a: Risks to the safety and health of team members or others in the lab?

     Yes. V. cholerae is a known pathogenic agent that causes severe dehydration in affected populations. We are going to minimize the risk of using this agent in several ways: first we are going to simulate the effects of V cholerae on E. coli. It has been reported that V cholerae displays antimicrobial properties1 and thus will kill E. coli in order to maximize its own survival in an aquatic environment. We will imitate the effects of V cholerae on E. coli through a series of known techniques used to lyse E. coli in the absences of V. cholerae. Since the premise of our project is to detect the presence of V. Cholerae in drinking water through the use of a reporter in E coli we do not actually need V cholerae in our experiments until the E. coli organism has been designed. At which time our E coli mutant will be tested with V cholerae to ensure that we have a positive result. At the time when we are using actual V. cholerae, we will be conducting the experiment at Walter Reed Army Institute of Research (WRAIR). WRAIR has labs and personnel who handle V. cholerae on a daily basis and are better equipped to work with this type of agent. We will work under the supervision of these well trained scientists to minimize the potential hazards of working with this agent. The majority of our work will be with E. coli strains that are non-pathogenic and not a threat to team member safety. Also, prior to beginning our research we completed a Department of the Army Form 7566, Composite Risk Management Worksheet. This worksheet allowed us to identify potential hazards and determine controls prior to beginning our work. Our residual risk level was determined to be LOW for this project.

1. MacIntyre, D.L. et al. PNAS November 9, 2010 vol. 107 no. 45 19520-19524

b. Risks to the safety and health of the general public if released by design or accident?

    We do not anticipate and safety or heath concerns for the general public. As mentioned above, the majority of our research deals with strains of E. coli that are non-pathogenic. The only potentially dangerous part of our research involved our final tests with V. cholerae; however, those tests will be conducted in Biosafety Level appropriate labs under the supervision of trained Army scientists.

c. Risks to environmental quality if released by design or accident?

    We do not anticipate any concerns to the environment if our research is released in any manner. The E. coli strains we are using are non-pathogenic and for the tests with V. cholerae we will be using appropriate BSL-2 or higher labs run by the US Army under the supervision of trained Army scientists.

    Please explain your responses (whether yes or no) to these questions.

    The only potential risks from our project comes from our final tests of our design with V. cholerae. Since we will be conducting these tests in the appropriate BSL laboratory, under the supervision of trained Army scientists, there is really no real risk.

     Specifically, are any parts or devices in your project associated with (or known to cause):

- pathogenicity, infectivity, or toxicity?
   No, our created device will not have any pathogenicity, infectivity, or toxicity.

- threats to environmental quality?
    No, our device will not have any threat to the environment.

- security concerns?
    No, our device will not have any safety concerns.

b. Describe and document safety, security, health and/or environmental issues as you submit your parts to the Registry.

     There are none because we will be submitting a non-virulent strain of E. coli.

a. Does your institution have its own biosafety rules and if so what are they?

     Yes, they are on our internal server, so a link is not possible.

b. Does your institution have an Institutional Biosafety Committee or equivalent group? If yes, have you discussed your project with them?

     No, we do not have a Institutional Biosafety Committee. We have a few professors who deal with biological research, and they ensure the safety of all bioliogical projects.

Will / did you receive any biosafety and/or lab training before beginning your project? If so, describe this training.

     Yes, everyone working in our biological labs must complete a safety training course before they are allowed to work in the lab. The course covers what Biosafety Levels are available and what types of organisms qualify at those levels. It also discusses storing of reagents, disposal of waste, as well as procedures for safely and appropriately operating the equipment.