the potential for much more. Improvements in
biotechnologies for fisheries science will enhance the regulation, management,
and productively of fisheries.
Living marine resources already contribute significantly to the U.S. and world
economies. For example, U.S. trade in algal products such as carrageenan and
alginic acids totals several $100 million annually. Marine resources have the
potential to contribute much more to the national economy. Science needs to
provide (1) technology for ensuring harvest of fishes at high and sustainable
levels, (2) efficient and progressive technology for producing and marketing
safe seafood, (4) the basis for new approaches to producing food, feed, and
industrial materials and processes in an increasingly technological and
competitive world, as well as (4) human resources for application of
biotechnology in industry.
Among the key needs are the following:
technology for assessing genetic diversity and manipulating the genetic
characteristics of marine plants, animals, and microorganisms,
technology for the mass culture of food species in closed and off-shore
aquacultural systems,
methods for diagnosis and control of disease in aquacultural species,
technology for control of reproductive cycles of aquacultural species,
technology for use of single-celled organisms and cells of higher organisms
4
Marine Biotechnology
in bioreactors for production or chemical products,
defining biosynthetic pathways for marine biopolymers and other
biochemicals of interest to the chemical industry,
technology for controlling the production of metabolic products, and
defining the mechanism of action and natural function of potential new
model compounds for the drug and agrichemical industries.
technology for waste management and byproduct recovery in seafood
processing and other water dependent industries, and for maintaining quality
and safety of seafood,
technology for precisely discriminating between fish species and strains,
methods for defining ecological relationships among fishes and prey
important to defining management strategies in fisheries,
What is Being Done Now?
The National Marine Fisheries Service and the National Sea Grant College
Program conduct research that addresses some of the key issues. Advances in
this research are encouraging. They have resulted in industrial investment and
development at significant levels and improved our understanding of
parameters controlling fish populations. (See Appendix I on page 17 for
examples.)
The National Sea Grant College Program through its 29 coastal and Great
Lakes programs conducts aquacultural research in molecular genetics and
selective breeding, physiology and endocrinology, nutrition, and pathology.
This research focuses primarily on penaeid shrimp, salmonids, hard clams, and
striped bass - species that have yielded major commercial development. In
addition, Sea Grant sponsors a small program of marine biotechnological
research directed to exploiting the biochemistry of marine organisms for new
approaches to industrial processing and for models for new products. It also
sponsors research in seafood science directed to improving technology in the
seafood processing industry.
The National Marine Fisheries Service conducts a limited program of activity
in the following locations:
Milford. CT and Oxford. MD - bivalve culture techniques with emphasis on
oyster pathogens and their control,
Galveston, TX - sea turtle "head start" program and shrimp culture
5
Marine Biotechnology
techniques,
Manchester. WA - Pacific salmon broodstock
development, Atlantic salmon disease reduction, and
pen-rearing and holding techniques,
o Little Port Walter. AK - Pacific salmon broodstock protection (jointly with
the State of Alaska).
All these efforts are directed to enhancement of wild stocks that are threatened
from (1) over-exploitation, (2) habitat destruction, and (3) diseases and
epizootic outbreaks.
Why is Further Effort Needed?
U.S. research in support of marine biotechnology and biotechnological research
directed to solving problems in fisheries management and seafood regulation
have barely begun to address the range of problems and opportunities that can
be solved or exploited through modern molecular science. For the United
States to properly protect and manage its living marine resources and to
maintain its leadership in a world highly competitive in technology, it must
increase its investment in research supporting marine biotechnology, which is
developing rapidly in some industrialized countries, and in development of
human resources for a competitive industrial sector.
Additional effort is needed to (1) develop fundamental knowledge about natural
products and processes of marine organisms in order to provide models for new
commercial products and new approaches to industrial processing and to
maintain U.S. competitiveness in a developing field; (2) develop biological,
engineering, and DNA technology for culture of marine species in controlled
systems in order to protect fisheries through market substitution of aquacultural
products, enhance natural stocks with hatchery-produced animals, balance trade
in seafood, and compete technologically in aquaculture which is a rapidly
growing sector worldwide; (3) upgrade technology in the seafood processing
industry in order to meet foreign competition in quality, safety, and
productivity and to help the industry meet increasingly stringent environmental
regulation, and (4) provide a sound scientific understanding of the dynamics of
fish populations in order to manage fisheries for optimal protection and
economic benefit.
"Biotechnology for the 21st Century", the recent report of the Federal
Coordinating Council on Science, Engineering, and Technology shows that out
of the $3.8 billion federal investment in biotechnological research only a little
over one percent is in support of marine biotechnology. The report states, "The
majority of plant and invertebrate animal phyla on Earth are either exclusively
or predominantly marine. They often exhibit processes and produce
6
Marine Biotechnology
substances with no terrestrial counterparts. Many of these marine organisms
are so poorly understood that they have yet to be fully described and named.
The open ocean is home to a vast array of photosynthetic plants, bacteria, and
other microorganisms whose poorly understood metabolic activity is vital to the
Earth's well-being and can be exploited for useful purposes. the breadth of
research opportunities cannot be addressed adequately with current levels of
investment."
Why in FY 1994?
NOAA has identified the urgency to rebuild and better manage the Nation's
fisheries as one of its primary strategic goals. Improved techniques in fisheries
that provide more accurate and timely information is essential for rational
management of fisheries, therefore NOAA's investment in biotechnologies for
fisheries applications should be considered high priority in order to accomplish
this goal. The stage has recently been set for collaborative efforts and
developments between NOAA, academia, and international marine science
communities to conduct coordinated research for better understanding
biophysical processes that affect the recruitment of economically important
fisheries. In addition, the Department of Commerce is focussing on program
priorities stressing economic growth and job creation. Now is the time to
provide incentives to the marine science community to work together in the
development of biotechnologies which can promote commercial development
and enhance fisheries science. For example, although aquacultural production
in the United States is growing, it is not keeping pace with that in Europe and
Asia, where it is being developed aggressively.
7
Marine Biotechnology
Why NOAA?
This initiative speaks directly to the Department of Commerce's efforts to
stress economic growth and job creation through:
promoting entrepreneurship to increase new business formation and make
new jobs,
facilitating industrial and governmental efforts to improve the quality of
American products and services, and
pursuing a linked and balanced approach to meeting the Nation's
environmental and economic competitiveness goals.
It also addresses previously stated goals of the Department of Commerce:
to enhance human resources through greater educational
opportunities,
to speed up the commercialization of new technologies.
to promote international trade in a global economy,
to promote the expansion of industrial R&D and accelerate the commercial
application of new technologies, and
to support balanced management of the oceanic and atmospheric
environment.
NOAA is responsible for managing the Nation's living marine resources and is
the international leader in science for rational management and assessment of
them. NOAA through the National Sea Grant College Program is mandated to
develop living marine resources and has made itself a leader in research
supporting marine biotechnology. NOAA has a continuing obligation to the
Nation to encourage and sponsor the development of biotechnologies that
enhance fisheries science and marine economic development. NOAA's current
and planned research is complementary to that of other federal agencies whose
primary efforts in marine biotechnology and in application of molecular
techniques to addressing marine issues are characterized by the following:
National Science Foundation - basic research for the purpose of enhancing
knowledge of biological processes in the ocean and marine environmental
processes; role of marine plankton in carbon and nutrient cycling.
Office Naval Research - fundamental research on the role of microorganisms in
oceanic processes, on understanding and controlling biological processes
8
Marine Biotechnology
affecting operations of ships, and on bioprocessing for naval applications.
National Institutes of Health - development of marine natural products for
treatment of cancer and AIDS; development of culture and genetic
enhancement techniques for marine species useful as models in physiological
and toxicological research.
Department of Agriculture - research in support of aquaculture of fresh water
fishes.
Food and Drug Administration - testing of seafood for safety, verifying
effectiveness of and developing new methods for determining safety.
Department of Energy - basic research on microbiological processes in coastal
environments.
The academic research role is distinct from industrial efforts. Except in the
area of seafood science, academic research starts at a more fundamental level.
It spawns ideas and new approaches for the commercial sector. For example, in
regard to marine natural products, academic scientists determine structures of
native molecules which may serve as templates for testing and structural
modification by industry. Industry must develop economic methods for large-
scale synthesis or biological production of compounds of commercial
importance. Pharmaceutical houses also must conduct the extensive
toxicological and clinical research and testing required by FDA. Academicians
can elucidate biosynthetic pathways and natural functions related to novel drug
candidates and isolate related enzymes which represent receptors related to
drug action. Knowledge of these enzymes can lead to an understanding of drug
action at the molecular level and stimulate new lines of industrial effort.
In seafood science and technology the boundaries between industry and
academe are not precise. However, most of the 1600 seafood processors in the
United States are small operations - less than $2,000,000 in annual sales. Few
have research components; they have few, if any, technical experts on their
staffs. Thus, government and academe play an essential role in research and
technical assistance for this industry.
9
Marine Biotechnology
What Actions are Proposed?
The National Marine Fisheries Service and the National Sea Grant College
Program will initiate or expand research in support of marine biotechnology
and its applications in fisheries science and management in the following areas
of need and opportunity:
Molecular genetics and genetic diversity. The development of new
industrial products and processes based on exploiting the biochemical processes
of marine organisms - marine biotechnology for the 21st century - depends on
fundamental advances in science that will provide the basis for genetic
engineering of plants, animals, and microorganisms. Thus, basic research will
be directed to developing DNA technology for manipulating, introducing, and
expressing genes in aquacultural food species (finfish, crustaceans, and
mollusks) as well as species with potential for use either in producing chemical
products or in industrial processing - lower invertebrates, macroalgae, bacteria,
and cyanobacteria. These advances will provide strains that grow faster, have
higher efficiency in food conversion, produce higher proportions of muscle or
desirable compounds, synthesize metabolites at greater rates, or catabolize
waste materials or toxic effluents more efficiently. Among the advancements
needed are (1) determining mechanisms by which gene expression is regulated,
(2) developing methods by which foreign genes and additional copies of natural
genes can be added to genomes of marine species, (3) developing techniques
for transferring gene clusters responsible the synthesis of useful secondary
metabolites. For development of ideally protective fisheries management
schemes it will be necessary to continue development and to apply technology
for unequivocal discrimination between fish species and strains and for
determining the degree of genetic diversity within species.
Growth and production of aquatic species. A range of biological and
engineering research is needed to develop and improve technology for
aquaculture in the U.S. and to develop a competitive position with respect to
other countries. Research is needed (1) to provide for completion of the
entire life cycle of marine aquacultural species in captivity, (2) to control
and synchronize reproductive and growth cycles, (3) to make gene probes
and compound probes for highly sensitive assessing of endocrine activity,
(4) to develop gene probes and other molecular assays for detecting and
measuring pathogenic viruses and bacteria, (5) to develop vaccines and other
measures for controlling disease and parasites, (6) to improve technology for
production and handling of larvae in hatcheries, (7) to define nutritional
10
Marine Biotechnology
requirements and to improve nutritional value of live feeds, and (8) to define
ecological factors affecting production in polyculture systems and in open
ponds.
Bio-organic chemistry and pharmacology. A spectrum of biochemical and
biological research will be conducted in this category. It will focus on (1)
determining the structures of novel lipids and other unique small molecules,
(2) isolating, identifying, and determining function of enzymes controlling
important processes, (3) isolating and identifying bioactive secondary
metabolites, (4) determining the process and site of action of novel
substances that elicit physiological responses in ways different from standard
drugs and industrial chemicals, (5) defining pharmacophores through
molecular structure, synthesis, and computer modelling, (6) determining role
of bioactive natural products in cellular processes, (7) defining properties of
marine materials, particularly biopolymers, as a basis for industrial use, (8)
defining biosynthetic pathways producing useful metabolites, (9) developing
methods for manipulating materials into new forms, and (10) developing
modified prototype materials.
Cell and tissues culture, bioreaction, and bioprocessing. This research
includes basic physiology and nutrition of marine microorganisms and cells
of higher organisms that will provide the scientific base for their use in
controlled systems for producing commercial substances. The research will
focus on (1) determining nutritional and environmental controls on
metabolism, especially secondary metabolism, (2) determining relationships
between symbionts in production of metabolites, (3) developing techniques
for giving halophytic plants useful agricultural properties or properties of
value in restoring degraded environments (4) determining factors that
promote production of useful materials and (5) developing biochemical
engineering technology for use of saline organisms in bioreactors and photo-
bioreactors. For example, basic advancements are needed for developing
technology to use culture cells of macroalgae in bioreactors to produce
useful biochemicals such as enzymes, pharmaceuticals, and agrichemicals.
Technology for seafood processing and other water-dependent
industries. The seafood processing industry is now facing serious problems
in meeting increasingly stringent environmental regulations; economic
technology is not available for water treatment and recycling and other
functions in closed system aquaculture. Research is needed (1) to develop
methods and technology for biological filtration and water reuse, (2) to
define chemical, physical, and biological factors influencing water quality
11
Marine Biotechnology
and develop methods, including biological pre-conditioning, for their control,
(3) to develop and improve methods for effluent control and biological
treatment of wastes, (4) to develop approaches to recovery of byproducts,
such as enzymes and functional proteins, from seafood processing wastes,
(5) to consistently produce, store, and transport seafood of high organoleptic
and microbial quality, (6) to develop reliable and economic methods for
shellfish depuration, and (7) to develop and improve technology for
preventing economic fraud through dishonest substitution of species.
Fish species and stocks. Improved techniques for rapid species and stock
identification and assessment are crucial to the rebuilding and better
management of the Nation's wild stock fisheries. Research will focus on (1)
precise techniques to replace old, meristic techniques in identification of
species and stocks, (2) techniques for distinguishing wild from cultured
species or stocks in the market for enforcement purposes, (3) techniques
(e.g., mitochondrial DNA) for verifying species identity in the marketplace
to prevent product substitution and mislabelling.
Recruitment processes and ecological relationships. Improved molecular
techniques are needed for measuring biological parameters and determining
biological processes and ecological relationships that bear on fishery
management decisions, development of alternative strategies, and
interpretation of the effects of anthropogenic perturbations, such as pollution
and harvesting, on important species. Predator-prey relationships and
growth and maturation of populations are of particular importance.
Specifically, the research will focus in part on (1) techniques (e.g., RNA-
DNA condition index) for measuring factors associated with recruitment, (2)
techniques for identification of prey, and (3) techniques (e.g., stable isotopic)
for investigating the long-term historical changes in ecosystem trophic
structure.
12
Marine Biotechnology
What Will It Cost?
(dollars in millions)
Major Actions
FTE Amount
1
Molecular genetics
2.0
2.0
Fish Growth
0.0
1.5
Bio-organic chemistry
0.0
1.5
Cell culture, bioreaction
0.0
0.8
Seafood technology
0.0
1.2
Fish identification
5.0
1.5
Eco-relationships
4.0
1.5
Total Request for FY 1994
11.0
10.0
1 1 FTE OAR
10 FTE NMFS
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Marine Biotechnology
What Are the Benefits?
New types of industrial materials and processes and new approaches to use
of living marine resources.
New companies to manufacture or biologically produce marine products.
Increased food supply and economic competitiveness through aquaculture.
New jobs in aquaculture and other bioindustries.
Improved efficiency and competitiveness in seafood processing and higher
quality seafood.
Environmentally compatible technology for waste management in
aquaculture and processing seafood.
Human resources for careers in high technology.
Improved management of fish stocks.
Increased and better prediction of resource levels
available to the fishing industry.
14
Outyear Funding Levels
(dollars in thousands)
FY 1994 FY 1995 FY 1996 FY 1997 FY 1998 FY 94-98
Major Components
Molecular Genetics
$2,000
$2,000
$2,100
$2,200
$1,900
$10,200
Fish Growth
$1,500
$1,500
$2,000
$2,500
$1,900
$9,400
Bio-organic Chemistry
$1,500
$2,000
$2,000
$2,100
$1,000
$8,600
Cell Culture, Bioreaction
$800
$1,000
$1,500
$1,000
$1,000
$5,300
Seafood Technology
$1,200
$1,500
$1,500
$1,800
$1,200
$5,500
Fish Identification
$1,500
$1,600
$1,700
$1,800
$500
$7,100
Ecosystem Relationships
$1,500
$1,600
$1,700
$1,800
$500
$7,100
and
Total Request
$10,000
$11,200
$12,500
$13,200
$8,000
$54,100
7
APPENDIX I
Examples of Important Advancements
Research in the National Oceanic & Atmospheric Administration has developed -
> science and technology for synchronizing spawning of abalone and controlling
settlement of their larvae so that hatcheries could be developed for these mollusks
which now are cultured commercially in California.
>
much of the science and production technology on which a new industry in
aquaculture of hybrid stripped bass is burgeoning. Annual production is now over
1,000,000 pounds with over 10 producers in the mid-Atlantic region.
>
a fast-growing, more attractive hard shell clam which is the basis of a $7 million
aquacultural development in South Carolina.
>
a triploid oyster that makes possible a yearround rather than a seasonal oyster industry
and contributed to the revival and stabilization of the oyster industry on the West
Coast.
> the science and technology for controlled farming of seaweeds that produce
industrial polymers. The polymer carrageenan from production of these farms is the
basis of $100's of millions of industrial products (Carrageenan replaces fat for
juiciness in McDonald's McLean burgers.)
> two "all-fish" expression vectors that will be useful in genetic engineering of fish and
made generic contributions to DNA technology, e.g., showed the B-actin gene of carp
to be nearly identical to the B-actin gene of mice and set the stage for using fertilized
fish eggs for research that cost about $3 each instead of transgenic mice embryos that
cost $300 to $3000 each.
> technology for determining and controlling molecular weight in production of
chitosan from shellfish wastes, for producing microcrystalline chitosan, and for
extruding it in fibers that can be woven. Research has shown that treatment of wheat
seeds with chitosan protects resultant plants from disease and increases wheat
production by up to 10% and that there is a spectrum of other uses for chitosan. These
developments were a basis of Inside R&D's forecast that chitin/chitosan sale would
increase to near $2 billion over the next few years.
> vaccines for two major microbial diseases of salmon. Preliminary field tests show
them to be effective. This research sets the stage for commercial development of more
effective and inexpensive vaccines and will contribute significantly to the economic
viability of trout and salmon farming.
>
a rapid enzyme-linked immunosorbent assay (ELISA) for the detection of Vibrio
cholerae in oysters. It can be applied to a spectrum of homogenized samples. A
commercial firm has adapted this technology to produce a small hand-held kit into
which a dipstick, previously exposed to sample, can be inserted. A squeeze of the
fingers exposes the sample to diagnostic reagents. Within ten minutes a positive
sample produces a color reaction discernable to the naked eye. The company is
sending millions of these kits to Peru and other places in South American where they
will be used to help combat an epidemic of cholera. The cholera bacterium has been
identified in Gulf of Mexico waters; thus, the new assay is expected to help keep only
safe shellfish in commercial trade.
> an inexpensive biochemical "dip-stick", monoclonal antibody assay for ciquatoxin
which is a major problem in finfish from tropical areas. The corresponding disease
ciguatera is one of the primary diseases associated with seafood. The invention is a
compact, portable test kit used to test flesh near the gills of fish. Hawaii Chemtect
International, Inc. will produce the assay kits commercially.
This research identified -
> representatives of a new class of anti-inflammatory agent that is the basis of over
$10,000,000 in R&D investment at Allergan, Inc. which is developing a drug to
combat psoriasis.
> new chemical and pharmacological classes of anti-inflammatory agents that are the
basis of major R&D by a new company Osteoarthritis Sciences, Inc. that will be
working with Massachusetts General Hospital.
> the first human hormone, a potent immunohormone, from a plant source.
Determined the biosynthetic pathway for this hormone in an alga and showed it to be
one of a whole class of algal products that are active in the biochemical pathways
controlling inflammation and other disease states in humans.
FY 1994 Budget Initiative
Marine Biotechnology
For
Economic Development
FUNDING
ALTERNATIVES
National Oceanic and Atmospheric Administration
U.S. Department of Commerce
Marine Biotechnology
Interpreting the Alternatives
Budget Alternative 1 - Full Request
$10.0 million in FY 1994
Even budget Alternative 1 would provide the basis for only preliminary
research in some of the research areas covered by the initiative. (The
initiative was put forward first at the $20 million level.) Because the range of
species, problems, and opportunities is so broad in research geared to
applying biotechnological techniques in fisheries management and to
exploiting marine biological products and processes in high technology,
funding at this level should be increased sharply in succeeding years.
Budget Alternative 2
$7.9 million in FY 1994
At this budget level initiating research to investigate the implications of
genetic diversity in fisheries management would be delayed until fiscal year
1995. Assessing genetic changes in fish stocks from environmental
perturbations would be delayed and efforts to use molecular techniques in
sorting variables controlling trophic structures would be cut back.
1
Marine Biotechnology
Alternative Funding Levels
(In millions of dollars)
Major Components
Alternative 1
Alternative 2
Alternative 3
94
95
96
97
98
94-98
94
95
96
97
98
94-98
94
95
96
97
98
94-98
Molecular Genetics
2.0
2.0
21
2.2
1.9
10.2
1.0
2.0
2.0
2.1
2.2
9.6
Fish Growth
1.5
1.5
2.0
2.5
1.9
9.4
1.5
1.5
2.0
2.5
2.5
10.0
Bio-organic Chemistry
1.5
2.0
2.0
2.1
1.0
8.6
1.5
2.0
2.0
2.1
2.2
9.8
Bioreaction
0.8
1.0
1.5
1.0
1.0
53
0.8
1.0
1.5
1.0
2.5
6.8
Scafood Technology
1.2
1.5
1.5
1.8
1.2
5.5
1.2
1.5
1.5
1.5
1.8
72
Fish Identification
1.5
1.6
1.7
1.8
0.5
7.1
0.9
1.5
1.6
1.7
1.8
7.5
Ecosystem Studies
1.5
1.6
1.7
1.8
0.5
7.1
1.0
1.5
1.6
1.7
1.8
7.6
Marine Biotechnology
Alternative Funding Levels
Major Actions
1
2
Molecular Genetics
Fish Growth
Bio-organic Chemistry
Bioreaction
Seafood Technology
Fish Identification
Ecosystem Studies
Full Implementation
Partial Implementation
No Implementation
3
Marine Biotechnology
Alternative Funding Levels
Outcomes and Products
1
2
3
Molecular Genetics
1998
1999
Fish Growth
1996
1997
Bio-organic Chemistry
1997
1997
Bioreaction
1998
1998
Seafood Technology
1997
1998
Fish Identification
1995
1995
Ecosystem Studies
1997
1997
4
A
SEA GRANT INITIATIVE
MARINE BIOTECHAOLOGY
Competing in the 21st Century
CONTENTS
Marine Biotechnology: Research, Competitiveness and Technology Transfer
2
Sea Grant: The Nation's Marine Research Network
5
Molecular Frontiers in the Ocean Sciences
Molecular Genetics
8
Bio-Organic Chemistry and Pharmacology
10
Immunobiology and Pathology
12
Endocrinology and Developmental and Reproductive Biology
14
Environmental and Evolutionary Biology
16
Applications of Marine Biotechnology
Aquaculture
18
Seafood Safety and Human Health
20
Environmental Remediation
22
Biofilms and Corrosion
24
Biomaterials and Bioprocessing
26
Marine Biotechnology and Society
Policy and Public Responsibility
28
Economics of Marine Biotechnology
30
Education and Technology Transfer
31
MARINE BIOTECHNOLOGY
Competing in the 21st Century
"A revolution in the ocean sciences has
begun, with the application of the modern
tools of biotechnology, molecular and
cellular biology to marine organisms and
ecosystems. The change is expected to be
fundamental in nature, exponential in
pace and unprecedented in its scientific
and economic impact
within a decade,
quantum leaps will have been made, not
just in the amount of knowledge, but in
the types of insights into the fundamental
and longstanding problems of ocean
sciences
"
- National Science Foundation
1990
MARINE BIOTECHNOLOGY
RESEARCH, COMPETITIVENESS AND TECHNOLOGY TRANSFER
The United States has
F
or millennia the oceans have been a source of food, minerals and other natural
an important lead in
products. But as population and human needs continue to increase, so too do the
the rapidly burgeoning
pressures on those resources. If we as a nation are to meet these growing needs, if
we are to take advantage of the bounty the oceans offer, if we are to protect the viability
field of marine
of our coastal environments, we must commit ourselves to a national program that will
biotechnology. But the
build on our current scientific achievements and develop national expertise for the
country stands to lose
future.
its lead to other
No element of science and technology can match the potential of molecular
nations, which are
biology and biotechnology to transform the lives of people around the world. While
powerful molecular technologies already are being applied to the study of marine
aggressively pursuing
organisms, we have hardly begun to take advantage of their potential. To meet this
new technologies.
challenge, research communities, government agencies and the private sector must
interact more effectively. Current efforts simply are not adequate: the United States has
no national program in marine biotechnology. It is only through a comprehensive plan
that we will be able to meet the technological challenge at home and competition from
abroad.
2
A Sea Grant Initiative in Marine Biotechnology
Economics of Biotechnology - Challenge and Competition
The public sector in the United States has provided less than $50 million annu-
ally for research and development in marine biotechnology; in Japan, that figure is
between $900 million and $1 billion. Over the next ten years, for example, the Japanese
Ministry of International Trade and Industry will bring an additional $200 million to
the field and will support the creation of two centers of marine biotechnology, reflect-
ing its assessment of marine biotechnology as the "the greatest remaining technological
and industrial frontier." The United States, while assisting other governments in build-
ing capabilities in marine biotechnology, has only scattered efforts supporting research
and development.
A national vision for development of marine biotechnology will lead to applica-
tions useful to many industries and, ultimately, the American consumer and world
markets.¹ It will reverse the current trend where products from marine microbiology
are already being imported into this country from abroad, further eroding the country's
trade deficit.
Achievements and Potential
Since 1983, limited public funding of marine biotechnology has still resulted in
more than 170 United States patents. Sea Grant programs across the nation have been
instrumental in helping to support developments such as new classes of anti-inflamma-
tory agents that have become the basis of major investment by the pharmaceutical
industry, vaccines that combat major microbial diseases of salmon and a new assay that
a commercial firm has used to produce a kit for rapid detection of contaminated sea-
food.
To exploit the unlimited possibilities that aquatic organisms have for protecting
public health, for restoring degraded ecosystems, for improving seafood production
and safety and for developing an array of new products, Sea Grant proposes an initia-
tive with clear national goals that will help guide marine biotechnology in the United
States.
1
Biotechnology for the 21st Century. 1992. Federal Coordinating Council for Science, Engineering and
Technology, Washington, D.C.
Research, Competitiveness and Technology Transfer
3
OPPORTUNITIES AND CRITICAL NEEDS
MARINE BIOTECHNOLOGY IN THE UNITED STATES
The United States is the current world leader in research expertise in marine biotechnology. However, our
leadership faces stiff competition from other countries that are moving ahead with strong national investment and
planning. Focused research in marine biotechnology in concert with commercial development offers the promise
of economic and social opportunities: it will lead to new industries and new jobs; it will help upgrade and advance
higher education to meet United States needs in an increasingly technical and competitive world. It will assist in
reversing our trade deficit, which in seafood alone is $2.4 billion dollars a year, second only to petroleum; it will
lead to new international markets and overall economic development.
A national commitment to research and development in marine biotechnology will also help us respond to
the critical needs of society; it will:
Open new avenues for monitoring health and treating disease
Provide innovative techniques to restore and protect aquatic ecosystems
Increase the food supply through aquaculture
Enhance seafood safety and quality
Develop new types and sources of industrial materials and processes
Expand knowledge of biological and geochemical processes in the world ocean
This document describes the framework for initiating this important and exciting program in marine
biotechnology. Three broad elements - Molecular Frontiers in the Ocean Sciences, Applications of Marine Bio-
technology, and Marine Biotechnology and Society - encompass the range of research, application and education
needed to exploit this new technology and ensure its wise use. Each element, in turn, includes examples of signifi-
cant advancements to date and outlines directions for future research and development in this challenging field.
Marine biotechnology has made an auspicious beginning - this Sea Grant initiative gives the United
States a means to chart a course through the 90s and into the 21st century.
4
A Sea Grant Initiative in Marine Biotechnology
SEA GRANT: THE NATION'S MARINE RESEARCH NETWORK
For more than a quarter century, the
Productive research in
National Sea Grant College Program has
support of marine
promoted excellence in marine research
and outreach. Sea Grant operates through
biotechnology has been
twenty-nine coastal programs and numer-
well underway in Sea
ous discrete inland projects, involving
Grant programs around
hundreds of universities, scientists, educa-
the country. Despite
tors and students. During the past two
modest funding, this
decades, Sea Grant has provided benefits
to resource management agencies and to a
effort represents a core
range of marine-related industries - to
of experience for the
those in commercial and recreational
nationally coordinated
fishing, aquaculture, shipping, mining,
initiative.
boating, seafood processing and biotech-
nology.
The key to the Sea Grant concept is partnership. One-third of each Sea Grant
program's funds must come from nonfederal sources, from state or private funds.
Federal funds, provided through the National Oceanic and Atmospheric Administra-
tion (NOAA), often serve as a catalyst, helping to mobilize support for important
marine-related research and education activities. Sea Grant, then, provides an excellent
mechanism for pursuing coordinated efforts, where corporate and other support can be
joined with state and federal monies to fund research, technology transfer and scale-up
activities.
As the outreach arm of NOAA, Sea Grant provides a link to academia, business
and industry, other federal agencies, including the Environmental Protection Agency,
the National Science Foundation, the National Institutes of Health, Departments of
Agriculture, Interior and Defense, and the general public.
Sea Grant: The Nation's Marine Network
5
Sea Grant and Marine Biotechnology
Productive research in support of
marine biotechnology has been well
underway in Sea Grant programs around
the country. Despite modest funding, this
effort represents a core of experience for
the nationally coordinated initiative in
marine biotechnology that Sea Grant now
proposes. Sea Grant programs have
developed an effective managerial infra-
structure with a strong track record and
are clearly capable of directing a major
national initiative. In addition, Sea Grant
is the only agency in the marine sector
with experience in outreach programs targeted to the transfer of marine science and
technology and to the improvement of education in aquatic sciences.
Sea Grant has demonstrated experience in integrating public policy consider-
ations into multi-disciplinary research and education programs. Part of Sea Grant's
primary mission includes working together with federal and state agencies and other
organizations, public and private, to consider critical marine-related issues. New
developments in molecular biology - and their commercial application - will have
significant ethical, ecological and economic implications. Sea Grant programs have a
strong record of approaching such issues, helping to bring together expertise from
across disciplines to foster balanced analyses and workable solutions.
The Need to Act Now
Marine biotechnology has the potential to develop rapidly - and to provide
major economic returns to the nation. To take advantage of this opportunity, however,
we must have an aggressive program of marine biotechnology research and develop-
ment that draws on cutting-edge science underway in laboratories around the country.
We must encourage and support multi-disciplinary research and ensure rapid technol-
6
A Sea Grant Initiative in Marine Biotechnology
ogy transfer. We must actively plan for partnerships with industry and commercial
A national initiative in
enterprise, and facilitate efficient technology transfer. Most importantly, we must train
marine biotechnology
the next generation of scientists and technologists or risk losing the slim competitive
edge we now have.
will fund the best
To assure the relevance of program elements, a focused initiative, open to re-
science throughout the
searchers throughout the nation, will be guided by an advisory panel of academic and
nation, to exploit this
industrial scientists, economists and managers and will build upon the ideas and
new technology.
recommendations in the Biotechnology Research Initiative put forward by the Federal
Coordinating Council on Science, Engineering and Technology, under the guidance of
the President's science advisor.
The United States has an important lead in the rapidly burgeoning field of
marine biotechnology. But as has happened with other emerging technologies, the
country stands to lose its lead to other nations, most notably Japan, which are aggres-
sively pursuing new technologies. By strengthening its leadership role now, the United
States can help assure its competitive position as the stage is set for the next century.
Sea Grant: The Nation's Marine Network
7
MOLECULAR FRONTIERS IN THE OCEAN SCIENCES
MOLECULAR GENETICS
Knowledge of the genetics of marine organisms will
yield important information about their phylogeny,
evolution, disease, symbiosis, ecological adaptation and
physiology. This information will improve our ability to
understand and manage complex ecosystems. Also,
information gained about simpler organisms such as
bacteria, algae or invertebrates will give us insights into
the functioning of more complex mammalian systems.
The introduction of foreign genetic material into
organisms and genetic manipulation to induce sterile,
polyploid or hybrid stocks has been accomplished with
a few marine species. In some cases, these results have
been immediately applied in commercial aquaculture.
These methodologies can also be used in the manage-
ment and enhancement of wild stocks. For example,
genetic markers can be used to differentiate various
strains, or to separate hatchery from wild populations. Examination of DNA has
shown that some fish and shellfish populations consist of various substocks, often with
differing abilities to adapt to environmental stresses. This observation suggests that
genetic engineering could be used to improve survival and productivity of cultured
stocks.
Marine viruses, recently shown to infect many phytoplankton and bacteria, are
thought to play a major role in plankton dynamics. They may also provide a means for
incorporating foreign genetic material into marine algae, which have proved resistant
to genetic engineering, but which have great potential as sources of new chemicals and
materials.
8
A Sea Grant Initiative in Marine Biotechnology
THE CHALLENGE
Determine the
Molecular Genetics of
Aquatic Organisms:
Identify the basis for
unique adaptations
Characterize
environmental
Exciting new areas of research in this promising field include:
factors controlling
Certain Antarctic fish produce novel glycoproteins which inhibit ice crystal
gene expression
growth in their tissues; use of molecular techniques may permit their large-scale pro-
duction for research and practical application. It may be possible to transfer the genes
Use aquatic
coding for this natural antifreeze to other species in order to improve their growth and
organisms as
survival in cold environments.
molecular models
The unique physiology of hydrothermal vent organisms - in particular their
Develop new
adaptation to life at high pressures, high hydrogen sulfide content and at temperatures
techniques in
which would denature most proteins - is receiving deserved attention. Molecular
genetic methods are being used to clone the genes of barophilic (high-pressure) bacteria
molecular biology
with the goal of studying the mechanisms of pressure control on gene expression.
DNA-fingerprinting techniques demonstrated that traditional stock assess-
ments of Atlantic salmon were erroneous, resulting in a large share of valuable United
States stocks being given over to European fishing interests.
Basic studies of fish gene expression have shown that carp contain many genes
similar to those of mice. This has led to the use of fertilized transgenic fish eggs as a
substitute for transgenic mouse embryos in genetic studies, with considerable savings
in cost and handling effort.
Molecular Frontiers in the Ocean Sciences
9
BIO-ORGANIC CHEMISTRY AND PHARMACOLOGY
While the number of truly novel chemicals from terres-
trial plants and microbial fermentation has declined,
marine natural products chemists have shown that
almost every class of marine organism elaborates a wide
variety of molecules with unique structural features.
Pharmacologists, physiologists and biochemists have
demonstrated that many of these novel marine products
modify fundamental life processes in ways suggesting
biomedical applications. These molecules can serve as
leads to guide the pharmaceutical and chemical indus-
tries in developing new products.
Because marine species may have evolved the
production of chemicals for protection against preda-
tion, infection and competition, some of these chemicals
are proving useful in agricultural and medical applica-
tions. By determining the biochemical pathways by
which these compounds are produced - and the envi-
ronmental or physiological triggers controlling their production - techniques of
enhanced commercial production can be developed.
Ground-breaking discoveries in marine chemistry, pharmacology and biotechnology
will provide essential help that the American pharmaceutical industry needs in its efforts to
cure intractable forms of cancer, inflammation, arthritis and viral infections. New classes of
marine invertebrates and microorganisms are needed as a source of medicinal, agricultural
and industrial agents; in particular, bacterial symbionts (now known to be the source of
many novel marine compounds) hold a tremendous potential for biotechnological exploita-
tion. Further examination of molecular systematics and biogeography of compound-
producing organisms can greatly improve the search for new sources.
New fermentation and related production technologies must be developed which
10
A Sea Grant Initiative in Marine Biotechnology
apply to marine
THE CHALLENGE
bacteria, fungi and
Discover New
related species. Such
Bioactive Materials:
advances will make
possible further
research on how
Identify new sources
drugs work and will
of drugs
provide new leads to
Determine
bio-organic chemists
studying the struc-
biosynthetic
ture and production
pathways
pathways of these
materials. New
Define structure of
approaches in defin-
marine-derived drugs
ing molecular structure, including the use of powerful new computer techniques, will
Characterize drug-
lead to synthesis of marine-derived drugs and will offer new potential solutions to
production of larger quantities of rare drugs. Genetic engineering - the transfer of
receptor interactions
genes encoding for synthesis of the compound of interest into more manageable organ-
Define molecular
isms -holds particular promise for mass production.
Recent developments include:
mechanisms of
Manoalide, an anti-inflammatory and analgesic agent isolated from a Pacific
action
sponge, is now in clinical trials. Its action differs from that of standard drugs and it
appears free of the side-effects of steroids.
A substance isolated from shark cartilage inhibits blood supply to tumors, thus
restricting their growth. Bryozoans and tunicates have also yielded novel compounds
with highly specific antitumor activity; some are now undergoing clinical trials.
Halenquinone, isolated from a sponge, is a powerful new antibiotic, while
didemnin, from a tunicate, exhibits antiviral and anticancer activity.
Extracts of a sponge have yielded a potent insecticide; especially interesting is
the finding that this compound may actually be produced by a bacterium living in the
sponge. Accumulating evidence suggests bacteria as the source of many bioactive
marine chemicals such as tetrodotoxin.
Molecular Frontiers in the Ocean Sciences
11
IMMUNOBIOLOGY AND PATHOLOGY
Animals and plants in the marine
environment are subject to disease,
parasitism and tissue pathologies
such as tumors. And as with
terrestrial species, these patholo-
gies may be due to microbial
agents or to environmental stress.
The ecological or economic impacts
of these diseases can be costly. For
example, a probable virus has been
implicated in the recent massive
die-off of the black sea urchin,
Diadema, in the Caribbean; grazing
of fouling algae by this urchin is
considered vital to coral reef health. Disease and parasites have brought about the
virtual elimination of oyster populations in many areas, with corresponding economic
and societal dislocations. Tumors in fish from coastal waters have been ascribed to
exposure to toxic pollutants, though the exact mechanism of such impacts remains
unclear. Determining the causes of these tumors, whether pollutants, infectious agents
or other factors, will have a direct effect on public use and management of the resource.
There is growing evidence that aquatic viruses, abundant in most systems, play a major
role in the control of bacterial and algal populations. Infection by viruses thus may
impact production and nutrient cycling, as well as plankton diversity and abundance.
The inability to culture many marine bacteria and viruses, or to elucidate the life
cycles of parasites, hampers the diagnosis and treatment of disease. The immunological
response of marine species, particularly invertebrates, to disease agents is not well-
understood, nor is the impact of pollutants on the immune system. The aquatic envi-
ronment itself makes the isolation, identification and quantification of potential disease
12
A Sea Grant Initiative in Marine Biotechnology
agents difficult. The
THE CHALLENGE
techniques of marine
molecular biology and
Investigate Disease
biotechnology show
Processes:
tremendous promise for
addressing these prob-
Use marine
lems. Of particular
organisms as
importance would be the
biomedical models
development of gene
probes or immunochemi-
Develop new
cal agents for disease
diagnostic techniques
diagnosis; establishment of fish and shellfish cell cultures to support basic research on
the molecular basis of pathogenesis; production of vaccines by recombinant DNA
Prevent and treat
technology; production of molecular probes or biomarkers for assessing effects of
diseases in aquatic
environmental stress on organisms; and determination of the relationship between
organisms
environmental stress and disease resistance in fish and shellfish.
Recent examples of such advances are:
Determine the role of
The induction of specific enzymes in deep-sea fish, established using mono-
environmental stress
clonal antibody techniques, indicates biological changes due to anthropogenic chemi-
on disease
cals are occurring even in the deep ocean. Molecular techniques have identified specific
mutations, of uncertain cause, in critical genes associated with diseases such as cancer
Explore cell-to-cell
in fish.
recognition
Gene probes have been developed for several viral diseases of shrimp. These
have made possible the establishment of disease-free brood stock for United States
shrimp hatcheries and will help prevent the loss of stocks during grow-out.
Flow cytometry and specific immunological labeling are being employed to
identify and enumerate pathogens, including cryptic life stages of parasites, in natural
waters. Molecular probes are being developed to elucidate life cycles or identify alter-
nate hosts of parasites which infect fish or shellfish.
Molecular Frontiers in the Ocean Sciences
13
ENDOCRINOLOGY AND DEVELOPMENTAL AND
REPRODUCTIVE BIOLOGY
Reproduction, development and growth in marine
organisms, as in all animals, are regulated through
the orderly release of hormones. These hormones are
produced by the neuroendocrine system which
integrates information from the genome and the
environment. The central role of the neuroendocrine
system in the regulation of growth and development
can be exploited to generate the technology necessary
for the efficient and reliable propagation of important
food species. A knowledge of hormones and of
endocrine regulation of growth can also be used to
stimulate individual growth and improve productiv-
ity while reducing feed and other costs to the farmer; hormonal growth promoters of
farm animals were among the first products of the biotechnology industry. For these
same reasons, the application of cooperative research between endocrinology and
molecular biology is critical if aquaculture is to significantly increase the food supply of
both the nation and the world. A knowledge of hormone and gene interactions in the
control of growth, reproduction and other aspects of physiology provides important
new avenues for restoring populations of endangered species and in limiting popula-
tions of noxious organisms.
These approaches must be combined with a thorough understanding of the
developmental biology of marine organisms. Many organisms pass through periods of
development called critical periods in which mortality is high. While the factors in-
volved in these critical periods remain largely undefined, they can have a strong nega-
tive impact on the economics of aquaculture and on the fisheries mitigation efforts of
hatcheries. Characterizing the sources of such critical periods and overcoming their
limits will provide essential tools in producing and growing many important marine
organisms.
14
A Sea Grant Initiative in Marine Biotechnology
The intersection of endocrinology,
THE CHALLENGE
molecular biology and developmental
Describe the Molecular
biology can provide still other important
assets. Thus, research is essential not only
Basis for Reproduction
in terms of developing useful products
and Development:
and technologies, but also in ensuring that
they are applied responsibly.
Identify genetic
Recent research areas include:
factors controlling
Cloning of growth hormone and
reproduction
growth promoting factor genes of some
commercially important fish has led to
Discover biomedical
production of rapidly-growing stocks.
uses for hormones of
Injections of growth hormone
aquatic organisms
biosynthesized by bacteria containing
this gene increase the growth rate of
Identify internal
trout, while transgenic carp and catfish
factors directing
containing copies of this gene grow up
to 50% faster than controls.
growth and
Identification of factors control-
development
ling spawning and settlement of abalone and oysters has allowed synchronized spawn-
Uncover the
ing in captivity, leading to the development of commercial hatcheries for these valuable
shellfish.
molecular adaptive
Development of technologies for delivering growth hormones and gonado-
mechanisms of
tropin-releasing hormone (GnRH) to fish in culture, either through micro-encapsulation
aquatic organisms
or through implants, has made it possible to induce spawning in captive stocks.
Molecular Frontiers in the Ocean Sciences
15
ENVIRONMENTAL AND EVOLUTIONARY BIOLOGY
Rapid advances in marine biotechnology make it
possible to answer some of the most intractable basic
problems in modern biological oceanography. This was
emphasized at a 1990 workshop supported by the
National Science Foundation, the Office of Naval
Research, and NOAA/Sea Grant, which concluded that
"the impact of this new technology is similar to the
impact of computer technology; both are completely
revolutionizing the capability to address complex
scientific issues." Marine biotechnology will provide
ocean scientists with a new means of knowing, a new set
of tools with which to examine basic ocean processes and to link these processes to the
global ecosystem. Questions involving the distribution, characterization, recruitment
and movements of marine organisms, their evolutions, adaptations, and interactions,
and the elucidation of production, consumption and cycling rates are particularly
amenable to biotechnological tools.
For example, the vast majority of micoorganisms in the oceans cannot be cultured,
yet they play essential roles in the cycling and transformation of materials in the bio-
sphere. Nucleic acid hybridization, monoclonal antibodies and other techniques of
molecular genetics now are being used to characterize these cells and examine their
activity.
This improved understanding will, in turn, enhance our ability to develop practi-
cal uses for the unique adaptations of marine organisms, to manage marine ecosystems
and populations, and to restore impacted environments. However, significant barriers
exist to the rapid incorporation of new technologies into the ocean sciences. Among
these are the relatively small number of ocean scientists experienced in the tools of
molecular biology and biotechnology, which emphasizes the need to incorporate train-
ing and interdisciplinary communication into any program in marine biotechnology.
16
A Sea Grant Initiative in Marine Biotechnology
Promising areas of research include:
THE CHALLENGE
Use of gene probes to rapidly identify and enumerate marine organisms,
particularly small but ecologically important forms such as phytoplankton and zoo-
Explore Ecological and
plankton. This work is currently extremely labor intensive, and can be a major bottle-
Evolutionary Processes:
neck in oceanographic research.
Investigation of harmful effects of the ozone "hole" in the Antarctic are being
Determine ecosystem
carried out by examination of DNA of marine organisms exposed to increased UV
processes relating to
radiation. UV-tolerant forms are also being examined for potential natural sunscreens.
environmental
Employing molecular techniques to examine symbiotic relationships between
species, such as the identification of nitrogen-fixing symbionts, as well as the molecular
change
and genetic basis which controls "self-recognition" of cells. The latter is important to
Characterize the
questions such as coral bleaching (the expulsion of algal symbionts by stressed coral
animals) and the infective mechanisms of certain protozoan parasites.
phylogeny and
evolution of marine
organisms
Delineate stocks and
natural populations
Clarify
biogeography and
biodiversity
Assess the ecological
roles of
microorganisms
Molecular Frontiers in the Ocean Sciences
17
APPLICATIONS OF MARINE BIOTECHNOLOGY
AQUACULTURE
Aquaculture is the growth of aquatic organisms in a controlled
environment. Such environments may be bioreactors, open or
closed raceways, ponds or natural bodies of water. The aim of
such culture is to be able to produce items of economic import
such as pharmaceutical agents, feed additives, isotopically
enriched chemicals, polymers, lipids with petroleum potential
and foodstuffs. The United States has a significant annual
trade deficit in seafood, so increasing our nation's capability in
aquaculture of food species would provide considerable
economic benefit. There is also a growing market for produc-
tion of ornamental fish, including captive breeding of tropical
species now rare in their native countries. Economically viable
aquaculture requires that the entire life cycle of a species be
completed in captivity, yet many forms of potential importance
do not reproduce under these conditions. Currently, funda-
mental research in physiology and endocrinology is directed
primarily to understanding reproduction and growth of cultured species, and develop-
ing means for its control.
Other major areas of activity include research on means to increase the productiv-
ity or food value of the cultured species; drugs and vaccines to enhance immunity to
disease or other stresses; genetic improvement of strains and identification of deleteri-
ous or desirable genes within stocks; vaccines, drugs and feeds tailored to specific
species and means to increase the palatability, quality and safety of cultured food
products.
Sea Grant has supported - and continues to support - groundbreaking re-
search in aquaculture. Among recent accomplishments have been:
Development of a triploid oyster that makes possible a year-round rather than
18
A Sea Grant Initiative in Marine Biotechnology
THE CHALLENGE
Produce More and
Healthier Seafood:
Enhance growth and
productivity
Control reproduction
of cultured stocks
seasonal oyster production - this achievement has contributed greatly to the revival of
Improve disease
the West Coast oyster industry.
resistance and
Use of DNA markers to differentiate between wild and hatchery-released
stocks of fish, such as salmon, steelhead and striped bass, particularly in areas where
diagnosis
wild, genetically-diverse stocks are threatened by habitat loss, overharvesting or com-
Produce drugs and
petition from non-native species.
feeds tailored to each
Development of vaccines against two major diseases of salmon, IPN and IHN
virus. This research sets the stage for commercial development of improved vaccines to
species
increase survival in cultured trout and salmon.
Improve genetic
makeup of strains
Applications of Marine Biotechnology
19
SEAFOOD SAFETY AND HUMAN HEALTH
Fish and shellfish provide an important component to the
global diet - in many countries, seafood represents the
major (or only) source of protein for thousands of people.
Population pressure and the need to maximize the global
food supply will mean an increased reliance on seafood in
the future. There are, however, obstacles to this goal. In
many tropical areas, the presence of ciguatoxin in reef fish
greatly limits utilization of this resource. Other naturally-
occurring toxins, such as paralytic shellfish poisoning, may
prevent consumption of shellfish over wide areas. Virulent
pathogens can contaminate the seafood supply, putting
large segments of the population at risk. Some of these
disease organisms, such as Vibrio cholerae, are endemic to
marine systems; others indicate contamination with human
or animal wastes. The presence of chemical toxicants in fish
or shellfish is an increasing problem in industrial societies. Transfer of products across
national boundaries, and the relative lack of inspection and certification at most stages
of harvest and processing makes the issue of seafood safety a growing concern world-
wide.
Marine biotechnology can give us the capability to prevent or detect these prob-
lems, and to ameliorate their impact. Most importantly, it can help us answer questions
about how these problems arise - what are the processes which lead to the contamina-
tion of reef fish with ciguatoxin, what ecological conditions favor the microorganisms
which produce the toxin, and how can their presence be detected? What processes
enable endemic species of bacteria to cause epidemics of acute disease? How are toxic
chemicals made biologically available to fish and shellfish, and what metabolic pro-
cesses lead to their accumulation in tissues of exposed organisms? What are the long-
term human health impacts of prolonged exposure to these contaminants?
20
A Sea Grant Initiative in Marine Biotechnology
Because of the
THE CHALLENGE
direct threat to
human health, as
Safeguard Human
well as the need for
Health:
increasing the
world's food supply,
Detect contaminated
the issue of seafood
CRABS
seafood using rapid
safety is receiving
considerable atten-
and sensitive
tion from scientists,
methods
policy makers and
the public. The
Characterize ecology
potential of marine
of disease organisms
biotechnology to
Improve depuration
address many of
methods
these issues is
demonstrated by successes to date:
Enhance shelf life of
Development of an inexpensive biochemical "dip-stick" monoclonal antibody
seafood
assay for ciguatoxin, which can affect finfish from most tropical areas. This test kit is
being produced commercially in Hawaii.
Use of molecular techniques to elucidate the pathways leading to toxin forma-
tion by marine organisms, to chemically characterize these toxins and to determine the
genetic coding governing their production.
Development of a rapid enzyme-linked immunosorbant assay (ELISA) for
Vibrio cholerae in oysters. A commercial firm has adapted this technology to produce a
small hand-held kit for detection of contaminated seafood; millions of these kits will be
sent to South America to help combat the cholera epidemic.
Applications of Marine Biotechnology
21
ENVIRONMENTAL REMEDIATION
Marine organisms are also sources of
novel bio-mediated pathways for pro-
cessing and degrading a wide variety of
natural and manmade substances.
Degradation in aquatic environments by
naturally occurring organisms or com-
munities, or in bioreactors containing
these organisms, offers potential for the
disposal or cleanup of hazardous mate-
rials. In fact, waste processing in most
modern sewage treatment facilities
relies to a great extent on the manipula-
tion of bacterial metabolism. Similarly,
toxic industrial wastes or other effluents
can be treated by properly selected
aquatic microbes which have the capa-
bility (or have been genetically manipu-
lated to acquire the capability) to break down these materials. Biosensors are being
developed which use naturally-occurring marine proteins combined with information
technology, for example, fiber optics and microcircuitry, to monitor for very low con-
centrations of toxicants.
Research is being initiated to identify the biochemical pathways of these pro-
cesses, and to understand how these activities are distributed, regulated and main-
tained. There is a need to accelerate the search for naturally-occurring organisms which
have the potential to degrade or process materials of interest - bacteria occurring near
natural oil seeps - and to identify the genes responsible for these capabilities. Signifi-
cant commercial potential for industrial use will follow, either by employing the origi-
nal organisms or by inserting the appropriate genes into more traditional species.
22
A Sea Grant Initiative in Marine Biotechnology
A number of applications are already
THE CHALLENGE
being developed which employ marine spe-
cies, and others are being currently studied.
Protect and Restore the
These include:
Aquatic Environment:
Oceanic bacteria have been discovered
that directly oxidize and precipitate iron,
Isolate or
manganese, cobalt, nickle and other valuable
bioengineer
and strategic metals. The genes and enzymes
of these bacteria may be the key to separating
organisms that
these metals from low-grade ores, bypassing
degrade pollutants
more expensive and environmentally-damag-
Determine metabolic
ing industrial processes now employed.
Related to the above, bacteria have also
pathways to degrade
been found that reverse these processes - that
hazardous
is, they can reduce or solubilize many metals
substances
(some toxic), and thus may be able to play a
role in the remediation of pollution.
Develop processes to
In Israel, a new petroleum-emulsifying
clean up waste
agent has been developed from marine bacte-
streams
ria. A multi-million dollar business now produces this material for use in the petro-
leum industry, with production licensed in over a dozen countries including the United
Design biological
States.
controls for nuisance
Chitosan, a product extracted from shellfish waste, is being used to treat wheat
species
seeds to reduce fungal infestation, with resultant increases in germination and ultimate
yield (up to 10%). Many other applications of chitin and chitosan are currently under
development, including medical materials; much of the original research in this mate-
rial was supported by Sea Grant.
A test plant employing naturally occurring bacteria which degrade phenols has
demonstrated a 99% drop in the concentration of chlorinated phenols from 100 to 1 part
per million in a bioreactor system. These procedures were tested successfully by the
Environmental Protection Agency at a Superfund site, and two firms have contracted to
use these procedures in commercial applications.
Applications of Marine Biotechnology
23
BIOFILMS AND CORROSION
Biofouling and corrosion are major costs in commercial and
U.S. Naval operations in marine environments. The occur-
rence of natural biofouling or corrosion-resistant substances
has been demonstrated and these compounds merit inten-
sive investigation at a molecular level to develop new meth-
ods for controlling these processes. Such approaches require
an understanding of the attachment mechanisms of organ-
isms that form biofilms, the growth of these films and how
these processes influence fouling and the electrochemistry of
corrosion.
There is an urgent need to develop newer, less toxic
means of controlling biofouling of surfaces - both because
of increasingly restrictive environmental regulations, such as
the ban of tributyltin paints, and the current problems with
exotic, invasive fouling organisms such as zebra mussels.
Similarly, corrosion of marine materials can be intensified by
microbial activity, and clarification of the biochemical and
electrochemical pathways involved may allow control of these processes. Biofilms, and
the invasion of tissues by surface-active bacteria, are also primarily involved in a
number of human health problems, including dental caries, prosthesis septicemia and
interstitial cystitis. There are also many potential benefits from a better understanding
of biofilm formation, such as improved waste water treatment (trickling filter design),
aquaculture (setting of oysters and other shellfish), agriculture and industry.
The naturally evolved chemicals which serve to reduce competition between
surface-living organisms and bind organisms to surfaces under adverse adhesive
conditions are potential areas for investigation, as are the cues which signal setting or
metamorphosis in fouling macrofauna. These and other avenues are being pursued,
including the following:
24
A Sea Grant Initiative in Marine Biotechnology
THE CHALLENGE
Reduce Fouling and
Corrosion of Marine
Structures:
Develop non-toxic
fouling controls
Determine the role of
microorganisms in
The organic matrix in oyster shell has been found to be a potent inhibitor of growth
marine corrosion
of crystalline calcium carbonate, the principal component of mineral scaling on marine
surfaces. Synthetic substances modeled after this matrix also inhibit deposition of mineral
Describe molecular
scale. Research on the exact mechanisms involved is continuing while earlier results are
processes involved in
being developed into commercial applications.
Recent developments in the study of bacterial exopolymers have shown that consid-
fouling and corrosion
erable differences exist in the metal-binding activity of these materials. This observation is
Develop biomedical
now being expanded to look at the implications for corrosion of metal surfaces through
applications
enhanced microbial activity.
The observation of antagonistic interactions between closely related strains of film-
forming bacteria, whereby one strain inhibits adhesion of the other clone, has led to the
isolation of a material which shows a broad range of activity against film-forming bacteria
and phytoplankton. This substance is now being further characterized and tested with Sea
Grant support. It may have wide potential applications as a safer fouling-control agent.
Bacterial biofilms promote the successful settling and metamorphosis of oyster
larvae, and in fact these films produce DOPA-like substances which act as cues and induc-
ers of settlement. Research in this area has led to the patenting of a product, derived from
these substances, and its use in a number of oyster hatcheries to produce cultchless spat.
DOPA proteins may have application as inhibitors of corrosion, as well.
Applications of Marine Biotechnology
25
BIOMATERIALS AND BIOPROCESSING
Marine organisms synthesize numerous chemi-
cals with bioactive properties: metabolites,
proteins, enzymes, polysaccharides, lipids and
other materials which have direct application in
health and life science. Determining the physi-
ological and environmental role of many of these
materials is likely to lead to new industrial pro-
cesses and applications, for example, in bio-
remediation and in control of pests or diseases.
While most research on marine natural
products has focused on identification, isolation
and characterization and testing of the material for activity or utility, these are only the
initial steps: elucidation of metabolic pathways by which materials are produced and
identification of the genes responsible also will provide the bases for advanced technol-
ogy, Because biosynthetic production, rather than extraction from the organisms, holds
promise for more economical processes, this approach needs thorough exploration.
Marine-derived polymers have potential application in a variety of products, among
the most exciting being superconductors.
Photobioreaction may warrant attention both for production of energy and for
material production. Light-harvesting chlorophyll and protein complexes can be
reconstituted onto artificial membranes and are capable of collecting energy and trans-
ducing electrons with efficiencies comparable to photovoltaic cells. Under conditions of
nutrient limitation, some microalgae produce hydrocarbons and lipids in quantities up
to 65 percent of their dry weight. Application of DNA technology and other modern
methods may provide economically viable approaches to exploring this biosynthetic
capability.
For some applications, the quantities of materials required or the cost of obtaining
them may limit - for a time - the commercialization of natural products. In these
26
A Sea Grant Initiative in Marine Biotechnology
cases, the study of models
THE CHALLENGE
may reveal alternatives that
are more cost-effective to
Exploit Marine Natural
produce than the naturally-
Products for Human
derived materials, but
Benefit:
which retain their desirable
characteristics.
Develop sensors
Related areas of
for continuous
marine biotechnology are
already highly productive,
monitoring
and many new products are
Discover new
in use or in development.
prosthetic materials
Among these are:
Technology for the controlled farming of seaweed has allowed the production
Develop new uses
of biopolymers with many uses in industry. For example, carrageenan is widely used in
for industrial
the food and cosmetic industries and is the basis of hundreds of millions of dollars of
commercial trade. Other algal polymers, such as agar and alginic acids, are also essen-
byproducts
tial to a variety of biotechnological research and processing.
Use marine materials
Marine glues which adhere firmly underwater are being developed from the
for novel
naturally-produced byssal glues of mussels. Such adhesives can be used in bone and
teeth repair and may have other medical applications.
applications
Highly-charged oyster-shell proteins have been used as models to launch a new
Engineer marine
polymer technology. These new biodegradable and non-toxic compounds can be used
organisms for
to replace the hundreds of millions of pounds of non-degradable acrylic-based poly-
mers employed annually as additives in detergents, dispersants and in other industrial
innovative industrial
applications.
uses
Marine biomass production as a source of energy or useful chemicals is now
being studied; these investigations focus primarily on macroalgae but microalgae,
marine grasses and marsh plants, are also potential sources. It may be possible, for
example, to apply molecular genetic techniques and produce rapidly growing strains
that are able to grow in normally unproductive saline soils, providing animal fodder,
fuel or raw materials in marginal or degraded environments.
Applications of Marine Biotechnology
27
MARINE_BIOTECHNOLOGY_AND_SOCIETY
POLICY AND PUBLIC RESPONSIBILITY
THE CHALLENGE
Biotechnology gener-
ally has engendered
Promote Responsible
complex ethical, legal,
Use of Marine
political and social
Biotechnology:
issues. As more and
more research institu-
tions use the advanced
Develop new
techniques of biotech-
approaches for
nology in their work,
establishing
as genetically engi-
protocols
neered organisms are
made ready for field
Adopt policies to
testing, and as the
promote research and
products produced by
investment
genetically engineered
organisms multiply in
Encourage
the market places, the
cooperative projects
number and complexity of public issues are certain to increase. Neither researchers nor
between institutions,
their home institutions can ignore these issues or fail to become involved in the public
agencies and
debate that will influence how rules governing research and its applications are formu-
lated and how funding for scientific activities is apportioned.
governments
It is unclear to what extent marine biotechnology raises issues beyond those
Facilitate the
raised in other biotechnology fields. While the majority of products generated by
transfer of
marine biotechnology research may differ in kind and should pose few special problems to
industries, regulatory agencies or the patent office, major differences are likely to be
information and
in regard to future field testing of genetically manipulated organisms. Since in the
technologies
aquatic environment there are few natural barriers to prevent an organism from mov-
28
A Sea Grant Initiative in Marine Biotechnology
ing from one site to another, containing test organisms within one area becomes very
difficult. Moreover, the transfer of genetic materials among organisms is problematical:
for example, a recent discovery of vast numbers of viruses in ocean waters leaves open
the question of whether introduced genes may be transferred from one species to
another via virus vectors.
Marine biotechnology research, and the application of these results for public
benefit, must include due consideration of ethical and regulatory issues. There will be
the need to balance freedom to conduct research and to develop products with appro-
priate oversight and guidance. Existing policies, especially the protocols governing
work in genetic engineering, will need to be adapted to guide research and develop-
ment in marine biotechnology.
Marine Biotechnology and Society
29
ECONOMICS OF MARINE BIOTECHNOLOGY
THE CHALLENGE
Marine biotechnology has received relatively scant
attention in the United States, despite its obvious
Evaluate Economic
potential and despite the remarkable productivity
Benefit of Marine
that current research has demonstrated. It is un-
Biotechnology:
likely that this level of achievement can be sustained
if funding levels are not improved, and consistent
Perform cost-benefit
support provided to research and development
efforts.
analyses
Considering its potential, the present support
Evaluate economic
for marine biotechnology is modest. Total research
potential of new
investment at academic and public institutions in
products and
the United States, excluding industry research, was approximately $44 million in 1991.
Funding grew from $38 million in 1988 and is expected to reach $50 million by 1994.
processes
After adjusting for inflation, these figures represent no significant growth in investment
Develop new markets
for marine biotechnology research over this period.
for products
Total support since 1984 for marine biotechnology research and development,
Facilitate investment
exclusive of private sector investment, is estimated at $181 million. This support has
resulted in 170 patents for funds expended to date, a large number of patents per
in marine
research dollar given the academic orientation of most institutions which emphasize
biotechnology
basic research.
Provide guidance for
With limited funding, marine biotechnology has been very successful in increas-
new businesses and
ing our stock of economically important information. The ultimate value, however, will
industries
come from how this knowledge is applied to new product and process development.
Although figures on overall value of marine biotechnology products are not available,
there are estimates that on average the stock market value of a company increases by
$810,000 with the awarding of a patent.
30
A Sea Grant Initiative in Marine Biotechnology
EDUCATION AND TECHNOLOGY TRANSFER
Development of new methods, products
THE CHALLENGE
and knowledge is only the first step; to
be fully utilized, this new information
Develop Human
must be transferred - to entrepreneurs,
Resources and New
educators, institutions and industry.
Partnerships:
Formal mechanisms to disseminate
research results, to instruct potential
Train scientists and
users, to facilitate the granting of patents
technicians
and the licensing of products will facili-
tate this process. Sea Grant has a
Educate the public
network of extension and communica-
tions personnel that could meet many of
Promote
these needs. It is a base upon which to
interdisciplinary
build additional efforts in technology
activity
transfer. This new direction will be both
a challenge and an opportunity. Cer-
Provide links
tainly expertise in many areas, such as
between research and
intellectual property law, must be augmented. But the infrastructure is in place and
industry
needs no duplication.
Four major program elements are proposed:
Develop protocols
Scientific Entrepreneurship: Scientists need to learn the realities of the business
for technology
world, and those involved in business must understand the principles of the scientific
method. We will establish programs which emphasize cross-training, and which allow
transfer
students from each discipline to become familiar with the approaches and needs of
both fields.
Scientific Training: A lack of trained personnel to drive the emerging marine
biotechnology industry is one factor causing United States industrial growth to lag
behind our foreign competitors. We will establish training programs to develop the
Marine Biotechnology and Society
31
skills necessary for students at the college
level, for faculty at colleges, universities
and vocational institutions and for scien-
tists in both industry and academia.
Public Awareness: While marine
biotechnology has great economic
potential for this nation, it is essential that
the public be informed about this science
and feel comfortable with its use. The
public awareness program will employ
on-site training, seminars and production
of teaching materials aimed at students
from elementary grades to college, as
well as the general public.
Minority Outreach Program:
The scientific and economic
challenges of the next century will re-
quire action and input from our entire population. Demographic realities, as well as the
moral imperative to share benefits of technological and economic progress with all
segments of this society, mandate the increased involvement of women and minorities
in science and industry. This program element will include a mentorship program to
encourage students on an individual basis, and provide them with research experience
in a supportive environment.
32
A Sea Grant Initiative in Marine Biotechnology
SEA GRANT INSTITUTIONS
Alaska Sea Grant College Program
New Jersey Marine Sciences Consortium
For further information on marine
University of Alaska
Rutgers University
biotechnology, contact one of the
California Sea Grant College Program
New York Sea Grant Institute
following Sea Grant Programs:
University of California, San Diego
State University of New York at Stony Brook
California Sea Grant College
Southern California Sea Grant Program
North Carolina Sea Grant College Program
University of California, San Diego
University of Southern California
North Carolina State University
La Jolla, California 92093-0232
(619) 534-4440
Connecticut Sea Grant College Program
Ohio Sea Grant College Program
University of Connecticut
The Ohio State University
Maryland Sea Grant College
Taliaferro Hall, University of
Delaware Sea Grant College Program
Oregon Sea Grant College Program
Maryland
University of Delaware
Oregon State University
College Park, Maryland 20742
Florida Sea Grant College
(301) 405-6371
Puerto Rico Sea Grant College Program
University of Florida
University of Puerto Rico
Hawaii Sea Grant College Program
Georgia Sea Grant College Program
Rhode Island Sea Grant College Program
University of Hawaii
University of Georgia
Honolulu, Hawaii 96822
University of Rhode Island
(808) 956-7031
Hawaii Sea Grant College Program
South Carolina Sea Grant Consortium
University of Hawaii
University of South Carolina
Photography and art credits: Skip
Illinois-Indiana Sea Grant Program
Texas Sea Grant College Program
Brown, cover and pp. 1,3,8,9 (right),
University of Illinois
Texas A&M University
17,20,22-24,30 and 32; Reginal Harrell, pp.
2 and 14; Mike Reber, p. 5; National
Louisiana Sea Grant College Program
Virginia Sea Grant College Program
Oceanic and Atmospheric Administration
Louisiana State University
University of Virginia
(NOAA), pp. 6,11 (right), and 27;
Maine/New Hampshire Sea Grant
Timothy K. Maugel, pp. 7 and 13;
Washington Sea Grant College Program
College Program
Maryland Biotechnology Institute, pp. 9
University of Washington
(left) and 10; Gene Small, p. 11 (left);
University of Maine
Scott Forbes, p. 12; Tim Keating,
University of New Hampshire
Wisconsin Sea Grant Institute
p. 15; Chris D'Elia, p. 16; Norm Pruitt, p.
University of Wisconsin
18; Dennis Drenner, p. 19 (top); Steve
Maryland Sea Grant College Program
Coon, p. 19 (bottom); Sandy Harpe, pp.
University of Maryland System
Woods Hole Oceanographic Institution Sea
21 and 31; Ronald Weiner, p. 25 (left);
Grant Program
Massachusetts Sea Grant College Program
Charles Ramcharan, p. 25 (left); Susan
Woods Hole Oceanographic Institution
Foster, p. 26 (top and bottom); and
Massachusetts Institute of Technology
Michael W. Fincham, p. 28.
Michigan Sea Grant College Program
For information about Sea Grant, contact:
University of Michigan
Design by Sandy Harpe and
National Sea Grant College Program
Bremmer & Goris Communications, Inc.
Minnesota Sea Grant Program
NOAA, Sea Grant, R/OR1
University of Minnesota
1335 East-West Highway
This Sea Grant Initiative was
Mississippi/Alabama Sea Grant Consortium
Silver Spring, Maryland 20910-3226
coordinated by the Maryland Sea
University of Mississippi
Grant College.
AND
AT
AND
the
52
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CANADA
OF
OF
OF
OF
"Document Control for Division of Life Sciences"
ACTION
DOCUMENT NUMBER: 9203625
ATOR: 02
STATUS I
DIRECTORATE STATUS C
1:
CURIEN, Hubert: MINISTER OF SCIENCE, FRANCE
'O:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 12/04/92
SUBJECT: HE IS FORWARDING THE NAME OF SOMEONE TO CONTRIBUTE
TO OTA'S STUDY OF THE PATENTABILITY OF THE HUMAN
GENOME.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED: Clifford J. Gabriel
ACTION
STAFF
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ACTION: AS NECESSARY
SENDER'S DUE DATE:
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STAFF DUE DATE
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DATE COMPLETED:
DATE COMPLETED/DEPT: 12/23/92
COPIES TO: D. Allan Bromley
INTERNATIONAL/POLICY
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS:
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DEPT RECEIVED: 12/22/92
FILE: P-LIFE SCIENCES
CENTRAL FILES:
"Document Control for Division of Life Sciences"
ACTION
DOCUMENT NUMBER: 9203625
ATOR: 02
STATUS I
DIRECTORATE STATUS C
1:
CURIEN, Hubert: MINISTER OF SCIENCE, FRANCE
'O:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 12/04/92
SUBJECT: HE IS FORWARDING THE NAME OF SOMEONE TO CONTRIBUTE
TO OTA'S STUDY OF THE PATENTABILITY OF THE HUMAN
GENOME.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED: Clifford J. Gabriel
ACTION
STAFF
REQUIRED: AS NECESSARY
ACTION: AS NECESSARY
SENDER'S DUE DATE:
OSTP DUE DATE:
12/31/92
STAFF DUE DATE
12/31/92
DATE COMPLETED:
DATE COMPLETED/DEPT:
12/23/92
COPIES TO: D. Allan Bromley
INTERNATIONAL/POLICY
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS:
OSTP RECEIVED: 12/18/92
DEPT RECEIVED: 12/22/92
FILE: P-LIFE SCIENCES
CENTRAL FILES:
THE WHITE HOUSE
WASHINGTON
December 23, 1992
Dear Huburt Minister Curien:
Thank you for submitting the name of Monsieur Philippe Lazar as a potential
French contact for the OTA project on patenting human DNA sequences. I have
forwarded this information to Dr. Robyn Nashimi, OTA Project Director for this
activity.
Sincerely yours,
Duan
D. Allan Bromley
The
Assistant
to
the
President
The Honorable Hubert
Minister of
Research
1 rue Descartes
75005 Paris
France
and Curien Technology Science superbly and for Technology beat new
was and The very Duen
years
REPUBLIQUE
FRANCAISE
3625
MINISTERE
DE LA RECHERCHE
LE MINISTRE
ET DE L'ESPACE
20752/C
Paris, le :
4 DEC. 1992
Dear Allan,
Thank you very much for the information you sent me in
your letters dated October 5th and October 28th on the
patentability of genome fragments.
As regard the study conducted by OTA, I recommend you to
get in touch with :
Monsieur Philippe LAZAR
Directeur Général de l'Institut
National de la Santé et de la
Recherche médicale
101, rue de Tolbiac
75654 PARIS CEDEX 13
Tél. : 44 23 60 00
I look forward to meeting you soon in Rambouillet.
Can
Hubert CURIEN
M. Allan BROMLEY
Assistant du Président
pour la science et la technologie
Maison Blanche
Hold Executive Office Bulding
WASHINGTON DC - 20106 USA
1, rue Descartes, 75005 PARIS. Tél.: 46.34.
Mary
"Document Control for Division of Life Sciences"
TYPE:
ACTION
DOCUMENT NUMBER: 9203557
ORIGINATOR: 02
STATUS I
DIRECTORATE STATUS C
FROM:
LANG, Serge: YALE UNIVERSITY
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 11/30/92
SUBJECT: HE IS WRITING REGARDING THE HANDLING OF THE GALLO
CASE.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED: D.A. Henderson
ACTION
STAFF
REQUIRED: AS NECESSARY
ACTION: Necessary Action
SENDER'S DUE DATE:
OSTP DUE DATE:
12/23/92
STAFF DUE DATE
12/23/92
DATE COMPLETED:
DATE COMPLETED/DEPT: 12/15/92
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS: Response from OSTP would be inappropriate and not necessary, per
DAH. Close out record.
1
OSTP RECEIVED: 12/09/92
DEPT RECEIVED: 12/14/92
FILE: P-LIFE SCIENCES
CENTRAL FILES:
Withdrawal/Redaction Sheet
(George Bush Library)
Document No.
Subject/Title of Document
Date
Restriction
Class.
and Type
01. Letter w/
To: Distribution List From: Serge Lang
11/30/92
(b)(7c), (b)(2)
attachments
Re: Handling of the Gallo Investigation (14 pp.)
Collection:
Record Group:
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Office:
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Series:
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Subseries:
General Science Files
WHORM Cat.:
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Life Sciences: General [2 of 7] [1992]
Date Closed:
3/15/2010
OA/ID Number:
62038-006
FOIA/SYS Case #:
2005-0336-F
Appeal Case #:
Re-review Case #:
Appeal Disposition:
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(b)(1) National security classified information [(b)(1) of the FOIA]
P-2 Relating to the appointment to Federal office [(a)(2) of the PRA]
(b)(2) Release would disclose internal personnel rules and practices of an
P-3 Release would violate a Federal statute [(a)(3) of the PRA]
agency [(b)(2) of the FOIA]
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(b)(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
(b)(4) Release would disclose trade secrets or confidential or financial
P-5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
(b)(6) Release would constitute a clearly unwarranted invasion of
P-6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
(b)(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed of
(b)(8) Release would disclose information concerning the regulation of
gift.
financial institutions [(b)(8) of the FOIA]
(b)(9) Release would disclose geological or geophysical information
PRM. Removed as a personal record misfile.
6 -SCIENCE & GOVERNMENT REPORT
© October 1, 1992
Medical Editor Axes Dingell's Remarks About Gallo
Two dreadnoughts accustomed to having their own way,
report these deaths to NIH as required by grant regulations and
-The New England Journal of Medicine (NEJM) and Rep.
erroneously reported in The Lancet that he had observed no adverse
John Dingell (D-Mich.), have been scrapping over the
reactions in the human subjects. Dr. Gallo again had an explana-
journal's insistence on deleting comments about the Gallo
tion. He explained that the statement in The Lancet was an
case from the published version of a lecture, "Misconduct in
inadvertent error, and his failure to comply with NIH procedure
Medical Research," delivered last May by Dingell.
was a result of his unfamiliarity with the regulations, despite some
The Congressional flagellator of scientific ethics and the
20 years of employment at NIH.
nation's leading medical journal are in dispute as a result of
More recently, in the controversy over the AIDS blood test, Dr.
an invitation for Dingell to deliver the Shattuck Lecture at
Gallo first stated that the virus he used was definitely different
from that used by the competing French team. When genetic
the annual meeting of the Massachusetts Medical Society,
sequencing proved that the viruses were identical, Dr. Gallo
publisher of the NEJM. Jerome B. Kassirer, Editor of the
suggested that the French must have taken his virus. When that
Journal, nominated Dingell for the lecture, established in
claim was challenged, Dr. Gallo explained that there must have
1890, and usually published in the NEJM; and, ironically, it
been an inadvertent contamination in his laboratory. Meanwhile,
is Kassirer who insists on sanitizing Dingell's text, though
there were also questions about the cell-line in which Dr. Gallo
the editor, in a post-lecture letter to Dingell, commented that
grew his viruses. Initially, Dr. Gailo seemed to suggest that the
"Your point of view, as espoused in the manuscript, is far
cell-line was his own development. It eventually emerged that the
more moderate than others have painted it...."
cell-line belonged to Dr. Adi Gazdar, a researcher at another NIH
In the lecture, Dingell repeated his often-expressed
institute. Dr. Gallo explained that this was a misunderstanding,
assertion that the scientific community is reluctant to police
that he never intended to deprive Dr. Gazdar of credit, but merely
renamed the cell-line for convenience.
itself against scientific misconduct, which, he said, robs the
taxpayers and deprives legitimate scientists of support.
This is a deeply troubling case. An eminent scientist who heads
Numerous incidents of scientific fabrication and plagiarism
one of the most important laboratories in the world is embroiled in
so many instances of inadvertent errors, miscommunications, and
have been spotlighted by his Subcommittee on Oversight
unfortunate coincidences. We understand that the NIH itself
and Investigations, Dingell continued. In response, he said,
receives millions of dollars each year in royalties from the blood
his motives "have been misrepresented, particularly by
test, but that should be no impediment to NIH's objectively
persons who have everything to lose from the truth For
a
assisting Dr. Gallo in resolving his difficulties.
time, we were excoriated as a band of philistines incapable
of understanding science and as a troop of inquisitors en-
In a letter to Dingell dated June 1 concerning publication
gaged in a senseless witch hunt." Dingell then summarized
of the lecture, NEJM Editor Kassirer stated, "As I men-
some of the more pungent investigations of recent times,
tioned to you immediately after the lecture, I have taken the
including that of Robert C. Gallo, the NIH virologist, whose
liberty of deleting your comments about Robert Gallo. First,
claimed roles in the identification of the AIDS virus and the
in all the others [cases described in the lecture], fraudulent
development of the AIDS blood test have spawned nasty
material has been retracted in print. Second, the principal al-
disputes and a long-running federal investigation.
legations against Gallo are based on apparent coincidences,
About Gallo, the following is verbatim from Dingell's
misunderstandings, and inadvertent errors. While these al-
Shattuck Lecture text:
legations embellish the case you make, they have not been
Finally, there is the matter of Dr. Robert C. Gallo, the NIH's
shown to constitute overt fraud. Third, the Gallo case has
world-famous AIDS researcher. Because the Subcommittee has
been exhaustively covered in Science, and repetition of
not yet completed its investigation, I cannot tell you what our
these allegations seems superfluous." Referring to institu-
conclusion will be. I can say, however, that one of the things that
tions criticized by Dingell in his discussion of scientific
puzzles and troubles us is the large number of unusual misunder-
misconduct, Kassirer added: "In a spirit of fairness, I will
standings and coincidences in which Dr. Gallo appears to be
be offering officials at Harvard, Tufts, MIT, Pittsburgh, and
entangled.
NIH an opportunity to submit short replies in the correspon-
After Dr. Zaki Salahuddin, one of his longtime laboratory
dence section that will appear in the same issue as your
scientists, was convicted of a felony in connection with his
lecture."
activities at Dr. Gallo's laboratory, Dr. Gallo explained that he had
been unaware of Dr. Salahuddin's activities. In short order, Dr.
Responding to Kassirer in a letter dated August 14,
Prem Sarin, Dr. Gallo's Deputy Laboratory Chief, was indicted for
Dingell stated: "My understanding is that the printed lecture
activities unrelated to those of Dr. Salahuddin but also stemming
is supposed to reflect the lecture actually delivered, with
from work at the laboratory. Dr. Gallo explained that he knew
only minor changes I am concerned that your comments
nothing of his Deputy Laboratory Chief's misconduct and that
relative to the Gallo issue may reflect a misunderstanding of
these two separate criminal cases involving his laboratory were
the facts and circumstances. For example, your statement
unfortunate coincidences.
that 'the principal allegations against Gallo are based on
Then we learned that two human subjects described in an
apparent coincidences, misunderstandings, and inadvertent
article coauthored in The Lancet by Dr. Gallo and French re-
errors' is erroneous; at most, one might say that 'the princi-
searcher Dr. Daniel Zagury had died, but that Dr. Gallo failed to
(Continued on Page 7)
October 1, 1992
SCIENCE & GOVERNMENT REPORT-7
Kassirer Says Lawyers Advised Him to Edit Dingell
(Continued from Page 6)
pal allegations against Gallo are based on what Gallo claims
are coincidences, misunderstandings, and inadvertent er-
rors.' I have made some minor adjustments in the text to
clarify the distinction," Dingell wrote, and then proceeded
to another matter.
"Additionally," Dingell wrote, "your point that 'in all
the others fraudulent material has been retracted in print'
also appears to reflect a misimpression. In the Cleveland
Clinic case [discussed in Dingell's lecture], no retraction has
ever been printed, and in the [David] Baltimore case, Dr.
Baltimore has recently expressed an intention to retract his
retraction. On the other hand, there has been at least one
significant printed retraction in the Gallo case. Dr. Gallo has
retracted in print his initially vehement claim that his virus
was independent of the Institut Pasteur's (although he con-
tinues to deny any wrongful intent in his appropriation of the
Pasteur virus)."
Dingell conceded Kassirer's prerogative to edit the lec-
ture, but noted that "I hope you would understand that I
would want to reserve the option of writing a letter to the
editor or otherwise expressing my disagreement." Noting
Kassirer's invitation for responses to the published lecture to
appear in the same issue, Dingell wrote that "my under-
standing is that the Journal' normal practice is to publish an
article and then at some future point to publish responses
together with the author's reply to the critiques."
In a response dated September 1, "enclosing our final
revision," Kassirer stated, "you will note that I have deleted
the material about Gallo as I described in my first letter.
Because I had concerns about this part of your address from
the beginning, I submitted it to the Massachusetts Medical
Society's lawyers, and they concurred that it would be best
from a legal standpoint to drop this section Needless to
say, you would be free to submit a letter to the editor to
protest this deletion." Kassirer added, "I have not sent a
copy of your manuscript to any of the institutions named in
your manuscript, and I will honor your request not to do so.
To Order or Renew
We will, as you request, follow the normal practice of
Science & Government Report
publishing the paper and then at a future time publish the
Northwest Station, Box 6226A
responses along with your reply." If corrections and refer-
Washington, D.C. 20015
ences are promptly supplied, he concluded, "we will have
Renew my subscription;
Check enclosed
the lecture out before the end of the year."
The reported legal advice is puzzling, given that the
Enter my subscription;
Please Bill
Gallo controversies have long been on the public stage,
Institutional subscribers: one year, $395.00
;
two years, $670.00
including a Congressional hearing. In fact, virtually every-
thing Dingell said about Gallo has previously appeared in
(Foreign airmail, $35.00 per year, foreign surface $15.00
per year additional.)
print, as editor Kassirer noted in observing that "the case has
been exhaustively covered in Science"-as well as, he
Name
might have added, in other publications.
Address
In his bumbling venture into censorship, Kassirer has
Zip
denied his readers the views of a Congressman with exten-
sive power in biomedical affairs, and nourished Mr. Din-
Toll-Free Subscription Service: 1-800-522-1970;
gell's dark suspicions of establishment institutions.-DSG
In Wash., D.C.: 785-5054
Withdrawal/Redaction Sheet
(George Bush Library)
Document No.
Subject/Title of Document
Date
Restriction
Class.
and Type
02. Cover sheet
To: Allan Bromley From: Kevin O'Neill
9/28/92
(b)(6)
& Letter
Re: Assistance with securing work visa for client [personal
information redacted] (2 pp.)
Collection:
Record Group:
Bush Presidential Records
Office:
Science and Technology Policy, Office of (OSTP)
Series:
Bromley, D. Allan, Files
Subseries:
General Science Files
WHORM Cat.:
File Location:
Life Sciences: General [2 of 7] [1992]
Date Closed:
3/15/2010
OA/ID Number:
62038-006
FOIA/SYS Case #:
2005-0336-F
Appeal Case #:
Re-review Case #:
Appeal Disposition:
P-2/P-5 Review Case #:
Disposition Date:
AR Case #:
MR Case #:
AR Disposition:
MR Disposition:
AR Disposition Date:
MR Disposition Date:
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act [5 U.S.C. 552(b)]
P-1 National Security Classified Information [(a)(1) of the PRA]
(b)(1) National security classified information [(b)(1) of the FOIA]
P-2 Relating to the appointment to Federal office [(a)(2) of the PRA]
(b)(2) Release would disclose internal personnel rules and practices of an
P-3 Release would violate a Federal statute [(a)(3) of the PRA]
agency [(b)(2) of the FOIA]
P-4 Release would disclose trade secrets or confidential commercial or
(b)(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
(b)(4) Release would disclose trade secrets or confidential or financial
P-5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
(b)(6) Release would constitute a clearly unwarranted invasion of
P-6 Release would constitute a clearly unwarranted invasion of
personal privacy [(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
(b)(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed of
(b)(8) Release would disclose information concerning the regulation of
gift.
financial institutions [(b)(8) of the FOIA]
(b)(9) Release would disclose geological or geophysical information
PRM. Removed as a personal record misfile.
TYPE:
ACTION
DOCUMENT NUMBER: 9203477
ORIGINATOR: 02
STATUS I
DIRECTORATE STATUS C
FROM:
KELLOGG, DONNA J.: NORTHWESTERN UNIVERSITY MEDICAL SCHOOL
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 11/12/92
SUBJECT: SOLICITS DAB'S ASSISTANCE IN ENSURING THE CONTINUED
PARTICIPATION OF THE NATIONAL INSTITUTES OF HEALTH
IN THE DEMONSTRATION PROJECT
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED:
ACTION
STAFF
REQUIRED: AS NECESSARY
ACTION:
SENDER'S DUE DATE:
OSTP DUE DATE:
12/07/92
STAFF DUE DATE
DATE COMPLETED:
DATE COMPLETED/DEPT: 11/25/92
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS: Dr. Raub sent a response, dated 11/25/92, to an identical
letter, also dated 11/12/92, addressed to him from Kellogg;
therefore, this has been handled for OSTP. Close out record.
OSTP RECEIVED: 11/20/92
DEPT RECEIVED: 12/01/92
FILE: P-LIFE SCIENCES
CENTRAL FILES:
Many
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF SCIENCE AND TECHNOLOGY POLICY
WASHINGTON, D.C. 20506
November 25, 1992
Dear Ms. Kellogg:
Thank you for your letter to me regarding the decision by the National Institutes of Health
(NIH) to discontinue its participation in one of the activities of the Federal Demonstration
Project (FDP), i.e., the trial of a simplified application procedure for noncompeting
continuation grants. Your disappointment at this turn of events is understandable, for the
procedures by which agencies of the federal government handle noncompeting renewal
awards undoubtedly include unnecessary and unproductive administrative requirements and
therefore are an appropriate focus for an FDP initiative. Nevertheless, having discussed
the matter at length with some of my NIH colleagues, I recognize that their decision, made
in conjunction with higher-level officials of the Department of Health and Human Services
(DHHS), has a strong supporting rationale.
As I understand the issue, the crux of the problem is that the streamlined FDP procedure
for noncompeting renewals has failed to win strong support among the NIH funding units.
My colleagues report widespread concern among program- and grants-management staff
because the noncompeting renewal procedure now being tested does not generate all the
information they believe they need to fulfill their stewardship responsibilities. This
conclusion in turn has reinforced misgivings that senior DHHS policy officials have held
since this particular trial first was proposed. Whereas many of us hoped that real-world
experience with the streamlined procedure might allay the early concerns, the opposite has
proved true.
Under the circumstances, with so many key staff at several different levels of DHHS
disinclined to endorse the streamlined renewal process, I see no chance that the Department
will adopt it as standard policy. Further pursuit of this particular FDP activity as
currently designed therefore is likely to be an unproductive expenditure of energy,
resources, time, and good will. Regrouping and reassessing the issue in the light of the
concerns generated by the trial seems the better course.
2
I view this setback as unfortunate but far from lethal for FDP. The NIH decision neither
tarnishes the other FDP achievements nor diminishes the importance of our fundamental
goals. For my part, I will continue to be an advocate for FDP, as will many of my
colleagues. That will include searching for a broadly acceptable way to address anew how
we might make the noncompeting renewal process more efficient for both parties without
an actual or perceived compromise of stewardship.
Sincerely yours,
William 7 Paul
William F. Raub, Ph.D.
Special Assistant for Health Affairs
Ms. Donna J. Kellogg
Manager of Operations
Department of Cell, Molecular,
and Structural Biology
Northwestern University Medical School
303 East Chicago Avenue
Chicago, Illinois 60611-3008
Northwestern University Medical School
RECEIVED
Department of Cell, Molecular,
III
and Structural Biology
92 NOV 20 P12 26
Ward Building
303 East Chicago Avenue
Chicago, Illinois 60611-3008
(312) 503-8250
OSTP
Fax (312) 503-7912/4516
MAIL ROOM
November 12, 1992
D. Allen Bromley
Assistant to the President for Science and Technology
Old Executive Office Building
Room 358
1600 Pennsylvania Avenue, N.W.
Washington, DC 20500
Dear Mr. Bromely:
I write to solicit your assistance in ensuring the continued
participation of the National Institutes of Health in the
noncompeting continuation demonstration of the Federal
Demonstration Project (FDP). The continuation of this
demonstration, with full participation of the National Institutes
of Health, is consistent with the President's January 28, 1992
Memorandum for Certain Department and Agency Heads on the subject
of "Reducing the Burden of Government Regulations".
As you may know, the FDP was initiated in 1988 to help
eliminate unnecessary administrative burdens on sponsored research
and thereby enhance the research productivity of the United States.
The noncompeting continuation pilot of the Federal Demonstration
Project, initiated July 15, 1990, allowed participating federal
agencies to issue out year funding commitments based upon an annual
progress report. Some of the participating agencies, due to legal
requirements or major procedural disruption, continued the
requirement for a cover page. Other documentation was required
only if significant changes occurred in the size or scope of a
project.
A recent survey of the 1,092 researchers impacted by the
noncompeting application process perhaps best demonstrates its
importance. Overall, 1092 researchers reported time savings of
2.26 days under the noncompeting continuation demonstration of the
FDP. Collectively, researchers saved 2464 days, with 90 percent of
those days reinvested to scholarly activities. To provide another
perspective on these "time reinvestments", it can be said that the
study documents a total of 8.5 person-years of additional scholarly
activities. Further applying these rates of return, it is possible
to project that the overall additional investment in research
activity made possible by FDP was roughly eighteen person years of
research.
The McGaw Medical Center of Northwestern University
Page 2
I appreciate your efforts in ensuring the continuation of this
project of demonstrated importance to the academic community and
the nation's research enterprise.
Sincerely
Donna J. Kellogg
Manager of Operations
DJK:cb
"Document Control"
TYPE:
INFORMATION
DOCUMENT NUMBER: 9203493
ORIGINATOR: 02
STATUS C
DIRECTORATE STATUS
FROM:
STEWART, WILLIAM D.P.: CHIEF SCIENCE ADVISOR, UK
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 11/09/92
SUBJECT: A THANK YOU FOR YOUR LETTER OF OCTOBER 27TH AND
ASSURANCE THAT YOU WILL RECEIVE A COPY OF THE UK'S
REGULATIONS ONCE FINALISED.
DIRECTORATE
STAFF
ASSIGNED:
ASSIGNED:
ACTION
STAFF
REQUIRED:
ACTION:
SENDER'S DUE DATE:
OSTP DUE DATE:
STAFF DUE DATE
DATE COMPLETED:
DATE COMPLETED/DEPT:
COPIES TO: D. Allan Bromley
LIFE SCIENCES
INTERNATIONAL/POLICY
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS:
OSTP RECEIVED: 12/02/92
DEPT RECEIVED:
FILE: P-LIFE SCIENCES
CENTRAL FILES:
3493
received
MON
CABINET OFFICE
92 DEC / P12: 13
Office of Public Service and Science
OFFICE OF SCIENCE AND TECHNOLOGY
OSTP
70 Whitehall, London SW1A 2AS
MAIL ROOM
Telephone: 071-270 0259 Facsimile:071-270 0616
From the Chief Scientific Adviser and Head of Office
Professor William D.P. Stewart, FRS, FRSE
W0707
Dr Allan Bromley
Assistant to the President
for Science and Technology
The White House
Washington
USA
9 November 1992
Dear Allan,
Thank you for your letter of 27 October. I am pleased to hear
that the US biotechnology regulatory oversight mechanisms are
evolving to the risk-based philosophy established by the Office
of Science and Technology Policy, and I am grateful to you for
sending me a copy of their scope document.
As you noted, significant effort has been put into restructuring
the UK GMO regulations and there is now a general consensus that
previous concerns over the lack of clarity have been
appropriately addressed. Although the regulations are process
based, the EC regime makes provision for GMO products to be
considered under product legislation once risk assessment
procedures equivalent to that in the Deliberate Release Directive
have been incorporated, and the UK will continue to pursue this
policy.
I will ensure that you receive a copy of the UK's regulations
once they have been finalised, and look forward to our continued
efforts to work towards the international harmonization of
biotechnology regulations.
Best writes
your and
Bui.
PROFESSOR WILLIAM D P STEWART
"Document Control"
TYPE:
ACTION
DOCUMENT NUMBER: 9203526
ORIGINATOR: 02
STATUS I
DIRECTORATE STATUS
FROM:
IANNACCONE, Philip M.: NORTHWESTERN UNIVERSITY
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 11/05/92
SUBJECT: HE IS WRITING TO SOLICIT DR. BROMLEY'S ASSISTANCE IN
ENSURING THE CONTINUED PARTICIPATION OF THE NATIONAL
INSTITUTES OF HEALTH IN THE FEDERAL DEMONSTRATION
PROJECT.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED:
ACTION
STAFF
REQUIRED: DIRECT REPLY
ACTION:
SENDER'S DUE DATE:
OSTP DUE DATE:
12/16/92
STAFF DUE DATE
DATE COMPLETED:
DATE COMPLETED/DEPT:
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS:
OSTP RECEIVED: 12/02/92
DEPT RECEIVED:
FILE: P-LIFE SCIENCES
CENTRAL FILES:
3526
Northwestern University Medical School
Markey Program in
III
Developmental Biology
303 East Chicago Avenue
Chicago, Illinois 60611-3008
(312) 503-5232
Philip M. Iannaccone, MD, DPhil
Director
November 5, 1992
D. Allan Bromley
Assistant to the President for Science and Technology
Old Executive Office Building
Room 358
1600 Pennsylvania Avenue, N.W.
Washington, DC 20500
Dear Mr. Bromley,
I write to solicit your assistance in ensuring the continued participation of the National
Institutes if Health in the noncompeting continuation demonstration of the Federal
Demonstration Project (FDP). The continuation of the demonstration, with full
participation of the National Institutes of Health, is consistent with the President's January
28, 1992 Memorandum for Certain Department and Agency Heads on the subject of
"Reducing the Burden of Government Regulations".
As you may know, the FDP was initiated in 1988 to help eliminate unnecessary
administrative burdens on sponsored research and thereby enhance the research
productivity of the United States. The noncompeting agencies to issue out year funding
commitments based upon annual progress report. Some of the participating agencies, due
to legal requirements or major procedural disruption, continued the requirement for a cover
page. Other documentation was required only if significant changes occurred in the size or
scope of a project.
A recent survey of the 1,092 researchers impacted by the noncompeting application process
perhaps best demonstrates its importance. Overall, 1,092 researchers reported time savings
of 2.26 days under the noncompeting continuation demonstration of the FDP. Collectively,
researchers saved 2464 days, with 90 percent of those days reinvested in scholarly activities.
To provide another perspective on these "time reinvestments", it can be said that the study
documents a total of 8.5 person-years of additional scholarly activities. Further applying
these rates of return, it is possible to project that the overall additional investment in
research activity made possible by FDP was roughly eighteen person years of research.
I appreciate your efforts in ensuring the continuation of this project of demonstrated
importance to the academic community and the nation's research enterprise.
Sincerely,
Philip and M. Iannaccone
Professor
PMI/sb
The McGaw Medical Center of Northwestern University
Mary
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF SCIENCE AND TECHNOLOGY POLICY
WASHINGTON, D.C. 20506
November 25, 1992
Dear Dr. Iannaccone:
Thank you for your letter to me regarding the decision by the National Institutes of
Health (NIH) to discontinue its participation in one of the activities of the Federal
Demonstration Project (FDP), i.e., the trial of a simplified application procedure for
noncompeting continuation grants. Your disappointment at this turn of events is
understandable, for the procedures by which agencies of the federal government handle
noncompeting renewal awards undoubtedly include unnecessary and unproductive
administrative requirements and therefore are an appropriate focus for an FDP
initiative. Nevertheless, having discussed the matter at length with some of my NIH
colleagues, I recognize that their decision, made in conjunction with higher-level officials
rationale. of the Department of Health and Human Services (DHHS), has a strong supporting
As I understand the issue, the crux of the problem is that the streamlined FDP
procedure for noncompeting renewals has failed to win strong support among the NIH
funding units. My colleagues report widespread concern among program- and grants-
management staff because the noncompeting renewal procedure now being tested does
not generate all the information they believe they need to fulfill their stewardship
responsibilities. This conclusion in turn has reinforced misgivings that senior DHHS
policy officials have held since this particular trial first was proposed. Whereas many of
us hoped that real-world experience with the streamlined procedure might allay the early
concerns, the opposite has proved true.
Under the circumstances, with so many key staff at several different levels of DHHS
disinclined to endorse the streamlined renewal process, I see no chance that the
Department will adopt it as standard policy. Further pursuit of this particular FDP
activity as currently designed therefore is likely to be an unproductive expenditure of
energy, resources, time, and good will. Regrouping and reassessing the issue in the light
of the concerns generated by the trial seems the better course.
2
I view this setback as unfortunate but far from lethal for FDP. The NIH decision neither
tarnishes the other FDP achievements nor diminishes the importance of our fundamental
goals. For my part, I will continue to be an advocate for FDP, as will many of my
colleagues. That will include searching for a broadly acceptable way to address anew how
we might make the noncompeting renewal process more efficient for both parties without
an actual or perceived compromise of stewardship.
Sincerely yours,
Bill Baul
William F. Raub, Ph.D.
Special Assistant for Health Affairs
Dr. Philip M. Iannaccone
Professor
Markey Program in Developmental
Biology
Northwestern University Medical School
303 East Chicago Avenue
Chicago, Illinois 60611-3008
"Document Control"
TYPE:
INVITATION
DOCUMENT NUMBER: 9203616
ORIGINATOR: 02
STATUS C
DIRECTORATE STATUS
FROM:
MORI, Wataru: COUNCIL FOR SCIENCE AND TECHNOLOGY, JAPAN
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 11/14/92
SUBJECT: HE IS FORWARDING A COPY OF RTHEIR REPORT "GUIDELINES
FOR RECOMBINANT DNA EXPERIMENT".
DIRECTORATE
STAFF
ASSIGNED:
ASSIGNED:
ACTION
STAFF
REQUIRED:
ACTION:
SENDER'S DUE DATE:
OSTP DUE DATE:
STAFF DUE DATE
DATE COMPLETED:
DATE COMPLETED/DEPT:
COPIES TO: D. Allan Bromley
LIFE SCIENCES
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS: ENCLOSURES TO DAB.
OSTP RECEIVED: 12/07/92
DEPT RECEIVED:
FILE: P-LIFE SCIENCES
CENTRAL FILES:
3616
PRIME MINISTER'S
COUNCIL FOR SCIENCE AND TECHNOLOGY
Kasumigaseki 2/2/1, Chiyoda-ku, Tokyo, 100 JAPAN
Phone:(81)(3) 3581 1357, Fax:(81)(3) 3581 3079
November 14,1992
Dr. D. Allan Bromley
The Assistant to the President
for Science and Technology
The White House
Washington, D.C., USA
Dear Allan:
I am enclosing with this letter "Guidelines for Recombinant DNA
Experiment", which has been translated into English recently. I hope
it would be of use to you.
I am looking forward to seeing you again in December in France.
Sincerely yours,
Watam
Wataru Mori
Member of
Council for Science and Technology
TYPE:
ACTION
DOCUMENT NUMBER: 9203623
ORIGINATOR: 02
STATUS I
DIRECTORATE STATUS
FROM:
RIESENHUBER, Heinz: MINISTER FOR SCIENCE AND TECHNOLOGY,
GERMANY
TO:
DR. D.A. BROMLEY
DATE OF
city
CORRESPONDENCE: 11/02/92
SUBJECT: RE: THE PATENTABILITY OF GENOME SEQUENCES.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED:
ACTION
STAFF
REQUIRED: AS NECESSARY
ACTION:
SENDER'S DUE DATE:
OSTP DUE DATE:
12/30/92
STAFF DUE DATE
DATE COMPLETED:
DATE COMPLETED/DEPT:
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS:
OSTP RECEIVED: 12/17/92
DEPT RECEIVED: 02/23/32
FILE: P-LIFE SCIENCES
CENTRAL FILES:
Der Bundesminister
für Forschung und Technologie
5300 Bonn 2, November 26, 1992
Heinemannstraße 2
Fernruf (02 28) 590 oder 59-
Teletex 22 83 628 = BMFTb
Dr. D. Allan Bromley
Assistant to the President
for Science and Technology
The White House
Translation
Washington D.C.
USA
Dear Allan:
Thank you very much for your letters of October 5 and 28, 1992.
I have noted with interest that the US Patent and Trademark Office does not
permit patentability of genome sequences of unknown function. As you are
aware, this attitude corresponds to my own opinion in the ongoing
controversial discussion.
Thank you, too, for forwarding me the first project description. I eagerly
await the study to be drawn up by the Congressional Office of Technology
Assessment on the subject of the patentability of genome sequences. I
would be very interested to learn more about this when we meet in
Rambouillet. : consider it important that scientists from other countries aiso
be involved in this study.
With regard to the question who can be called upon to contribute to this
report on the German side, deliberations and discussions are still in progress.
- 2
As soon as a relevant decision has been taken you will be informed via the
German Embassy in Washington of the names of the German experts
selected.
Sincerely yours,
signed: Dr. Heinz Riesenhuber
Der Bundesminister
für Forschung und Technologie
5300 Bonn 2, 26.11.1992
Heinemannstraße 2
Fernruf (02 28) 590 oder 59-3407
Teletex 22 83 628 = BMFTb
Herrn
Dr. D. Allan Bromley
Assistent to the President
for Science and Technology
The White House
Washington D.C. / USA
Year
Alle,
vielen Dank für Ihre Briefe vom 5. und 28. Oktober 1992.
Ich habe mit Interesse davon Kenntnis genommen, daß das "Patent and
Trademark Office" eine Patentierbarkeit von Gensequenzen unbekannter
Zweckbestimmung ablehnt. Wie Sie wissen, entspricht dies auch meiner
Auffassung in der kontrovers geführten Diskussion.
Ich danke Ihnen auch für die Übersendung der ersten Projektbeschreibung
und sehe der Studie des "Congressional Office of Technology Assessment"
zur Patentierbarkeit von Gensequenzen mit großem Interesse entgegen. Es
würde mich freuen, bei unserem Treffen in Rambouillet näheres darüber zu
hören. Ich halte es für wichtig, daß an dieser Untersuchung auch Wissen-
schaftler anderer Länder beteiligt werden.
Zu Ihrer Frage, wer auf deutscher Seite zu diesem Bericht beitragen kann,
sind derzeit noch Überlegungen und Gespräche im Gange. Sobald eine Ent-
scheidung getroffen ist, werden Ihnen die Namen der deutschen Experten
über die Botschaft in Washington mitgeteilt.
Mit freundlichen Grüßen
Dr Heinz Riesenhuber
THE WHITE HOUSE
WASHINGTON
December 23, 1992
Dear Riesenhuber:
Minister wang
Your Science Counselor at the German Embassy in Washington, D.C.,
Dr. Klaus Schroeter, submitted the names of Professors Joseph Straus, and
Walter Dorfler as potential German contacts for the OTA project on patenting
human DNA sequences. Thank you for this information. I have forwarded this
information to Dr. Robyn Nashimi, ota Project Director for this activity.
Sincerely yours,
D. Nan Allan Bromley
The Assistant to the President
for
Science and Technology
The Honorable Heinz Riesenhuber
Minister of Science and Technology
Federal Republic of Germany
5300 Bonn 2
Heinemannstrasse 2
Happy and
Germany
TYPE:
ACTION
DOCUMENT NUMBER: 9203623
ORIGINATOR: 02
STATUS I
DIRECTORATE STATUS
FROM:
RIESENHUBER, Heinz: MINISTER FOR SCIENCE AND TECHNOLOGY,
GERMANY
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 11/02/92
SUBJECT: RE: THE PATENTABILITY OF GENOME SEQUENCES.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED:
ACTION
STAFF
REQUIRED: AS NECESSARY
ACTION:
SENDER'S DUE DATE:
OSTP DUE DATE:
12/30/92
STAFF DUE DATE
DATE COMPLETED:
DATE COMPLETED/DEPT:
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS:
OSTP RECEIVED: 12/17/92
DEPT RECEIVED:
FILE: P-LIFE SCIENCES
CENTRAL FILES:
SU
FAX:
MAIL:
OSTP #:
Date of Correspondence:
11/2
Date of Receipt of Correspondence: 12/17
From: Dr Heing Riesenhabe
Affiliation: germany minister of S&T
Subject: patentability 8 genome sequences
Action:
FYI:
Assign to: DLS
Due Date:
Copies to: Tom Ratchford DAB
I think a fax
of this is floating
around
<2,98
FAX:
MAIL:
OSTP #:
Date of Correspondence:
11/2
Date of Receipt of Correspondence: 12/17
From: Dr Heing Riesenhube
Affiliation: germany minister of S&T
Subject: patentability of genome sequences
Action:
FYI:
Assign to: DLS
Due Date:
Copies to: Tom Ratchford DAB
I think a fax
of this is floatirs
around
Der Bundesminister
für Forschung und Technologie
5300 Bonn 2, November 26,1992
Heinemannstraße 2
Fernruf (02 28) 590 oder 59-
Teletex 22 83 628 = BMFTb
Dr. D. Allan Bromley
Assistant to the President
for Science and Technology
The White House
Translation
Washington D.C.
USA
Dear Allan:
Thank you very much for your letters of October 5 and 28, 1992.
I have noted with interest that the US Patent and Trademark Office does not
permit patentability of genome sequences of unknown function. As you are
aware, this attitude corresponds to my own opinion in the ongoing
controversial discussion.
Thank you, too, for forwarding me the first project description. I eagerly
await the study to be drawn up by the Congressional Office of Technology
Assessment on the subject of the patentability of genome sequences. I
would be very interested to learn more about this when we meet in
Rambouillet. : consider it important that scientists from other countries also
be involved in this study.
With regard to the question who can be called upon to contribute to this
report on the German side, deliberations and discussions are still in progress.
- 2 - -
As soon as a relevant decision has been taken you will be informed via the
German Embassy in Washington of the names of the German experts
selected.
Sincerely yours,
signed: Dr. Heinz Riesenhuber
Der Bundesminister
für Forschung und Technologie
5300 Bonn 2, 26.11.1992
Heinemannstraße 2
Fernruf (02 28) 590 oder 59-3407
Teletex 22 83 628 = BMFTb
Herrn
Dr. D. Allan Bromley
Assistent to the President
for Science and Technology
The White House
Washington D.C. / USA
Year
Alle,
vielen Dank für Ihre Briefe vom 5. und 28. Oktober 1992.
Ich habe mit Interesse davon Kenntnis genommen, daß das "Patent and
Trademark Office" eine Patentierbarkeit von Gensequenzen unbekannter
Zweckbestimmung ablehnt. Wie Sie wissen, entspricht dies auch meiner
Auffassung in der kontrovers geführten Diskussion.
Ich danke Ihnen auch für die Übersendung der ersten Projektbeschreibung
und sehe der Studie des "Congressional Office of Technology Assessment"
zur Patentierbarkeit von Gensequenzen mit großem Interesse entgegen. Es
würde mich freuen, bei unserem Treffen in Rambouillet näheres darüber zu
hören. Ich halte es für wichtig, daß an dieser Untersuchung auch Wissen-
schaftler anderer Länder beteiligt werden.
Zu Ihrer Frage, wer auf deutscher Seite zu diesem Bericht beitragen kann,
sind derzeit noch Überlegungen und Gespräche im Gange. Sobald eine Ent-
scheidung getroffen ist, werden Ihnen die Namen der deutschen Experten
über die Botschaft in Washington mitgeteilt.
Mit freundlichen Grüßen
Dr Heinz Riesenhuber
"Document Control"
TYPE:
ACTION
DOCUMENT NUMBER: 9203377
ORIGINATOR: 02
STATUS I
DIRECTORATE STATUS
FROM:
PURSER, Ken: SOUTHERN CROSS CORPORATION
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 10/29/92
SUBJECT: HE IS REQUESTING A CONTACT NAME AT THE NATIONAL
CANCER INSTITUTE WHO WOULD BE ABLE TO GIVE HIM NAMES
IN THE BIOMEDICAL FIELD TO COMMUNICATE WITH TO
EXPLAIN AMS AND ITS POTENTIAL USES.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED:
ACTION
STAFF
REQUIRED:
FOR DAB'S SIGNATURE
ACTION:
SENDER'S DUE DATE:
OSTP DUE DATE:
11/16/92
STAFF DUE DATE
DATE COMPLETED:
DATE COMPLETED/DEPT:
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS:
OSTP RECEIVED: 10/06/92
DEPT RECEIVED:
FILE: P-LIFE SCIENCES
CENTRAL FILES:
3377
Southern Cross Corporation
426C Boston Street
Topsfield, MA 01983, USA
October 29, 1992
Dr. D. Allan Bromley
Assistant to the President for Science & Technology
The White House
Pennsylvania Avenue
Washington, DC 20006
Dear Al:
I am sure you are aware of the work being done at Lawrence Livermore by John
Vogel, Ken Turteltaub and their associates who are using 14C Accelerator Mass
Spectrometry to measure the concentration levels of potentially carcinogenic
chemicals in animal organs when the ingested concentrations are close to
actual human doses. Their measurements are in contrast to most laboratory
studies where the ingested concentrations may be as much as 10⁴ to 10⁷
greater; any natural DNA repair mechanisms will probably be overwhelmed at
these high concentrations.
I believe that the technique of AMS represents an important new resource for
biomedical research and, although John Vogel and his colleagues are
publishing and giving talks on the subject, I would like to augment their efforts
by presentations to the biomedical community that would be slanted more
towards educating existing 14C users to the fundamental advantages of AMS
for detecting long-lived isotopes. Unfortunately, the few interactions I have had
to date with such audiences suggests a significant potential barrier exists
between AMS and biomedicine and that education is needed to enhance
coupling - probably by both parties!
The existing 14C workers I have talked to usually start off believing that 10⁶-fold
enrichment will still be essential with AMS and they look at me skeptically when
I tell them that to achieve an atom counting rate >3,000 14C events/second the
tracer enrichment need be only 100 times above natural levels; also, that from a
100µg carbon sample this rate will be maintained for 15 minutes. Their eyes
really roll when I point out that using AMS for 14C detection the enrichments
cannot be much greater than 1000 and, thus, the permanent disposal of waste
becomes a low-cost non-issue: If one gram of 100-fold enriched waste is
diluted with 100 grams of fuel oil the mixture can be incinerated to produce a
Phone: (508) 887 0028
FAX: (508) 887 0031
Dr. D. Allan Bromley
Assistant to the President for Science & Technology
October 29, 1992
Page 2
concentration of 14C radioactivity in the stack gasses not greater than that
naturally present in the atmosphere. Communication is tough, however, and
one listener left the meeting still talking about dpm!
While I am reluctant to ask, it would be helpful if you could suggest a contact at
the National Cancer Institute, or elsewhere, who would be able to give me
names in the biomedical field with whom I could communicate to explain AMS
and its potential usefulness.
Other news: The AMS machine at Woods Hole is working well. It measures
14C/12C ratios with accuracies of =0.5% and runs unattended around the clock
at an average rate of one sample per hour. The WHOI group is presently
measuring about 1500 samples per year and only limitations in the throughput
of their sample conversion lines are preventing WHOI from measuring the
4000/year they originally promised to the oceanographic community. I think
they will soon have this bottle-neck eliminated. Accuracies of 0.2%, or better,
can undoubtedly be achieved with modest effort if this becomes desirable.
There will soon be copies of the system at Groningen, Kiel and perhaps
Glascow. There are a bunch of others further out; Ted Litherland would like a
second one at Toronto and is working on the funding.
As you know, Peter Rose, Geoff Ryding, Hilton Glavish and I were supported by
Sumitomo Heavy Metals for over a year and worked with IMS in Vienna
developing the design for an Ion Lithography tool. However, now that IBM,
Toshiba, and Siemens have decided to use deep U.V. Optical Lithography for
the 256-Megabit DRAM, the need for ion lithography seems to have moved into
the next century. We are disappointed, but that is the luck of the game.
I plan to be in Washington during most of the week of December 7th and I
wondered if it might be convenient to drop by and see you for a few minutes
during one of the days of that week.
Best regards,
Ken huner
Ken Purser
Phone: (508) 887 0028
FAX: (508) 887 0031
"Document Control"
TYPE:
ACTION
ORIGINATOR: 02
DOCUMENT NUMBER: 9203289
STATUS I
DIRECTORATE STATUS
FROM:
DAVIS, Bernard: HARVARD MEDICAL SCHOOL
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 10/17/92
SUBJECT: HE IS WRITING REGARDING THE VIEW OF BASIC RESEARCH
VERSUS APPLIED RESEARCH.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED:
ACTION
STAFF
REQUIRED: AS/IF NECESSARY
ACTION:
SENDER'S DUE DATE:
OSTP DUE DATE:
11/10/92
DATE COMPLETED:
STAFF DUE DATE
DATE COMPLETED/DEPT:
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
REMARKS:
EXT:
OSTP RECEIVED: 10/29/92
DEPT RECEIVED:
FILE: P-LIFE SCIENCES
CENTRAL FILES:
3289
BACTERIAL PHYSIOLOGY UNIT
harvard MEDICAL SCHOOL
25 shattuck street
BOSTON, massachusetts 02115
TELEPHONE: (617) 732-2022
Oct. 17, 1992.
Dr. D. Allan Bromley,
Office of Science and Technology Policy,
The White House,
Washington, DC.
Dear Dr. Bromley,
Last June you sent me a copy of your annual report to Congress,
and I'm afraid I didn't get to read it until just now. I find it
excellent, in content and style. And in a way I'm particularly
happy to encounter it now, after seeing the stampede toward
applied research by Healy, Massey, and George Brown. With such
agreement it looks as though you will have a tough job defending
basic research as the nourishing source of major breakthroughs,
as you do 50 well in your report. I will take the liberty of
passing on a suggestion that I have made for the ASBMB Public
Affairs Advisory Committee, of which I am a member: that
under Bill MacElroy the NSF installed a major program of applied
research a couple of decades ago, called RANN, and it survived
for only a few years.
I had already drafted an OpEd on Healy's strategic plan, and it
is scheduled for the next week or two in the Wall Street Journal.
I hope it will be possible to add to it references to your
position and to the others that I have mentioned.
I believe it was Santayana who said that those who do not
remember history are condemned to repeat it. But illustrating
his point, I would guess that others probably had said the same
thing earlier and he did not know it.
Sincerely,
Bernard BOMain D. Davis
"Document Control for Division of Life Sciences"
TYPE:
ACTION
DOCUMENT NUMBER: 9203290
ORIGINATOR: 02
STATUS I
DIRECTORATE STATUS C
FROM:
HOSEY, M. Marlene: NORTHWESTERN UNIVERSITY MEDICAL SCHOOL
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 10/12/92
SUBJECT: SHE IS WRITING TO SOLICIT DR. BROMLEY'S ASSISTANCE
IN ENSURING THE CONTINUED PARTICIPATION OF NIH IN
THE FEDERAL DEMONSTRATION PROGRAM.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED: William Raub
ACTION
STAFF
REQUIRED: AS NECESSARY
ACTION: AS NECESSARY
SENDER'S DUE DATE:
OSTP DUE DATE:
11/10/92
STAFF DUE DATE
11/16/92
DATE COMPLETED:
DATE COMPLETED/DEPT: 11/25/92
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS: Dr. Raub responded to this letter as well as one addressed to
him.
OSTP RECEIVED: 10/30/92
DEPT RECEIVED: 11/10/92
FILE: P-LIFE SCIENCES
CENTRAL FILES:
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF SCIENCE AND TECHNOLOGY POLICY
WASHINGTON, D.C. 20506
November 25, 1992
Dear Professor Hosey:
Thank you for your letters to Dr. D. Allan Bromley and me regarding the decision by the
National Institutes of Health (NIH) to discontinue its participation in one of the
activities of the Federal Demonstration Project (FDP), i.e., the trial of a simplified
application procedure for noncompeting continuation grants. Your disappointment at
this turn of events is understandable, for the procedures by which agencies of the federal
government handle noncompeting renewal awards undoubtedly include unnecessary and
unproductive administrative requirements and therefore are an appropriate focus for an
FDP initiative. Nevertheless, having discussed the matter at length with some of my
NIH colleagues, I recognize that their decision, made in conjunction with higher-level
officials of the Department of Health and Human Services (DHHS), has a strong
supporting rationale.
As I understand the issue, the crux of the problem is that the streamlined FDP
procedure for noncompeting renewals has failed to win strong support among the NIH
funding units. My colleagues report widespread concern among program- and grants-
management staff because the noncompeting renewal procedure now being tested does
not generate all the information they believe they need to fulfill their stewardship
responsibilities. This conclusion in turn has reinforced misgivings that senior DHHS
policy officials have held since this particular trial first was proposed. Whereas many of
us hoped that real-world experience with the streamlined procedure might allay the early
concerns, the opposite has proved true.
Under the circumstances, with so many key staff at several different levels of DHHS
disinclined to endorse the streamlined renewal process, I see no chance that the
Department will adopt it as standard policy. Further pursuit of this particular FDP
activity as currently designed therefore is likely to be an unproductive expenditure of
energy, resources, time, and good will. Regrouping and reassessing the issue in the light
of the concerns generated by the trial seems the better course.
2
I view this setback as unfortunate but far from lethal for FDP. The NIH decision
neither tarnishes the other FDP achievements nor diminishes the importance of our
fundamental goals. For my part, I will continue to be an advocate for FDP, as will
many of my colleagues. That will include searching for a broadly acceptable way to
address anew how we might make the noncompeting renewal process more efficient for
both parties without an actual or perceived compromise of stewardship.
Sincerely yours,
Bill Roub
William F. Raub, Ph.D.
Special Assistant for Health Affairs
Professor M. Marlene Hosey
Department of Pharmacology
Northwestern University Medical School
303 East Chicago Avenue
Chicago, Illinois 60611-3008
3290
Northwestern University Medical School
Department of Pharmacology
III
303 East Chicago Avenue
Chicago, Illinois 60611-3008
(312) 503-8212
Fax (312) 503-5349
October 12, 1992
Mr. D. Allan Bromley
Assistant to the President for Science and Technology
Old Executive Office Building
Room 358
1600 Pennsylvania Avenue, N.W.
Washington, DC 20500
Dear Mr. Bromley:
I write to solicit your assistance in ensuring the continued participation of
the National Institutes of Health in the noncompeting continuation demonstration
of the Federal Demonstration Project (FDP). The continuation of this
demonstration, with full participation of the National Institutes of Health, is
consistent with the President's January 28, 1992 Memorandum for Certain
Department and Agency Heads on the subject of "Reducing the Burden of
Government Regulations".
As you may know, the FDP was initiated in 1988 to help eliminate
unnecessary administrative burdens on sponsored research and thereby enhance
the research productivity of the United States. The noncompeting continuation
pilot of the Federal Demonstration Project, initiated July 15, 1990, allowed
participating federal agencies to issue out year funding commitments based upon
an annual progress report. Some of the participating agencies, due to legal
requirements or major procedural disruption, continued the requirement for a
cover page. Other documentation was required only if significant changes
occurred in the size or scope of a project.
A recent survey of the 1,092 researchers impacted by the noncompeting
application process perhaps best demonstrates its importance. Overall, 1,092
researchers reported time savings of 2.26 days under the noncompeting
continuation demonstration of the FDP. Collectively, researchers saved 2464
days, with 90 percent of those days reinvested in scholarly activities. To provide
another perspective on these "time reinvestments", it can be said that the study
documents a total of 8.5 person-years of additional scholarly activities. Further
The McGaw Medical Center of Northwestern University
applying these rates of return, it is possible to project that the overall additional
investment in research activity made possible by FDA was roughly eighteen
person years of research.
I appreciate your efforts in ensuring the continuation of this project of
demonstrated importance to the academic community and the nation's research
enterprise.
Sincerely,
marlene Hosey
M. Mariene Hosey
Professor
MMH/mcf
TYPE:
ACTION
DOCUMENT NUMBER: 9203123
ORIGINATOR: 02
STATUS I
DIRECTORATE STATUS
FROM:
GOLDMAN, Robert D.: NORTHWESTERN UNIVERSITY MEDICAL SCHOOL
TO:
DR. D.A. BROMLEY
DATE OF
CORRESPONDENCE: 10/12/92
SUBJECT: HE IS WRITING TO SOLICIT DR. BROMLEY'S SUPPORT TO
ENSURE THE CONTINUED PARTICIPATION OF NIH IN THE
FEDERAL DEMONSTRATION PROGRAM.
DIRECTORATE
STAFF
ASSIGNED: LIFE SCIENCES
ASSIGNED:
ACTION
STAFF
REQUIRED: AS NECESSARY
ACTION:
SENDER'S DUE DATE:
OSTP DUE DATE:
10/29/92
STAFF DUE DATE
DATE COMPLETED:
DATE COMPLETED/DEPT:
COPIES TO: D. Allan Bromley
WHITE HOUSE TRACKING #:
CONTACT PERSON:
PHONE:
EXT:
REMARKS:
OSTP RECEIVED: 10/19/92
DEPT RECEIVED:
FILE: P-LIFE SCIENCES
CENTRAL FILES:
3123
Northwestern University Medical School
Department of Cell, Molecular,
III
and Structural Biology
Ward Building 7-311
303 East Chicago Avenue
Chicago, Illinois 60611-3008
(312) 503-8250 or 503-4215
Fax (312) 503-0954
Robert D. Goldman, PhD
Stephen Walter Ranson Professor
October 12, 1992
and Chairman
Dr. D. Allan Bromley
Assistant to the President for Science and Technology
Old Executive Office Building
Room 358
1600 Pennsylvania Avenue, N.W.
Washington, DC 20500
Dear Dr. Bromley:
As Chairman of a medical school basic science department and a National
Institutes of Health (NIH) grantee, I wish to ask for your assistance in helping to make
certain that the NIH is able to continue its participation in the non-competing continuation
Federal Demonstration Project. The participation of the NIH in this demonstration is
consistent with the President's January 28, 1992 Memorandum for Certain Department
and Agency Heads aimed at "Reducing the Burden of Government Regulations".
I am certain that you know that this project which started in 1988, is aimed at the
elimination of unnecessary administrative burdens on federally sponsored research.
Through the elimination of these burdens, research productivity has risen over these past
few years. In a recent survey, the 1,092 researchers participating in the project nationwide
reported a time savings of 2.26 days during the preparation of non-competing renewal
applications. Therefore on a collective basis at least 2,464 days were saved and at least
90% of the time saved was invested in scholarly pursuits. In other terms, this
reinvestment of the time of researchers has amounted to 8.5 person years of additional
scholarship for the nation.
Based on the above considerations, there is no doubt that the FDP has paid off
tremendously and will continue to do SO. Please help to make certain that the NIH
continues to participate in this project.
Respectfully yours,
Robert D. Goldman
RDG/ld
The McGaw Medical Center of Northwestern University