Larry D. Sanders

1

11. Ethical Issues in Biotechnology

• Larry D. Sanders
• AGEC 4990 February 2002

Dept. of Ag Economics Oklahoma State
University
2
Issues OptionsBiotechnology 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, pharmacologypharming)

3
Issues OptionsBiotechnology

• 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 ProceduresEligibility Criteria

• Plant species corn, cotton, potato, soybean,
  tobacco, tomato, or additional plant species as
  determined.
• Material is stably integrated.
• Material is known doesnt result in plant
  disease.
• Material doesnt (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 dont 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 ProceduresPermitting 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/organism Agency Reviewed 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
• Utilitarianbenefits 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.
• Sandersvarious professional presentations
• Thompson, P.B., Agricultural Ethics Research,
  Teaching and Public Policy, Iowa State
  University, Ames, 1998.