]]]]]]      HOW GENETIC ENGINEERING GOT A BAD NAME      [[[[[[[[[
                       by Donald L. Ritter            (2/27/1989)

Reprinted by permission  from IMPRIMIS, February 1989, the  
monthly journal of Hillsdale College, Michigan, a college that 
does not accept government money. Donald Ritter, A METALLURGIST, 
is the only scientist in the US House of Lords (R-Pa). He uses 
reason instead of emotions and is thus an utter misfit in his 
environment.  [Sysop's note.]

          [Kindly uploaded by Freeman 10602PANC]

   There seems to be a serious condition afflicting America today
which I  and others  have labeled  ``chemophobia.''  It  is often
communicated through misinformation, sensationalism and political
activism, but its real source is a mix of utopianism, fear of the
unknown, and hostility towards  science and the established order
of  society  itself.   It  feeds  on  scientific  illiteracy,  is
contagious,  and  generally  extends  to  all  Western industrial
nations.

FEAR AND IGNORANCE
   To  those with  healthy, positive  views  of who  we are  as a
nation  and  as  a  people, science  is  an  invaluable  tool for
protecting  and  enhancing life;  but  to  those in  the  grip of
chemophobia, science seems  to be an  instrument of environmental
and biological degradation  born mostly of  corporate greed.  The
media, seeking subscriber dependence, with most reporters lacking
science backgrounds, seems determined  to advance this dark view.
Since we  depend on  television news  and the  national and local
press for nearly all of our information, it has had a devastating
impact.    Armies  of   activists,   lawyers  and   white  knight
politicians join the  media in claiming  to protect our interests
against alleged impending disaster.
   Meanwhile, our educational  system continues to  do a poor job
of  teaching  the  basic biology,  chemistry,  math,  and physics
skills which  are essential  to an  understanding of  science and
technology in the world.
   Most Americans are concerned  about pesticides, air pollutants
and the like.   But they are unfamiliar  with crucial facts about
the hazards of daily life, like  the fact that the cancer hazards
of most  ``harmful substances''  regulated by  the government are
literally outweighed  by the  dangers of  chemical carcinogens in
the ``natural'' food we eat every day.
   How then can we expect American people to realize that not all
man-made  chemicals are  dangerous,  and, indeed,  that  most are
actually ``the grease  for the gears  of the modern technological
society?''  Furthermore, how can we expect them to appreciate the
progress engendered by the  democratic capitalistic experience in
which scientific innovation plays such an important role?
   One bitter fruit of our ignorance  -- and resulting fear -- is
the   current   attack  on   biotechnology,   especially  genetic
engineering.  As a result,  the biotechnology industry, which has
grown rapidly in  the last few years  and exhibits great promise,
is on the brink of stalling.  A stampede of rules and regulations
could keep us held back in  the laboratory, when we should be out
in the marketplace.   The good news  is that countless laboratory
and  field tests  are proving  that  biotechnology can  work.  In
1986, the widely publicized ``Frostban'' experiment in California
demonstrated  how engineered  bacteria can  safely be  sprayed on
strawberry plants  to help them  resist frost.  In  the long run,
successful products like  Frostban can help  us avoid millions of
dollars in damage for all kinds of crops.

INNOVATION STALLED
   But  if   that  seems   like  a   reason  to   celebrate,  the
biotechnology industry isn't doing  cartwheels.  The company that
makes Frostban, Advanced General  Sciences (AGS), was so battered
by a  long and arduous  regulatory struggle with  the federal and
state governments over testing that  it had to merge with another
company just to  stay afloat.  In  January of 1988,  the New York
Times  reported  that other  companies  interested  in developing
genetically-engineered  products are  standing on  the sidelines.
Fewer than ten companies are now active in that field -- and even
if some are moving forward with field tests, they all are waiting
for clearer  signals form  the regulatory  agencies.  The future,
quite simply, looks uncertain.
   Few   laymen   have   the   necessary   knowledge   to   grasp
biotechnology's potential, so it is no wonder that the critics of
genetic  engineering   have  been   spectacularly  successful  in
creating a sense  of fear.  Fear  usually emerges from ignorance,
and this  is nowhere  more clear  than in  biotechnology.  Public
anxiety over  perceived environmental risks  is outweighing sound
scientific analysis  and, when  mirrored in  public policy,  is a
serious obstacle  to scientific  innovation and  the necessity to
rapidly commercialize scientific advances.
   At first the biotechnology community was self-regulating.  The
Asilomar   Conference   of   1975   established   guidelines  for
recombinant  DNA  research   in  laboratories  receiving  federal
funding.   Since  1974, the  Recombinant  DNA  Advisory Committee
(RAC) of the National Institutes  of Health (NIH) has relaxed the
guidelines  twice, because  scientists have  been able  to safely
manage the risks associated with DNA research.
   Prior  to the  1980s, NIH  took the  position that  no federal
agency  had  the  authority  to  regulate  private  biotechnology
research,  so  the federal  government  was not  involved  in any
further regulatory activity.  The biotechnology industry began to
grow, largely in the laboratory, and it complied voluntarily with
RAC guidelines.  During this time, proponents of regulation tried
to  convince Congress  to  make compliance  mandatory,  but their
attempts were unsuccessful.
   Thus,  in  the  early  part  of  this  decade,  many ambitious
entrepreneurs entered  the biotechnology  field.  Over two-thirds
of all biotechnology firms have been in business for less than 10
years.  These entrepreneurs can revolutionize the way we live: by
working to  find treatments  for diabetes,  cancer, and  AIDS; by
improving  food  production with  stronger  animals  and hardier,
disease-resistant plants; and by  creating microbial organisms to
control insects and toxic wastes.
   They exhibit a  refreshing ``can-do'' attitude.   So it is not
surprising that they want to take their products out of the realm
of the laboratory and into the real world.  They desire to create
useful  products and  to make  profits, but  also to  meet global
challenges of hunger, disease, and waste disposal.
   In the  last few  years, when  the biotechnology  industry was
prepared  to test  its  new products  in  the field,  it  faced a
national  uproar  over whether  genetically  engineered organisms
should be ``released'' into  the environment.  In the mid-to-late
1980s, it  is understandable  that the  focus of  legislative and
regulatory attention had to shift: Guidelines for mere laboratory
research -- which  were not appropriate  any longer --  had to be
replaced.  But  this shift  was dramatically  affected by critics
who dominated  the public  debate, casting  a cloak  of suspicion
over all biotechnology innovation.
   Jeremy Rifkin  is biotechnology's  most outspoken  critic.  He
was quoted in  the Washington Post  in early 1988  as saying that
genetic   engineering  is   ``so   powerful  and   so  inherently
wrongheaded  that `in  the  mere act  of  using it,  we  have the
potential to  do irreparable  psychological, environmental, moral
and social harm to ourselves and the world.' ''
   It hardly mattered amidst such widely-believed but unwarranted
charges that the scientific  community has overwhelmingly decided
that  biotechnology is  safe.  The  National Academy  of Sciences
published a  report in 1988  on the  possible environmental risks
associated with the deliberate  release of genetically engineered
organisms,  concluding that  there ``is  no evidence  that unique
hazards exist in either the  use of recombinant DNA techniques or
in  the movement  of genes  between unrelated  organisms.''  Some
significant  field tests  have  shown that  microorganisms aren't
posing any hazards.  But no one  has stepped forward to tell this
to the  American people.  News,  especially good  news that isn't
sensational, just doesn't make the front page, so biotechnology's
opponents continue to file lawsuits and grab publicity.

REGULATORY AGENCY OVERLAP
   Fortunately,   the   study   group   which   President  Reagan
established in 1984 to  review biotechnology regulation opted for
a balanced  approach.  It decided  to create  ``a coordinated and
sensible  review process.''   This process,  it was  hoped, would
``minimize the  uncertainties and inefficiencies  that can stifle
innovation and impair the competitiveness of U.S. [biotechnology]
industry,'' while simultaneously weighing  risks.  The result was
a document called  the ``Coordinated Framework  for Regulation of
Biotechnology.''  Whether  it is  genuinely coordinated, however,
remains to be seen.
   The  ``Framework''   states  quite   correctly  that  existing
regulations  are adequate,  but in  its  preamble, it  lists five
separate federal agencies which have statutory authority over all
biotechnology research  and development:  the National Institutes
of  Health (NIH);  the  United States  Department  of Agriculture
(USDA); the Environmental  Protection Agency (EPA);  the Food and
Drug Administration (FDA); and the Occupational Health and Safety
Administration   (OSHA).   There   is  considerable   overlap  of
authority between  these watchdog  agencies, and  to make matters
worse,  the preamble  leaves  crucial definitions  like ``release
into the environment'' up to subsequent determination.
   Immediate problems  have resulted since  regulators have begun
to  apply laws  to  microorganisms designed  to  regulate plants,
pesticides  and   foods.   Companies  desiring   to  comply  with
regulations  are  unsure  of  how  to  do  so,  or  they  receive
conflicting information from  the government.  And  the result is
too often a loud hue and cry  in the media.  We can return to the
example of the  AGS product, Frostban,  whose concept was simple:
Researchers  started  with two  bacteria  called  pseudomonas [P.
syringae and P.  fluorescens], which have  literally been with us
since the beginning of time.   [Pseudomonas act as nucleators for
the condensation  of water  and the  formation of  ice crystals.]
They altered one single gene, leaving the microorganism unable to
form  ice at  low temperatures  [just  barely below  the freezing
point].

MOONSUITING THE BIOTECHNOLOGY INDUSTRY
   AGS's  first  rooftop  test  of  Frostban  complied  with  NIH
guidelines for a  deliberate release.  Those  were the first such
guidelines available.   But because  the company  hadn't obtained
the EPA's approval, the EPA fined the company and delayed further
testing.   The   EPA  finally  approved   outdoor  tests.   Local
regulators thereupon jumped into the  act and required testers to
wear moonsuits --  yes, moonsuits like  astronauts wear, complete
with helmet, gloves,  and breathing pack --  and required them to
erect a fence around the test site!
   According to a reporter's account of the second Frostban test,
a dozen people  swarmed over a  strawberry patch the  size of two
tennis courts, distributing hundreds  of petri dishes and setting
up equipment on  steel towers.  (The drama  mounted when a vandal
trespassed  upon the  plot and  uprooted  some of  the strawberry
plants.   An  environmental  protester  stood  before  television
cameras and praised this act.)  Then, an AGS scientist dressed in
a  moonsuit took  up a  garden  sprayer; simultaneously,  the EPA
official  present at  the site  signaled  for some  60-odd vacuum
pumps  to  begin  to  suck  up  air  samples.   And  the intrepid
scientist,  probably bewildered  by all  the attention,  began to
spray.
   I can't imagine a scene more carefully crafted to frighten the
biotechnology  industry into  abandoning  its plans  to  test new
products.   Nor   is  this   experience  unique.    The  statutes
themselves  create  ample opportunities  for  confusion.   Let us
assume that  a company  desires to  genetically engineer  a plant
that will resist diseases.   Well, under the Federal Insecticide,
Fungicide and  Rodenticide Act  (FIFRA), the  EPA regulates plant
pests.  So  both agencies would  have jurisdiction  to review the
application.  The  company would face  at least  two standards of
review  and   chances  are   other  agencies   would  also  claim
jurisdiction.
   Experience with the current regulatory system suggests that it
is  time  for  reform.  Regulatory  uncertainty  is  quite simply
eroding  America's  lead  in  biotechnology.   Other  nations are
moving more aggressively into  commercial products and processes.
We  need to  streamline the  cumbersome bureaucratic  tangle that
arose under the so-called  ``Coordinated Framework,'' in order to
bring more  certainty to  the process,  and, above  all, to allow
American biotechnology  companies to  confront global competition
head-on.
   New companies, new jobs, and indeed whole new technologies and
new  industries  are  within our  grasp.   Great  goals  of human
endeavor  are  at   stake.   We  must   create  a  climate  where
biotechnology can help us reach them.

              ------------------------------------

   Don Ritter  is currently  serving his  sixth term  in the U.S.
House of Representatives  for the 15th  district of Pennsylvania.
One of a handful of House members with a technological background
and the only  one at the  doctoral level, he  earned his M.A. and
Sc.D. degrees from  the Massachusetts Institute  of Technology in
metallurgy.  Before his election to Congress, he taught and was a
research administrator at Lehigh  University.  He has also served
as  a  consultant to  industry  in  the fields  of  materials and
manufacturing.   In the  House, Dr.  Ritter  serves on  the House
Energy  and  Commerce  and  the  Science,  Space  and  Technology
Committees.  He  also chairs  the Republican  Task Force  on High
Technology and Competitiveness.

              ------------------------------------
      [The Following is not part of the original article.]
`AIDS and Frostban', Access to Energy, June 1987, p. 3.
Campbell, Gerald R.  Biotechnology: An Introduction.  Summit, NJ:
   American Council on Science and Health, January 1988.

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