&ER&
                               United States
                               Environmental Protection
                               Agency
                              Office of Exploratory
                              Research
                              Washington DC 20460
                               Research and Development
                              EPA-600/S8-81-020 Dec. 1981
Project  Summary
                               Assessment of  Future
                               Environmental Trends and
                               Problems:  Industrial  Use of
                               Applied Genetics and
                               Biotechnologies
                               Robert H. Zaugg and Jeff R. Swarz
                                This study represents a portion of an
                               overall  EPA/ORD  assessment of
                               future environmental trends and prob-
                               lems. The focus of this summary is the
                               industrial use of applied genetics. The
                               pharmaceutical, chemical,  energy,
                               mining, and pollution control indus-
                               tries are examined.
                                Following a brief historical review of
                               the important developments in basic
                               biological research that heralded the
                               advent of modern biotechnology, the
                               summary describes the  variety of
                               experimental and commercial tech-
                               niques encountered in this field. These
                               methods include recombinant DNA
                               technology, mutagenesis, cell fusion
                               procedures, immobilized bioprocesses,
                               and fermentation technology.
                                The section entitled "Interested
                               Parties" lists those who are actively
                               involved in the commercialization of
                               applied  genetics. Over 100 U.S. busi-
                               ness firms  and about 50  foreign
                               concerns are  identified  as  having
                               substantial  commercial interest in
                               biotechnology.  This section also
                               describes the role of U.S. government
                               agencies in examining progress in this
                               field.
                                Much of the summary consists of an
                               industry-by-industry  analysis of
                               current  R&O activities in biotechnol-
                               ogy, an estimate of future prospects.
                              and an  assessment of potential
                              environmental  and  health hazards
                              associated with  these  activities.
                              Trends are identified and, wherever
                              possible, schedules for  the
                              appearance of  new applications are
                              predicted.
                                The final section summarizes the
                              findings and makes recommendations
                              to the EPA regarding future action in
                              the field of applied genetics.
                                This summary is submitted in fulfill-
                              ment of Contract No. 68-02-3638 by
                              Teknekron Research, Inc., under the
                              sponsorship of the U.S.  Environ-
                              mental Protection Agency.  This
                              summary covers the period October 1,
                              1980 to February 28, 1981 and the
                              work was completed as of March 31,
                              1981.
                                This Project Summary was develop-
                              ed by EPA's  Office of Strategic
                              Assessment and Special  Studies,
                              Office  of Exploratory  Research,
                              Washington, DC, to announce key
                              findings of the research project that is
                              fully documented in a separate report
                              of the same title (see Project Report
                              ordering information at back).


                              Introduction
                                Applied  genetics  has  recently
                              emerged as an exciting technology that:

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(1) may contribute significantly to the
solution  or  alleviation of world-wide
problems such as dwindling food and
energy supplies,  infectious  diseases,
cancer and environmental  pollution;
(2)  has  stimulated over  one  billion
dollars in capital investment by private
business in the  United States;  and
(3) has occasioned a heated and contro-
versial debate  within  academic  and
government circles regarding issues of
safety, academic freedom, and societal
ethics. These events have arisen largely
from scientific advances made in basic
biological research during the past 10
years.  Scientists  are   now  able  to
manipulate the genetic material (DNA)
of living cells, thus making possible the
transfer of specific genes from the cells
of one organism to the cells of another.
Consequently, for the first time, man is
able to make fundamental changes in
the inherent structure of living things,
thereby  endowing   organisms  with
characteristics  that  were  previously
unavailable to them.
  This new  technology, referred to as
"recombinant DNA," is the most pub-
licized and controversial issue  in the
applied genetics field, but it represents
just one of several biological techniques
that  are  increasingly being applied to
commercial  processes in the industrial
sector. This summary describes these
techniques and summarizes their appli-
cation to industrial processes in phar-
maceuticals,  chemicals,  energy,
mining, and pollution  control. Future
uses  of  these  technologies are also
projected within each industrial sector
and,  most  importantly,  potential
environmental  and   health  hazards
associated with either current or future
applications  of  biotechnology   are
identified. Finally, the EPA is provided
with  several recommendations as to
those areas requiring additional study,
as well as the  advisability of promul-
gating regulations designed to oversee
commercial  activities.
Technology of Applied
Genetics
   The  technology  encompasses  a
variety of procedures and processes.

  •  Non-recombinant DNA methods
     for inducing genetic alterations in
     cells include: (1) mutagenesis, in
     which physical or chemical agents
     (mutagens)  induce  mutations in
     the DNA; (2) cell fusions, in which
     two cells  of differing types are
     fused  together into a single unit
     that manifests characteristics of
     both parental cell types; "hybrid-
     omas" that produce monoclonal
     antibodies represent a very useful
     application of this technique; and
     (3) simple genetictransformations
     of cells can be accomplished by
     merely exposing the cells to puri-
     fied DMA which, under appropriate
     conditions, is taken up by the cells
     and  incorporated  into cellular
     DNA.

  •  Immobilized bioprocesses refer to
     various  methods of confining, or
     immobilizing, intact cells or cellu-
     lar  enzymes  within   an  inert
     matrix,  followed by passage of
     substrate  materials through this
     "bioreactor." Applications of this
     technology will become popular in
     all industrial sectors; some pollu-
     tion   control   practices already
     employ versions of this technology,
     such  as rotating biological discs
     and  trickling  filters  for   waste
     water treatment.

  •  Fermentation technology, although
     practiced  for centuries, will  be
     increasingly in demand owing to
     the requirement of mass-producing
     microorganisms  and   microbial
     products.  Traditional  batch  fer-
     mentations will be  supplanted
     increasingly by modern fermenta-
     tion  techniques,  such   as
     continuous flow and solid phase
     processes.

  •  Gene   therapy  in  humans, al-
     though  still highly experimental,
     may soon permanently cure tragic
     genetic diseases such  as sickle
     cell anemia and thalassemia, by
     providing  patients with  DNA that
     replaces the defective genes.

Interested Parties
  The immense excitement generated
by applied genetics arose from findings
made over the past decade in university
laboratories. These scientific  advances
quickly  burgeoned   into  a  rapidly
growing multi-million dollar industry.
Meanwhile,  various  government
agencies have become interested in this
area owing in part to concerns about the
overly fast  commercialization of tech-
nologies whose safety has  not been
established absolutely.
  University labs have provided most of
the fundamental advances in both the
science and engineering aspects of bio-
technology. Many university scientists
have  become affiliated with  genetic
engineering firms. This situation has
occasioned some rivalry among univer-
sity  scientists  who  now view their
research as potentially lucrative. As a
result, the qualities of cooperation and
intercommunication that once charac-
terized academic  research have been
seriously compromised.
  Over  100  U.S.   companies  are
engaged in some aspect of modern
applied genetics. Many  large corpora-
tions, particularly those that emphasize
research and development, have initi-
ated in-house programs in biotechnol-
ogy.  These  include  virtually  all
pharmaceutical firms, most energy and
chemical   companies,  and  several
agriculture  and food  product  firms.
Meanwhile,  dozens   of new,  small
genetic engineering firms have sprung
up in recent years. These entrepreneur-
ial ventures, which are exemplified  by
Cetus  Corp. and Genetech  Inc., have
used  risk-taking  investors  for initial
support but can now count on revenues
generated through research contracts
negotiated with large companies, such
as Dow Chemical, Eli Lilly, and  Hoffmann-
LaRoche.
  The  federal  government became
involved with applied  genetics primaril}
in response to concerns, first expressec
by  research scientists in  the mid
1970's,  that  the  continued  use  o
recombinant DNA  techniques couU
produce  new organisms  that migh
escape  from  the  laboratory  am
endanger the human population and thi
environment. The National Institute a
Health (NIH) has set forth recommendei
procedures for constructing  and hand
ling  recombinant   DNA   molecules
These guidelines  are mandatory  fo
federally-sponsored  research and ar
voluntary for commercial firms engage
in  recombinant  DNA  research  an
development. Since their first publice
.tion in the Federal Register in Summe
1976,  the  guidelines  have  bee
amended considerably and now reflei
a more confident and relaxed attituc
about  the potential  risks inherent  i
these activities. The most recent versic
of  the  guidelines  appeared  in tr
November  21,  1980,  issue  of  tr
Federal Register.
  Other federal agencies involved wit
recombinant DNA issues include:

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  •  The Food and Drug Administration
     (FDA), whose interest stems from
     the fact that the first commercial
     products emerging from this new
     technology   are   intended  for
     human  use;  namely,  human
     insulin,  growth  hormone, and
     interferon. As of  June 1980, the
     position of the FDA was that drugs
     produced by recombinant  DNA
     techniques could  not be marketed
     under existing INDs or NDAs as
     simply changes in manufacturing
     technique.

  •  The  Occupational   Safety and
     Health  Administration   (OSHA),
     which  announced  (during  the
     Carter Administration) that it will
     develop  a  recombinant   DNA
     regulatory policy over the next two
     years.

  •  The National Institute for  Occu-
     pational  Safety  and  Health
     (NIOSH), which  is  interested in
     examining several worker  safety
     issues  related  to  commercial
     recombinant DNA activities.

  The question of patent protection for
products and processes evolving from
applied genetics research and develop-
ment is both controversial and important
to commercial firms anxious to protect
their investment. Two recent events are
noteworthy.

  •  On June 16, 1980, the Supreme
     Court ruled that patent protection
     cannot be denied io living  things
     provided that the  principal criteria
     for patentability (namely, that the
     item be new, useful, and non-
     obvious) are met  satisfactorily.

  •  On December  2, 1980, Stanford
     University and the  University of
     California were jointly awarded a
     patent dealing with techniques
     and processes commonly used in
     recombinant  DNA   experiments.
     The protection afforded by  this
     patent will permit the universities
     to license the  technology to any
     company that  wishes to employ
     the techniques  (i.e., every  firm
     engaged in  recombinant  DNA
     research and  development)  and
     they will collect  royalties  on its
     use.

  The practice of applied genetics in
foreign  countries  has generally
proceeded in a fashion similar to that in
the United States. In contrast to U.S.
activities,   however,  some  foreign
governments  have supplied consider-
able  financial  backing   to  fledgling
genetic  engineering  enterprises. The
governments of both Britain and France
have  established  nationally owned
genetic  engineering  companies.  In
Japan, more than a dozen large chem-
ical  and  pharmaceutical firms  are
actively  pursuing biotechnology
programs  with  government support.
Likewise, private firms in Canada and
Israel  have   undertaken  ambitious
projects in genetic engineering applied
to agriculture, industrial chemicals, and
waste management.
Industrial Applications,
Trends,  Potential Hazards

Pharmaceutical Industry
  The  largest efforts  to  date toward
commercial application of modern bio-
logical techniques have taken place in
the pharmaceutical industry.  The fol-
lowing  new or improved drugs  and
vaccines  are  likely  to  be  the  first
marketable  products stemming  from
recombinant DNA technology;

  •  Interferon, a protein made by most
     cells   of  higher  organisms in
     response to virus infections,  may
     prove to be a valuable anti-viral
     drug as well  as a potential anti-
     cancer agent.

  •  Insulin, a hormone  made in the
     pancreas, is a necessity of life for
     most diabetics. Currently, insulin
     is obtained from cows and pigs,
     but recombinant DNA technology
     will make possible a  steady supply
     of human insulin that will replace
     the animal insulins as the prefer-
     red drug for treating diabetes.

  •  Human  growth  hormone,  or
     somatotropin, is produced in the
     pituitary   gland   and  mediates
     growth and stature, particularly in
     children. Its value as a therapeutic
     in humans is still speculative, but
     growth hormone may be useful in
     the treatment of ulcers, burns,
     bone fractures, and bone deterior-
     ation,  as well  as  dwarf ism in
     children.
  •  Somatostatin  is a  hypothalamic
     hormone that may have thera-
     peutic potential in the treatment
     of diabetes.

  •  Thymosin,  a  thymus hormone,
     regulates  the development of a
     portion of the  immune system and
     may have  application in cancer
     therapy.

  •  Beta-endorphin  is  a  naturally
     occurring  opiate that mimics the
     action of morphine. It has consid-
     erable therapeutic  potential as a
     safe, non-narcotic pain-killer.

  •  Urokinase, a kidney enzyme, dis-
     solves blood clots and may reduce
     the likelihood of heart attacks and
     strokes.

  The  second  major pharmaceutical
area in which recombinant DNA tech-
niques are finding considerable applica-
tion is  in the development of new, safe
vaccines.  Vaccines  to   combat  the
following viral  and bacterial  disease-
causing agents are  now under develop-
ment:

  •  Hepatitis virus, which causes  a
     serious  liver   disease that  has
     reached epidemic proportions in
     some parts of the world.

  •  Influenza virus, the many forms of
     which  have  made  reliable
     vaccines unobtainable using con-
     ventional techniques.

  •  Foot-and-mouth  disease virus,
     which causes a life-threatening
     disease among domesticated live-
     stock.

  •  Gonococcus   bacteria,  which
     cause a  type of venereal  disease.

  •  Pathogenic E.  coli,  which cause
     severe diarrhea in children.

  •  Oral bacteria,  which are respon-
     sible for tooth decay.

  Future   developments  within   the
pharmaceutical  area are likely to be
involved with  plants and  sea creatures
as sources of new and powerful drugs,
human monoclonal antibodies for use
as in vivo diagnostics and therapeutics,
and techniques  for effectively trans-
planting genes into human recipients.

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This last advance, although  10 to  15
years distant,  will bring about many
political  and  ethical  issues  whose
seriousness will outweigh any technical
obstacle.
  Applied genetics, especially  recom-
binant  DNA   technology, has been
promoted to a greater extent in  the
pharmaceutical industry than in other
industrial sectors. For this reason, the
potential risks arising  from  this new
technology have  been assessed in the
context of laboratory  and  industrial
practices pertinent to the pharmaceuti-
cal  sector. Several risk assessments
have been conducted to evaluate the
safety  of using £.  coli K12 as a host
bacterium  for the  manufacture  of
human proteins via recombinant DNA
techniques. The viewpoints reached by
these evaluations are:

  •  It is virtually impossible for K12 to
     colonize the human gut or to be
     communicated  between  individ-
     uals.

  •  The insertion  into K12 of gene
     sequences from human pathogens
     would not  create a pathogenic
     K12  strain  and  would  present
     fewer risks than those pathogens
     existing freely in nature.

  •  The ingestion of a K12 strain that
     synthesizes and secretes a human
     hormone, such as insulin, would
     not contribute significantly to the
     hormone  levels  that  occur
     naturally.

  •  The bacterial synthesis of human
     proteins  in  the  Gl  tract   (or
     elsewhere in the body) would not
     likely trigger  an  auto-immune
     response to the human substance.

  Apprehensions  regarding the use of
other microorganisms, such as Bacillus
subtilis or Saccharomyces cerevisiae,
as host organisms for recombinant DNA
have been far less than fears attending
the use of E. co//" K12.
  NIH  and NIOSH have examined the
issue of worker safety in the pharma-
ceutical industry within the context of
recombinant  DNA activities. NIH  has
established a set of recommendations
for large-scale fermentation of recom-
binant  DNA   organisms  with  which
industrial firms are expected to comply
voluntarily. NIOSH has conducted walk-
through  surveys  of two  commercial
fermentation   plants  (Eli  Lilly   and
Genetech). Lilly operates an eminently
safe fermentation plant, which serves to
set the standard of practice in this area.
  The pharmaceutical area as a whole
appears to be well equipped to deal with
the  experimental  and  engineering
safety  issues  that are posed by the
advent of recombinant DNA technology
in particular, and by the various applica-
tions of biotechnology in general.

Chemical Industry
  The fruits of applied genetics are less
immediate in this industry than in the
drug sector, but  biological processes
and renewable resources will eventu-
ally  replace  the  physical-chemical
transformations  of  petroleum feed-
stocks   upon  which  the  chemical
industry  is  currently based.  Some
projects underway or planned include:

  • An immobilized bioprocess for the
     oxidation  of alkenes to their
     corresponding alkene oxides.

  • The  commercial  production of
     microbial  enzymes  for  use in
     various  industrial  processes.
     These enzymes include amylases
     used to break down polysacchar-
     ides   for  biomass  conversions,
     proteases for use as meat tender-
     izers, oxidases  and  isomerases
     that perform highly specific chem-
     ical transformations of interest to
     specialty chemical manufacturers.

  •  The  direct  production of simple
     organic compounds by microbial
     fermentation. These compounds
     include  acetone,   acetic  acid,
     butanol, citric acid,  ethanol, gly-
     cerol,  isopropanol,   lactic  acid,
     methanol,  propionic  acid,  and
     numerous amino acids.

  •  The production of surfactants or
     detergents  from microbial  fer-
     mentation,  particularly  from
     certain species of photosynthetic
     algae.

  •  The  isolation  and  commercial
     production  of  several  complex
     organic compounds from higher
     plants. Examples include natural
     rubber from guayule and euphor-
     bia,  terpenoids  and insecticides
     from  the  juniper and  scorpion
     flowers, and long-chain fatty acids
     from Lunaria and Vernonia.
  The future applications of biotech-
nology in the chemical  industry will
reside  largely in  the manufacture of
certain high-priced specialty chemicals
rather than  in the production of bulk
commodity substances. The economics
favoring the  future use of bioprocess in
this industry will  depend substantially
on  process  design  and engineering
characteristics,  rather  than  on  the
biotechnology involved.
  Potential risks involved in the use of
applied   genetics  in  the  chemical
industry include the following:

  •  The  species  of  microorganisms
     likely to be utilized in the chemical
     industry differ from those in the
     drug industry.  These  microbes
     include Pseudomonas.  Acineto-
     bacter.  and  Flavobacteria, about
     which  little  is  known  regarding
     pathogenicity in man.

  •  The chemical industry is unaccus-
     tomed   to   the  application  of
     biological processes as a business
     enterprise and   individual firms
     may be unaware  of   potential
     hazards inherent in these activ-
     ities.

  •  The  chemical  industry has  a
     poorer  record  than the
     pharmaceutical  industry in areas
     related to worker safety and envi-
     ronmental   protection,   causing
     apprehension as to the  introduc-
     tion of  new technologies for which
     industry-wide experience is
     limited.
Energy Industry
  Biological processes may someday
supply a  major proportion of work
energy needs. Current activities in thi:
industry, however, are limited to tw<
general areas:

  •  The  conversion of biomass  inu
     more useful fuels, such as ethane
     or methane gas.

  •  Microbiologically  enhanced  oi
     recovery,  in  which microorgan
     isms injected into a spent oil we
     may serve to rejuvenate the resei
     voir by degrading a portion of th
     residual oil (thereby lowering th
     viscosity), repressurizing the we
     by producing carbon dioxide ga
     or by manufacturing chemical su
                                  4

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     factants  that  would
     tightly bound oil.
mobilize
  The  range  of  potential  uses  of
biotechnology in the energy industry is
very wide, although most of these possi-
bilities  lie far  in the  future.  These
prospects include:

  •  The  mass-production of  hydro-
     carbons from microbes  (such  as
     algae) and from higher plants.

  •  The  production of hydrogen gas
     from water using enzymes iso-
     lated from plant chloroplasts.

  •  The development of a solar battery
     in which  immobilized photosyn-
     thetic biosystems mediate a direct
     conversion  of  sunlight  into
     electricity.

  •  The  use  of  iron-oxidizing Thio-
     bacilli to  mobilize the  inorganic
     mineral content  of  oil  shale  or
     coal, thereby generating  porous
     zones that  may  expedite in situ
     retorting or gasification  schemes.

The large-scale commercial application
of biotechnology to the energy sector is
at a very early stage of development.
Nevertheless, some speculations can be
made  regarding  potential  hazards  of
these developments.

  •  The  production in the U.S. of suf-
     ficient ethanol to have significant
     impact on domestic fuel supplies
     will   require  the  diversion  of
     enormous   quantities  of  food
     crops, particularly corn, for use as
     biomass feedstock.

  •  The  use of cellulosic feedstock in
     ethanol  production   may  entail
     large-scale deforestation.

  •  The  use of municipal or agricul-
     tural wastes as raw materials for
     ethanol or biogas production may
     entail  risks associated  with the
     transport  of these wastes  to a
     central fuel generating plant.

  •  The  species of  microorganisms
     likely to be utilized in the  energy
     sector for enhanced oil recovery
     schemes  (Pseudomonas  and
     Acinetobacter, for example) are
     potentially serious pathogens  in
     man.
  •  Established energy companies are
     not  accustomed to dealing with
     biological systems as a means of
     producing energy and, thus, may
     be unaware of potential hazards
     resulting from their use.

Mining Industry
  The  impact  of biotechnology in  the
mining  industry is  currently  quite
limited  in scope, consisting largely of
bacterial leaching operations in which
metals are solubilized from low grade
ores   by   acidophilic,  iron-oxidizing
bacteria of the Thiobacillus, Leptospiril-
lum, and  Sulfolobus genera. Approxi-
mately  12% of U.S. copper production
stems from bacterial leaching. In addi-
tion,  these microbes  are  useful  in
leaching  any  mineral  containing
adequate  quantities of reduced sulfur,
or sulfide, such as pyrite (FeS2>, chalco-
pyrite (CuFeS2),  and zincblende (ZnS).
Bacterial  leaching  is  also  used
extensively to recovery  uranium from
ores that are rich in pyrite. ,
   Microorganisms of numerous types
are capable of accumulating metal ions
from dilute solutions. This activity can
be exploited to concentrate  valuable
metals from tailings ponds or waste
streams.
   Genetic engineering applied to
leaching  bacteria  may  be  used  to
increase the microbe's resistance to the
high concentrations of  metals being
leached, to improve the efficiency of the
leaching  process,  or  to  develop
anaerobic strains of leaching bacteria to
permit their use in the interior of huge
slag  heaps of  low-grade ore where
oxygen-free conditions exist.
   The limited scope of biotechnology in
the  mining industry confines the range
of environmental concerns that demand
consideration. However, all foreseeable
applications of biological processes in
this industry involve microbial systems
operating in relatively  open  environ-
ments, such as slag heaps or tailings
ponds.  Consequently, there are risks
that microorganisms or their metabolic
products will inadvertently contaminate
the local ecology. Specifically:

  •  Bacterial   leaching   operations
     generate  large quantities of sul-
     furicacidwhichcouldcontributeto
     the acidification of U.S. fresh water
     supplies.

  •  Thiobacilli and related species are
     not  known to  be pathogenic in
     man, but their increased use and
     greater exposure to human popu-
     lations may select for bacterial
     strains that  have acquired the
     ability to infect humans.

  •  The use of bacteria to concentrate
     metals from dilute mine  waters
     entails the risk that  such  metals
     will accumulate in the food chain.

  •  The mining industry has very little
     experience with  biological  pro-
     cesses. This lack of familiarity
     could  result  in  a  failure  to
     recognize  impending   environ-
     mental hazards or in an eagerness
     to carry out biological processes
     before their safety has been firmly
     established.

Pollution Control Industry
  Bioprocesses have long been instru-
mental to the practice of waste manage-
ment, but modern advances in applied
genetics may  greatly  facilitate the
remediation or  elimination of  some
present-day, intractable pollution prob-
lems.  Current  activities  in  the field
of biotechnology applied  to  pollution
control fall under three general head-
ings: (1) biodegradation of organic sub-
stances; (2) biological denitrif ication and
desulfurization;   and   (3)  biological
concentration of toxic heavy metals.
  Microbes  capable   of degrading
various  organic  pollutants,  such  as
petroleum   hydrocarbons,  pesticides,
herbicides,  and lignocellulosics, have
been identified and are under investiga-
tion.  A  better  understanding  of  the
biochemical nature of these organisms
will be required befaregeneticengineer-
ing can have an impact in this area.
  Microbial  systems  capable  of
metabolizing  sulfur-containing  and
nitrogen-containing  inorganic and
organic  substances have also been
identified. These organisms  will find
considerable utility in eliminating these
pollutants from industrial waste streams
and from fossil fuels prior to combustion.
  The  greatest   research and
development effort involving near-term
applications of biotechnology to pollu-
tion  control  will  be   in  developing
improved microbial strains for  decon-
tamination of polluted waste waters and
for in situ detoxification of contaminated
soils and sediments. However, a better
understanding must be acquired of the
types and activities of microorganisms
capable of degrading toxic chemicals.

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The follow! ng list outlines some aspects
of applied genetics and waste manage-
ment that will be under development.

  •  Cataloging the types of chemical
     transformations  performed  by
     microbes.

  •  Isolating and characterizing the
     genetic material  and enzymes
     responsible fortheobserved trans-
     forming activity.

  •  Conducting  genetic engineering
     on organisms that occur naturally
     in a particular polluted  environ-
     ment in order to  improve the effi-
     ciency   or   survivability  of the
     organisms.

  •  Developing specific biotreatment
     systems for dealing in situ with
     toxic wastes.    *

  •  Designing bioreactors  for on-line
     waste  stream treatment that will
     reduce or eliminate toxic wastes at
     their source.

Conclusions and
Recommendations
  The U.S. economy is on the verge of a
"biology  boom."  Excitement over the
commercial  potential  of genetic  engi-
neering has been very high, as exempli-
fied by the considerable media attention
to this area,  as well as the enthusiasm
shown  by  financial  investors.   One
aspect of applied genetics, recombinant
DNA technology, has received the bulkof
public attention, in regard to both the
favorable and hazardous results  of its
application. But the risks inherent in the
practice of recombinant DNA techniques
are surely much fewer than originally
feared.
  As with other technological advances,
biotechnology will be  applied where it
will yield substantial commercial  pay-
off. Only the pharmaceutical industry is
likely to  realize  near-term  returns on
investments  in this new  technology.
Other industrial sectors will thoroughly
investigate naturally occurring biologi-
cal systems for potential commercializa-
tion  prior  to  making  significant
investments in  recombinant  DNA
technology.
  Biotechnologies other than recombi-
nant  DNA  have  received  less public
attention   but,  nevertheless,  are
expected tocontribute to the commercial
success  of  the  "biology  business."
Modern fermentation technologies will
be applied to relevant operations in all
industrial sectors, as will immobilized
bioprocesses,  such as  on-stream
bioreactors for waste stream detoxifica-
tion. Cell fusion techniques will undergo
further development as an alternative to
recombinant  DNA  methods  for pro-
ducing genetically altered organisms.
  Specific recommendations to the EPA
are as follows:

  •  Any environmental risks arising
     from industrial uses  of  applied
     genetics are speculative. At this
     time, there exists no compelling
     reason for the EPA to establish
     regulations in this area.

  •  Should  environmental  hazards
     emerge in  the future, it is probable
     that they can be handled within the
     existing   regulatory  framework
     (most notably  Toxic  Substances
     Control Act).

  •  TheEPAshouldcontinuetotakeaTi
     active role in  promoting applied
     research  and  development  of
     biological   waste  management
     processes  and techniques, with
     particular emphasis on acquiring a
     better understanding of the biology
     of relevant systems rather than on
     process design and engineering.

  •  The EPA should sponsor further
     investigation into the generation,
     dispersal, and control of biological
     aeosols.

     aerosols.

  •  The  EPA   should  endeavor  to
     monitor commercial and scientific
     developments   in  the  field  of
     applied  genetics with the aim of
     identifying both imminent  envi-
     ronmental  hazards  and areas
     where  this technology might be
     applied  to pollution   control
     problems.

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   Robert H. Zaugg and Jeff R. Swarz are with Teknekron Research, Inc..  1483
     Chain Bridge Road, McLean, VA 22101.
   Morris A. Levin is the EPA Project Officer (see below).
   The complete report, entitled "Assessment of Future Environmental Trends and
     Problems: Industrial Use of Applied Genetics and Biotechnologies, "• (Order
     No.  PB 82-118 951; Cost: $15.00, subject to change) will be available only
     from:
           National Technical Information Service
           5285 Port Royal Road
           Springfield, VA 22161
           Telephone:  703-487-4650
   The EPA Project Officer can be contacted at:
           Office of Strategic Assessment and Special Studies
           Office of Exploratory Research
           U.S. Environmental Protection Agency                         y
           Washington. DC 20460
•A- US GOVERNMENT PRINTING OFFICE, 1982— 559-092/3393

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