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<div class="h1_font_size">Safety</div>
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<div class="h2_font_size">Risk assessment</div>
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<p>&nbsp;</p>
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<p>&nbsp;</p>
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<div class="p_font_size" style="text-indent:0em">As our project is to use the rice as a factory to produce astaxanthin, and we also hope that aSTARice can serve as a kind of food in human’s daily lives one days, so we are very concerned about the safety of aSTARice.</div>
 +
<p>&nbsp;</p>
 +
<div class="p_font_size">We believe that risks are mainly embodied in two aspects. The frist problem is that the encoding products of marker genes might be toxic and allergenic potentially for human or livestock. Antibiotic genes might be transferred into gut microbes’ genome of humans or animals, increasing the resistance of the microbes to the antibiotic. The other one is that marker genes could spread through pollens or other ways into other organisms, which is termed gene flow. In population genetics, gene flow (also known as gene migration) is the transfer of alleles or genes from one population to another, which may lead to unimaginable damage to the ecological environment.</div>
 +
<p>&nbsp;</p>
 +
 +
<div class="p_font_size">In order to reduce the effects of pollen-mediated crop-to-crop transgene flow on environment, we use a technique called selectable marker-free system, so the final aSTARice is a marker-free transgenic plants(MFTPs). We design a <font style="font-style:italic">Cre-loxP</font> based side-direct recombinant system to knock out hygromycin phosphotransferase gene, minimizing the effect of the selectable maker gene.</div>
 +
<p>&nbsp;</p>
 +
<div class="p_font_size">To further reduce the unpredictable  threat of gene flow, we grow rice in pot culture and greenhouse-environment. What's more, we are also analyzing coding products by HPLC and trying to make sure that there is no harmful products in our rice.</div>
 +
<br>
 +
<div class="p_font_size">Because we are the first team who choose rice as a chassis, we have to assess the safety for rice. Rice is the self-pollinated plant so that the genotype in the individuals is pure and homogeneous. The probabilities that two flowers take place cross-pollinated is one percent, and the distance of the spread of rice pollen is close to one meter. Rice isn’t included in the white line, so we make a  checked-in on the official website.</div></div>
 +
<p>&nbsp;</p>
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 +
<p>&nbsp;</p>
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<p>&nbsp;</p>
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<div class="h2_font_size">Design for marker free</div>
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<p>&nbsp;</p>
 +
<p>&nbsp;</p>
 +
<div class="p_font_size">In this part, we used a site-specific <font style="font-style:italic">Cre/loxP</font> recombination to delete the selective marker. To delete the selective resistance gene in transgenic rice, a marker-free element was used to assemble into four-gene multigene vector. This marker-free element was placed between two <font style="font-style:italic">loxP</font> sites, and consists of a HPT (hygromycin) resistance gene expression cassette and a <font style="font-style:italic">Cre</font> gene expression cassette controlled by anther-specific promoter (Figure 1). When <font style="font-style:italic">Cre</font> gene was expressed in transgenic rice anther, the Cre enzyme deleted the marker-free element between two <font style="font-style:italic">loxP</font> sites. <a href="https://2016.igem.org/Team:SCAU-China/Design#markerfree" text-decoration=underline>You can read more details, please click here! </a></div>
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<p>&nbsp;</p>
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<img alt="image" class="img-responsive"  align="center" src="https://static.igem.org/mediawiki/2016/e/ea/T--SCAU-China--safety1.jpg">
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<div class="p_font_size" style="margin-bottom:20px"><small><font style="font-weight:bold">Figure 1</font> &nbsp;&nbsp;The schematic diagram of the marker-free element. <font style="font-style:italic">PV4</font> is an anther-specific promoter that drives <font style="font-style:italic">Cre</font> gene expression in anther.</small></div>
 +
<p>&nbsp;</p>
  
 
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<div class="h2_font_size">Laws & regulations </div>
<div class="column full_size">
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<p>&nbsp;</p>
 
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<p>&nbsp;</p>
 
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<div class="p_font_size">The credibility of the policy about “aSTARice” transgenic rice project:</div>
<p>Please visit <a href="https://2016.igem.org/Safety">the main Safety page</a> to find this year's safety requirements & deadlines, and to learn about safe & responsible research in iGEM.</p>
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<p>&nbsp;</p>
 
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<div class="p_font_size"><font style="font-weight:bold">The World Health Organization</font></div>
<p>On this page of your wiki, you should write about how you are addressing any safety issues in your project. The wiki is a place where you can <strong>go beyond the questions on the safety forms</strong>, and write about whatever safety topics are most interesting in your project. (You do not need to copy your safety forms onto this wiki page.)</p>
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<p>&nbsp;</p>
 
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<div class="p_font_size">In 2002, the World Health Organization claimed in"20 questions about genetically modified food". All of the genetically modified products as so far in the international market have passed the risk assessment by the national authorities. These different assessments in general follow the same basic principles, including the environment and human health risk assessment. These assessments are transparent, they did not show any risk for human health.</div>
</div>
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<p>&nbsp;</p>
 
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<div class="p_font_size"><font style="font-weight:bold">The United Nations</font></div>
 
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<p>&nbsp;</p>
<div class="column full_size">
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<div class="p_font_size">The Food and Agriculture Organization of the United Nations in 2003-2004, in "the food and agriculture condition report”clearly pointed out that the current existed modified crops and food is safe, the method used to test its safety is appropriate. So far, there is no safety accident caused by eating genetically modified crops. Millions of people eat the food derived from genetically modified crops, mainly maize, soybean and rape seed, but did not find any adverse effect.</div>
<h5>Safe Project Design</h5>
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<p>&nbsp;</p>
 
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<div class="p_font_size"><font style="font-weight:bold">The European</font></div>
<p>Does your project include any safety features? Have you made certain decisions about the design to reduce risks? Write about them here! For example:</p>
+
<p>&nbsp;</p>
 
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<div class="p_font_size">In 2009, the transgenic group of European food safety authority set out an authoritative scientific opinion about herbicide resistant and insect-resistantcrops that in terms of impact on the environment of human and animal health, gm is the same safe as non-gm, without any harm to health and the environment.</div>
<ul>
+
<p>&nbsp;</p>
<li>Choosing a non-pathogenic chassis</li>
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<div class="p_font_size"><font style="font-weight:bold">The United States</font></div>
<li>Choosing parts that will not harm humans / animals / plants</li>
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<p>&nbsp;</p>
<li>Substituting safer materials for dangerous materials in a proof-of-concept experiment</li>
+
<div class="p_font_size">In 2010, the National Academy of Sciences of the United States claimed in “the influence on American agricultural sustainability ”. In general, compared to traditional agricultural technology for American farmers, genetically modified has created a huge environmental benefits and economic benefits.</div>
<li>Including an "induced lethality" or "kill-switch" device</li>
+
<p>&nbsp;</p>
</ul>
+
<div class="p_font_size">The World Health Organization, the Food and Agriculture Organization of the United Nations, the US Food and Drug Administration and other international organizations and authorities have said the current approval of commercialization of transgenic food is safe and edible.</div>
 
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<p>&nbsp;</p>
</div>
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<div class="p_font_size"><font style="font-weight:bold">China</font></div>
 
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<p>&nbsp;</p>
<div class="column half_size">
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<div class="p_font_size">The Chinese government attaches great importance to the management work of the safety of agricultural genetically modified organisms, has formed a set of law which is suitable for China's national situation and consistent with international convention of laws and regulations, technical regulations and management system. As a result,it has achieved remarkable results in accordance with the implementation of safety management.</div>
<h5>Safe Lab Work</h5>
+
<p>&nbsp;</p>
 
+
<div class="p_font_size">1. The legal system: the agricultural genetically modified organisms safety management regulations, the measures for the administration of agricultural genetically modified organisms safety assessment, the safety measures for the administration of import of agricultural genetically modified organisms, the identification measures for the administration of agricultural genetically modified organisms, the agricultural genetically modified organisms processing measures for examination and approval, the inspection and quarantine measures for the administration of entry and exit of genetically modified products.</div>
<p>What safety procedures do you use every day in the lab? Did you perform any unusual experiments, or face any unusual safety issues? Write about them here!</p>
+
<p>&nbsp;</p>
 
+
<div class="p_font_size">2. The administrative management system: joint inter-ministerial meeting, agricultural genetically modified organisms safety management leading group, the provincial administrative department of agriculture, municipal (county) level administrative department of agriculture.</div>
</div>
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<p>&nbsp;</p>
 
+
<div class="p_font_size">3. Technical support system, safety evaluation, detection, monitoring and technical standards.</div>
<div class="column half_size">
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<p>&nbsp;</p>
<h5>Safe Shipment</h5>
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<div class="h2_font_size">Lab work</div>
 
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<p>&nbsp;</p>
<p>Did you face any safety problems in sending your DNA parts to the Registry? How did you solve those problems?</p>
+
<div class="p_font_size"><font style="font-weight:bold">Training</font></div>
</div>
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<p>&nbsp;</p>
 +
<div class="p_font_size">Members in our team have read the established laboratory safety principles of our school, and the topics in our safety training can be summarized as follows:</div>
 +
<p>&nbsp;</p>
 +
<div class="p_font_size"><font style="font-weight:bold">1. Non-biological operations:</font></div>
 +
<p>&nbsp;</p>
 +
<div class="p_font_size">&nbsp;&nbsp;1.1 Handling toxic chemicals</div>
 +
<p>&nbsp;</p>
 +
<div class="p_font_size">&nbsp;&nbsp;1.2 Emergency measures(such as how to tackle fire, electric leakage and negligent wounds)</div>
 +
<p>&nbsp;</p>
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<div class="p_font_size">&nbsp;&nbsp;1.3 Instruments and facilities operation principles</div>
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<p>&nbsp;</p>
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<div class="p_font_size"><font style="font-weight:bold">2. Biological operations:</font></div>
 +
<p>&nbsp;</p>
 +
<div class="p_font_size">&nbsp;&nbsp;2.1 Potential threats of our engineering bacterium (<font style="font-style:italic">Escherichia coli</font>)</div>
 +
<p>&nbsp;</p>
 +
<div class="p_font_size">&nbsp;&nbsp;2.2 Effective protection during organism operations</div>
 +
<p>&nbsp;</p>
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<div class="p_font_size">&nbsp;&nbsp;2.3 Waste materials handling measures</div>
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<p>&nbsp;</p>
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<div class="p_font_size">&nbsp;&nbsp;2.4 Emission rules</div>
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<p>&nbsp;</p>
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<div class="row" style="margin-top:20px">
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<div class="col s6">
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<img alt="image" class="img-responsive col s11" src="https://static.igem.org/mediawiki/2016/0/07/T--SCAU-China--safetu_01.JPG">
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<img alt="image" class="img-responsive col s11" src="https://static.igem.org/mediawiki/2016/2/23/T--SCAU-China--safety2.jpg">
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<div class="p_font_size"><font style="font-weight:bold">Rules and Regulations</font></div>
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<p>&nbsp;</p>
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<div class="p_font_size">We have graduate students as our supervisors to ensure our operation correctness preventing safety problems. All of our team members have at least been working in a lab for 3 months and received biosafety training. The biosafety guidelines of our institution can be describe as follows:</div>
 +
<p>&nbsp;</p>
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<div class="p_font_size">1. All laboratories must be specially design and should set up strict management systems, standard operation procedures and rules. </div>
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<p>&nbsp;</p>
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<div class="p_font_size">2. Each staff should be equipped with personal safety equipment to avoid direct contact with the pathogenic microorganism or toxic chemicals.</div>
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<p>&nbsp;</p>
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<div class="p_font_size">3. New staffs should be well trained and pass the experiment test before performing experiments themselves.</div>
 +
<div class="p_font_size">4. One person at least in each laboratory should take charge of biosafety and establish a continuous biosafety training program.</div>
 +
<p>&nbsp;</p>
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<div class="p_font_size">5. Laboratories should establish emergency handling procedures and have routine inspection for all of the equipment.</div>
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<p>&nbsp;</p>
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Latest revision as of 11:22, 3 December 2016

SCAU

Safety
Risk assessment

 

 

As our project is to use the rice as a factory to produce astaxanthin, and we also hope that aSTARice can serve as a kind of food in human’s daily lives one days, so we are very concerned about the safety of aSTARice.

 

We believe that risks are mainly embodied in two aspects. The frist problem is that the encoding products of marker genes might be toxic and allergenic potentially for human or livestock. Antibiotic genes might be transferred into gut microbes’ genome of humans or animals, increasing the resistance of the microbes to the antibiotic. The other one is that marker genes could spread through pollens or other ways into other organisms, which is termed gene flow. In population genetics, gene flow (also known as gene migration) is the transfer of alleles or genes from one population to another, which may lead to unimaginable damage to the ecological environment.

 

In order to reduce the effects of pollen-mediated crop-to-crop transgene flow on environment, we use a technique called selectable marker-free system, so the final aSTARice is a marker-free transgenic plants(MFTPs). We design a Cre-loxP based side-direct recombinant system to knock out hygromycin phosphotransferase gene, minimizing the effect of the selectable maker gene.

 

To further reduce the unpredictable threat of gene flow, we grow rice in pot culture and greenhouse-environment. What's more, we are also analyzing coding products by HPLC and trying to make sure that there is no harmful products in our rice.

Because we are the first team who choose rice as a chassis, we have to assess the safety for rice. Rice is the self-pollinated plant so that the genotype in the individuals is pure and homogeneous. The probabilities that two flowers take place cross-pollinated is one percent, and the distance of the spread of rice pollen is close to one meter. Rice isn’t included in the white line, so we make a checked-in on the official website.

 

 

 

Design for marker free

 

 

In this part, we used a site-specific Cre/loxP recombination to delete the selective marker. To delete the selective resistance gene in transgenic rice, a marker-free element was used to assemble into four-gene multigene vector. This marker-free element was placed between two loxP sites, and consists of a HPT (hygromycin) resistance gene expression cassette and a Cre gene expression cassette controlled by anther-specific promoter (Figure 1). When Cre gene was expressed in transgenic rice anther, the Cre enzyme deleted the marker-free element between two loxP sites. You can read more details, please click here!

 

image
Figure 1   The schematic diagram of the marker-free element. PV4 is an anther-specific promoter that drives Cre gene expression in anther.

 

Laws & regulations

 

 

The credibility of the policy about “aSTARice” transgenic rice project:

 

The World Health Organization

 

In 2002, the World Health Organization claimed in"20 questions about genetically modified food". All of the genetically modified products as so far in the international market have passed the risk assessment by the national authorities. These different assessments in general follow the same basic principles, including the environment and human health risk assessment. These assessments are transparent, they did not show any risk for human health.

 

The United Nations

 

The Food and Agriculture Organization of the United Nations in 2003-2004, in "the food and agriculture condition report”clearly pointed out that the current existed modified crops and food is safe, the method used to test its safety is appropriate. So far, there is no safety accident caused by eating genetically modified crops. Millions of people eat the food derived from genetically modified crops, mainly maize, soybean and rape seed, but did not find any adverse effect.

 

The European

 

In 2009, the transgenic group of European food safety authority set out an authoritative scientific opinion about herbicide resistant and insect-resistantcrops that in terms of impact on the environment of human and animal health, gm is the same safe as non-gm, without any harm to health and the environment.

 

The United States

 

In 2010, the National Academy of Sciences of the United States claimed in “the influence on American agricultural sustainability ”. In general, compared to traditional agricultural technology for American farmers, genetically modified has created a huge environmental benefits and economic benefits.

 

The World Health Organization, the Food and Agriculture Organization of the United Nations, the US Food and Drug Administration and other international organizations and authorities have said the current approval of commercialization of transgenic food is safe and edible.

 

China

 

The Chinese government attaches great importance to the management work of the safety of agricultural genetically modified organisms, has formed a set of law which is suitable for China's national situation and consistent with international convention of laws and regulations, technical regulations and management system. As a result,it has achieved remarkable results in accordance with the implementation of safety management.

 

1. The legal system: the agricultural genetically modified organisms safety management regulations, the measures for the administration of agricultural genetically modified organisms safety assessment, the safety measures for the administration of import of agricultural genetically modified organisms, the identification measures for the administration of agricultural genetically modified organisms, the agricultural genetically modified organisms processing measures for examination and approval, the inspection and quarantine measures for the administration of entry and exit of genetically modified products.

 

2. The administrative management system: joint inter-ministerial meeting, agricultural genetically modified organisms safety management leading group, the provincial administrative department of agriculture, municipal (county) level administrative department of agriculture.

 

3. Technical support system, safety evaluation, detection, monitoring and technical standards.

 

Lab work

 

Training

 

Members in our team have read the established laboratory safety principles of our school, and the topics in our safety training can be summarized as follows:

 

1. Non-biological operations:

 

  1.1 Handling toxic chemicals

 

  1.2 Emergency measures(such as how to tackle fire, electric leakage and negligent wounds)

 

  1.3 Instruments and facilities operation principles

 

2. Biological operations:

 

  2.1 Potential threats of our engineering bacterium (Escherichia coli)

 

  2.2 Effective protection during organism operations

 

  2.3 Waste materials handling measures

 

  2.4 Emission rules

 

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Rules and Regulations

 

We have graduate students as our supervisors to ensure our operation correctness preventing safety problems. All of our team members have at least been working in a lab for 3 months and received biosafety training. The biosafety guidelines of our institution can be describe as follows:

 

1. All laboratories must be specially design and should set up strict management systems, standard operation procedures and rules.

 

2. Each staff should be equipped with personal safety equipment to avoid direct contact with the pathogenic microorganism or toxic chemicals.

 

3. New staffs should be well trained and pass the experiment test before performing experiments themselves.
4. One person at least in each laboratory should take charge of biosafety and establish a continuous biosafety training program.

 

5. Laboratories should establish emergency handling procedures and have routine inspection for all of the equipment.

 

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