Compliance

All studies involving materials derived from humans or non-human primates, including unfixed tissues, primary cells, and established cell lines must be regarded as potentially biohazardous and are regulated under the California OSHA Bloodborne Pathogens (BBP) Standard (https://www.dir.ca.gov/title8/5193.html). These materials must be manipulated under BSL-2 containment conditions and are regarded as “potentially infectious materials” under the BBP Standard. Laboratories using human and primate-derived materials need to register with the IBC.

Transgenic plants created and maintained in the laboratory and greenhouse environment are subject to provisions of NIH Guidelines and are part of the IBC purview. Transfer of transgenic plants or receiving of transgenic plants from other approved institutions is exempt from NIH guidelines. Field releases, however, are not covered by NIH Guidelines because the release of those organisms is subject to notification and permit requirements under the USDA. To effectively manage releases in accordance with the provisions of USDA notification or permit, all CSUMB personnel and units associated with the work must be informed of these provisions and restrictions, even if the CSUMB PI is not the responsible person on the notification or permit. Failure to do so may result in accidental environmental release, which can lead to sanctions for CSUMB and the holder of the notification or permit.

The creation of transgenic rodents and other animals must be registered with and approved by the IBC. The creation of transgenic animals includes direct gene delivery (i.e. transformation) and/or the crossing of two different transgenic strains (or a transgenic strain crossed with a non-progenitor wild-type strain). The purchase or transfer of transgenic rodents for experiments that require only BSL-1 containment are exempt from NIH Guidelines.

CSUMB does not support the use of select agents or toxins at this time (11/09/2021). 

Infectious agents and toxins that are considered by the Department of Health & Human Services (DHHS) or USDA to have the potential to pose substantial harm or a severe threat to human, animal or plant health, or plant products are regulated as ‘select agents’. The current select agent list (https://www.selectagents.gov/SelectAgentsandToxinsList.html) and this process includes a significant security clearance component, conducted by the Federal Bureau of Investigation, for the facility and all who will have access to the select agent or toxin.

CSUMB does not support research that involves Dual Use Research of Concern at this time (11/09/2021).

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. Additional information is available at: https://osp.od.nih.gov/biotechnology/dual-use-research-of-concern/.