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Biobeef Blog
- DNA is NOT a drug. And regulating genome edited research animals as a drug is unworkable. March 9, 2022Investigational research animals that have been genome edited CANNOT enter the food supply in the United States, irrespective of the edits they carry, unless the researcher that has produced that animal has submitted an FDA Investigational New Animal Drug (INAD), and additionally has obtained a food use authorization which requires a TON of paperwork and […]
- Public Acceptance of Animal Genomics and Biotechnology October 14, 2021Animal biotechnology is the application of modern molecular techniques to animals. Genetic engineering and cloning are two older forms of animal biotechnology , and genome editing is a more recent entrant. Animal genomics is the scientific study of structure, function and interrelationships of both individual genes and the genome in its entirety. Utilization of genomic […]
- Contemplated Regulatory Framework (Part #4) December 28, 2020This is part 4 of a 1, 2, 3, 4 part series on Regulation of Genetically Modified Animals I am in perhaps a somewhat rare position regarding the contemplated USDA regulatory framework, as I actually have several animals from amenable species (sheep, cattle) on the ground that were developed using “techniques that use recombinant, synthesized, […]
- Regulation of Genetically Modified Animals Part #3 December 28, 2020This is part 3 of a 1, 2, 3, 4 part series on Regulation of Genetically Modified Animals So what is the USDA’s proposal for the regulation of genetically engineered animals? In a nutshell, it proposes moving regulation of food animals that are genetically engineered for agricultural purposes such as human or animal food, fiber, […]
- Regulation of Genetically Modified Animals Part #2 December 28, 2020This is part 2 of a 1, 2, 3, 4 part series on Regulation of Genetically Modified Animals The “Guidance for Industry #187” entitled, “Regulation of Intentionally Altered Genomic DNA in Animals” was published in the Federal Register in 2017, and a public comment period followed. I wrote about my concerns regarding this approach in […]