November 19, 2015

Summary

FDA has analyzed the potential impact of the agency’s proposed approval of New Animal Drug Application (NADA) # 141-454 on the environments of the global commons and of foreign nations not participating or otherwise involved in the action and, has determined that there would be no significant impacts. Therefore, Executive Order 12114 does not apply to this action.

The Executive Order

Executive Order 12114, “Environmental Effects Abroad of Major Federal Actions” (44 FR 1957, January 9, 1979), requires federal agencies “taking major Federal actions . . . having significant effects on the environment outside the geographical borders of the United States and its territories and possessions” to be informed of pertinent environmental considerations, and to take such considerations into account in making decisions regarding such actions,¹ and is separate from the National Environmental Policy Act (NEPA).The Executive Order requires agencies to have procedures in effect for environmental consideration of major Federal actions and for preparation of appropriate environmental documents to aid in decision-making. It is intended solely to establish internal procedures for Federal agencies and does not create any private cause of action (Executive Order section 3-1). Exempted from the Executive Order are actions that the agency has determined do not have a significant effect on the environment outside the United States (Executive Order section 2-5(i)).

The procedures mandated under Executive Order 12114 require agency decision-makers to take into consideration major federal actions that have a significant effect on:

(a) the environment of the global commons outside the jurisdiction of any nation (e.g., the oceans or Antarctica);

(b) the environment of a foreign nation not participating with the United States and otherwise not involved in the federal action;

(c) the environment of a foreign nation which provide to that nation:

(1) a product, or physical project producing a principal product or an emission or effluent, which is prohibited or strictly regulated by Federal law in the United States because its toxic effects on the environment create a serious public health risk; or

(2) a physical project which in the United States is prohibited or strictly regulated by Federal law to protect the environment against radioactive substances;

(d) natural or ecological resources of global importance designated for protection under this subsection by the President, or in the case of such a resource protected by international agreement binding on the United States, by the Secretary of State.

The Executive Order further defines “the environment" to include only the natural and physical environment, but not social, economic, or other environments (Executive Order section 3-4).

FDA’s Environmental Assessment under NEPA

Under NEPA, FDA conducted an environmental assessment (EA) of FDA’s proposed action on the NADA related to AquAdvantage Salmon, which are triploid, hemizygous, all-female Atlantic salmon (Salmo salar) bearing a single copy of the α-form of the opAFP-GHc2 recombinant DNA construct at the α-locus in the EO-1α lineage. FDA determined in its EA and finding of no significant impact (FONSI) that the development, production, and grow-out of AquAdvantage Salmon under the conditions established in the NADA and as described in the EA would not result in significant effects on the quality of the human environment in the United States. See EA, Section 7.8, and FONSI.

Conclusion on Environmental Impacts on the Global Commons and Foreign Nations not Participating in the Action

FDA concludes that that the agency’s proposed approval of the NADA related to AquAdvantage Salmon would not have significant impacts on the environments of the global commons, or foreign nations not participating and not otherwise involved in theaction when produced and grown under the conditions of use for the proposed action.² FDA reached this conclusion because, under the conditions established in the NADA, the possibility that genetically engineered fish would escape from the multiple and redundant forms of effective physical containment at both facilities, and enter the local environments of Prince Edward Island (PEI), Canada or Panama is extremely low. In the highly unlikely event that the fish should escape from the PEI facility it is highly unlikely that they would survive to reproduce and establish. Finally, the combination of triploidy and an all-female population is expected to render AquAdvantage Salmon effectively and functionally sterile resulting in complete reproductive containment. These characteristics essentially preclude establishment of a population of these fish in the accessible environments in the highly unlikely event that an escape occurs. These conclusions are consistent with those reached by Canadian authorities based on their qualitative Failure Mode Analysis of the physical barriers and operational procedures involving containment at both the PEI and Panamanian facilities.

The greatest potential risk to the global commons or other foreign nations would occur in the event of the escape of AquAdvantage broodstock from the PEI facility. These fish are reproductively competent and will be homozygous for the opAFP-GHc2 gene (EA, Figure 4). There are also non-GE Atlantic salmon in the PEI facility as these fish are needed in the production process. As a result, the potential for reproduction and establishment of these fish has been considered in the event of an escape, which although highly unlikely, cannot be totally eliminated. As discussed in the EA, Atlantic salmon have not been found in the Fortune River since before the year 2001 (see EA, Section 7.4 .2 and Section 6.1.1.3; Guignion, 2009; Carins et al., 2010; Guignion et al., 2010). They also have not been found in any of the other watersheds on the northeast coast of PEI in the most recent surveys conducted in 2007 and 2008 (Cairns et al., 2010). This indicates a very low potential for reproduction and establishment given that Atlantic salmon were once intentionally stocked in many of these rivers and the Fortune River was once well known for its salmon run (Guignion et al., 2010). Given that growth-enhanced Atlantic salmon in general do not have a reproductive advantage compared to non-GE Atlantic salmon, and sometimes are disadvantaged (see EA Section 5.2.2.7; Moreau et al., 2011a; Moreau and Fleming, 2011 ), it is expected that a significant number of fish would need to escape in order for there to be any potential chance of reproduction and establishment. As discussed in Section 7.2.1 of the EA, there is a very low probability of that occurring at the PEI egg production facility due to the many levels of containment there, which has been confirmed by Failure Mode Analysis conducted by Canadian authorities. EA, Section 7.4.2.

The only potential means for establishment (or pseudo-establishment³) would be through the escape of reproductively competent broodstock at the PEI facility or through a continual series of escapes at the Panama facility. Neither of these scenarios is likely given the physical containment measures in place at both facilities. Both would require the escape of a significant number of animals, a condition that is even less likely. Given the difficulty in reintroducing Atlantic salmon into rivers in which they once occurred, and the lack of any self-sustaining populations on the west coast of the United States and Canada where significant numbers of Atlantic salmon escape each year from net pen salmon farms, these scenarios are considered even more unlikely. Therefore, given the available information, FDA concludes that there is a negligibly small likelihood that AquAdvantage Salmon would reproduce and establish self-sustaining populations if they escaped from facilities either in PEI or Panama. Although slightly greater, the hypothetical risk that reproductively competent AquAdvantage broodstock that have escaped from the PEI egg production facility could establish self-sustaining populations is not considered significant given the current lack of Atlantic salmon in the Fortune River and surrounding watersheds.

Discussion

FDA considered the potential for survival, dispersal, reproduction and establishment in Canada and Panama and evaluated in the context that these events are involved in the exposure pathways that could potentially result in effects on the environment in the United States in the EA. The EA concluded: “The collective information on the potential for survival, dispersal, reproduction and establishment indicates that exposure pathways for AquAdvantage Salmon to reach the United States are incomplete⁴; therefore, no effects are expected on the environment of the United States (including populations of endangered wild Atlantic salmon in Maine).” See EA, Section 7.8.

The same analyses and conclusions apply with respect to the global commons, foreign nations not a party to this action, and natural resources or ecological resources of global importance (wild Atlantic salmon populations), because the exposure pathways originate in the same locations (i.e., PEI and Panama).

The nearest global commons to the PEI facility are waters of the Atlantic Ocean off the eastern Canadian seaboard. For GE salmon to reach the global commons would require a significant migration either through the Cabot Strait and around Cape Breton Island or through the Strait of Canso that separates Cape Breton Island from the Nova Scotia mainland. There is no reason to expect any escaped/released AquAdvantage Salmon to undertake this type of migration given that these fish are produced from domesticated hatchery stocks as are farm-raised Atlantic salmon. In general, escaped farm-raised Atlantic salmon of hatchery origin, as they mature, show a strong tendency to migrate into rivers in the vicinity of the site of escape (Ferguson et al., 2007). If AquAdvantage Salmon and broodstock behave similarly, and they would be expected to because of their domesticated genetic background, AquAdvantage adults should remain in the general vicinity of the PEI broodstock facility in the event of an escape or release, while pre-smolt life stages would not be expected to survive the local high salinity conditions. See EA, Section 7.5.1.1.1.

Even if AquAdvantage Salmon and broodstock were to undertake a migration to the global commons or foreign nations not participating in the action (e.g., Greenland, Iceland), it is unlikely that any significant numbers would survive the journey. Based on recent return rate data for U.S. and Canadian Atlantic salmon stocks, marine survival rates for wild origin Atlantic salmon are very low (0.16 to 6.1%) and those for hatchery origin Atlantic salmon are even lower, 0.04 to 0.5% (ICES, 2009). Triploidy has been shown to further reduce survival/recapture rates of salmon in the field (O’Flynn et al., 1997). In fact, a study of the controlled release of micro-tagged triploid and diploid groups of Atlantic salmon (both mixed-sex and all-female groups) on the western coast of Ireland found that the return rate of triploid salmon, both to the coast and fresh water, was substantially reduced compared to diploid salmon (Cotter et al., 2000a). In another study on Atlantic salmon, Wilkins et al. (2001) have reported that recapture rates for triploids were reduced by an additional 76 to 88% compared to diploids, suggesting that overall marine morality rates for triploids would likely exceed 99%, and could in some cases be greater than 99.9%. Mortality rates for AquAdvantage broodstock would be expected as least as high and perhaps higher (>99%) because of their higher metabolism and food requirements, susceptibility to predation, and adaptation to feeding on synthetic aquaculture diets. See EA, Section 7.5.1.1.1.

Given the migration routes and distances, the relatively small number of adult fish available for escape/release from the PEI broodstock facility, and expected very high mortality rates (>99%) for escaped/released fish, any significant direct or indirect effects on the global commons or foreign nations not participating in the action are highly unlikely as a result of escape or release of GE Atlantic salmon from the sponsor’s PEI facility.

Likewise, with regard to the grow-out facility in Panama, it is highly unlikely that there would be significant effects on the global commons or foreign nations not participating in the action (including nearby countries in Central and South America), if there were an escape or release of AquAdvantage Salmon from the sponsor’s grow-out facility. The grow-out facility is located in the highlands of Panama many miles upstream from the Pacific Ocean and as discussed in Sections 6.1.2.1 and 7.3.1.2 of the EA, high water temperatures and other forms of geographic/geophysical containment apply to the local watershed to insure with a high degree of probability that AquAdvantage Salmon would not reach the Pacific Ocean.

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1  FDA’s regulations incorporate the Executive Order under 21 CFR 25.60 (“Other Requirements”).

2 Impacts on the environment of foreign nations as described in section 2-39(c)-(d) of the Executive Order are not relevant to this action.

3 Pseudo-establishment is a condition in which there is not true establishment of a permanent population through reproduction, but rather when a population is present on a continual or semi-continual basis through escape or release of fish (i.e., not through reproduction per se).

4 “Incomplete” in this context means that there is no unbroken exposure pathway between the source of the AquAdvantage Salmon and the United States.