Regulating Transgenics The Biopharming Tale

1. Regulating Transgenics The Biopharming Tale Biotechnology Education Forum NDSU Extension Inservice Training Carrington, ND February 18, 2003 Phil McClean Department of Plant Science North Dakota State University

2. What is Biopharming? Biopharming Definition Growing transgenic crops that express pharmaceutical products Examples: Drugs Antibodies Proteins

3. Why use this technology? Familiar Production Systems • 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

4. 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

5. 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)

6. Each Step Is Regulated By A Different Agency 1. Developing the Biopharm Transgenic Local Institutional Biosafety Committee • Ensures the genetic engineering experiments are sage • Field Testing the Transgenic

7. 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

8. 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

9. 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)

10. 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

11. Other Regulatory Problems Starlink (Aventis) - 2000 • 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

12. GT200 Roundup Canola (Monsanto) - 2002 • 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

13. 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)