1. It’s a food… It’s a drug… It’s AquAdvantage Salmon! Ricardo Carvajal Hyman, Phelps & McNamara, P.C. www.hpm.com www.fdalawblog.net 21 st Annual Tulane Environmental Law & Policy Summit

2. 2 Federal Food, Drug, & Cosmetic Act  110 year legacy  Periodic amendments  Safety  Innovation  Broad, flexible authority

3. Definitions are key  201(s) - Food additive: any substance the intended use of which can reasonably be expected to become a component of food  Food additives are subject to premarket approval  Exception: the use of the substance is generally recognized as safe (GRAS)  409 - Whether food additive or GRAS, the use of the substance must be “safe” = “reasonable certainty of no harm” 3

4. Food from GE plants  1992 statement of policy  Nucleic acids are presumed GRAS  Intended expression products – it depends  Voluntary premarket consultation  Why not regulate food from GE animals the same way? 4

5. Definitions are key (part 2)  201(g) - Drug: any article (other than food) intended to affect a structure or function of man or animal.  201(v) - New animal drug: not GRASE, and not use for material extent or material time.  Subject to premarket approval 5

6. Food from GE animals  2009 guidance  rDNA construct intended to affect structure or function is a drug  Submission and approval of a new animal drug application (NADA) is required 6

7. Extensive review  Product definition  Molecular characterization of the construct  Molecular characterization of the GE animal lineage  Phenotypic characterization of the GE animal  Durability plan  Environmental and food/feed safety  Claim validation 7

8. Approval of AAS  Investigational new animal drug status in 1995  NADA approved on Nov. 19, 2015  20 years, >$80 million 8

9. Focus on safety  FDA applied standard applicable to food additives  There is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.  It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of any substance 9

10. Focus on safety (2)  AAS meets the standard of identity for Atlantic salmon  There are no meaningful differences in food composition  No biologically relevant differences in total protein, specific amino acids, vitamins, fatty acids, ratios of fatty acids, including omega-3 and omega-6 fatty acids 10

11. Focus on safety (3)  Food from AAS is as safe as food from non- GE Atlantic salmon  There is a reasonable certainty of no harm from consumption of food from AAS 11

12. No significant environmental impact  Produced in secure facilities in Canada and Panama  Multiple and redundant forms of physical containment  Possibility of escape and survival is “extremely remote”  Because animals are all-female and sterile, possibility of reproduction in wild is “extremely remote” 12

13. Labeling  Limited authority to compel labeling  201(n) – label is misleading if it fails to reveal “material” facts  Longstanding interpretation of materiality  Obvious and fair policy solution – “non-GMO” 13

14. Beyond safety  Sociopolitical views  Economic interests  DC playbook 14

15. 15

16. 16

17. 17 QUESTIONS ?