Synthetic Biology Industry: Biosafety Risks to Workers
Synthetic biology involves two closely related capabilities: (1) the design, assembly, synthesis, or manufacture of new genomes, biological pathways, devices, or organisms not found in nature for use in agriculture, bio-manufacturing, health care, energy, and other industrial sectors and (2) the redesign of existing genes, cells, or organisms for the purpose of drug discovery and gene therapy. Synthetic biology has accelerated the growth of the biotechnology sector of the US economy. This rapid growth has been accompanied by a corresponding increase in the number of workers employed in the synthetic biology industry.
The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the National Institute for Occupational Safety and Health, the Centers for Disease Control and Prevention, or the US Department of Health and Human Services.
- Bej, A. K., Perlin, M. H., & Atlas, R. M. (1988). Model suicide vector for containment of genetic engineered microorganisms. Applied and Environmental Microbiology, 54(10), 2472–2477.Google Scholar
- Bergeson, L. L., Campbell, L. M., Dolan, S. L., et al. (2015). The DNA of the U.S. regulatory system: Are we getting it right for synthetic biology? Washington, D.C.: Wilson Center. Retrieved from http://www.synbioproject.org/publications/dna-of-the-u.s-regulatory-system/. Accessed on 16 Mar 2018.Google Scholar
- Carter, S. R., Rodemeyer, M., Garfinkel, M. S., & Friedman, R. (2014). Synthetic biology and the U.S. biotechnology regulatory system: Challenges and options. J. Craig Venter Institute. Retrieved from http://www.jcvi.org/cms/fileadmin/site/research/projects/synthetic-biology-and-the-us-regulatory-system/full-report.pdf. Accessed on 16 Mar 2018.
- Center for Biosecurity of UPMC. (2012). The industrialization of biology and its impact on national security. Retrieved from http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2012/2012-06-08-industrialization.pdf. Accessed on 13 Mar 2018.
- Convention on Biological Diversity. (2015). Report of the Ad Hoc technical expert advisory group on synthetic biology. UNEP/CBD/SYNBIO/AHTEG/2015/1/3. Retrieved from https://www.cbd.int/doc/meetings/synbio/synbioahteg-2015-01/official/synbioahteg-2015-01-03-en.pdf. Accessed on 19 Mar 2018.
- deGrandpre, A. (2017). The survival of a Mars mission could depend on astronaut urine. Washington Post August 23, 2017. Retrieved from https://www.washingtonpost.com/news/speaking-of-science/wp/2017/08/23/the-survival-of-a-mars-mission-could-depend-on-astronaut-urine/?utm_term=.903e0a6953c8. Accessed 19 Mar 2018.
- Department of Defense (DOD). (2015). Technical assessment: Synthetic biology. Office of Technical Intelligence, Office of the Assistant Secretary of Defense for Research & Engineering. Retrieved from http://defenseinnovationmarketplace.mil/resources/OTI-SyntheticBiologyTechnicalAssessment.pdf. Accessed 19 Mar 2018.
- Department of Health and Human Services (DHHS). (2009). Biosafety in microbiological and biomedical laboratories (DHHS Publication No. (CDC) 21–1112) (5th ed.). U.S. Department of Health and Human Services. Retrieved from https://www.cdc.gov/biosafety/publications/bmbl5/bmbl.pdf. Accessed on 16 Mar 2018.
- Environmental Protection Agency. (2015). Pesticides; Agricultural Worker Protection Standard Revisions, November 2, 2015. Retrieved from https://www.gpo.gov/fdsys/pkg/FR-2015-11-02/pdf/2015-25970.pdf. Accessed on April 2, 2018.Google Scholar
- Food and Drug Administration (FDA). (2017). FDA approval brings first gene therapy to the United States: CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukemia. FDA News Release. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm. Accessed on 15 Mar 2018.
- Fredrickson, D. S. (1980). A history of the recombinant DNA guidelines in the United States. Retrieved from https://profiles.nlm.nih.gov/FF/B/B/K/C/_/ffbbkc.pdf. Accessed on 2 Apr 2018.
- Friends of the Earth U.S., International Center for Technology Assessment, & ETC Group. (2010). The principles for the oversight of synthetic biology. Retrieved from http://www.etcgroup.org/sites/www.etcgroup.org/files/The%20Principles%20for%20the%20Oversight%20of%20Synthetic%20Biology%20FINAL.pdf. Accessed 16 Mar 2018.
- Garfinkel, M. (2012). Biological containment of synthetic microorganisms: Science and policy. European Science Foundation/Standing Committee for Life, Earth, and Environmental Sciences Strategic Workshop, November 13–14, 2012. Retrieved from http://www.embo.org/documents/science_policy/biocontainment_ESF_EMBO_2012_workshop_report.pdf. Accessed on 29 Mar 2018.
- Garfinkel, M. S., Endy, D., Epstein, G. L., & Friedman, R. M. (2007). Synthetic genomics: Options for governance. Retrieved from http://www.synbiosafe.eu/uploads/pdf/Synthetic%20Genomics%20Options%20for%20Governance.pdf. Accessed on 16 Mar 2018.
- Grady, D. (2017). Work stops at C.D.C.’s top deadly germ lab over air hose safety. The New York Times, February 17, 2017. Retrieved from https://www.nytimes.com/2017/02/17/health/cdc-germ-lab-safety.html. Accessed on 20 Mar 2018.
- Leduc, S. (1910). Theorie physico-chimique de la vie et generations spontanees (p. 202). Paris: A. Poinat.Google Scholar
- Lowrie, H., & Tait, J. (2010). Policy brief: Guidelines for the appropriate risk governance of synthetic biology. Lausanne: International Risk Governance Council. Retrieved from http://www.irgc.org/IMG/pdf/irgc_SB_final_07jan_web.pdf. Accessed on 16 Mar 2018.Google Scholar
- Moe-Behrens, G. H. G., Davis, R., & Haynes, K. A. (2013). Preparing synthetic biology for the world. Frontiers in Microbiology, 4(5), 1–10.Google Scholar
- National Archives and Records Administration. (1992). Exercise of federal oversight within scope of statutory authority: Planned introductions of biotechnology products into the environment. Federal Register, 57(39), 6753–6762.Google Scholar
- National Research Council of the National Academies. (2015). Industrialization of biotechnology: A roadmap to accelerate the advanced manufacturing of chemicals. Washington, D.C.: The National Academies Press.Google Scholar
- NIH. (2016). NIH guidelines for research involving recombinant or synthetic nucleic acid molecules (NIH guidelines). U.S. Department of Health and Human Services, National Institutes of Health, Office of Science Policy, April, 2016. Retrieved from https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.html. Accessed on 15 May 2018.
- NIOSH. (2009). Approaches to safe nanotechnology: Managing the health and safety concerns associated with engineered nanomaterials (DHHS (NIOSH) Publication No. 2009–125). Cincinnati: U.S. Department of the Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Retrieved from http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf. Accessed on 29 Mar 2018.Google Scholar
- NIOSH. (2014). The state of the national initiative on prevention through design (DHHS (NIOSH) Publication No. 2014–123). Cincinnati: U.S. Department of the Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Retrieved from http://www.cdc.gov/niosh/docs/2014-123/pdfs/2014-123.pdf. Accessed on 29 Mar 2018.Google Scholar
- Occupational Safety and Health Administration (OSHA). (2018). Infectious diseases rulemaking. Retrieved from https://www.osha.gov/dsg/id/index.html. Accessed on 14 Mar 2018.
- Office of Science Technology and Policy (OSTP). (1986). Coordinated framework for regulation of biotechnology. Executive Office of the President, June 26, 1986. Retrieved from http://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf. Accessed on 20 Mar 2018.
- Office of Science Technology and Policy (OSTP). (2017). Modernizing the regulatory system for biotechnology products: Final version of the 2017 update to the coordinated framework for the regulation of biotechnology. Retrieved from https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf. Accessed on 14 Mar 2018.
- OSHA. (1985). Agency guidelines on biotechnology. Federal Register, 50(71), 14468–14469.Google Scholar
- OSHA. (2005a). Toxic and hazardous substances, Code of Federal Regulations, Title 29, Part 1910.1000. 2005. pp. 7–18. Retrieved from https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=9991&p_table=STANDARDS. Accessed on 20 Mar 2018.
- OSHA. (2005b). Access to employee exposure and medical records, Code of Federal Regulations Title 29, Part 1020. 2005. pp. 93–102. Retrieved from https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10027. Accessed on 20 Mar 2018.
- OSHA. (2010). Bloodborne pathogens, Code of Federal Regulations, Title 29, Part 1910.1030. 2010. pp. 265–278. Retrieved from https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051. Accessed on 20 Mar 2018.
- OSHA. (2014a). Hazard communication, Code of Federal Regulations, Title 29, Part 1910.1200. 2014. pp. 463–591. Retrieved from https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099. Accessed on 20 Mar 2018.
- OSHA. (2014b). Occupational exposure to hazardous chemicals in laboratories, Code of Federal Regulations, Title 29, Part 1910.1450. 2014. pp. 591–651. Retrieved from https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10106. Accessed on 20 Mar 2018.
- OSHA. (2014c). Respiratory protection, Code of Federal Regulations, Title 29, Part 1910.134. 2014. pp. 426–452. Retrieved from https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=12716. Accessed on 20 Mar 2018.
- Phelan, M. (2018). Why fungi adapt so well to life in space. Scienceline, March 7, 2018. Retrieved from http://scienceline.org/2018/03/fungi-love-to-grow-in-outer-space/. Accessed on 29 Mar 2018.
- Pollack, A., & Wilson, D. (2010). Safety rules can’t keep up with biotech. The New York Times, May 27, 2010. Retrieved from http://www.nytimes.com/2010/05/28/business/28hazard.html?_r=0. Accessed on 20 Mar 2018.
- Presidential Commission for the Study of Biomedical Issues. (2010). New directions: The ethics of synthetic biology and emerging technologies. Washington, D.C.: Presidential Commission for the Study of Biomedical Issues. Retrieved from https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/PCSBI-Synthetic-Biology-Report-12.16.10_0.pdf. Accessed on 29 Mar 2018.Google Scholar
- Schlimgen, R., Howard, J., Wooley, D., Thompson, M., Baden, L. R., Yang, O. O., Christiani, D. C., Mostoslavsky, G., Diamond, D. V., Gilman Duane, E., Byers, K., Winters, T., Gelfand, J. A., Fujimoto, G., Hudson, W., & Vyas, J. M. (2016). Risk associated with lentiviral vector exposures and prevention strategies. Journal of Occupational and Environmental Medicine, 58(12), 1159–1166.CrossRefGoogle Scholar
- Stanford University. (2018). Biosafety manual. Retrieved from https://ehs.stanford.edu/manual/biosafety-manual. Accessed 20 Mar 2018.
- SynBioBeta. (2017). The synthetic biology industry: Annual growth update. Retrieved from http://synbiobeta.com/wp-content/uploads/sites/4/2017/03/Synthetic-Biology-Industry-Annual-Growth-Update-2017.pdf. Accessed 20 Mar 2018.
- Synthetic Biology Leadership Council. (2015). Biodesign for the bioeconomy: UK synthetic biology strategic plan 2016. Retrieved from http://www.synbio.cam.ac.uk/news/synbio-strategic-plan-2016. Accessed 19 Mar 2018.
- Synthetic Biology Project. (2018). What is synthetic biology? Washington, D.C.: Woodrow Wilson Center. Retrieved from http://www.synbioproject.org/topics/synbio101/definition/. Accessed on 19 Mar 2018.Google Scholar
- Tomas, H. A., Rodriquez, A. F., Alves, P. M., & Corodinha, A. S. (2013). Chapter 12: Lentiviral gene therapy vectors: Challenges and future directions. In F. M. Molina (Ed.), Gene therapy: Tools and potential applications. Open Source, InTech, 2013. Retrieved from http://www.intechopen.com/books/gene-therapy-tools-and-potential-applications/lentiviral-gene-therapy-vectors-challenges-and-future-directions. Accessed on 19 Mar 2018.
- Trump, B. D., Foran, C., Rycroft, T., Wood, M. D., Bandolin, N., Cains, M., et al. (2018). Development of community of practice to support quantitative risk assessment for synthetic biology products: Contaminant bioremediation and invasive carp control as cases. Environment Systems and Decisions, 38(4), 517–527.CrossRefGoogle Scholar
- University of Cincinnati. (2014). Viral vectors: Web training. Biosafety Office. Retrieved from http://researchcompliance.uc.edu/biosafety/Training/ViralVectorWebtraining.aspx. Accessed on 20 Mar 2018.
- Verbeek, J. H., Ijaz, S., Mischke, C., Ruotsalainen, J. H., Mäkelä, E., Neuvonen, K., Edmond, M. B., Sauni, R., Kilinc Balci, F. S., & Mihalache, R. C. (2016). Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff. Cochrane Database of Systematic Reviews, (4), CD011621. https://doi.org/10.1002/14651858.CD011621.pub2.
- Villano, J. S., Follo, J. M., Chappell, M. G., & Collins, M. T., Jr. (2017). Personal protective equipment in animal research. Comparative Medicine, 67(3), 203–214.Google Scholar
- White House. (2012). National bioeconomy blueprint. Washington, D.C.: Executive Office of the President. Retrieved from https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/national_bioeconomy_blueprint_april_2012.pdf. Accessed on 19 Mar 2018.Google Scholar
- World Health Organization (WHO). (2004). Laboratory biosafety manual (3rd ed.). Geneva: World Health Organization. Retrieved from http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf. Accessed on 16 Mar 2018.Google Scholar
- Yin, H., Kauffman, K. J., & Anderson, D. G. (2017). Delivery technologies for genome editing. Nature Reviews: Drug Discovery, 16, 387–399.Google Scholar
- Young, A. (2016). CDC labs repeatedly faced secret sanctions for mishandling bioterror germs. USA Today, May 10, 2016. Retrieved from http://www.usatoday.com/story/news/2016/05/10/cdc-lab-secret-sanctions/84163590/. Accessed 20 Mar 2018.
- Young, A., & Penzenstadler N. (2015). Inside America’s secretive biolabs. USA Today, May 28, 2015. Retrieved from http://www.usatoday.com/story/news/2015/05/28/biolabs-pathogens-location-incidents/26587505/. Accessed 20 Mar 2018.
- Zufferey, R., Dull, T., Mandel, R. J., et al. (1998). Self-inactivating lentivirus vector for safe and efficient in vivo gene delivery. Journal of Virology, 72(12), 9873–9880.Google Scholar