Genome editing and gene drive: a set of selected references
Autor: http://genpeace.blogspot.com | Publicado: 2016-05-10T03:44:00-07:00


Dear Reader.



The
discovery of a genome editing system in bacteria and its use for editing
genomes of many organisms is transforming the way biotechnology is done.
Likewise, the use of the gene drives (a form of stimulating biased inheritance
of particular genes to alter entire populations) opens up new applications for
the control of pests and invertebrate vectors or hosts, whenever they have a
short life cycle. But the knowledge of the two techniques is far from being
widespread and sufficient, even among geneticists.



In parallel
with the rapid development of genome editing and gene drives, regulatory issues
arise questioning the applicability of risk assessment procedures, as
originally established for GMOs, and legal issues, such as the inclusion of
this or that product in the regulatory framework of each country, regulatory
asynchrony, the ethical issues involved, etc.



Any
meaningful discussion of these issues must be grounded in updated and quality
information. We therefore collected and offer the reader a set of selected
references that may be helpful in understanding both new technologies and in
establishing the applicability and eventual limits of present risk assessment
rules of new genome-edited or gene drive products.



We split a
little arbitrarily texts in three subsets, the first devoted to the issue of
genome editing by the CRISPR/Cas9 system, the second to gene drives and the
third for risk assessments available for the GM Aedes aegypti previously evaluated by CTNBio in Brazil and
considered safe for commercial use in 2014. The latter references also include
general considerations on GM mosquitoes and emphasize the importance of new
tools in vector control, particularly in mosquito-borne diseases.



The texts
whose links follow below can be of various kinds: scientific articles,
technical reports, reviews written by scientists, reviews written by activists,
conference presentations, etc. Many are available to the general public. Texts
marked with a square are suitable for a first approach to the subject. The search
for texts was not exhaustive and therefore we know that there may be relevant
texts that are not listed below. So over the next few months, other texts may
be added, appropriately highlighted as new.



Finally, we
remind the reader that national regulatory frameworks should not regulate a
technology, but their products. In fact, each product carries its risks and
benefits, even if produced by the same technology. The serious mistake many
countries committed regulating the technology, rather than the product, should
not be repeated again. We also recall that the risk assessment conceptual basis,
as established for GMOs, probably will suffice for a careful and responsible risk
assessment of products arising from any other technology, especially the CRISPR
system / Cas9.





A. Selected texts on genome editing issues



A1. Texts describing the technology and general
issues

Bhaya D, Davison M, Barrangou R, 2011. CRISPR-Cas Systems in Bacteria and Archaea:
Versatile small RNAs for adaptive defense and regulation. Annu. Rev. Genet.
45:273–97. http://www.ncbi.nlm.nih.gov/pubmed/22060043 



Anonymous,
2016. CRISPR/Cas9 Guide. https://www.addgene.org/crispr/guide/ &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

Medina-Aparicio L, Rebollar-Flores JE, Gallego-Hernández AL,
Vázquez A, Olvera L, Gutiérrez-Ríos RM, Calva E, Hernández-Lucas I, 2011. The CRISPR/Cas Immune System Is an
Operon Regulated by LeuO, H-NS, and Leucine-Responsive Regulatory Protein in
Salmonella enterica Serovar Typhi. J. Bacteriol. 193(10): 2396-2407. http://jb.asm.org/content/193/10/2396.full 

&nbsp; 

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<![endif]--><!--[if !vml]--><!--[endif]-->Ran FA, Hsu PD, JWright J, Agarwala
V, Scott DA, Zhang F, 2013. Genome engineering using the CRISPR-Cas9 system.&nbsp; Nature Protocols 8(11): 2281-2308&nbsp;&nbsp;&nbsp; doi:10.1038/nprot.2013.143.&nbsp;




A2. Texts on regulatory and ethical issues
(risk assessment, risk analysis, legal framework, etc.)

Jasanoff S,
Hurlbut JB, Saha K, 2015. "CRISPR Democracy: Gene Editing and the Need for
Inclusive Deliberation." Issues in Science and Technology 32, no. 1 (Fall
2015).&nbsp; http://issues.org/32-1/crispr-democracy-gene-editing-and-the-need-for-inclusive-deliberation/ 



Hoffman S,
2016. CRISPR: The GMO technology that needs no regulation, says USDA. Organic
Consumers Association. https://www.organicconsumers.org/news/crisprgmotechnologyneedsnoregulationsaysusda 



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<![endif]--><!--[if !vml]--><!--[endif]-->Entine J, 2015. Ethical and
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Magnus D,
Martinez N, 2016. In Embryo research we need laws first, then science.&nbsp; http://time.com/4204059/crisprregulation/ 



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<![endif]--><!--[if !vml]--><!--[endif]-->Caplan AL, Parent B, Shen M,
Plunkett C, 2015. No time to waste—the ethical challenges created by CRISPR. EMBO
reports 16(11): 1421-1426. http://embor.embopress.org/content/16/11/1421.long 

The Third
World Network, 2016. Gene Editing: In Urgent Need of Regulation. http://www.biosafetyinfo.net/article.php?aid=1216 





B. Selected texts on gene drive issues



B1. Texts describing the technology and general
issues

Anonymous,
2016. A review of the safety &amp; efficacy of genetically engineered mosquitoes.
Effective Altruism Forum.&nbsp; http://effective-altruism.com/ea/tp/a_review_of_the_safety_efficacy_of_genetically/ 



Hammond A,
Galizi R, Kyrou K, Simoni A, Siniscalchi C, Katsanos D, Gribble M, Baker D,
Marois E, Russell S, Burt A, Windbichler N, Crisanti A, Nolan T, 2016. A
CRISPR-Cas9 gene drive system targeting female reproduction in the malaria
mosquito vector Anopheles gambiae.
Nat Biotechnol. 34(1):78-83. http://www.ncbi.nlm.nih.gov/pubmed/26641531 



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<![endif]--><!--[if !vml]--><!--[endif]-->Esvelt K, Church G, Lunshof J, 2014.
"Gene Drives" and CRISPR could revolutionize ecosystem management.
Scientific American Blog Network. http://blogs.scientificamerican.com/guestblog/genedrivesandcrisprcouldrevolutionizeecosystemanagement/?print=true 



B2. Texts on regulatory and ethical issues
(risk assessment, risk analysis, legal framework, etc.)



Westra J, van der
Vlugt CJB, Roesink CH, Hogervorst PAM, Glandorf DCM. 2016. Gene drives. Policy report. RIVM
Letter report 2016-0023 (National Institute for Public Health and the
Environment, The Netherlands) - http://rivm.nl/en/Documents_and_publications/Scientific/Reports/2016/februari/Gene_drives_Policy_report 



Anonymous,
2015. Engineering the Future: How Can the Risks and Rewards of Emerging
Technologies Be Balanced? Report. World Economic Forum. http://reports.weforum.org/global-risks-2015/part-2-risks-in-focus/2-4-engineering-the-future-how-can-the-risks-and-rewards-of-emerging-technologies-be-balanced/



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<![endif]--><!--[if !vml]--><!--[endif]-->Oye KA, Esvelt K,Appleton E,
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<![endif]--><!--[if !vml]--><!--[endif]-->Carter SR, 2015.&nbsp; Gene Drives and the U.S. Biotechnology
Regulatory System. Presentation. J. Craig Venter Inst. http://nas-sites.org/gene-drives/files/2015/11/2-Carter-NAS-Gene-Drive-webinar.pdf&nbsp; 



Pennisi E,
2015.&nbsp; Gene drive workshop shows
technology’s promise, or peril, remains far off. http://www.sciencemag.org/news/2015/10/gene-drive-workshop-shows-technology-s-promise-or-peril-remains-far






<!--[if !supportLists]-->C.&nbsp;&nbsp;&nbsp;
<!--[endif]-->Selected texts on OX513A Aedes aegypti risk assessment and
general issues on GM insects



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<![endif]--><!--[if !vml]--><!--[endif]-->Beech CJ, Koukidou M, Morrison NI, Alphey
L. 2012. Genetically Modified Insects: Science, Use, Status and Regulation. International
Centre for Genetic Engineering and Biotechnology (ICGEB). Collection of
Biosafety Reviews Vol. 6 (2012): 66-124. http://www.icgeb.org/biosafety/publications/collections.html 



Beech CJ, Nagaraju J, Vasan SS, Rose RI, Othman RY, Pillai
V, Saraswathy TS, 2009. Risk
analysis of a hypothetical open field release of a self-limiting transgenic Aedes aegypti mosquito strain to combat
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FDA, 2016.
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Anonymous,
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<![endif]--><!--[if !vml]--><!--[endif]-->Anonymous, 2014. The Guidance
Framework for testing genetically modified mosquitoes. http://www.who.int/tdr/publications/year/2014/guide-fmrk-gm-mosquit/en/