Skip to main content
Log in

History and future of genetically engineered food animal regulation: an open request

  • TARC X
  • Published:
Transgenic Research Aims and scope Submit manuscript

Abstract

Modern biotechnology resulted from of a series of incremental improvements in the understanding of DNA and the enzymes that nature evolved to manipulate it. As the potential impact of genetic engineering became apparent, scientists began the process of trying to identify the potential unintended consequences. Restrictions to recombinant DNA experimentation were at first self-imposed. Collaborative efforts between scientists and lawyers formalized an initial set of guidelines. These guidelines have been used to promulgate regulations around world. However, the initial guidelines were only intended as a starting point and were motivated by a specific set of concerns. As new data became available, the guidelines and regulations should have been adapted to the new knowledge. Instead, other social drivers drove the development of regulations. For most species and most applications, the framework that was established has slowly allowed some products to reach the market. However, genetically engineered livestock that are intended for food have been left in a regulatory state of limbo. To date, no genetically engineered food animal is available in the marketplace. A short history and a U.S.-based genetic engineer’s perspective are presented. In addition, a request to regulatory agencies is presented for consideration as regulation continues to evolve. Regulators appear to have shown preference for the slow, random progression of evolution over the efficiency of intentional design.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  • Berg P, Mertz JE (2010) Personal reflections on the origins and emergence of recombinant DNA technology. Genetics 184:9–17. doi:10.1534/genetics.109.112144

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Berg P, Baltimore D, Boyer HW, Cohen SN, Davis RW, Hogness DS, Nathans D, Roblin R, Watson JD, Weissman S, Zinder ND (1974) Letter: potential biohazards of recombinant DNA molecules. Science 185:303

    Article  CAS  Google Scholar 

  • Berg P, Baltimore D, Brenner S, Roblin RO, Singer MF (1975) Summary statement of the Asilomar conference on recombinant DNA molecules. Proc Natl Acad Sci USA 72:1981–1984

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Brinster RL (1974) The effect of cells transferred into the mouse blastocyst on subsequent development. J Exp Med 140:1049–1056

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Chakrabarty AM (1973) Genetic fusion of incompatible plasmids in Pseudomonas. Proc Natl Acad Sci USA 70:1641–1644

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Chakrabarty AM (1981) Microorganisms having multiple compatible degradative energy-generating plasmids and preparation thereof. US4259444 A

  • Cohen SN (2013) DNA cloning: a personal view after 40 years. Proc Natl Acad Sci USA 110:15521–15529. doi:10.1073/pnas.1313397110

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Cohen SN, Chang AC (1973) Recircularization and autonomous replication of a sheared R-factor DNA segment in Escherichia coli transformants. Proc Natl Acad Sci USA 70:1293–1297

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Cohen SN, Chang AC, Boyer HW, Helling RB (1973) Construction of biologically functional bacterial plasmids in vitro. Proc Natl Acad Sci USA 70:3240–3244

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Crotty S (2003) Ahead of the curve. David Baltimore’s life in science. University of Claifornia Press, Claifornia

    Google Scholar 

  • Evans MJ (1972) The isolation and properties of a clonal tissue culture strain of pluripotent mouse teratoma cells. J Embryol Exp Morphol 28:163–176

    CAS  PubMed  Google Scholar 

  • Gavin W (2014) ATryn®: 1st GE (genetically engineered) animal success story for production of a human recombinant pharmaceutical. BMC Proc 8(Suppl 4):O4. doi:10.1186/1753-6561-8-S4-O4

    Article  PubMed Central  Google Scholar 

  • Gordon JW, Scangos GA, Plotkin DJ, Barbosa JA, Ruddle FH (1980) Genetic transformation of mouse embryos by microinjection of purified DNA. Proc Natl Acad Sci USA 77:7380–7384

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products [WWW Document] (2001). http://www.pewtrusts.org/en/research-and-analysis/reports/2001/09/03/guide-to-us-regulation-of-genetically-modified-food-and-agricultural-biotechnology-products. Accessed 6.28.15

  • Hammer RE, Pursel VG, Rexroad CE, Wall RJ, Bolt DJ, Ebert KM, Palmiter RD, Brinster RL (1985) Production of transgenic rabbits, sheep and pigs by microinjection. Nature 315:680–683

    Article  CAS  PubMed  Google Scholar 

  • Hilts PJ (1982) Federal agency on gene splicing proposed. Wash, Post A4

    Google Scholar 

  • Holdren JP, Shelanski H, Vetter D, Goldfuss C (2015) Improving transparency and ensuring continued safety in biotechnology. https://www.whitehouse.gov/blog/2015/07/02/improving-transparency-and-ensuring-continued-safety-biotechnology

  • Jaenisch R (1976) Germ line integration and Mendelian transmission of the exogenous Moloney leukemia virus. Proc Natl Acad Sci USA 73:1260–1264

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Jaenisch R, Mintz B (1974) Simian virus 40 DNA sequences in DNA of healthy adult mice derived from preimplantation blastocysts injected with viral DNA. Proc Natl Acad Sci USA 71:1250–1254

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Jaenisch R, Fan H, Croker B (1975) Infection of preimplantation mouse embryos and of newborn mice with leukemia virus: tissue distribution of viral DNA and RNA and leukemogenesis in the adult animal. Proc Natl Acad Sci USA 72:4008–4012

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • James C (1997) Global status of transgenic crops in 1997. ISAAA briefs no. 5. ISAAA, Ithaca, NY, pp 31

  • Jensen F, Koprowski H, Ponten JA (1963) Rapid transformation of human fibroblast cultures by simian virus. Proc Natl Acad Sci US A 50:343–348

    Article  CAS  Google Scholar 

  • Kelly TJ, Smith HO (1970) A restriction enzyme from Hemophilus influenzae. II. J Mol Biol 51:393–409

    Article  CAS  PubMed  Google Scholar 

  • Luo Y, Lin L, Bolund L, Jensen TG, Sørensen CB (2012) Genetically modified pigs for biomedical research. J Inherit Metab Dis 35(4):695–713. doi:10.1007/s10545-012-9475-0

    Article  CAS  PubMed  Google Scholar 

  • Lyall J, Irvine RM, Sherman A, McKinley TJ, Núñez A, Purdie A, Outtrim L, Brown IH, Rolleston-Smith G, Sang H, Tiley L (2011) Suppression of avian influenza transmission in genetically modified chickens. Science 331(6014):223–226. doi:10.1126/science.1198020

    Article  CAS  PubMed  Google Scholar 

  • Mintz B (1977) Teratocarcinoma cells as vehicles for mutant and foreign genes. Brookhaven Symp Biol 82–95

  • Morrow JF, Berg P (1972) Cleavage of Simian virus 40 DNA at a unique site by a bacterial restriction enzyme. Proc Natl Acad Sci USA 69:3365–3369

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Morrow JF, Cohen SN, Chang AC, Boyer HW, Goodman HM, Helling RB (1974) Replication and transcription of eukaryotic DNA in Escherichia coli. Proc Natl Acad Sci USA 71:1743–1747

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • National Research Council, Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology, Committee on Agricultural Biotechnology, Health, and the Environment (2002) Animal biotechnology: scientific concerns. The National Academies Press, Washington. www.nap.edu

  • National Research Council, Committee on Genetically Modified Pest-Protected Plants, Board on Agriculture and Natural Resources, Division on Earth and Life Studies (2000) Genetically modified pest-protected plants: science and regulation. The National Academies Press, Washington. doi:10.17226/9795

  • Papaioannou VE, McBurney MW, Gardner RL, Evans MJ (1975) Fate of teratocarcinoma cells injected into early mouse embryos. Nature 258:70–73

    Article  CAS  PubMed  Google Scholar 

  • Richt JA, Kasinathan P, Hamir AN, Castilla J, Sathiyaseelan T, Vargas F, Sathiyaseelan J, Wu H, Matsushita H, Koster J, Kato S, Ishida I, Soto C, Robl JM, Kuroiwa Y (2007) Production of cattle lacking prion protein. Nat Biotechnol 25(1):132–138

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Smith HO, Wilcox KW (1970) A restriction enzyme from Hemophilus influenzae. I. Purification and general properties. J Mol Biol 51:379–391

    Article  CAS  PubMed  Google Scholar 

  • Van Eenennaam AL (2013) GMOs in animal agriculture: time to include a risk: benefit analysis in regulatory decisions. J Anim Sci Biotechnol 4:37

    Article  PubMed  PubMed Central  Google Scholar 

  • Van Eenennaam AL, Hallerman EM, Muir WM (2011) The science and regulation of food from genetically engineered animals. CAST Commentary QTA2011-2, Council for Agricultural Science and Technology. http://www.cast-science.org/file.cfm/media/news/CAST_GE_Food_Commentary_FINAL_B817876FF1BF4.pdf

  • Van Eenennaam AL, Muir WM, Hallerman EM (2013) Are unaccountable regulatory delay and political interference undermining the FDA and hurting American competitiveness? Food Drug Policy Forum 3(13):1–20

    Google Scholar 

  • Wall RJ, Powell AM, Paape MJ, Kerr DE, Bannerman DD, Pursel VG, Wells KD, Talbot N, Hawk HW (2005) Genetically enhanced cows resist intramammary Staphylococcus aureus infection. Nat Biotechnol 23(4):445–451

    Article  CAS  PubMed  Google Scholar 

  • Walters EM, Prather RS (2013) Advancing swine models for human health and diseases. Mo Med 110(3):212–215

    PubMed  Google Scholar 

Download references

Acknowledgments

This manuscript was improved by attention to the comments of a thorough, thoughtful, anonymous reviewer.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Kevin D. Wells.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Wells, K.D. History and future of genetically engineered food animal regulation: an open request. Transgenic Res 25, 385–394 (2016). https://doi.org/10.1007/s11248-016-9935-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11248-016-9935-7

Keywords

Navigation