A Menagerie of Moral Hazards: Regulating Genetically Modified Animals

Recombinetics (St. Paul, MN, USA) has produced hornless Holstein cows (Carlson et al., 2016). The hornless or “polled” phenotype results from naturally occurring mutations at the POLLED locus, common in beef breeds but not in dairy breeds.

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As reviewed in U.S. Food & Drug Administration, “Guidance for Industry: Regulation of Intentionally Altered Genomic DNA in Animals, Draft Guidance #187,” available at <https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf> (last visited February 5, 2018).

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Genus (Basingstoke, UK) has developed pigs resistant to porcine reproductive and respiratory syndrome virus.

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See the work of the Genetic Biocontrol of Invasive Rodents (GBIRd).

Revive & Restore has several de-extinction projects. “Passenger Pigeon Project,” Revive & Restore, available at <http://reviverestore.org/about-the-passenger-pigeon/> (last accessed February 5, 2018).

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M. Wadman , “FDA to regulate genetically engineered animals,” Nature, September 19, 2008, available at <http://www.nature.com/news/2008/080919/full/news.2008.1120.html> (last accessed February 5, 2018). Quote from Randall Lutter, Deputy Commissioner for Policy of the FDA.

Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 et seq. (1938).

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“Draft revised GFI #187 is intended to clarify that, unless otherwise excluded, the altered genomic DNA in an animal (referred to in this document as ‘‘animals with intentionally altered genomic DNA’’) that is intended to affect the structure or function of the body of the animal or, in some cases, to diagnose, cure, mitigate, treat, or prevent disease in the animal, meets the drug definition in section 201(g) of the FD&C Act.” U.S. Food & Drug Administration, Notice, “Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Availability,” 82 Fed. Reg. 6561 (January 19, 2017), available at <https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-00839.pdf> (last visited February 5, 2018).

Simultaneous calls with regards to updated guidance around genetically edited plants, and mosquitoes. “FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products,” U.S. Food & Drug Administration, last modified June 20, 2017, available at <https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm536949.htm> (last visited February 5, 2018).

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National Academies of Sciences, Engineering and Medicine, Preparing for Future Products of Bio-technology (Washington, DC: The National Academies Press, 2017), doi: 10.17226/24605.

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X.S. Liu et al ., “Editing DNA Methylation in the Mammalian Genome,” Cell 167 (2016): 233-247, available at <https://www.nature.com/articles/537588c> (last accessed February 5, 2018).

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