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Date:    Mon, 10 Feb 97 15:18:11 -0800 
From:    IATP <iatp@igc.apc.org>
To:      Recipients of conference <env.biotech@conf.igc.apc.org>
Subject: IP/Biodiversity News January 24, 199

Intellectual Property & Biodiversity News
Produced by the Institute for Agriculture and Trade Policy
January 24, 1997
Volume 6, Number 1
_____________________________
Headlines
- - BRITAIN BARS TRANSPLANTS FROM ANIMALS TO HUMANS; U.S. APPROVES
- - EU VOTES ON NOVEL FOOD REGULATION
- - TRADE SANCTIONS IMPOSED ON ARGENTINA OVER IPR DISPUTE
- - HERBICIDE APPROVED FOR USE ON GENETICALLY ENGINEERED CORN
- - COMPANY INTRODUCES PERPETUAL STORAGE OF DNA
_____________________________
BRITAIN BARS TRANSPLANTS FROM ANIMALS TO HUMANS; U.S. APPROVES

The British government on January 16 barred xenotransplants, 
the transplant
of animal organs to humans, until the risk of disease 
transmission is better
understood. The decision was based on a report by a 
government-appointed
panel of experts concerned that transplanted animal organs 
could introduce
new diseases to humans. The government said that new 
legislation will be
introduced as soon as possible to govern species to species 
transplants, but
has made it clear that emergency legislation will be 
implemented when
necessary to halt human trials. Imutran, a Cambridge-based 
company, who is
pioneering the use of genetically modified pigs to provide 
human organs, said
they accepted that further research was needed before 
proceeding with
clinical trials.

The U.S. Food and Drug Administration (FDA) issued a set of 
xenotransplant
guidelines in September of 1996 that allows animal to human 
transplants, and
puts the responsibility for health and safety at the level of 
local hospitals
and medical review boards. A group of 44 top virologists, primate
researchers, and AIDS specialists have attacked the FDA 
guidelines, saying,
"based on knowledge of past cross-species transmissions, 
including AIDS,
Herpes B virus, Ebola, and other viruses, the use of animals 
has not been
adequately justified for use in a handful of patients when the 
potential
costs could be in the hundreds, thousands or millions of human 
lives should a
new infectious agent be transmitted." On January 16, the FDA 
said it would
issue revised guidelines eventually, based on comments from 
both opponents
and advocates of xenotransplantation.

"Britain Bans Transplants from Animals to People," STAR 
TRIBUNE, January
17, 1997; "Brits Bar Xenotransplants," ASSOCIATED PRESS, 
January 17, 1997.

EU VOTES ON NOVEL FOOD REGULATION

The European Parliament, in a vote of 339 to 60 on January 16, 
passed the
Novel Food Regulation which will allow most genetically 
engineered  food to
be sold without being labeled. Dagmar Roth-Behrendt, a German 
Socialist in
charge of the legislation, told the assembly that the 
compromise worked out
with European Union governments was inadequate but urged 
passing to avoid a
legal vacuum. 

The Regulation requires labeling if the product contains a 
"live" genetically
altered element, or if the novel food is shown through 
scientific analysis to
be significantly different from conventional foods. The 
Regulation also
provides that bulk deliveries of raw materials such as soya, 
maize and other
goods do not have to be labeled as long as "information for 
consumers on the
possibility that genetically modified organisms may be 
present," is provided.


It will not require rigorous health and safety tests before 
authorization and
allows manufacturers of genetically engineered foods to market 
their product
with only a notification to the European Commission that the 
novel foods are
"essentially equivalent" to traditional ones. It has not yet 
been determined
how the Regulation will be implemented, nor what information 
must be provided
by the manufacturer to the Commission to determine labeling status.

The Regulation related to genetically engineered labeling will 
supersede any
national state legislation. For example, the Netherlands 
legislation
requiring all genetically engineered products to be labeled 
will now be
overruled. 

A MORI survey found that 78% of those surveyed in Sweden, 77% 
in France, 65%
in Italy and Holland, 63% in Denmark, and 53% in Great Britain 
were "not
happy to eat genetically engineered food." In a previous study 
78% of those
surveyed in Germany were opposed to food derived from genetic 
engineering.

"Europe Caves In To American Pressure: European Parliament 
Votes in Novel
Food Regulation,," Greenpeace Press Release, January 16, 1997; 
Gillian
Handyside, "EU Accepts Pro-Industry Labeling Law," REUTERS, 
January 16, 1997.

TRADE SANCTIONS IMPOSED ON ARGENTINA OVER IPR DISPUTE

The United States Trade Representative-designate Charlene 
Barshefsky
announced on January 15, that the U.S. will withdraw 50 percent 
of trade
benefits granted to Argentina under the U.S. Generalized System of
Preferences (GSP). The administration issued a Federal Register 
Notice
requesting public comment within 30 days outlining which 
Argentine products
should be excluded from GSP duty-free treatment. The final list 
of products
that will lose GSP treatment will be published about March 1. 
Under a U.S.
Government "special 301 program," which favors advancement of U.S.
intellectual property rights (IPRs) around the world, the 
sanction decision
was the result of an out-of-cycle review to assess the new 
legislation
Argentina enacted on intellectual property rights on December 
18. 

Under the new legislation, pharmaceutical inventors must submit 
scientific
and technical data that supports safety claims to Health 
Ministries to obtain
marketing approval. The new legislation specifically permits 
Argentine
competitors to rely on data that has been submitted for 
registration in
Argentina, the United States and certain other countries. . The 
U.S. feels it
fell short in that it does not prevent competitors from relying 
upon
inventor's test data when the rival firms seek market approval.

"USTR-Designate Barshefsky Announces GSP Sanctions Against 
Argentina for
Continuing IPR Problems," Office of the United States Trade 
Representative,
Press Release, January 15, 1997.

HERBICIDE APPROVED FOR USE ON GENETICALLY ENGINEERED CORN

AgrEvo USA received approval from the U.S. Environmental 
Protection Agency
(EPA) on January 17 for use of Liberty Herbicide, a 
non-selective herbicide
that provides control of a broad range of broadleaf weeds and 
grasses
including corn. More than four thousand acres of Liberty Link 
corn and
several hundred acres of Liberty Link soybeans in 33 states 
were treated with
the  herbicide in 1996 under an EPA Experimental Use Permit. 
The herbicide
will be sold in the $1.3 billion U.S. corn herbicide market to 
be used on
corn that has been genetically engineered for resistance to the 
active
ingredient in the herbicide. "AgrEvo discovered a gene that conveys
resistance to Liberty Herbicide's active ingredient, 
glufosinate-ammonium,
and we have made the genetics available to seed companies that 
want to market
Liberty Link Seed hybrids," said Jeff Springsteen, AgrEvo's 
Marketing
Manager.  More than 95 companies have become partners with 
AgrEvo on the
Liberty Link Seed and are offering more than 180 transgenic 
corn hybrids for
purchase. Seed companies have transferred the Liberty Link gene 
into some of
their best performing hybrid lines.

"Liberty Herbicide Approved for Use in Corn Market," AGNET, 
January 17, 1997.

COMPANY INTRODUCES PERPETUAL STORAGE OF DNA

"The time of death is the last easy opportunity to retrieve a 
DNA sample,"
said George Kriegshauser, the regional president for Service 
Corporation
International, a company that owns several funeral homes and 
cemeteries. He
said his company was taking "a very, very soft approach" to 
promote storing
in perpetuity a person's DNA with a product being offered to 
funeral home
directors by GeneLink in New Jersey. John R. DePhillipo, Chief 
Executive
Officer of GeneLink, sees funeral directors as the start of a 
DNA banking
empire. He is beginning to approach cancer specialists and 
pathologists to
sell the services. He said other obvious places would be 
infertility clinics.

David Newcomer, a funeral director at D.W. Newcomer's Sons, a 
funeral home in
Kansas City, said "we hope to make a profit." He declined to 
say what the
profit would be. The DNA retrieval kits cost the funeral homes 
approximately
$100. GeneLink is suggesting funeral homes charge $175-$295 for 
collection of
DNA and storage for 25 years. The process of retrieving DNA 
from the deceased
person is to swab the inside of the person's mouth with a 
normal cotton swab.
The DNA is then sent to GeneLink where it is processed to 
retrieve human DNA
from the mix with other DNA such as bacteria. 

Dr. Barbara Weber, a medical geneticist at the University of 
Pennsylvania
also stores DNA for research purposes. She said the company was 
capitalizing
on "people's fears about their DNA." Medically, unless a
person has a strong history of disease, she said, "I can't see 
that this is
going to be of tremendous value."

Gina Kolata, "A Headstone, a Coffin and Now, the DNA Bank," THE 
NEW YORK
TIMES, December 24, 1996.

EVENTS

4th International Symposium on In Situ and On-Site 
Bioremediation, April
28-May 1, New Orleans, LA. Contact: Bioremediation Symposium 
Registrar, The
Conference Group, Tel: 800-783-6338: FAX: 614-488-5747; email:
102632.3100@compuserve.com).

Bio '97 International Biotechnology Meeting & Exhibition, June 
8-12, Houston,
Texas. Contact: Bio International Meetings Department, 
Biotechnology Industry
Organization, Tel: 202-857-0244; FAX: 202-331-8132).

RESOURCES

Linda Tagliaferro, "Genetic Engineering: Progress or Peril?" 
discusses
current and potential uses and risks of genetic engineering  in 
a high school
level format; Lerner Publications Company.

Sheldon Krimsy and Roger Wrubel, "Agricultural Biotechnology 
and the
Environment: Science, Policy and Social Issues," discusses the 
ongoing
transformation of agriculture, exploring the impact of genetic 
engineering
from scientific, social, ethical, and ecological perspectives; 
University of
Illinois Press, 1325 South Oak Street, Champaign, IL 61820.

Intellectual Property & Biodiversity News is produced by the 
Institute for Agriculture and Trade Policy, Mark Ritchie, 
President.
Edited by Jean Carruthers.  Electronic mail versions are 
available 
free of charge for subscribers. For information about fax 
subscriptions contact: IATP, 2105 1st Ave. S., Minneapolis, 
MN 55404.  For information on subscribing to this and other 
IATP 
news bulletins, send e-mail to: iatp-info@iatp.org.  IATP 
provides 
contract research services to a wide range of corporate and 
not-for-
profit organizations.  For more information, contact Dale 
Wiehoff 
at 612-870-0453 or send email to: dwiehoff@iatp.org.


Date:    Mon, 10 Feb 97 15:18:11 -0800 
From:    IATP <iatp@igc.apc.org>To:      Recipients of conference <env.biotech@
	  conf.igc.apc.org>Subject: IP/Biodiversity News January 24, 199

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