Team:LA Biohackers/Practice and Policy
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- | <a href="https://2014.igem.org/Team:LA_Biohackers/ | + | <a href="https://2014.igem.org/Team:LA_Biohackers/Practice and Policy"style="color:#000000"> Practice and Policy </a></td> |
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people, workspace and equipment, funding, and regulatory compliance. | people, workspace and equipment, funding, and regulatory compliance. | ||
<br> | <br> | ||
- | <br | + | <br> |
<b>The Idea</b> | <b>The Idea</b> | ||
<br> | <br> | ||
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more and more labs responsibly enter and thrive in the DIY synthetic biology space, those more fearful | more and more labs responsibly enter and thrive in the DIY synthetic biology space, those more fearful | ||
and less supportive of this technology may soon have to find a different tune as well. | and less supportive of this technology may soon have to find a different tune as well. | ||
+ | <br><br> | ||
+ | At the federal level, there are a number of administrative agencies and guidelines relevant to the community laboratory that hopes to practice synthetic biology. Although many of these are aimed at the traditional lab setting, the aspiring community laboratory should abide by all pertinent regulations for the number of reasons stated above. Most importantly, the community laboratory should follow relevant guidelines to ensure the safety of lab its members. Additionally, the lab should strive to ensure they do not adversely affect the environment around them.<sup>10</sup> | ||
+ | <br><br>For example, the National Institute of Health (NIH) has compiled a set of guidelines for the regulation of research involving recombinant and synthetic nucleic molecules.<sup>13</sup> The Center for Disease Control and Prevention (CDC) has cited the NIH Guidelines as the key reference in assessing risk and establishing an appropriate biosafety level for work involving recombinant DNA molecules.<sup>14</sup> Any group that seeks funding from the NIH must comply by these guidelines. Often, other funding sources | ||
+ | require compliance with these guidelines. Generally, the NIH Guidelines provide a sensible backdrop for any DIY organization.Here, the NIH defines recombinant and synthetic nucleic molecules as molecules that a) are constructed by joining nucleic acid molecules, and b) can replicate in a living cell (i.e. recombinant nucleic acids); nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or molecules that result from the replication of those described in (i) or (ii) above.<sup>13</sup> | ||
+ | <br> | ||
+ | <br>Six different categories of experiments involving recombinant or synthetic nucleic acid molecules are recognized by the NIH Guidelines.<sup>13</sup> These categories encompass experiments that: a) require Institutional Biosafety Committee (IBC) approval, RAC review, and NIH Director approval before initiation; b) require NIH/OBA and Institutional Biosafety Committee approval before initiation; c) require Institutional Biosafety Committee and Institutional Review Board approvals and RAC review before research participant enrollment; d) require Institutional Biosafety Committee approval before initiation; e) require Institutional Biosafety Committee notification simultaneous with initiation; and those that are exempt from the NIH Guidelines.<sup>13</sup> Again, while compliance with these guidelines is mandatory only if the group receives NIH funding, these guidelines are often seen as the best current practice. Additionally, and more relevant to the aspiring community laboratory, four risk | ||
+ | groups are recognized by the NIH Guidelines.<sup>13</sup> These risk groups then determine the appropriate biosafety level applied to the specific experiment. The biosafety level and risk assessment help determine the appropriate containment conditions and how organisms should be handled. | ||
+ | <br> | ||
+ | </br>Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans and correlate to a Biosafety Level of 1 (BSL-1). This group can include Escherichia coli and baculovirus. BSL-1 follows standard microbiological practices allows work to be done on open bench tops, suggests that standard microbiological practices are followed and suggests the posting of biohazard signs. Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available. Agents in this group fall under a Biosafety Level of 2 (BSL-2), and may include adenovirus, all human and non-human primate blood contaminated specimens, and herpes simplex virus. BSL-2 suggests restricted lab access during | ||
+ | experimental work, biological safety cabinets, biohazard signs, specific training in handling of agents and personnel protective equipment. Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available. RG3 agents fall under a Biosafety Level of 3 (BSL-3), and may include M. tuberculosis and concentrated Lentivirus. Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available. The latter two groups stipulate much more strenuous safety guidelines, but most aspiring community laboratories will be unlikely to work with | ||
+ | agents falling under RG3 or RG4. <sup>13, 15, 16</sup> | ||
+ | <br> | ||
+ | <br>In the context of the LA Biohackers’ experiment, the primary types of experimental agent, | ||
+ | Bacillus subtilis or Eschericia coli, fall under RG1 and BSL-1. The aim of the experiment, however, is | ||
+ | to use these agents as hosts for the DNA of agents that are more difficult to modify either due to the | ||
+ | complexities of their growth requirements or lack of transformational tools, such as Mycoplasm | ||
+ | genetalium. According to the NIH Guidelines, experiments involving the DNA of agents from RG2, | ||
+ | RG3 within a nonpathogenic host may be performed under BSL-2 containment guidelines. | ||
+ | Additionally, experiments involving the DNA of agents from RG4 within a nonpathogenic host may be | ||
+ | performed under BSL-2 containment guidelines after demonstrating that only a totally and irreversibly | ||
+ | defective fraction of the agent’s genome is present in the given recombinant.<sup>13</sup> Thus, should any group | ||
+ | choose to apply the method demonstrated by the LA Biohackers, BSL-2 adherence will likely be | ||
+ | required. | ||
+ | <br> | ||
+ | <br>Aspiring community laboratories should also be wary of their impact on the environment. Thus, | ||
+ | the laboratory should take great care to abide by the relevant Environmental Protection Agency (EPA) | ||
+ | regulations as well as regulations promulgated by the Food and Drug Administration (FDA). FDA | ||
+ | regulations, however, would likely only apply if the group sought commercial application of their | ||
+ | experiments. EPA regulations that will likely apply to the aspiring community laboratory deal mainly | ||
+ | with the disposal of hazardous waste. For example, the LA Biohackers sought and received the | ||
+ | appropriate permit to allow for the disposal of their hazardous waste products.The EPA has written | ||
+ | detailed regulations to make sure that TSDFs operate safely and protect people and the environment. | ||
+ | The EPA wrote these regulations to implement the Resource Conservation and Recovery Act (RCRA) | ||
+ | of 1976 and the Hazardous and Solid Waste Amendments of 1984. The U.S. Congress passed these | ||
+ | laws to address public concerns about the management of hazardous waste.<sup>14, 17</sup> | ||
+ | <br> | ||
+ | <br>Compounding the general risk of hazardous waste to the environment is the generally | ||
+ | unpredictable nature of synthetic agents as compared to natural agents. For example, the inherent | ||
+ | pathogenicity of a microorganism greatly depends on the regulation of its virulence genes. Even the | ||
+ | smallest of nucleotide changes may have a dramatic effect on the pathogenesis or the viability of the | ||
+ | organism.<sup>18</sup> Additionally, many pathogenic bacteria contain clusters of genes called pathogenicity | ||
+ | islands (PAI). | ||
+ | These are not present in related non-pathogenic bacteria. Thus, in experiments such as | ||
+ | the one conducted by the LA Biohackers, the transfer of the DNA of a pathogenic agent into a non-pathogenic agent may have wholly unexpected results when released into a set environment.<sup>18</sup> | ||
+ | |||
+ | |||
+ | Specifically, until we know how a partially or wholly synthetic agent’s sequence, structure, and | ||
+ | biological context contribute to its biological properties it will be difficult to predict how it will exert | ||
+ | its influence on the environment.<sup>19</sup> Adding to this uncertainty is the fact that the synthetic biology field | ||
+ | is progressing at a lightning-fast pace. New techniques are being developed every day that may enable | ||
+ | the ability to generate novel organisms with unknown properties, such as enhanced virulence. These | ||
+ | developments pose novel risks to biosafety, and present a multitude of ethical considerations, and only | ||
+ | reinforce the need to practice synthetic biology under stringent biosafety guidelines.<sup>19</sup> | ||
+ | <br> | ||
+ | <br>Community laboratories should also be mindful of the type of organization they seek to create at | ||
+ | the federal level. A larger group, such as the LA Biohackers, with its rental fees, membership fees, and public outreach and teaching may be more concerned with this aspect than the fledgling community | ||
+ | laboratory in a neighbor’s garage, for example. In the case of the LA Biohackers, they sought and | ||
+ | received approval from the IRS to incorporate as a Section 501(c)(3) tax exempt entity. | ||
+ | <br> | ||
+ | <br>To be exempt under Section 501(c)(3) of the Internal Revenue Code an organization’s purpose | ||
+ | must be charitable, religious, educational, scientific, literary, testing for public safety, fostering national | ||
+ | or international amateur sports competition, and preventing cruelty to children or animals. Here, | ||
+ | charitable includes the advancement of education or science.<sup>20</sup> | ||
+ | Thus, a group that seeks to follow the model of the LA Biohackers, which prides itself in | ||
+ | serving its community as a learning tool, may do well to aspire to these purposes. Groups that do not | ||
+ | want or are unable to function in this manner are just as relevant, but are likely unable to achieve tax | ||
+ | exempt status. These groups should still be mindful of the various organizational entity classifications | ||
+ | promulgated by their state. | ||
+ | <br> | ||
+ | <br>Typically, a community laboratory will not need to give much thought to potential international | ||
+ | regulatory issues. There are, however, certain research subjects that would warrant international | ||
+ | concern. For example, the World Medical Association (WMA) has developed the Declaration of | ||
+ | Helsinki as a statement of ethical principles for medical research involving human subjects, including | ||
+ | research on identifiable human material and data.<sup>21</sup> Most aspiring community laboratories will be | ||
+ | unlikely to venture into this research area as it is mostly aimed at clinical application of medical | ||
+ | research. | ||
+ | <br> | ||
+ | <br>Arguably more relevant, however, are the international implications under the Convention on | ||
+ | Biological Diversity (CBD) and the Nagoya Protocol (NP), which the United States has yet to ratify. | ||
+ | The CBD aims to conserve biological diversity, promote sustainable use, and provide fair access to any | ||
+ | benefits that may arise from genetic sources.<sup>22</sup> Biological diversity is represented by the multitude of | ||
+ | plants, animals, microorganisms, genetic differences between species and the wide variety of | ||
+ | ecosystems that occur on Earth. The combinations of these factors has made the planet uniquely | ||
+ | suitable to flourishing life.<sup>23</sup> | ||
+ | <br> | ||
+ | <br>The Nagoya Protocol servers to further develop the third main goal of the CBD: fair access to | ||
+ | any benefits that may arise from genetic sources.<sup>24</sup> It is an international agreement which aims at | ||
+ | sharing the benefits arising from the utilization of genetic resources in a fair and equitable way, | ||
+ | including by appropriate access to genetic resources and by appropriate transfer of relevant | ||
+ | technologies, taking into account all rights over those resources and to technologies, and by appropriate | ||
+ | funding, thereby contributing to the conservation of biological diversity and the sustainable use of its | ||
+ | components.<sup>25</sup> In the international context, the CBD and NP provide meaningful progress for third-world countries who would greatly benefit from new and innovative genetic research and would | ||
+ | generally lack the resources on their own to conduct the same research. | ||
+ | <br> | ||
+ | <br>In the context of synthetic biology, the CBD and NP apply to the genetic material often used | ||
+ | by researchers. Synthetic biology research and experimentation necessarily utilize significant quantities | ||
+ | of tangible genetic material. Thus, a fledgling community laboratory should strive to meet the | ||
+ | admirable standards set forth by the CBD and NP.<sup>26</sup> The extent of this application, however, is unclear, as synthetic biology is not specifically addressed by the CBD or NP. | ||
+ | <sup>27</sup> Specifically, although the NP | ||
+ | does note the term “derivative” and defines it as a gene segment produced or isolated by human | ||
+ | manipulation, synthetic gene segment produced by human manipulation, or a synthetic analogue | ||
+ | chemicals or gene segments, it does not extensively address the impact of synthetic biology. | ||
+ | Nevertheless, the CBD an NP provide meaningful goals that a community laboratory should strive | ||
+ | towards. | ||
+ | <br> | ||
+ | <br>The model of a community laboratory set forth by organizations such as the LA Biohackers is | ||
+ | well on its way to promoting these goals, as exemplified by their mission statement: The mission of the | ||
+ | Los Angeles Biohackers is to make science accessible to people of all ages and educational | ||
+ | backgrounds.<sup>28</sup> | ||
<br><br> | <br><br> | ||
<b><u>Sources</b></u><br><br> | <b><u>Sources</b></u><br><br> | ||
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<br> | <br> | ||
14: http://www.biohackers.la/name | 14: http://www.biohackers.la/name | ||
+ | <br> | ||
+ | 13: http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html | ||
+ | <br> | ||
+ | 14: www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf | ||
+ | <br> | ||
+ | 15:www.ibc.pitt.edu/RiskGroups/RiskBiosafetyChart2007.htm | ||
+ | <br> | ||
+ | 16: 2013.igem.org/Safety/Risk_Group_Table | ||
+ | <br> | ||
+ | 17: http://www.epa.gov/waste/hazard/tsd/permit/prmtguid.htm#permit | ||
+ | <br> | ||
+ | 18: www.ncbi.nlm.nih.gov/books/NBK50869/#ch2.s12 | ||
+ | <br> | ||
+ | 19: osp.od.nih.gov/sites/default/files/resources/NSABB%20SynBio%20DRAFT%20Report-FINAL%20(2)_6-7-10.pdf | ||
+ | <br> | ||
+ | 20: http://www.irs.gov/Charities-&-Non-Profits/Charitable-Organizations/Exemption-Requirements-Section-501(c)(3)- | ||
+ | Organizations | ||
+ | <br> | ||
+ | 21: http://www.wma.net/en/30publications/10policies/b3/index.html | ||
+ | <br> | ||
+ | 22: http://www.cbd.int/convention/text/ | ||
+ | <br> | ||
+ | 23: www.cbd.int/convention/guide/default.shtml | ||
+ | <br> | ||
+ | 24: http://www.cbd.int/abs/text/default.shtml. | ||
+ | <br> | ||
+ | 25: http://www.cbd.int/abs/ | ||
+ | <br> | ||
+ | 26: http://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=5916&context=faculty_scholarship | ||
+ | <br> | ||
+ | 27: Scholarship.law.duke.edu/cgi/viewcontent.cgi?article5916&context=faculty=scholarship | ||
+ | <br> | ||
+ | 28: http://www.biohackers.la/about | ||
</p> | </p> | ||
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Latest revision as of 02:58, 18 October 2014
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