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

PIFB Products on Transgenic Animals “Biotech in the Barnyard” Conference (September 2002) “Future Fish” Report (January 2003) Stakeholder Forum—Animal Working Group ( ) Public Sentiment About GM Food (September 2003) Forthcoming Products –Transgenic Insects Report –Policy Options Report

Biotech in the Barnyard Conference 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

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

Public Sentiments about Genetically Modified Food, September 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

A Majority Of Americans Oppose The Genetic Modification Of Animals Do you favor or oppose scientific research into the genetic modifications of animals? 17% Strongly 46% Strongly

Americans Are Most Comfortable With The Genetic Modification Of Plants Ranked by mean (out of 10)

Americans Are Much More Likely To Support Genetic Modification Of Plants Than Animals Good reason to GM Bad reason to GM (darker shading=stronger intensity) PlantAnimal

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. 512—the INAD and NADA processes; the Animal Health Protection Act and AQ laws; and to a lesser extent, the AWA and FSIS authorities

FDA Option One FFDCA 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 oEnvironmental review authority unclear oBy law, confidential and no public participation oResearch animals and the INAD process oRegulations, guidance and definitions needed

FDA Option Two FFDCA 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 o GRAS process already controversial for some ( e.g. “voluntary notification,” and “not a formal safety ‘approval’ by FDA) o Non-food uses of food animals; containing, identifying and tracking o No authority to conduct and enforce environmental safety reviews

APHIS Option Animal 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 oEnvironmental review authority unclear and limited to livestock oIntrastate movement, research animals and progeny issues oPost-market controls may be unclear if GM animal is “deregulated” oFDA still responsible for food safety review—two agency+ issue oNew law, but no legislative history indicating intent for GM animals

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

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