When it comes to guidelines on rDNA research, your location is perhaps the most important factor in determining which rules your lab is subject to. However, there are certain regulations that apply to a broad geographic range of labs.
These are published by the World Health Organization (WHO), the Centers for Disease Control (CDC), and the National Institutes of Health (NIH). Depending on where your research is taking place, you may also be required to adhere to guidelines established by your city’s board of health or the IBC of your university. Here are the main points of each document, as well as where to find more info on these complex regulations.
WHO
The World Health Organization’s guidelines focus mainly on doing good science and making sure that experiments involving rDNA are safe and reproducible. Lab procedures like ensuring a pure culture and proper storing of potentially active biological materials are outlined here, and the main purpose of the guidelines is as a readable guide to the vast amount of more specific paperwork that the WHO has produced on rDNA and microbial research. In terms of hard-set rules, the WHO largely defers to national regulatory agencies when discussing specifics and violation conditions.
Full regulations: http://www.who.int/biologicals/biotherapeutics/rDNA_DB_final_19_Nov_2013.pdf
CDC
The Centers for Disease Control gets a bit more into the finer points of doing biological research than the WHO, and outlines industry standard information. Perhaps the most pertinent information in this publication is the establishment and explanation of the different biosafety levels (BSL), as well as animal biosafety levels and appropriate precautions to be taken at each. These guidelines are critical in establishing a new microbiology lab or moving or renovating an existing one, as the steps required during the construction and moving processes will largely be dictated by these regulations. Also notable in this publication is an extensive list of microbes commonly dealt with in labs, including mode of infection and recommended biosafety level for each. One area of these regulations that is often overlooked is preventing allergic reactions to lab animals, so read extra carefully if you’re going to be doing this type of testing. For more information, tune in to our webinar on the matter next month.
Full regulations: http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf
NIH
The set of rDNA guidelines put out by the NIH is by far the most in-depth of these three, and is a wealth of information on the specifics of the day-to-day operations of a bio lab that receives NIH funding. First off, the NIH sets out specifically what constitutes a “Major Action”, or, what changes in research will require approval from the NIH director before they can begin. These types of experiments include mainly the transfer of a resistance gene to a microorganism that would compromise the ability of the lab to contain or destroy the microbe. The NIH also goes on to outline a tiered system for which changes in research objectives will require which types of organizational approval, from requiring time at an RAC (rDNA Advisory Committee) meeting to not requiring approval outside of the institution’s own biosafety committee simultaneous with commencing work.
Full regulations:
https://osp.od.nih.gov/biotechnology/nih-guidelines/
To ensure you're compliant with these guidelines and get a free assessment check out our biosafety services in the link below.
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