Biotech In The Barnyard

1
Biotech In The Barnyard

• Presentation to
• USDA AC-21 Committee
• December 5th, 2003
• Michael Rodemeyer, Executive Director
• Pew Initiative on Food and Biotechnology

2
PIFB Products on Transgenic Animals

• Biotech in the Barnyard Conference (September
  2002)
• Future Fish Report (January 2003)
• Stakeholder ForumAnimal Working Group
  (2001-2003)
• Public Sentiment About GM Food (September 2003)
• Forthcoming Products
• Transgenic Insects Report
• Policy Options Report

3
Biotech in the BarnyardConference on Transgenic
Animals

• Two-day event held September 2002 in Dallas, TX
• Followed by one-day workshop on cloned animals
  with CVM
• More than 150 participants
• Representatives from Industry, Government
  agencies, Consumer groups, Animal welfare
  advocates, Scientists and Policy Analysts
• Issues addressed
• Potential uses of genetically engineered and
  cloned animals
• NAS Report Animal Biotechnology Science-Based
  Concerns
• Ethical and animal welfare considerations
• Human health and environmental concerns
• State of the technology and future trends
• Marketing issues
• Regulation of transgenic and cloned animals

4
Lessons Learned in Dallas, TX

• General enthusiasm, particularly among
  researchers and industry, exists for the benefits
  of transgenic and cloned animals especially
  those that improve human health or enhance animal
  breeding options and productivity
• But complex concerns about ethics and animal
  welfare could complicate the introduction of
  products derived by animal biotech IF these
  concerns are not addressed BEFORE products are
  widely available
• It is unclear if consumers are prepared for the
  arrival of food products from cloned and
  transgenic animals
• Regulations and laws will need to be updated to
  help industry and producers to commercialize
  products and to build public trust

5
Public Sentiments about Genetically Modified
Food, September 2003

• 1000 Adults Interviewed
• Conducted by The Mellman Group (D) and Public
  Opinion Strategies (R)
• Interviews Conducted Between August 7-10, 2003
• Margin Of Error /- 3.1 Overall
• Margin Of Error Higher For Subgroups
• Complete Poll at http//pewagbiotech.org/research/
  2003update/

6
A Majority Of Americans Oppose The Genetic
Modification Of Animals
Do you favor or oppose scientific research into
the genetic modifications of animals?
46 Strongly
17 Strongly
7
Americans Are Most Comfortable With The Genetic
Modification Of Plants
Ranked by mean (out of 10)
8
Americans Are Much More Likely To Support
Genetic Modification Of Plants Than Animals
Good reason to GM
Bad reason to GM
(darker shadingstronger intensity)
9
Overview of the AWG of the Stakeholder Forum

• The AWG Members from TransOva, NCBA, Cargill,
  ED, U of Wisc, and CFA 10 in-person meetings and
  numerous conference calls Focused on safety
  issues of transgenic animals that could enter the
  food supply, not insects, companion animals, lab
  animals or ethical/animal welfare issues
• Issues of Concern Food Safety, Animal Safety,
  Environmental Safety, Public Participation and
  Transparency, Animal I.D. and Tracking,
  Post-Commercialization Controls, Guidance,
  Definitions and Regulations
• Authorities Reviewed FFDCA, in particular Sec.
  512the INAD and NADA processes the Animal
  Health Protection Act and AQ laws and to a
  lesser extent, the AWA and FSIS authorities

10
FDA Option OneFFDCA Section 512

• Key Regulatory Theories
• (advanced by the OSTP-CEQ Case Studies, January
  2001)
• New Animal Drug
• Safe and Effective
• Interstate Commerce
• Section 512 Strengths
• FDA must ensure drug is safe for humans and the
  animal
• Intent to alter structure and function clear
• Drug marketing is illegal without prior FDA
  approval
• FDA can require some post-market controls via
  label
• Section 512 Challenges
• Environmental review authority unclear
• By law, confidential and no public participation
• Research animals and the INAD process
• Regulations, guidance and definitions needed

11
FDA Option TwoFFDCA Section 409

• Key Regulatory Theories
• Food, Food Additive, and GRAS
• Section 409 Strengths
• Relatively well-defined food safety review
  process used for plant-based GM foods
• Possibly more expedient food safety review than
  the Section 512 process, particularly if
  declared GRAS exempt
• Section 409 Challenges
• GRAS process already controversial for some (
  e.g. voluntary notification, and not a formal
  safety approval by FDA)
• Non-food uses of food animals containing,
  identifying and tracking
• No authority to conduct and enforce
  environmental safety reviews

12
APHIS OptionAnimal Health Protection Act

• Key Regulatory Theories
• Disease, Vector and Pest
• Livestock and Farm
• Interstate Movement
• AHPA Strengths
• Broad authorities and definitions
• APHIS has history and infrastructure for animal
  I.D. and tracking
• No legal prohibition against pre-market approval
  system, or transparency and public participation
  in existing AQ laws
• AHPA Challenges
• Environmental review authority unclear and
  limited to livestock
• Intrastate movement, research animals and progeny
  issues
• Post-market controls may be unclear if GM animal
  is deregulated
• FDA still responsible for food safety reviewtwo
  agency issue
• New law, but no legislative history indicating
  intent for GM animals

13
Developing Issues

• CVM letter to universities conducting GM animal
  research (May 2003)
• Cloned Animals and products from cloned animals
  (November 2003)
• GloFish (December 2003)

14
Summary

• Promising technology for industry, agriculture
  and consumers
• Regulatory pathway to market unclear at this time
  which is a challenge for industry, consumers and
  policy makers
• Credible, comprehensive system to affirm the food
  and environmental safety of GM animals needed
• Forum to consider ethical and animal welfare
  issues that fall outside regulatory agency
  authorities needed
• Consumer education and acceptance could be
  challenging
• GM animal issues in urgent need of attention for
  all interested parties