Gene Drive Basics - Biosafety

Final action under NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Federal Register, National Institutes of Health,  2024-06-15 11:54:59.
Changes to the NIH Guidelines to include specific considerations and requirements for conducting research involving gene drive modified organisms in contained research settings.

Points to consider in seeking biosafety approval for research, testing, and environmental release of experimental genetically modified biocontrol products during research and development

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W. K. Tonui, V. Ahuja, C. J. Beech, J. B. Connolly, B. Dass, D. C. M. Glandorf, et al.,  Transgenic Research,  31:607. 2022-10-04 08:24:50.
Novel genetically modified biological control products (referred to as “GM biocontrol products”) are being considered to address a range of complex problems in public health, conservation, and agriculture, including preventing the transmission of vector-borne parasitic and viral diseases as well as the spread of invasive plant and animal species. These interventions involve release of genetically modified organisms (GMOs) into the environment, sometimes with intentional dissemination of the modification within the local population of the targeted species, which presents new challenges and opportunities for regulatory review and decision-making. Practices developed for GMOs, primarily applied to date for GM crops may need to be adapted to accommodate different types of organisms, such as insects, and different technologies, such as gene drive. Developers of new GM biocontrol products would benefit from an early understanding of safety data and information that are likely to be required within the regulatory dossier for regulatory evaluation and decision making. Here a generalizable tool drawing from existing GM crop dossier requirements, forms, and relevant experience is proposed to assist researchers and developers organize and plan their research and trialing. This tool requires considering specifics of each investigational product, their intended use, and country specific requirements at various phases of potential product development, from laboratory research through contained field testing and experimental release into the environment. This may also be helpful to risk assessors and regulators in supporting their systematic and rigorous evaluation of new biocontrol products.

Infravec2 guidelines for the design and operation of containment level 2 and 3 insectaries in Europe

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E. Pondeville, A.-B. Failloux, F. Simard, P. Volf, A. Crisanti, R. E. Haghighat-Khah, N. Busquets, F. X. Abad, A. J. Wilson, R. Bellini, S. Marsh Arnaud, A. Kohl and E. Veronesi,  Pathogens and Global Health,  2022-08-22 07:08:22.
With the current expansion of vector-based research and an increasing number of facilities rearing arthropod vectors and infecting them with pathogens, common measures for containment of arthropods as well as manipulation of pathogens are becoming essential for the design and running of such research facilities to ensure safe work and reproducibility, without compromising experimental feasibility. These guidelines and comments were written by experts of the Infravec2 consortium, a Horizon 2020-funded consortium integrating the most sophisticated European infrastructures for research on arthropod vectors of human and animal diseases. They reflect current good practice across European laboratories with experience of safely handling different mosquito species and the pathogens they transmit. As such, they provide experience-based advice to assess and manage the risks to work safely with mosquitoes and the pathogens they transmit. This document can also form the basis for research with other arthropods, for example, midges, ticks or sandflies, with some modification to reflect specific requirements.

World Health Organization laboratory biosafety manual, 4th edition

Geneva: World Health Organization,  2022-06-15 12:13:23.
International laboratory biosafety guidance describing best practices and a risk assessment framework to promote a responsible safety culture globally.

Containment Practices for Arthropods Modified with Engineered Transgenes Capable of Gene Drive Addendum 1 to the Arthropod Containment Guidelines, Version 3.2

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American Committee of Medical Entomology,  Vector-Borne and Zoonotic Diseases,  2021-10-28 20:19:33.
Responsible conduct of research is a cornerstone of rigorous scientific discovery. Institutional committees, independent advisory panels, and expert steering groups are among the frameworks in academia meant to provide guidance and assurances that research activities do not result in harm to the environment, research staff, or public safety. For research involving arthropods of public health importance, several documents currently exist to guide investigators in methodologies to consider for reducing risks from arthropod escape. However, to date, there has been no standardized set of recommendations on containment practices for arthropods modified with engineered transgenes capable of gene drive. This document is meant to serve as a practical reference to fill that gap. Recommendations outlined here address containment considerations when a risk assessment indicates a possibility of establishment of a new arthropod vector species or genetically modified arthropods in the local environment.

Biosafety in microbiological and biomedical laboratories (BMBL), 6th edition

US Department of Health and Human Services, Public Health Service,  2020-06-15 12:14:36.
Publication from the US CDC and NIH recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective.

Arthropod containment guidelines, version 3.2

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American Committee of Medical Entomology,  American Society of Tropical Medicine and Hygiene Vector-Borne and Zoonotic Diseases,  19:3:152-173. 2019-01-18 00:00:00.
In 2003, just a few months after I became editor of Vector-; Borne and Zoonotic Diseases, we published the Arthropod; Containment Guidelines, likely our first of what would become; known as an Open Access publication. The concept to; produce the guidelines resulted from a discussion with staff; from the National Institutes of Health that had been involved; in supporting efforts to develop the capacity to genetically; engineer mosquitoes. What followed was more than a 2-year; effort by members of the American Committee for Medical; Entomology (ACME)—a subgroup of the American Society; of Tropical Medicine and Hygiene (ASTMH). Drafts of the; document were widely circulated among researchers and; vector biologists, and revised several times until a consensus; document was finalized. The guidelines were rapidly embraced; by the international community as the ‘‘go-to’’ reference; document for those working with arthropod vectors in; laboratories, and administrators on committees that oversee; these facilities.