Team:Tec-Monterrey/safetypage/qanda

From 2011.igem.org

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   <h2>PROJECT</h2>
   <h2>PROJECT</h2>
     <div class="panelcontent" style="">
     <div class="panelcontent" style="">
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 +
             
 +
                <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectoverview">overview</a></p>
             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectparts">parts</a></p>
             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectparts">parts</a></p>
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             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectmodeling">modeling</a></p>
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             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectmodeling">genetic frame</a></p>
 +
            <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectresults/methods">methods</a></p>
 +
            <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectresults">results</a></p>
 +
            <p><a href="https://2011.igem.org/Team:Tec-Monterrey/teamha">human approach</a></p>
 +
            <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectprotocols">protocols</a><p>
             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/safetypage">safety</a></p>
             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/safetypage">safety</a></p>
             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectnotebook">notebook</a></p>
             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectnotebook">notebook</a></p>
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             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/projectresults">results</a></p>
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             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/sampledata">sample data</a></p>
           </div>
           </div>
</div>
</div>
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    <p><a href="https://2011.igem.org/Team:Tec-Monterrey/teammembers">members</a></p>
    <p><a href="https://2011.igem.org/Team:Tec-Monterrey/teammembers">members</a></p>
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             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/teaminstallations">installations</a></p>
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             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/teaminstallations">headquarters</a></p>
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            <p><a href="https://2011.igem.org/Team:Tec-Monterrey/teamha">human approach</a></p>
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             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/microcongreso">micro congress</a></p>
             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/microcongreso">micro congress</a></p>
             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/teamfriends">friends</a></p>
             <p><a href="https://2011.igem.org/Team:Tec-Monterrey/teamfriends">friends</a></p>
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<div class="content">
<div class="content">
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<div style="text-align:center;">
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<a href="https://2011.igem.org/Team:Tec-Monterrey/safetypage">
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<img src="https://static.igem.org/mediawiki/2011/0/05/Safetyqa02.png" > </a>
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 +
<a href="https://2011.igem.org/Team:Tec-Monterrey/safetypage/qanda">
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<img src="https://static.igem.org/mediawiki/2011/e/e6/Biosafty02.png"> </a>
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  <!--in sub pages, this divisions should be comments! :D-->
  <!--in sub pages, this divisions should be comments! :D-->
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<body>
<body>
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<div align="justify">
<div style="-moz-border-radius: 4px;-webkit-border-radius: 4px;">
<div style="-moz-border-radius: 4px;-webkit-border-radius: 4px;">
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<div class="frame" id="frame1" style="background-color:#e5e5e5;">
<br>
<br>
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   <p class="textojustif">NEW SAFETY AND SECURITY QUESTIONS
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   <p class="textojustif">Unlike other countries, for example U.S.A., in Mexico the terms &quot;biosafety&quot; and &quot;biosecurity&quot; are not used; instead, the term &quot;biosafety&quot; comprises both of them, with the definition of &quot;biosafety&quot; as &quot;the actions and measures of evaluation, monitoring, control and prevention that must be assumed when carrying out activities with genetically engineered organisms, with the intention to prevent, avoid or reduce any possible risk that those activities could cause to the human health or the environment and biological diversity, including the harmlessness aspects of those organisms destined to their use or consumption.<br />
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      </p>
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<br><br>
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    <p class="textojustif"><br />
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1. Would the materials used in your project and/or your final
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      In this project, according to the Approved List of Biological Agents of the ACDP, the organism that we are using has a biosecurity level of 2. This information tells us that the host could present some risk since <i>Escherichia coli</i> is infectious to mammals, including human beings. These bacteria can be acquired by injection, ingestion or autoinoculation.<br />
-
product
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      <br />
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pose:
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      The project involves two constructs with different functions, neither of which codify to any hazardous substance. In the first case, the organism has a higher impact to human health because of the biosecurity level of <i>E. coli</i> where membrane proteins with enzymes will be bound. The reactant that shall be transformed is saccarose with the help of a beta-fructofuranosidase, obtaining fructose and glucose in the process, which are both innocuous towards the environment. For the second case, the initial reactant is cellulose, being transformed to glucose monomers via a cellulase; this could be possibly harmful to the environment in case the bacteria escaped the laboratory, due to cellulose being the main component of the cell wall of plants. <br />
-
<br><br>
+
      <br />
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a. Risks to the safety and health of team members or others in the
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      This could represent a problem and thus, an environmental impact assessment should be done; however, with the appropriate measurements, bacteria should not escape from the area where they are manipulated (inside the laboratory), to not affect the public safety. Nevertheless, there is no evidence in the literature of any previously reported hazard of our enzyme, despite its industrial and bioremediation applications.<br />
-
<br><br>
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      <br />
-
The biological device in which we worked on this project doesn’t pose
+
      Health problems during research are not present if scientists follow suitable laboratory practices and facilities. In order to accomplish this, we talked with the coordinators of the R&D Laboratory; they taught us the minimum safety requirements to work and the disposal of waste, to make sure that the microorganisms we worked with could not be freed to the environment due to an accident or irresponsibility.<br />
-
a risk to any of the team members’ health if correctly handled, however we
+
      <br />
-
should always consider that they carry an antibiotic resistance.
+
      We found out that the Biotechnology School and &quot;Centro de Biotecnología FEMSA&quot; (FEMSA's Biotechnology Center), where we worked, had a Biosafety Committee that reviewed the protocols employed in the laboratory, the substances we employ and the protocol of hazardous waste management, including the use, treatment and disposal of these kind of waste. Subsequently, we asked the Committee for a visit to our laboratory to check that the previously written measures were correctly applied or, if not, to make suggestions to strengthen the protocol's weak points. Moreover, we sought advice from the president of the Biosafety Committee of the Tec de Monterrey Campus Monterrey's School of Medicine. This allowed us to have two different points of view about the measurements applied in the laboratory.<br />
-
Nevertheless, we must also take in mind the chemicals employed
+
      <br />
-
in the methods used for the completion of this project. In order to dispose
+
      In our project, diverse biosecurity problems could be present. In order to go beyond all of these obstacles, first of all, the level of biosafety required to each project must be known. If any of the parts codified for a toxin, or the organism used was highly infectious, stricter measures would be taken. Once the complete information of the project is known, it is important to follow the pertinent rules, laws and regulations.<br />
-
any of those hazardous substances, besides following the General Safety
+
      <br />
-
Regulations of the Laboratory, we also followed the Safety Regulations of
+
      Mexico possesses the &quot;Ley de Bioseguridad de Organismos Genéticamente Modificados&quot; (Biosecurity Law for Genetically Modified Organisms), which establish that, in the case of scientific and technologic investigation, the GMO must be used in confinement. Also, it is necessary to fill a registry book for the activities of confined use that are done, to apply the confinement measures whose execution must be adapted to the most advanced and modern scientific and technologic knowledge of risk management and treatment, final disposal and waste elimination of GMO generated on diverse activities. Another of the neccesary means, as dictated by the law, is to form an internal biosafety commission, who must to make sure that the principles of good practices of scientific investigation are applied, and the biosafety rules are followed as the commission defines.<br />
-
Centro de Biotecnologia FEMSA. For example, in agarose gel electrophoresis
+
      <br />
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it is commonly used ethidium bromide or SYBR green; in this case, we
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      Regarding the placing, handling, treatment and disposal of hazardous waste, we followed the neccessary means that establishes the &quot;Norma Oficial Mexicana&quot; (Mexican Oficial Regulation) NOM-087-ECOL-SSA1-2002. Based on this regulation, disposable Petri dishes and plastic tubes with biological waste were placed in autoclave resistant bags for biohazardous waste, then placed in the autoclave.  The pipette tips were left in containers filled with antibenzyl (benzalkonium chloride) 1x for an entire day then placed in a red bag for hazardous waste.  The liquid waste was placed also in containers filled with antibenzyl 1x. All of the waste was then transported to the temporary warehouse for waste of the &quot;Laboratorio de Investigación del Centro de Biotecnología FEMSA&quot;. In order to accomplish this correctly, the coordination gave us the handbook for waste handling of the Investigation Laboratory, and we adapted it to our needs. Also, the coordinators instructed us about how to handle each kind of waste, to not have problems when transporting them to their respective area of the temporary warehouse.<br />
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followed a protocol for handling and disposal of the chemicals, placing objects
+
      <br />
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contaminated with it in special containers. In the case of pipette tips, those
+
      It is of great importance to have a good knowledge of the  necessary safety measures for working in the laboratory, as the safety of people working on it, and the success of the project, depend of that. Nevertheless, occasionally it is important that when investigators know the risks and benefits of their work, also they should inform to the rest of the population. Unfortunately, information about genetically engineered organisms not always reaches the people in a correct way. This is because the society's perception towards GMOs is more subjective than objective, being influenced by terms or situations unknown to them.<br />
-
were treated with Benzal and stirilized by autoclave. These measures were
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      <br />
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done to avoid direct contact between team members and hazardous material.
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      Regarding our biosafety approach, we made a survey related to the topic in order to measure the knowledge of people about biosafety and to know their opinion about genetically engineered food or GMOs used in the fabrication of products of diary consumption. The results can be seen in the biosafety page. A total of 100 people were surveyed. Despite 49% of them answered that they have heard the word &quot;biosafety&quot;, only 39% stated to know what the word means. We asked that people about the meaning of the word and, after viewing the answers, we concluded that only a few people know completely the meaning of biosafety. 78% of the people supported the use of genetically engineered organisms and the percentage was the same when we asked if they will use products of diary consumption even when knowing that the products were or were made with GMOs.<br />
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<br><br>
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      <br />
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b. Risks to the safety and health of the general public if released
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      However, the two last questions were specific cases that showed us more clearly the factors influencing perception of people regarding genetic modification of organisms and its use to solve them. In the first case, we took as an example the AH1N1 influenza virus outbreak and the recombinant vaccine made. When asking if they considered the making of that vaccine was safe to both investigators and patients, 89% of people agreed. In the other hand, when proposing a GMO that could support the Mexican sugar industry, but that the organism will be involved in the process of making high fructose syrup from sugar, the percentage decreased to 76%, despite &quot;experts&quot; assuring that there is not any risk of using them. From these questions we conclude that health has a high priority, so people would accept the use of GMOs in the making of a vaccine that could benefit to a great ammount of people. But when the GMOs are used to help economically unsustainable industries the response is less afirmative. This could be because the GMO would be employed to make a food product of high consumption, so it seems less reliable to use.<br />
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by design or accident?
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      <br />
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<br><br>
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      Up to this point, any process made in this work, considering the theoretical investigation and the information given to us by the biosafety experts from the Centro de Biotecnologia FEMSA, have allowed us to count with the appropriate means to keep ours and the environment's safety, and also to diminish the contamination present during the project development. All the knowledge gained is of great importance to the professional development of the team in regards of biosafety and, to the same extent, biosecurity.</p>
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Concerning the risks to people in general, the most dangerous
+
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problem we observed is the exposure to microorganisms that are resistant to
+
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antibiotics, inflicting a problem on the treatment of many diseases. For this
+
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reason, we concealed our bacteria for lab use only following the appropriate
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measures for handling and disposing them, such as stirilize the tubes and
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dishes containing modified bacteria after using them. Regarding chemical
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substances, we assured that every chemical used were properly disposed,
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even gloves used by the team when they made contact with any hazardous
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substance, to make sure any people outside the lab could be exposed to the
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chemicals.
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<br><br>
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c. Risks to environmental quality if released by design or
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accident?
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<br><br>
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Our biological devices pose few risks to the environment because
+
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we are using enzymes already present in other bacteria and undangerous
+
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substrates and products. However, there is a little environmental concern
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in one of our constructs. This construct employs cellulose as a substrate,
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but because all plants have cellulose in their cell wall it is possible that they
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could be degraded under unusual circumstances, thus generating a negative
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environmental impact. Again, caution measures must be taken in order to
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have the modified bacteria concealed so they don’t pose a direct threat to the
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environment.
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<br><br>
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d. Risks to security through malicious misuse by individuals,
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groups
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or states?
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<br><br>
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Our project doesn’t have any point of risk in regards of biosecurity. Due
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to the nature of the process and the microorganisms involved, the devices do
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not cause any hazard that could be misused by individuals, groups or states
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to affect people’s security and wellbeing.
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<br><br>
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Please explain your responses (whether yes or no) to these
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questions.
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Specifically, are any parts or devices in your project associated
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(or known to cause):
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<br><br>
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- pathogenicity, infectivity, or toxicity?
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Neither of our devices has an associated risk in these fields. The only
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possible concern could be the EstA protein used in the device, because it is
+
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capable of produce a toxin when the entire secuence is used; but because
+
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only a partial sequence of this protein is needed in the device (only the
+
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membrane expressing part), the toxin cannot be synthesized and the risk is
+
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therefore eliminated.
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<br><br>
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- threats to environmental quality?
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There is a very little, if not at all, concern about threats on the
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environment by our devices. As previously explained, if modified bacteria with
+
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the cellulase gene are misused or escape, there is a possibility that plants will
+
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have contact with them, creating a possible environmental damage especially
+
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if the affected organisms are ecologically valuable. However, this scenario
+
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is more a concern than a menace, because bacteria need to grow under
+
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specific conditions, and plants themselves have defense mechanisms against
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pathogenic microorganisms, so that possibility is greatly diminished.
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<br><br>
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- security concerns?
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<br><br>
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No, our project does not posess any danger to security in general,
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because the enzymes are designed only to convert sucrose into glucose and
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fructose, and cellulose on glucose. Regarding the rest of the devices, the
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-
parts only complement the enzymes to allow them to express and function
+
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properly, so they don’t pose a security threat.
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<br><br>
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2. If your response to any of the questions above is yes:
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<br><br>
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a. Explain how you addressed these issues in project design and while conducting laboratory work.
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<br><br>
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When designing our project, thanks to the opinion of many professors,
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we considered the risks that our device could have because of the enzymes
+
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and the reaction catalyzed. Interestingly enough, the enzymes are already
+
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used in other industries such as food and cleaning industries, so the
+
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measures taken to confine the bacteria were effective in case there was a risk
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to the environment or health in general. To accomplish an acceptable safety
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level, during the work time at the laboratory, every use of bacteria with the
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constructs was inside a laminar flow hood, disinfected before and after being
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used. Disposed material was placed in red bags for biological hazardous
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waste, and then stirilized in autoclave. In the end, the material is stored in red
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containers so they could be disposed by a certified company.
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<br><br>
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3. Under what biosafety provisions will / do you operate?
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<br><br>
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a. Does your institution have its own biosafety rules and if so
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what are they?
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<br><br>
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Up to this date, there is not a general biosafety handbook for the
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university’s laboratories. Nevertheless, we used the handbook provided to us
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by the university’s research center, that consists in a handbook for handling
+
-
and disposal of hazardous biological waste
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<p><a href="https://static.igem.org/mediawiki/2011/0/05/RPBI_protocol.pdf">(link)</a></p>
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and a handbook with the
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safety rules that must be followed within the lab (https://static.igem.org/mediawiki/2011/d/dd/Laboratory.Rules.pdf). Thanks to this, we
+
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were able to take the appropriate safety measures in the academic lab where
+
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we worked along the summer for this project.
+
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<br><br>
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b. Does your institution have an Institutional Biosafety Committee
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equivalent group? If yes, have you discussed your project with
+
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them?<br>
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Describe any concerns or changes that were made based on this
+
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review.
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<br><br>
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Yes, the university’s research center, “Centro de Biotecnologia
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-
FEMSA”, has a Biosecurity Committee, composed of three doctors from the
+
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institution. All of them received information about our project, the laboratory
+
-
protocols that we were using, and the biosafety measures we had; this was
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done to have our project checked by them so it could be improved.
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The Commitee told us that everything was in order and that we were
+
-
following appropriately the measures taken in the university. However, one
+
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of them noted a point that we had overlooked: that the use of cellulase
+
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in a construct could affect the environment because cellulose is the main
+
-
component of plants, representing thus a little biosafety concern. For this
+
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reason, the Commitee suggested us to follow the already established
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biosafety regulations, to not accidentally free transformed bacteria into the
+
-
environment.
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<br><br>
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c. Will / did you receive any biosafety and/or lab training before
+
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beginning your project? If so, describe this training.
+
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<br><br>
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Before initiating the project, some of our team members had already
+
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went to a conference about the laboratory rules that must be followed in the
+
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university’s Research Center, “Centro de Biotecnologia FEMSA”. The rest of
+
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us went to this conference when the project started. In this conference, the
+
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Research Center coordinators provided us the rules that we had to follow in
+
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those laboratories. The rulebook was adapted to the academic laboratory
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where we worked, the Genetic Manipulation and Molecular Diagnosis
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Laboratory ( http://www.salud.gob.mx/unidades/cdi/nom/compi/ley180305.html
+
-
 
+
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). Also, Marco Mata, head of the Research Center Safety
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Commission, supported us in the biosafety aspect of the project, informing us
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about the biosafety measures followed in the Research Center, and allowing
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us to take the same measures to our lab to work along the summer.
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<br><br>
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d. Does your country have national biosafety regulations or
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guidelines?
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<br><br>
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In Mexico, in matters of biosafety, there is a Regulation for the handling
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of Hazardous Biological Waste, which we followed to properly dispose all
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the waste generated by the project. ( http://www.salud.gob.mx/unidades/cdi/nom/087ecolssa.html).
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Moreover, there is a Biosafety Law for
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Genetically Modified Organisms ( http://www.salud.gob.mx/unidades/cdi/nom/compi/ley180305.html)..</p>
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Latest revision as of 20:53, 20 October 2011

wiki

iGEM

 

 


Unlike other countries, for example U.S.A., in Mexico the terms "biosafety" and "biosecurity" are not used; instead, the term "biosafety" comprises both of them, with the definition of "biosafety" as "the actions and measures of evaluation, monitoring, control and prevention that must be assumed when carrying out activities with genetically engineered organisms, with the intention to prevent, avoid or reduce any possible risk that those activities could cause to the human health or the environment and biological diversity, including the harmlessness aspects of those organisms destined to their use or consumption.


In this project, according to the Approved List of Biological Agents of the ACDP, the organism that we are using has a biosecurity level of 2. This information tells us that the host could present some risk since Escherichia coli is infectious to mammals, including human beings. These bacteria can be acquired by injection, ingestion or autoinoculation.

The project involves two constructs with different functions, neither of which codify to any hazardous substance. In the first case, the organism has a higher impact to human health because of the biosecurity level of E. coli where membrane proteins with enzymes will be bound. The reactant that shall be transformed is saccarose with the help of a beta-fructofuranosidase, obtaining fructose and glucose in the process, which are both innocuous towards the environment. For the second case, the initial reactant is cellulose, being transformed to glucose monomers via a cellulase; this could be possibly harmful to the environment in case the bacteria escaped the laboratory, due to cellulose being the main component of the cell wall of plants.

This could represent a problem and thus, an environmental impact assessment should be done; however, with the appropriate measurements, bacteria should not escape from the area where they are manipulated (inside the laboratory), to not affect the public safety. Nevertheless, there is no evidence in the literature of any previously reported hazard of our enzyme, despite its industrial and bioremediation applications.

Health problems during research are not present if scientists follow suitable laboratory practices and facilities. In order to accomplish this, we talked with the coordinators of the R&D Laboratory; they taught us the minimum safety requirements to work and the disposal of waste, to make sure that the microorganisms we worked with could not be freed to the environment due to an accident or irresponsibility.

We found out that the Biotechnology School and "Centro de Biotecnología FEMSA" (FEMSA's Biotechnology Center), where we worked, had a Biosafety Committee that reviewed the protocols employed in the laboratory, the substances we employ and the protocol of hazardous waste management, including the use, treatment and disposal of these kind of waste. Subsequently, we asked the Committee for a visit to our laboratory to check that the previously written measures were correctly applied or, if not, to make suggestions to strengthen the protocol's weak points. Moreover, we sought advice from the president of the Biosafety Committee of the Tec de Monterrey Campus Monterrey's School of Medicine. This allowed us to have two different points of view about the measurements applied in the laboratory.

In our project, diverse biosecurity problems could be present. In order to go beyond all of these obstacles, first of all, the level of biosafety required to each project must be known. If any of the parts codified for a toxin, or the organism used was highly infectious, stricter measures would be taken. Once the complete information of the project is known, it is important to follow the pertinent rules, laws and regulations.

Mexico possesses the "Ley de Bioseguridad de Organismos Genéticamente Modificados" (Biosecurity Law for Genetically Modified Organisms), which establish that, in the case of scientific and technologic investigation, the GMO must be used in confinement. Also, it is necessary to fill a registry book for the activities of confined use that are done, to apply the confinement measures whose execution must be adapted to the most advanced and modern scientific and technologic knowledge of risk management and treatment, final disposal and waste elimination of GMO generated on diverse activities. Another of the neccesary means, as dictated by the law, is to form an internal biosafety commission, who must to make sure that the principles of good practices of scientific investigation are applied, and the biosafety rules are followed as the commission defines.

Regarding the placing, handling, treatment and disposal of hazardous waste, we followed the neccessary means that establishes the "Norma Oficial Mexicana" (Mexican Oficial Regulation) NOM-087-ECOL-SSA1-2002. Based on this regulation, disposable Petri dishes and plastic tubes with biological waste were placed in autoclave resistant bags for biohazardous waste, then placed in the autoclave. The pipette tips were left in containers filled with antibenzyl (benzalkonium chloride) 1x for an entire day then placed in a red bag for hazardous waste. The liquid waste was placed also in containers filled with antibenzyl 1x. All of the waste was then transported to the temporary warehouse for waste of the "Laboratorio de Investigación del Centro de Biotecnología FEMSA". In order to accomplish this correctly, the coordination gave us the handbook for waste handling of the Investigation Laboratory, and we adapted it to our needs. Also, the coordinators instructed us about how to handle each kind of waste, to not have problems when transporting them to their respective area of the temporary warehouse.

It is of great importance to have a good knowledge of the necessary safety measures for working in the laboratory, as the safety of people working on it, and the success of the project, depend of that. Nevertheless, occasionally it is important that when investigators know the risks and benefits of their work, also they should inform to the rest of the population. Unfortunately, information about genetically engineered organisms not always reaches the people in a correct way. This is because the society's perception towards GMOs is more subjective than objective, being influenced by terms or situations unknown to them.

Regarding our biosafety approach, we made a survey related to the topic in order to measure the knowledge of people about biosafety and to know their opinion about genetically engineered food or GMOs used in the fabrication of products of diary consumption. The results can be seen in the biosafety page. A total of 100 people were surveyed. Despite 49% of them answered that they have heard the word "biosafety", only 39% stated to know what the word means. We asked that people about the meaning of the word and, after viewing the answers, we concluded that only a few people know completely the meaning of biosafety. 78% of the people supported the use of genetically engineered organisms and the percentage was the same when we asked if they will use products of diary consumption even when knowing that the products were or were made with GMOs.

However, the two last questions were specific cases that showed us more clearly the factors influencing perception of people regarding genetic modification of organisms and its use to solve them. In the first case, we took as an example the AH1N1 influenza virus outbreak and the recombinant vaccine made. When asking if they considered the making of that vaccine was safe to both investigators and patients, 89% of people agreed. In the other hand, when proposing a GMO that could support the Mexican sugar industry, but that the organism will be involved in the process of making high fructose syrup from sugar, the percentage decreased to 76%, despite "experts" assuring that there is not any risk of using them. From these questions we conclude that health has a high priority, so people would accept the use of GMOs in the making of a vaccine that could benefit to a great ammount of people. But when the GMOs are used to help economically unsustainable industries the response is less afirmative. This could be because the GMO would be employed to make a food product of high consumption, so it seems less reliable to use.

Up to this point, any process made in this work, considering the theoretical investigation and the information given to us by the biosafety experts from the Centro de Biotecnologia FEMSA, have allowed us to count with the appropriate means to keep ours and the environment's safety, and also to diminish the contamination present during the project development. All the knowledge gained is of great importance to the professional development of the team in regards of biosafety and, to the same extent, biosecurity.