Larry D. Sanders AGEC 4990: February 2002

1. 11. Ethical Issues in Biotechnology Larry D. Sanders AGEC 4990: February 2002 Dept. of Ag Economics Oklahoma State University

2. Issues & Options:Biotechnology & Info Technology • Precision or Prescription Agriculture: the “Great Green Hope”? • Robotics, GPS, Microsensors, By-plant Prescription Production • May minimize environmental concerns • May reduce hunger challenge • Who can afford it? • The next wave is for non-food uses (nutraceuticals, pharmacology—”pharming”)

3. Issues & Options:Biotechnology • Bio-engineered Seed/GMOs/GEOs • genetically altered attributes (Bt crops: “bacillus thuringiensis”) • Concerns: • unintended direct ecosystem impacts • unintended mutation impacts • unintended human impacts when eaten • labeling to give consumer choice • “Microsofting” of agricultural input marketing

4. Biotechnology Regulation • USDA (primarily APHIS) • Plant pests, plants, veterinary biologics • EPA • Microbial/plant pesticides, new uses of existing pesticides, novel micro-organisms, new herbicidals • FDA • Food, feed, food additives, veterinary drugs, human drugs & medical devices

5. Federal Definition of Agricultural Biotechnology “. . . a collection of scientific techniques, including genetic engineering, that are used to create, improve, or modify plants, animals, and microorganisms.”

6. Key laws • Federal Plant Pest Act • Federal Insecticide, Fungicide, & Rodenticide Act • Federal Food, Drug, & Cosmetic Act • Toxic Substance Control Act • Federal Food, Drug, & Cosmetic Act

7. USDA-APHIS Procedures • Procedures to obtain permit or provide notification prior to introducing regulated article in US. • Regulated articles: organisms/products altered or produced thru genetic engineering that are plant pests. • Petition process to determine non-regulated status. • If determined non-regulated, free of APHIS review.

8. USDA-APHIS Procedures:Eligibility Criteria • Plant species: corn, cotton, potato, soybean, tobacco, tomato, or additional plant species as determined. • Material is stably integrated. • Material is known & doesn’t result in plant disease. • Material doesn’t (1) cause production of infectious entity, (2) encode substances that may be toxic to nontarget organisms, or (3) encode products for pharmaceutical use. • Genetic sequences from plant viruses don’t pose significant risk of creating new plant virus. • The plant has not been modified to contain material from animal or human pathogens.

9. USDA-APHIS Procedures:Permitting Process • Applicant for field testing provides info about plant • If approved, APHIS/state officials may inspect before/during/after • Petition for commercial production seeks “non-regulated” status • If approved, treated like any other plant w/o additional APHIS action

10. Other USDA Agencies with Biotech Role • FSIS • FAS • ARS • ERS • CSREES • AMS • GIPSA

11. FDA Proposal* & Draft Guidance** (Jan ’01) *Changes voluntary consultation to mandatory *Require food developers to --notify FDA at least 120 days in advance of intent to market food or animal feed developed thru biotech, & --to provide info to demonstrate the product is as safe as its conventional counterpart *Proposing to increase transparency of review process **Draft guidance provides direction to manufacturers with voluntary labeling procedures *Comment by 28 Mar 01 **Comment by 13 Mar 01

12. Biotech Regulatory Oversight Examples New trait/organismAgencyReviewed for Viral resistance in food crop USDA Safe to grow EPA Safe for environment FDA Safe to eat Herbicide tolerance in food crop USDA Safe to grow EPA New use of companion herbicide FDA Safe to eat Modified flower color ornamental crop USDA Safe to grow Modified soil bacteria degrades pollutants EPA Safe for environment

13. The Ethics of Labeling/Using Biotech Food • Labels as educational tools • Procedural theory (informed consent) • Utilitarian (trade-offs) • Market-driven or government mandated labels? • Rights theory (negative)—responsibility of state to not interfere • Utilitarian—benefits vs. costs

14. The Ethics of Labeling/Using Biotech Food • Scientifically sound • Scientific norms debatable but not ethically • Labeling is an ethical issue • Performance focused evaluation (justified in terms of acceptability & desirability of consequences)—benefits vs. costs • Structure focused evaluation (protection of rights as precondition to ethically legitimate use of state power)—consent & fairness • Conduct focused evaluation (character & virture)—religion or social class may include dietary rules; honesty & voluntary action may also motivate industry or create expectations in consumers

15. The Ethics of Labeling/Using Biotech Food • Rights arguments may appear irrational/naïve • May fail to understand or see as irrelevant utilitarian arguments • May see decisions without consent as arrogant • Utilitarians may see rights or consent as irrelevant • Biologists/economists/producers who are consequence-oriented may ignore citizen input • Invitation of citizens in risk assessment & regulatory hearings may permit conflict resolution as a move to structure-focused criteria of participation & consent • Performance evaluation may see science/economics as objective in ignoring special interests, but may be biased against ethics of structure & conduct

16. Other Ethical Issues • Biotech to solve hunger? • Biotech to solve chemical overuse? • Loss of producer independence w/contracting w/biotech companies? • Consumer choice? • Risk from long-term use (unintended consequences to humans, plants, animals)? • It may be too late; compensation, remediation, or acceptance?

17. References Bechdol, B. “Overview of Biotechnology Policy Issues”, presentation to Southern Extension Economics Committee, Williamsburg, VA. June 2000. Lin, W.W. & Harwood, J.L. “Biotechnology: Production, Marketing & Policy Issue Perspectives”, presentation to Southern Extension Economics Committee, Williamsburg, VA. June 2000. Sanders—various professional presentations Thompson, P.B., Agricultural Ethics: Research, Teaching and Public Policy, Iowa State University, Ames, 1998.