Biotech In The Barnyard

Presentation toUSDA 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 (2001-2003)

• Public Sentiment About GM Food (September 2003)

• Forthcoming Products– Transgenic Insects Report– Policy Options Report

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

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 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/

A Majority Of Americans Oppose The Genetic Modification Of Animals

32%

58%

10%

0%

20%

40%

60%

80%

Favor Oppose DK

Do you favor or oppose scientific research into the genetic modifications of animals?

17%Strongly

46%Strongly

1.31

2.27

3.61

3.81

4.24

6.08

0 5 10

Plants

Microbes

Animals (food sources)

Insects

Animals (otherpurposes)

Humans

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 GMBad reason to GM

(darker shading=stronger intensity)

45%-43%

49%-41%

51%-43%

55%-41%

57%-35%

58%-33%

62%-33%

64%-28%

69%-25%

70%-24%

71%-21%

81%-14%

-100% -50% 0% 50% 100%

more affordable Rx--plants

reduce need to use pesticides

create peanuts -- no allergic reactions

develop healthy veg oil

more affordable ind compounds--plants

new grass--not mow as often

goats milk--bullet-proof vests

provide organs for human transplant

fruits/veg that last longer

produce beef w/ less fat

more affordable Rx--animals

reduce cost of fish

Plant Animal

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 Challengeso Environmental review authority unclearo By law, confidential and no public participationo Research animals and the INAD processo Regulations, 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 Challengeso 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 trackingo 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

o Environmental review authority unclear and limited to livestock o Intrastate movement, research animals and progeny issueso Post-market controls may be unclear if GM animal is

“deregulated”o FDA still responsible for food safety review—two agency+ issueo New 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