Is adaptation or transformation needed? Active nanomaterials and risk analysis
Source abstract
Abstract
Nanotechnology has been a key area of funding and policy for the United States and globally for the past two decades. Since nanotechnology research and development became a focus and nanoproducts began to permeate the market, scholars and scientists have been concerned about how to assess the risks that they may pose to human health and the environment. The newest generation of nanomaterials includes biomolecules that can respond to and influence their environments, and there is a need to explore whether and how existing risk-analysis frameworks are challenged by such novelty. To fill this niche, we used a modified approach of upstream oversight assessment (UOA), a subset of anticipatory governance. We first selected case studies of “active nanomaterials,” that are early in research and development and designed for use in multiple sectors, and then considered them under several, key risk-analysis frameworks. We found two ways in which the cases challenge the frameworks. The first category relates to how to assess risk under a narrow framing of the term (direct health and environmental harm), and the second involves the definition of what constitutes a “risk” worthy of assessment and consideration in decision making. In light of these challenges, we propose some changes for risk analysis in the face of active nanostructures in order to improve risk governance.
Source: openaire · Quality: candidate unverified · Source record ↗
Research context
OpenAlex topics: Risk Perception and Management
SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.
References (58)
Show source-provided references
1. Anderson M et al (2004) Risk assessment for invasive species. Risk Anal 24(4):787–79310.1111/j.0272-4332.2004.00478.x ↗
2. Arts JHE et al (2015) A decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping). Regul Toxicol Pharmacol 71(2):S1–S2710.1016/j.yrtph.2015.03.007 ↗
3. Barben D, Fisher E, Selin C, Guston DH (2008) Anticipatory governance of nanotechnology: foresight, engagement, and integration. In: Hackett EJ, Amsterdamska O, Lynch ME, Wajcman J (eds) The New Handbook of Science and Technology Studies. MIT Press, Cambridge, pp 979–1000
4. Blatch GL, Lässle M (1999) The tetratricopeptide repeat: a structural motif mediating protein-protein interactions. Bioessays 21:932–93910.1002/(SICI)1521-1878(199911)21:11<932::AID-BIES5>3.0.CO;2-N ↗
5. Brown PK, Qureshi AT, Moll AN, Hayes DJ, Monroe WT (2013) Silver nanoscale antisense drug delivery system for photoactivated gene silencing. ACS Nano 7(4):2948–295910.1021/nn304868y ↗
6. Byrd DM, Cothern CR (2005) Introduction to risk analysis: a systematic approach to science-based decision making. Ecological risk analysis. Government Institutes Press, Lanham, pp 311–327
7. Castellano L, Stebbing J (2013) Deep sequencing of small RNAs identifies canonical and non-canonical miRNA and endogenous siRNAs in mammalian somatic tissues. Nucleic Acids Res 41:3339–335110.1093/nar/gks1474 ↗
8. EPA (1998) Guidelines for ecological risk assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, EPA/630/R095/002F
9. Ezell BC et al (2010) Probabilistic risk assessment and terrorism risk. Risk Anal 30(4):575–58910.1111/j.1539-6924.2010.01401.x ↗
10. FDA (2015a) Food and drug administration. Biotechnology consultation—note to file biotechnology notification file no. 132. http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm436168.htm
11. FDA (2015b) Food and drug administration. Biotechnology consultation—note to file biotechnology notification file no. 141. http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm436173.htm
12. Fedorov Y, Anderson EM, Birmingham A, Reynolds A, Karpilow J, Robinson K et al (2006) Off-target effects by siRNA can induce toxic phenotype. RNA 12(7):1188–119610.1261/rna.28106 ↗
13. Fjeld R et al (2007) Chapter 11. Dose-response and risk characterization. Quantitative environmental risk analysis for human health. Wiley, Hoboken, pp 245–28210.1002/0470096209 ↗
14. Funtowicz, S, Ravetz J (2008) Post-normal science. In: Cleveland CJ (ed) Encyclopedia of earth. Environmental Information Coalition, National Council for Science and the Environment, Washington, DC
15. Gavankar S et al (2012) Life cycle assessment at nanoscale: review and recommendations. Int J Life Cycle Assess 17:295–30310.1007/s11367-011-0368-5 ↗
16. Grimm D (2011) The dose can make the poison: lessons learned from adverse in vivo toxicities caused by RNAi overexpression. Silence 2(1):1–610.1186/1758-907X-2-8 ↗
17. Grove TZ, Forster J, Pimienta G, Dufresne E, Regan L (2012) A modular approach to the design of protein-based smart gels. Biopolymers 97(7):508–51710.1002/bip.22033 ↗
18. Grove TZ, Regan L, Cortajarena AL (2013) Nanostructured functional films from engineered repeat proteins. J R Soc Interface 10(83):2013005110.1098/rsif.2013.0051 ↗
19. Gu HZ, Chao J, Xiao SJ, Seeman NC (2010) A proximity-based programmable DNA nanoscale assembly line. Nature 465:202–20510.1038/nature09026 ↗
20. Guston DH (2014) Understanding ‘anticipatory governance’. Soc Stud Sci 44(2):218–24210.1177/0306312713508669 ↗
21. Guston D, Sarewitz D (2002) Real-time technology assessment. Technol Soc 23:93–10910.1016/S0160-791X(01)00047-1 ↗
22. Helwak A, Kudla G, Dudnakova T, Tollervey D (2013) Mapping the human miRNA interactome by CLASH reveals frequent noncanonical binding. Cell 153:654–66510.1016/j.cell.2013.03.043 ↗
23. IRGC (2006) White paper on risk governance: towards an integrative approach. International Council on Risk Governance, Geneva. http://www.irgc.org
24. IRGC (2007) Nanotechnology risk governance. Policy brief. International Risk Governance Council, Geneva. http://www.irgc.org
25. Katoch R, Sethi A, Thakur N, Murdock LL (2013) RNAi for insect control: current perspective and future challenges. Appl Biochem Biotechnol 171(4):847–87310.1007/s12010-013-0399-4 ↗
26. Kaushik R, Balasubramanian R (2014) A comparative toxicity evaluation of Escherichia coli-targeted ssDNA and chlorine in HepG2 cells. Water Res 48:519–52810.1016/j.watres.2013.10.005 ↗
27. Kuzma J (2010) Nanotechnology in animal production: upstream assessment of applications. Livest Sci 130:14–2410.1016/j.livsci.2010.02.006 ↗
28. Kuzma J, Besley J (2008) Ethics of risk analysis and regulatory review: From bio- to nanotechnology. Nanoethics 2(2):149–16210.1007/s11569-008-0035-x ↗
29. Kuzma J, Verhage P (2006) Nanotechnology in agriculture and food production. Project on emerging nanotechnologies PEN4. Woodrow, Washington, DC
30. Kuzma J, Romanchek J, Kokotovich A (2008) Upstream oversight assessment for agrifood nanotechnology. Risk Anal 28:1081–109810.1111/j.1539-6924.2008.01086.x ↗
31. Lin C, Rinker S, Wang X, Liu Y, Seeman NC, Yan H (2008) In vivo cloning of artificial DNA nanostructures. Proc Natl Acad Sci 105(46):17626–1763110.1073/pnas.0805416105 ↗
32. Lin C, Liu Y, Yan H (2009) Designer DNA nanoarchitectures. Biochemistry 48(8):1663–167410.1021/bi802324w ↗
33. MacPhail RC et al (2013) Assessing nanoparticle risk poses prodigious challenges. WIREs Nanomed Nanobiotechnol 5:374–38710.1002/wnan.1216 ↗
34. Maynard A et al (2011) The new toxicology of sophisticated materials: nanotoxicology and beyond. Toxicol Sci 120(S1):S109–S12910.1093/toxsci/kfq372 ↗
35. Miller G, Wickson F (2015) Risk analysis of nanomaterials: exposing nanotechnology’s naked emperor. Rev Policy Res 32(4):485–51210.1111/ropr.12129 ↗
36. NRC (1983) Risk assessment in the federal government: managing the process. National Academies Press, Washington, DC
37. NRC (1996) Understanding risk. National Academies Press, Washington, DC
38. NRC (2009) Science and decisions. National Academies Press, Washington, DC
39. NSF (2006) Active nanostrutures and nanosystems (ANN). National Science Foundation Solicitation, NSF 06-595
40. Olsen SI et al (2001) Life cycle impact assessment and risk assessment of chemicals—a methodological comparison. Environ Impact Assess Rev 21(4):385–40410.1016/S0195-9255(01)00075-0 ↗
41. Paradise J, Tisdale AW, Hall RF, Kokkoli E (2009) Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology. J Law Med Ethics 37(4):598–62410.1111/j.1748-720X.2009.00434.x ↗
42. Parkin R (2007) Microbial risk assessment. Chapter 11. In: Robson MG, Toscano WA (eds) Risk assessment for environmental health. Wiley, San Francisco, pp 285–313
43. Petrick JS, Brower-Toland B, Jackson AL, Kier LD (2013) Safety assessment of food and feed from biotechnology-derived crops employing RNA-mediated gene regulation to achieve desired traits: a scientific review. Regul Toxicol Pharmacol 66(2):167–17610.1016/j.yrtph.2013.03.008 ↗
44. Renn O (1992) Concepts of risk: a classification. Chapter 3. In: Krimsky S (ed) Social theories of risk. Praeger, Westport, pp 53–79
45. Roco M (2004) Nanoscale science and engineering: unifying and transforming tools. AIChE J 50:890–89710.1002/aic.10087 ↗
46. Selness AR, Vennette RC (2006) Minnesota pest risk assessment: Emerald Ash Borer. MN Department of Agriculture Publication number: PRA-APLA-001
47. Sharp P (2001) RNA interference—2001. Genes Dev 15:485–49010.1101/gad.880001 ↗
48. Shatkin JA (2008) Informing environmental decision making by combining life cycle assessment and risk analysis. J Ind Ecol 12(3):278–28110.1111/j.1530-9290.2008.00031.x ↗
49. Shi Y, Zhang J, Jiang M, Zhu L, Tan H, Lu B (2010) Synergistic genotoxicity caused by low concentration of titanium dioxide nanoparticles and p,p′-DDT in human hepatocytes. Environ Mol Mutagen 51(3):192–20410.1002/em.20527 ↗
50. Stirling A (2007) Risk, precaution and science: towards a more constructive policy debate. EMBO Rep 8(4):309–31510.1038/sj.embor.7400953 ↗
51. Subramanian V, Youtie J et al (2010) Is there a shift to “active nanostructures”? J Nanopart Res 12(1):1–1010.1007/s11051-009-9729-4 ↗
52. USDA (2014) Okanagan specialty fruits Inc.’s petition (10-161-01p) for determination of non-regulated status of non-browning arcticTM apple events GD743 and GS784. https://www.aphis.usda.gov/brs/aphisdocs/10_16101p_dea.pdf
53. Wang T et al (2011) Self-replication of information-bearing nanoscale patterns. Nature 478:225–22810.1038/nature10500 ↗
54. Yang J, Hirschi KD, Farmer L (2015) Dietary RNAs: New stories regarding oral delivery. Nutrients 7:3184–319910.3390/nu7053184 ↗
55. Yu N, Christiaens O, Liu J, Niu J, Cappelle K, Caccia S et al (2013) Delivery of dsRNA for RNAi in insects: an overview and future directions. Insect Sci 20:4–1410.1111/j.1744-7917.2012.01534.x ↗
56. Zhang X, Zhang J, Zhu KY (2010) Chitosan/double-stranded RNA nanoparticle-mediated RNA interference to silence chitin synthase genes through larval feeding in the African malaria mosquito (Anopheles gambiae). Insect Mol Biol 19:683–69310.1111/j.1365-2583.2010.01029.x ↗
57. Zhang L et al (2012) Exogenous plant MIR168a specifically targets mammalian LDLRAP1: evidence of cross-kingdom regulation by microRNA. Cell Res 22:107–12610.1038/cr.2011.158 ↗
58. Zhang F et al (2014) Structural DNA nanotechnology: state of the art and future perspective. J Am Chem Soc 136:11198–1121110.1021/ja505101a ↗