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When will a genetic change cease to trigger regulatory oversight for the approval of gene-edited animals used in meat production?

A 2019 article has argued that the currently proposed U.S. regulation of gene-edited animals used in meat production is "not fit for purpose". Under the current system, the employment any technology that utilizes recombinant DNA (rDNA) in food animal breeding programs automatically triggers regulatory oversight that has made it virtually impossible to commercialise gene-edited food animals. The article argues that delaying or preventing the use of this technology in animal breeding programs is associated with very opportunity costs in terms of foregone genetic improvement.

It is not just the presence of a transgenic rDNA construct (i.e. an organism with a segment of DNA containing a gene sequence that has been isolated from another organism) that triggers mandatory premarket FDA regulatory oversight prior to commercial release, but rather it is the presence of any “intentionally altered genomic DNA” in an animal that initiates oversight.

This system is considered unreasonable by some geneticists as there is nothing inherently dangerous about consuming dietary DNA. In fact, we already consume millions of naturally-occurring DNA variations.

The 2016 report by the National Academies of Sciences, Engineering, Medicine agrees, and recommends a “product not process” regulatory trigger approach, where considerations about the product, and not the process that created the product is the sole relevant consideration for deciding for or against the need for premarket regulatory approval. Moreover, the USDA already regulates genetically modified plants in this way.[1]

When will a single non-transgenic genetic change, by way of recombinant DNA (rDNA) techniques such as CRISPR-Cas9, cease to trigger mandatory premarket FDA regulatory oversight prior to commercial release of gene-edited animals used in meat productions?


Resolution

This resolves when 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 animals used in meat production. Positive resolution does not require there to be no need for regulatory approval of GE animals, but simply that the method of rDNA techniques do not result in the default triggering of a regulatory oversight process. Positive resolution is consistent with there being various sorts of triggers for regulatory oversight stemming from other concerns (e.g. human food safety; environmental safety; target animal safety; effectiveness, amongst other factors) but positive resolution requires that using rDNA techniques does not by default raise concerns that trigger the need for for regulatory oversight.

Important note: If this question does not resolve positively before the end of 2032, it resolves as ">Dec 31, 2032".

One way the question resolves positively if the current FDA's guidance document #187 Regulation of Intentionally Altered Genomic DNA in Animals, which is currently in draft form, is scrapped, or is revised or replaced by another guidance document (in draft or final form) that specifies that the application of rDNA techniques to genetically alter animals used in meat production do not, by default, trigger a regulatory oversight process.

The question is resolved by consulting credible the reporting by the FDA, USDA, other regulatory body, or a researcher, research organisation or commercial enterprise familiar with the relevant regulatory matters and deemed credible by an admin.

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