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6-Regulations: U.S. agrobusiness organisations renew call for"pharma crop" moratorium



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                                  PART I
-------------------------------- GENET-news --------------------------------

TITLE:  GMA SAYS STRINGENT FDA AND USDA BIO-PHARMA REGS NEEDED TO MAINTAIN
        FOOD SUPPLY PURITY
SOURCE: Grocery Manufacturers of America, USA, Press Release
        http://www.gmabrands.com/news/docs/NewsRelease.cfm?DocID=1063
DATE:   Feb 6, 2003

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GMA SAYS STRINGENT FDA AND USDA BIO-PHARMA REGS NEEDED TO MAINTAIN FOOD
SUPPLY PURITY


----------------------------------------------------------------------------
   "To minimize the possible risks, a clear system of regulatory
    enforcement and liability needs to be in place for the development,
    testing and eventual commercialization of PMPs [plant-made
    pharmaceuticals] - just as we require strict regulations for
    conventional drugs made in brick and mortar facilities. Until then,
    no permits for new field trials or for commercialization should be
    issued by USDA because there is no room for trial and error."
----------------------------------------------------------------------------


Washington, DC, February 6, 2003 - In comments filed with the U.S. Food
and Drug Administration today, the Grocery Manufacturers of America said
plant-made pharmaceuticals (PMPs) require stringent new regulations to
ensure continued consumer confidence in the absolute safety of the U.S.
food supply.

GMA's comments were filed in response to proposed guidelines published by
the FDA that outline requirements for developing and manufacturing PMPs.
In its comments, GMA addressed the need to include clear direction in the
final guidelines for maintaining the purity of the U.S. food supply as
well. GMA stressed its support for the potential benefits of the
technology but said the FDA and U.S. Department of Agriculture must
implement more stringent regulations before the technology is more widely
used in new field trials approved by the USDA or in large-scale
commercialization. GMA's comments apply to plant-made industrial products
as well as PMPs.

"Biotechnology has great potential to bring new benefits to consumers,"
said GMA Senior Vice President of Government Affairs Mary Sophos.
"However, now is the time to ensure that the appropriate and necessary
regulations for PMPs are in place, and that safeguards for the U.S. food
supply are implemented before this technology is more widely used."

"Plant-made pharmaceuticals aren't meant to make it to the dinner table,"
added Sophos. "To minimize the possible risks, a clear system of
regulatory enforcement and liability needs to be in place for the
development, testing and eventual commercialization of PMPs - just as we
require strict regulations for conventional drugs made in brick and
mortar facilities. Until then, no permits for new field trials or for
commercialization should be issued by USDA because there is no room for
trial and error."

GMA's comments include recommendations for various procedures to reduce
the risk of intentional or unintentional contamination of the food supply
by PMPs, including:



* A presumption against the use of food/feed crops for pharmaceuticals
unless the company developing the drug product clearly demonstrates that
it is not feasible to use non-food crops.

* Additional biological and physical containment procedures such as
"terminator gene" technology, the use of large-scale greenhouses and
isolation distances need to be considered and utilized.

* Land, labor and equipment dedicated solely to growing PMPs. This
extends to carefully selecting and training "pharmers" on the proper
handling of PMPs.

* Communication plans and readily-available tests to detect the PMP
should be required as part of field permits before allowing any open-air
release of PMPs in the case of potential contamination.

GMA plans to work closely with the FDA and USDA as they implement
improved regulations for PMPs. Additionally, GMA will maintain an open
dialogue with the biotech industry and other stakeholders to ensure that
the regulations meet the needs of the evolving technology as well as the
needs of the food industry and consumers for absolute confidence in the
U.S. food supply.

The comments submitted by GMA were also signed by the American Bakers
Association, the Biscuit & Cracker Manufacturers Association, the Food
Marketing Institute, the Institute of Shortening & Edible Oils, the
International Dairy Foods Association, the National Confectioners
Association, the National Council of Chain Restaurants, the National
Restaurant Association, and the National Soft Drink Association.

###

GMA is the world's largest association of food, beverage and consumer
product companies. With U.S. sales of more than $460 billion, GMA members
employ more than 2.5 million workers in all 50 states. The organization
applies legal, scientific and political expertise from its member
companies to vital food, nutrition and public policy issues affecting the
industry. Led by a board of 42 Chief Executive Officers, GMA speaks for
food and consumer product manufacturers and sales agencies at the state,
federal and international levels on legislative and regulatory issues.
The association also leads efforts to increase productivity, efficiency
and growth in the food, beverage and consumer products industry.


Staff Contacts
Karil Kochenderfer

Press Contacts
Stephanie Childs (202) 337-9400 or www.gmabrands.com



                                  PART II
-------------------------------- GENET-news --------------------------------

TITLE:  No Use of Food or Feed Crops for Plant-Made Pharmaceutical
        Production Without A "100% Guarantee" Against Any Contamination,
        Says NFPA
SOURCE: National Food Processors Association, USA, Press Release
        http://www.nfpa-food.org/News_Release/020603NewsRelease.htm
DATE:   Feb 6, 2003

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No Use of Food or Feed Crops for Plant-Made Pharmaceutical Production
Without A "100% Guarantee" Against Any Contamination , Says NFPA

(Washington, D.C.) - In comments filed today with the Food and Drug
Administration, the National Food Processors Association (NFPA) strongly
urged that there be no use of food or feed crops to produce plant-made
pharmaceuticals (PMPs) or industrial chemicals "without a 100% guarantee
against any contamination of the food or feed supply."

"In the absence of demonstrated effective controls and procedures to
ensure against any contamination of the food or feed supply, NFPA
vigorously opposes the use of food or feed crops to produce PMPs," noted
Dr. Rhona Applebaum, NFPA's Executive Vice President and Chief Science
Officer. "Without such proven and effective controls, applications for
this technology should be applied only in non-food and feed crops that
are segregated from the food supply."

NFPA submitted comments in response to FDA's and USDA's Guidance for
Industry on Drugs, Biologics, and Medical Devices Derived from
Bioengineered Plants for Use in Humans and Animals, issued on September
12, 2002.

"NFPA acknowledges the current and potential benefits of this promising
technology," Dr. Applebaum said. "However, maintaining a safe, wholesome
and unadulterated food supply must remain the government's primary goal,
as it is for the food industry."

Dr. Applebaum stated "FDA has a zero tolerance for articles of food that
are not approved for human consumption. Consequently, it is our position
that if 100% prevention against adulteration is not achievable, food and
feed crops must not be used in the production of PMPs."

"The issues that should be addressed in both the Guidance and ultimately
in regulations should include standard operating procedures (SOPs) for
comprehensive treatment of biological containment, physical containment,
training throughout the development, production, and processing system,
identity preservation, security against intentional efforts to cause food
adulteration, monitoring and auditing during field tests and
commercialization, waste management and disposal, and accident detection
and response including the availability of workable testing methods," Dr.
Applebaum said. "Licensing of individuals involved with various stages of
PMP products should also be considered."

Dr. Applebaum said "USDA must take full advantage of its strong
regulatory authority under the Plant Pest Act and related laws to impose
permit conditions that will assure containment of PMPs, including
appropriate biological and physical containment measures and HACCP
controls. USDA must also use its extensive inspection authority, and
bolster the inspection resources dedicated to PMPs, to enable the Agency
to closely monitor production of PMPs to assure that permit conditions
are not violated. In addition, FDA, which has regulatory authority over
PMPs as drugs, should make clear that inadequate containment measures
will result in withholding approval of a New Drug Applications (NDA) or
other sanctions under the Federal Food, Drug, and Cosmetics Act."

NFPA made clear in its comments that "The food industry is clearly an
affected stakeholder in this issue. In a perfect world and if the food
industry had complete control of this promising technology from the
beginning, we would never have supported the use of food or feed crops
for the production of PMPs. The risk of contamination of the food or feed
supply is just too great. Unfortunately, PMP technology already has been
implemented in food and feed crops."

Dr. Applebaum concluded "In view of the 'hand we've been dealt,' the food
industry must have a '100% protection standard' against any contamination
of the food supply. If this standard cannot be met, we will vigorously
oppose the use of food or feed crops as 'factories' for pharmaceutical
and industrial chemical products. We can demand nothing less for our
consumers."

###


NFPA is the voice of the $500 billion food processing industry on
scientific and public policy issues involving food safety, food security,
nutrition, technical and regulatory matters and consumer affairs.


For more information on this issue, contact Timothy Willard, NFPA's Vice
President of Communications, at (+1-202) 637-8060, Libby Mikesell, Senior
Director of Communications, at (+1-202) 639-5919, or visit NFPA's Website
at www.nfpa-food.org.