Martin Nowak
Active member
While this report is not (yet) specific to reptiles, it seems to me a likely possibility. For those unaware, the FDA has regulations concerning “altering the genomics of animals” for various purposes. Such is termed “intentional genomic alterations” or IGAs. The FDA’s news releases (May 1, 2024) on altering animal genomics is:
“Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various purposes, such as improving agricultural productivity, enhancing disease resistance, and advancing biomedical research.”
IGAs are then defined:
“IGAs in animals are intentional genomic alterations made using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal.”
How might this be applied to reptiles / herptiles? Again, the FDA has several statements, one of which is:
“Conservation: Assisting in the preservation of endangered species by enhancing traits that improve survival and reproduction.”
A second has potential application to reptiles / herptiles given we know that certain diseases harbored by herptiles can be transmitted to humans:
“Public Health: Developing animals that are less susceptible to diseases that can be transmitted to humans.”
Other reasons in the FDA publications include agriculture and biomedical research.
Readers can hypothesize applications in herptiles: Cryptosporidiosis resistance in amphibians. Changes in temperature tolerances as climate change occurs. Reintroduction of species in altered habitats or reintroductions to new habitats. Resistance to pollutants. And so forth.
Hybridization for traits beyond phenotype appearance seem to not be directly addressed. However, rumors have persisted concerning attempts to release hybrid reptiles to re-establish populations. For example – and I have no memorialized proof, only rumors – that eastern indigos were hybridized with Texas indigos to release in Alabama. The logic – as gopher tortoises were in decline as a result primarily of allowing gassing of their burrows – it was hypothesized that behavior traits of Texas indigos not requiring tortoise burrows might be useful to re-establish indigos in the south. Rumors have persisted that such was tested. But I have no proof. The notion is nevertheless interesting fodder from many angles.
Is introducing non-locale genetic strain herptiles in habitats with remaining native genetic strains related to this FDA consideration? Or only as stated “using modern molecular technologies” to alter the DNA / genetics?
Readers thoughts and comments ?
Of further interest is that the FDA has “Memorandum(s) of Understanding” on this topic with the USDA and the USDHHS (link below).
Sources:
www.lexology.com
www.fda.gov
www.fda.gov
www.fda.gov
“Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various purposes, such as improving agricultural productivity, enhancing disease resistance, and advancing biomedical research.”
IGAs are then defined:
“IGAs in animals are intentional genomic alterations made using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal.”
How might this be applied to reptiles / herptiles? Again, the FDA has several statements, one of which is:
“Conservation: Assisting in the preservation of endangered species by enhancing traits that improve survival and reproduction.”
A second has potential application to reptiles / herptiles given we know that certain diseases harbored by herptiles can be transmitted to humans:
“Public Health: Developing animals that are less susceptible to diseases that can be transmitted to humans.”
Other reasons in the FDA publications include agriculture and biomedical research.
Readers can hypothesize applications in herptiles: Cryptosporidiosis resistance in amphibians. Changes in temperature tolerances as climate change occurs. Reintroduction of species in altered habitats or reintroductions to new habitats. Resistance to pollutants. And so forth.
Hybridization for traits beyond phenotype appearance seem to not be directly addressed. However, rumors have persisted concerning attempts to release hybrid reptiles to re-establish populations. For example – and I have no memorialized proof, only rumors – that eastern indigos were hybridized with Texas indigos to release in Alabama. The logic – as gopher tortoises were in decline as a result primarily of allowing gassing of their burrows – it was hypothesized that behavior traits of Texas indigos not requiring tortoise burrows might be useful to re-establish indigos in the south. Rumors have persisted that such was tested. But I have no proof. The notion is nevertheless interesting fodder from many angles.
Is introducing non-locale genetic strain herptiles in habitats with remaining native genetic strains related to this FDA consideration? Or only as stated “using modern molecular technologies” to alter the DNA / genetics?
Readers thoughts and comments ?
Of further interest is that the FDA has “Memorandum(s) of Understanding” on this topic with the USDA and the USDHHS (link below).
Sources:
FDA Updates Guidance on Intentional Genomic Alterations in Animals
Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the…
CVM Guidance for Industry #187A
This guidance clarifies FDA’s requirements and recommendations for developers of IGAs in animals.
CVM Guidance for Industry #187B
This document explains how FDA’s approval process applies to heritable intentional genomic alterations in animals.
MOU 225-24-010 with U.S. Department of Agriculture
This MOU outlines information sharing and regulatory cooperation related to intentional genomic alterations in animals subject to USDA jurisdiction.