The Biopharming Tale

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5 Δεκ 2012 (πριν από 4 χρόνια και 4 μήνες)

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NDSU

Extension

Regulating Transgenics

The Biopharming Tale


Phil McClean

Department of Plant Science

North Dakota State University

Biotechnology Education Forum

NDSU Extension Inservice Training

Carrington, ND

February 18, 2003

NDSU

Extension

What is Biopharming
?

Biopharming Definition

Growing transgenic crops that express


pharmaceutical products


Examples:


Drugs

Antibodies

Proteins

NDSU

Extension

Familiar Production Systems

Why use this technology?



Genes introduced into field crops



New productions systems not needed



Producer can use traditional growing strategies


Reduced End
-
Product Cost



Animal system: $1000
-

$5000 per gram protein



Plant System: $1
-

$10 per gram protein




Source
: The Roanoke Times, 2000

NDSU

Extension

Value of Biopharaming: Industry Estimates

Epicyte Pharmaceutical


200 acres of corn production


equal

to production of $400 million plant

ProdiGene


One bushel of corn expressing avidin (important chicken protein)


equal

to one ton of egss costing $1000


Source
: Los Angeles Times: June 4, 2002


NDSU

Extension

The Road to A Biopharm Product:

The Regulatory Process

Regulations Based on Existing (Not New) Regulations



Federal Plant Pest Act (FPPA)



Federal Food, Drug,and Cosmetic Act (FFDCA)



Federal Insceticide, Fungicide, and Rodenticide Act (FIFRA)



Toxic Substances Control Act (TSCA)

NDSU

Extension

Each Step Is Regulated By

A Different Agency

Local Institutional Biosafety Committee



Ensures the genetic engineering experiments are sage



Field Testing the Transgenic


1. Developing the Biopharm Transgenic


NDSU

Extension

2. Field Testing the Transgenic


USDA


APHIS




Sets standards for field trials



Approves field trials



Possibility of escape must be minimized


3. Commercial Production

USDA


APHIS




Proof that transgenic is not an environmental threat


is presented by company



Proof reviewed and transgenic declared


as non
-
regulated

NDSU

Extension

3. Plant is not toxic to environment


EPA




Approves transgenic with a pesticidal property (Bt crops)



Sets field toxicity levels

4. Food Safety Concerns

FDA




Developer provides summary of safety


and nutritional data



Data is voluntary but all released products


have followed this procedure



Proposed rule: summary data is pre
-
released


120 days before product reaches market

NDSU

Extension

The Biopharming Bust Story (2002)

Company
: ProdiGene

Product
: a corn transgenic expressing a drug that


prevents pig diarrhea

Field Test
: Plants grown in 2001 on Nebraska and Iowa farms;


same fields sown to soybean in 2002

Problem
: Volunteers corn transgenics discovered during the


season (IA) and after soybeans were harvested (NE)

Result
: IA
-

all field were burned


NE
-

all the soybeans in the elevator were confiscated

Why
: ProdiGene did not follow the field trial regulations

Cost:
Fine
-

$250,000 (not following regulations)


Restitution
-

$3 million (contaminated soybeans)


NDSU

Extension

The ProdiGene Fallout



ProdiGene fined $250,00



ProdiGene promised to cover $2.8 million


cost of contaminated soybeans



Company kept its permit to grow field trials, but



Promised to better follow APHIS regulations



Test plots will likely be grown outside the corn belt

NDSU

Extension

Other Regulatory Problems



Biotech industry ensured no contamination was occurring



Watchdog groups did testing



BT corn approved for
animal

consumption found in


products for
human
consumption



Occurred because of mixing



Aventis removes StarLink line from production



Company executives lose their jobs



Product found as late as December 2001 in Japan

Starlink

(Aventis)
-

2000

NDSU

Extension



Monsanto developed two Roundup resistant canola transgenics


One approved, RT73


One withdrawn, GT200



GT200 found in Canada canola



Why??


Most likely, cross pollination



Monsanto response


Asked USDA for non
-
regulatory status

GT200 Roundup Canola

(Monsanto)
-

2002

NDSU

Extension

Lessons Learned


The regulatory process is important


It must be followed


It should be viewed as a cost of business not a hindrance


The public watching


Be concerned for their viewpoint


Mistakes will be made


Inadvertent or otherwise (StarLink)


You can’t beat biology (GT200)