Environmental Assessment for AquAdvantage Salmon Environmental Assessment for AquAdvantage® Salmon An Atlantic salmon (Salmo salar L.) bearing a single copy of the stably integrated α-form of the opAFP-GHc2 gene construct at the α-locus in the EO-1α line Aqua Bounty Technologies, Inc. Submitted to the Center for Veterinary Medicine US Food and Drug Administration For Public Display August 25, 2010 Page 1 of 84 August 25, 2010 Environmental Assessment for AquAdvantage Salmon Table of Contents (Page 1 of 4) Title Page ............................................................................................................................. 1 Table of Contents ................................................................................................................. 2 List of Tables ....................................................................................................................... 6 List of Figures ...................................................................................................................... 6 List of Acronyms & Abbreviations ..................................................................................... 7 List of Definitions ................................................................................................................ 9 Summary ............................................................................................................................. 10 1.0 INTRODUCTION ................................................................................................... 12 1.1 Background and Overview .............................................................................. 12 1.2 Description of Product ..................................................................................... 13 1.3 Description of the Proposed Action: an NADA Approval for AAS .............. 13 1.3.1 The regulatory mandate ...................................................................... 13 1.3.2 Purpose of and need for the proposed action .................................... 14 1.3.3 Alternatives to the proposed action ................................................... 15 1.4 Regulatory Background ................................................................................... 15 1.5 Approach Taken in This Assessment .............................................................. 15 2.0 PRODUCT ............................................................................................................... 16 2.1 Product Definition ............................................................................................ 16 2.2 Characterization of the rDNA Construct ......................................................... 16 2.2.1 Characterization of the plasmid form, opAFP-GHc2 ......................... 17 2.2.2 Characterization of the integrated form, EO-1α ................................. 18 2.3 Durability of the Associated Genotype and Phenotype.................................... 20 2.4 Phenotypic Characterization of AAS vs. Wild and Domestic Salmon ............ 21 2.4.1 Biology of Atlantic salmon ................................................................. 23 2.4.1.1 Home range .......................................................................... 23 2.4.1.2 Life history ........................................................................... 23 2.4.1.3 Habitat .................................................................................. 25 2.4.1.4 Tolerance of physical factors .............................................. 25 2.4.1.5 Interaction with other organisms ........................................ 26 Page 2 of 84 August 25, 2010 Environmental Assessment for AquAdvantage Salmon Table of Contents (Page 2 of 4) 2.0 PRODUCT ................................................................................................. Continued 2.4.2 Domesticated and wild salmon ........................................................... 27 2.4.2.1 Salmon farming .................................................................... 27 2.4.2.2 Interactions between domesticated and wild salmon ......... 28 2.4.3 Genetically-engineered salmon ........................................................... 30 2.4.3.1 Metabolic rates .................................................................... 33 2.4.3.2 Tolerance of physical factors .............................................. 34 2.4.3.3 Behavior ............................................................................... 35 2.4.3.4 Resource or substrate use .................................................... 36 2.4.3.5 Impact of disease, parasites, and predation ........................ 36 2.4.3.6 Morphology and limits to growth maximization ................. 36 2.4.3.7 Reproduction ........................................................................ 37 2.4.3.8 Life history ........................................................................... 37 2.4.3.9 Summary characterization vs. non-transgenic salmon ....... 37 3.0 PRODUCTION, GROW-OUT, AND DISPOSAL ............................................ 38 3.1 Description of AquAdvantage Salmon Egg Production .................................. 38 3.1.1 General production plan ...................................................................... 38 3.1.1.1 Reproductive biology of AquAdvantage broodstock ........... 38 3.1.1.2 Technical details and logistics of commercial production . 41 3.1.2 Specific production plan ...................................................................... 43 3.2 Description of AquAdvantage Salmon Grow-Out .......................................... 44 3.3 Description of AquAdvantage Salmon Disposal ............................................. 46 3.3.1 Disposal of eggs and fish .................................................................... 46 3.3.2 Disposal of fish wastes ........................................................................ 47 3.3.3 Disposal of processing wastes ............................................................. 47 3.4 Labeling, Packaging, and Shipping ................................................................. 47 [End of Page] Page 3 of 84 August 25, 2010 Environmental Assessment for AquAdvantage Salmon Table of Contents (Page 3 of 4) 4.0 AFFECTED ENVIRONMENT ............................................................................. 48 4.1 Egg-Production Site ......................................................................................... 48 4.1.1 Physico-chemical properties ............................................................... 48 4.1.2 Biological/ecological properties .......................................................... 49 4.2 Grow-Out Site .................................................................................................. 50 4.2.1 Physico-chemical properties ............................................................... 50 4.2.2 Biological/ecological properties .......................................................... 53 4.3 Disposal Sites ................................................................................................... 53 5.0 POTENTIAL HAZARDS ...................................................................................... 53 5.1 Likelihood of Escape ....................................................................................... 54 5.2 Likelihood of Establishment ............................................................................ 55 5.3 Likelihood of Spread ........................................................................................ 57 5.4 Consequences of Potential Escape, Establishment, and Spread ..................... 57 6.0 STEPS TO MITIGATE HAZARDS .................................................................... 59 6.1 Biological Containment ................................................................................... 59 6.1.1 Production of all-female eggs ............................................................. 59 6.1.2 Induction of triploidy in all-female eggs ............................................ 59 6.1.2.1 Reliability of inducing triploidy ........................................... 60 6.1.2.2 Effectiveness of triploidy in inducing sterility ..................... 61 6.1.2.3 Residual spawning behavior ................................................ 61 6.2 Physical Containment ........................................................................................ 62 6.2.1 Containment for egg production ......................................................... 62 6.2.2 Containment for grow-out..................................................................... 65 6.2.3 Redundant, multi-level strategy ............................................................ 68 6.3 Geographical/Geophysical Containment ......................................................... 68 6.3.1 Environmental conditions at egg production and grow-out sites ....... 68 6.3.2 Site conditions vs. life-stage requirements ......................................... 69 [End of Page] Page 4 of 84 August 25, 2010 Environmental Assessment for AquAdvantage Salmon Table of Contents (Page 4 of 4) 7.0 JURISDICTIONAL AND REGULATORY ISSUES ........................................ 69 7.1 Effects on the Global Commons ...................................................................... 69 7.2 Effects on Foreign Nations Not a Party to This Action .................................. 70 7.3 Threatened and Endangered Species ..............................................................