Hostname: page-component-78c5997874-j824f Total loading time: 0 Render date: 2024-11-05T10:56:36.599Z Has data issue: false hasContentIssue false

A Menagerie of Moral Hazards: Regulating Genetically Modified Animals

Published online by Cambridge University Press:  01 January 2021

Abstract

Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Columns: Currents in Contemporary Bioethics
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

About This Column

Mark A. Rothstein serves as the section editor for Currents in Contemporary Ethics. Professor Rothstein is the Herbert F. Boehl Chair of Law and Medicine and the Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine in Kentucky. ([email protected])

References

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.Google Scholar
Reardon, S., “Welcome to the CRISPR Zoo,” Nature 531, no. 7593 (2016): 160163, available at <https://www.nature.com/news/welcome-to-thecrispr-zoo-1.19537> (last visited February 5, 2018).Google Scholar
U.S. Food and Drug Administration, Notice, “Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Availability,” 82 Fed.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).+(last+visited+February+5,+2018).>Google Scholar
“Regulations.gov — Docket Browser,” Regulations.gov, accessed December 14, 2017, available at <https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&dct=PS&D=FDA-2008-D-0394>. 159 comments were received; 8 were clear duplicates..+159+comments+were+received;+8+were+clear+duplicates.>Google Scholar
Purdom, C.E. and Lincoln, R.F., Genetics and Mutagenesis of Fish, ed. Schröder, J. H. (Berlin: Springer-Verlag, 1973).Google Scholar
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in U.S. Food & Drug Administration, “Guidance for Industry: Regulation of Intentionally Altered Genomic DNA in Animals, Draft Guidance #187,” available at 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).+(last+visited+February+5,+2018).>Google Scholar
Wang, H. et al., “One-step generation of mice carrying mutations in multiple genes by CRISPR/Cas-mediated genome engineering,” Cell 153 (2013): 910918, available at <http://www.ncbi.nlm.nih.gov/pubmed/23643243> (last visited February 5, 2018).CrossRefGoogle Scholar
Entis, E., “Aquadvantage Salmon: A Case Study in Transgenic Food,” Animal Biotechnology 9, no. 3 (1998): 165170, doi: 10.1080/10495399809525906.Google Scholar
Genus (Basingstoke, UK) has developed pigs resistant to porcine reproductive and respiratory syndrome virus.Google Scholar
Lyall, Jon et al., “Suppression of Avian Influenza Transmission in Genetically Modified Chickens,” Science 331, no. 6014 (2011): 223226, available at <http://science.sciencemag.org/content/331/6014/223>.Google Scholar
Stein, R., “CRISPR Bacon: Chinese Scientists Create Genetically Modified Low-Fat Pigs,” National Public Radio, October 23, 2017, available at https://www.npr.org/sections/thesalt/2017/10/23/559060166/crispr-bacon-chinese-scientists-create-genetically-modified-low-fat-pigs (last visited February 5, 2018).Google Scholar
Cyranoski, D., “Gene-edited ‘micropigs’ to be sold as pets at Chinese institute,” Nature 526, no. 7571 (2015): 18, available at <https://www.nature.com/news/gene-edited-micropigsto-be-sold-as-pets-at-chinese-institute-1.18448> (last visited February 5, 2018).Google Scholar
Fischer, K. et al., “Efficient production of multi-modified pigs for xenotransplantation by ‘combineering,’ genestacking and gene editing,” Scientific Reports 6, no. 29081 (2016), available at <https://www.nature.com/articles/srep29081.pdf> (last visited February 5, 2018).CrossRefGoogle Scholar
Rosenblum, A., “A Biohacker's Plan to Upgrade Dalmatians Ends Up in the Doghouse,” MIT Technology Review, February 1, 2017, available at <https://www.technologyreview.com/s/603530/a-biohackers-plan-to-upgrade-dalmatians-ends-up-in-the-doghouse/> (last visited February 5, 2018).Google Scholar
Goldberg, C., “One Step Closer To Making Mice That Fight Lyme, Scientists Ask Nantucket: Should We Move Forward?,” WBUR 90.9, August 17, 2017, available at <http://www.wbur.org/commonhealth/2017/08/17/gene-scientists-nantucket-lyme> (last visited February 5, 2018).Google Scholar
See the work of the Genetic Biocontrol of Invasive Rodents (GBIRd).Google Scholar
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).+(last+accessed+February+5,+2018).>Google Scholar
U.S. Environmental Protection Agency, “Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology,” available at <https://www.epa.gov/sites/production/files/2017-01/documents/2017_coordinated_framework_update.pdf> (last accessed February 5, 2018).+(last+accessed+February+5,+2018).>Google Scholar
U.S. Food & Drug Administration, Guidance for Industry: Regulation of genetically Engineered Animals Containing Heritable Recombinant DNA Constructs: Final Guidance, FDA-2008-D-0394 (Washington DC, 2009), available at <https://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0394-gdl.pdf> (last accessed February 5, 2018).+(last+accessed+February+5,+2018).>Google Scholar
Wadman, M., “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.Google Scholar
Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 et seq. (1938).Google Scholar
U.S. Food & Drug Administration, “Biotechnology Consultations on Food from GE Plant Varieties,” available at <https://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon> (last visited February 5, 2018).+(last+visited+February+5,+2018).>Google Scholar
Agriculture, Regulations of the Department of Agriculture, 7b C.F.R. §340.1 (2017), available at <https://www.gpo.gov/fdsys/pkg/CFR-2017-title7-vol5/pdf/CFR-2017-title7-vol5-sec340-1.pdf> (last visited February 5, 2018).+(last+visited+February+5,+2018).>Google Scholar
Waltz, E., “Gene-edited CRISPR mushroom escapes US regulation,” Nature, April 14, 2016, available at <http://www.nature.com/news/gene-edited-crispr-mushroom-escapes-us-regulation-1.19754> (last visited February 5, 2018).Google Scholar
“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).+(last+visited+February+5,+2018).>Google Scholar
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).+(last+visited+February+5,+2018).>Google Scholar
U.S. Department of Agriculture, Proposed Rule, “Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms,” 82 Fed. Reg. 51582 (November 7, 2017), available at <https://www.gpo.gov/fdsys/pkg/FR-2017-11-07/pdf/2017-24202.pdf> (last visited February 5, 2018).+(last+visited+February+5,+2018).>Google Scholar
“Regulations.gov — Search Results,” Regulations.gov, accessed December 14, 2017, available at <https://www.regulations.gov/searchResults?rpp=25&po=0&s=FDA-2008-D-0394&dct=PS> (last visited February 5, 2018).+(last+visited+February+5,+2018).>Google Scholar
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.Google Scholar
D.L. Kershen, comment on “Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Availability,” available at <https://www.regulations.gov/document?D=FDA-2008-D-0394-0365> (last visited February 5, 2018).+(last+visited+February+5,+2018).>Google Scholar
U.S. Department of Agriculture, Proposed Rule, “Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms,” 82 Fed. Reg. 7008 (January 19, 2017), <https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-00858.pdf> (last visited February 5, 2018).+(last+visited+February+5,+2018).>Google Scholar
Liu, X.S. et al., “Editing DNA Methylation in the Mammalian Genome,” Cell 167 (2016): 233247, available at <https://www.nature.com/articles/537588c> (last accessed February 5, 2018).CrossRefGoogle Scholar
U.S. Department of Agriculture, “Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms,” A Proposed Rule by the Animal and Plant Health Inspection Service on 01/19/2017, available at <https://www.federalregister.gov/documents/2017/01/19/2017-00858/importation-interstate-movement-and-environmental-release-of-certain-genetically-engineered> (last visited March 6, 2018).+(last+visited+March+6,+2018).>Google Scholar