1. Beyond Food and Evil Labeling and the Mindscape of American Agricultural Policy Jim Chen Dean and Professor of Law University of Louisville The Law and Policy of a Sustainable Food System Louisville Bar Association, Environmental Law Section August 17, 2010

2. rDNA technologies, regulatory concerns, labeling rDNA technologies deployed in agriculture Regulatory concerns: food safety, ecology, economy Laws governing food containing GMOs Beyond food and evil: The limits of organic labeling as a basis for a comprehensive GMO policy

3. rDNA technologies

4. rDNA technologies in agriculture Enrichment or fortification: golden rice Accelerated production: –rbST in milk production –GM salmon: Chinook growth gene + ocean pout trigger = year-round feeding schedule. Cf. Ex parte Allen (polyploid oysters) Herbicide resistance: “Roundup-ready” Pesticidal properties: Bt corn

5. Regulatory concerns

6. Lack of fitness for human consumption –Adulteration: general population. Starlink –Genetic source: specific, sensitive population Biological breakouts –Hybridization with wild relatives. GM canola –“Super salmon” outcompete wild relatives –Smaller organisms, faster evolutionary clock

7. Regulatory concerns, continued Resistance in target organisms –Bt-resistant insects –Cf. glyphosate resistance and the impact of nontherapeutic antibiotic use on human health Unintended harm to nontarget organisms –Bt’s impact on all Lepidoptera (monarch) –Cf. bee colony collapse and bioaccumulation Economic injury to nonadopting farmers

8. Laws regulating GMO use

9. Laws governing GMO use National Environmental Policy Act (NEPA) –Useless against alleged economic injury –USDA approvals of GM canola, beets, alfalfa Endangered Species Act (ESA) –Nontarget organisms and biological breakouts Food, Drug, and Cosmetic Act (FD&CA) Organic Foods Production Act (OFPA)

10. Labeling rules under the FD&CA and OFPA FD&CA §§ 402(a)(1), 409: adulteration –Outright bans and targeted labeling FD&CA §§ 201(n), 403(a)(1): misbranding New Plant Varieties (1992) –GRAS under §§ 201(s), 409 –No across-the-board labeling requirement

11. Labeling rules, continued Premarket Biotechology Notices and Voluntary Labeling Guidance (2001) –GM foods are presumptively marketable after completion of the PBN process –Labels disclosing GMOs are not required –“GM/biotech free” labels need disclaimers OFPA: The organic label has become the de facto signal of non-GMO status

12. The limits of labeling

13. The limits of labeling as GMO regulation The OFPA lacks the FD&CA’s consumer protection mandate –FD&CA patrols adulteration and misbranding –“Organic” makes no claims regarding the intrinsic safety or value of food. Nor could it. Often the right answer is an outright ban or a production-level limit, not a label Little or no impact on farm size or structure

14. Beyond food and evil

15. Behavioral psychology and the mindscape of American agricultural policy –Labeling puts all the weight of profound policy decisions on consumer-level choices –Food choices are notoriously irrational Sweet and greasy foods naturally appeal Every child knows that finicky eaters survive Law, science, and safety in the balance

16. Thank you Jim Chen jim.chen@louisville.edu 502-852-6879