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If DNA alterations continue to require FDA approval by default, how many intentionally genomic DNA altered animals will be determined as safe to eat, by the end of July 2025?

Genetic modification of farmed animals to increase the efficiency of food production, increase animal health and welfare, and reduce the environmental footprint, has been a goal for many decades (Tait-Burkard et al., 2018). This has been pursued by way of engineering and cloning farm animals to optimise for muscle growth, muscle size, feed conversion efficiency, disease resistance.

In addition to economic impacts, this could have various implications for animal welfare. Since a larger, more disease resistant animal produces more meat, fewer livestock is needed to produce a given output. Gene editing also makes possible tweaks that directly improve animal welfare: alterations that produce hornless cows could spare cows from having to be dehorned, whilst editing to produce pigs that lack testicular development would make mass surgical castration unnecessary.

However, worries have been voiced that intentional genomic DNA alterations could also be detrimental to animal welfare (HSUS Report, 2006).

The only genetically engineered animal to ever be approved for food purposes via the new animal drug provisions of the FD&C Act, the AquAdvantage salmon, a genetically engineered Atlantic salmon. The AquAdvantage was mired in regulatory limbo for years, and incurred development and regulatory costs running into the tens of millions of dollars (van Eenennaam et al., 2019). Only in 2019, did the FDA determine that AquAdvantage Salmon meets the statutory requirements for it being safe to eat.

If DNA alterations continue to require FDA approval by default, how many intentionally genomic DNA altered animals will be determined as safe to eat, by the end of July 2025?


Resolution

This question resolves as the number of variants of rDNA constructs in intentionally genomic DNA altered animals that are approved by the FDA by the end of July, 2025, for import and/or production, and determined to be safe to eat. What is here referred to as "variants of rDNA constructs in intentionally genomic DNA altered animals" or "animal drugs" are “an article (other than food) intended to affect the structure or any function of the body of … animals” (van Eenennaam et al., 2019). Details of some of the animals that have been approved for production or import are reported on the FDA website.

This resolves ambiguously if single non-transgenic genetic change, by way of recombinant DNA (rDNA) techniques (such by way of CRISPR-Cas9) ceases to trigger mandatory premarket FDA regulatory oversight prior to commercial release of gene-edited food animals anytime before the end of July, 2025. Specifically, this question resolves ambiguously if the question When will non-transgenic genetic change alone cease to trigger regulatory oversight for the approval of gene-edited animals used in meat production? resolves positively before the end of July, 2025.

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