Although we are confident that our project, SchistoGONE, will positively impact many communities with the absence of disease, we must follow ethical practices in implementing our project globally. Through a discussion on implementation, our team tackles how exactly we would install bioreactors and plates, safety issues that may arise, and even the local laws that would help or hurt us in reaching our goal.
Because our project targets a common disease directly instead of manufacturing a product for a market, there is no specific group of people that our yeast product would go to. Instead, our project would be widely implemented into public rivers and waterways where citizens bathe and gather water from, ultimately benefiting all people who could potentially contract schistosomiasis. Communities that lack sufficient funding on medical care would no longer place concern and resources on infections that are prevented, and citizens more vulnerable to the parasitic effects, like school children and the elderly, may join more recreational and physical activities involving rivers and lakes.
Implementation of SchistoGONE will require several steps, including thorough consideration of the laws in the country we will apply it
to. Unfortunately, in Africa, where schistosomiasis is most prevalent, there aren't any laws regarding synthetic biology safety. The
field is still becoming accepted globally and many countries are not prepared to take on financial risks. However, Nigeria, South
Africa, and Kenya do have laws in place, so we will be studying their laws in hopes that other countries will soon follow suit.
Firstly, there are policies and laws that would assist the implementation of SchistoGONE like the National Water Resources Policy,
which outlines the regulatory framework to achieve the goals of the state and Policy Statement 8 (Water Supply and Sanitation). It
includes initiatives to promote technology within the sanitation sector and prevent water-borne illnesses. However, complex disputes
regarding waterways in Nigeria—one of our target countries—in 2017 between National Inland Waterways Authority (NIWA) and
the state government may produce possible obstacles in implementing SchistoGONE in Nigeria. We would need to `go through the NIWA
Research, Planning, and Environment (RPE) Department, which is responsible for Health, Safety, and Environment, and also conduct an
extensive impact assessment to identify the main environmental implications of our project and how we can best create a low-risk,
low-reliability plan for public approval.
Most extensive information about synthetic biology laws in Nigeria, South Africa, and Kenya is in our policy review.
In order to prevent schistosomiasis, we will be genetically engineering W303 Saccharomyces cerevisiae yeast. The yeast will be placed on the shores of schistosomiasis-infected waters, attracting snails so that they will consume the yeast. Our modified W303 Saccharomyces cerevisiae yeast will produce sanguinarine inside its cell walls, which will be released after snails consume the yeast and enzymes inside the snail's stomach have broken through the cell membranes and walls. The sanguinarine will kill the worms inside the snails, removing the disease once it enters the snail's bloodstream.
We built a bioreactor to culture our yeast cells, and it will pump the yeast to plates on the shores of infected rivers. Snails will be attracted to the scent of the yeast and come up to the plates themselves. This way, we do not have to pour our compound into the rivers and risk disrupting other ecosystems and forms of life.
Since our project would greatly impact the communities SchistoGONE is implemented into, communicating with the people whose water source will be affected would be a top priority. The public will be informed thoroughly about all aspects of the project, including the scientific reasoning behind the components of SchistoGONE and any possible side effects of using or consuming the affected water. Education on this subject would hopefully create a relationship of trust between our team and the community, allowing for a constant stream of feedback and responses. Before implementation, we want to answer any questions citizens have and resolve any of their concerns so that SchistoGONE can benefit as many people as possible without becoming a source of grievance for any communities.
The effective implementation of SchistoGONE would be a lengthy and intensive process. With even more regulations to consider than in the previous sample area of Nigeria, adhering to all relevant African laws, extrapolating resources from out of one region and expanding into further regions (in terms of work-force wise, community acceptance) will take some time. After the preliminary support has been laid down for SchistoGONE and logistical issues are resolved, manual work will need to be carefully monitored along with the application of our project in order to gauge effectiveness and ensure uniformity.
One of the primary concerns regarding the practicality of the implementation of SchistoGONE is the potential impact to water quality
and the environment in a situation where our yeast is erroneously released. The high prevalence of schistosomiasis in water-scarce
regions and in populations dependent on natural bodies of water for most, if not all, of their water supply exacerbates the potential
concerns that released yeast may have in water. For instance, South Africa, a country affected by schistosomiasis, is currently facing
a water shortage crisis and as a result, authorities could be hesitant to put remaining water sources under potential risk of harm,
which may include yeast. Furthermore, as detailed comprehensively in our environmental analysis, rich biodiversity is centered in
water habitats within schistosomiasis-afflicted regions, and an uncontrolled release of yeast could result in ecosystem disruption.
The nature of our project, however, addresses these concerns. SchistoGONE intends on utilizing genetically modified S.Cerevisiae yeast
to synthesize antiparasitic products within isolated plates docked on the shore. The plates will contain a bioreactor and the
necessary medium in order to carry out this function. In a situation where yeast is released into the water, it will be relatively
benign. This is because without nutrients provided by the medium held in the plates and S.Cerevisiae's inability to compete for
resources with other microorganisms, it will quickly use up its surplus resources, enhanced by the usage of energy in producing
naturally inessential antiparasitic products, and die out. The excess production and release of antiparasitic products will not be of
much concern either, as the yeast requires a substrate to bind in order to synthesize these products which are not available outside
of the plates.
More information is provided in our environmental analysis.
In most cases, the yeast will not be harmful to snails. When released from the bioreactor, we have ensured that the yeast stays relatively benign, as it doesn't have the proper nutrients to sustain its lifestyle. While it might survive for a short period of time, other microorganisms will outcompete it, leading to no long-term impact on snails.
The Nigerian federal government is split into many distinct civil service departments, collectively known as the Federal Ministries of
Nigeria. There are two ministries that are relevant to our schistosomiasis project: the Federal Ministry of Water Resources and the
Federal Ministry of Public Health.
The Federal Ministry of Water Resources is responsible for developing and implementing policies to provide all Nigerians with safe
access to water. One such policy is the National Water Resources Policy, which outlines the regulatory framework to achieve the goals
of the state. As stated under the policy, water is a basic human right and an asset of the state, so private ownership of water is not
allowed. Since our plan targets publicly owned waterways, we would need to seek approval from the ministry to implement our project.
The ministry is heavily underfunded, so cooperation with private partners and donations are vital to the success of the program. In
the past, there have also been issues in maintaining proper surveying and monitoring post-implementation, so additional personnel and
resources would need to be provided.
Specifically, in accordance with the Policy Statement 8 (Water Supply and Sanitation), the ministry is responsible for providing
sufficient and adequate sanitation to enhance health. This includes initiatives to promote technology within the sanitation sector and
prevent water-borne illnesses. Since our project attempts to use technology to clean water and remove parasitic worms that can spread
schistosomiasis to humans, some of those initiatives would be likely to help us.
Established in 1997 under the Federal Ministry of Transport, the National Inland Waterways Authority (NIWA) was named the primary
authority for the regulation and development of inland navigable waterways in Nigeria. NIWA is the main governmental authority able to
regulate waterways throughout the nation, with responsibilities spanning from infrastructure development to navigation to
environmental surveying. Even with state governments attempting to gain control over their own waterways, such as the Lagos State
Waterways Authority, NIWA was still legally declared by the Federal High Court as the competent authority. Well, that was up until
2017.
After an appeal by the Lagos State authorities in July of 2017, the dispute over control of Nigerian waterways became much more
convoluted. Both the state government and NIWA claim to have won the authority to control the navigable waterways in Lagos, with
representatives on both sides publicly announcing to the media their opinion. It is generally accepted that all interstate waterways,
those that run between two or more states, are under federal jurisdiction. This includes most of the largest bodies of water in
Nigeria—such as the River Niger, the River Benue, and Lake Chad—which supply water to the majority of Nigerians. All
intrastate and inland waterways, those that start and end entirely within one state, not mentioned under the NIWA are under state
jurisdiction, though there is little clarity over the definition of "other intrastate waterways." The hazy line between state and
federal authority in Nigeria complicates the process of seeking approval for projects involving waterways across the nation.
In order for our project to be legally approved and granted a permit to implement SchistoGONE, we would likely need to go through the
NIWA Research, Planning, and Environment (RPE) Department, which is responsible for Health, Safety, and Environment. While
schistosomiasis is not explicitly listed among their responsibilities, the RPE handles all policy issues, budget preparations, and
project monitoring about the surrounding environment of waterways. To attain public approval, we would need to conduct an extensive
impact assessment to identify the main environmental implications of our project and how we can best create a low-risk,
low-reliability plan. The funding for the project would have to come entirely from Public Private partnerships (PPP), as previous
efforts by the Nigerian federal government to curb schistosomiasis were unsuccessful and these programs are generally underfunded.
Before implementation, we would have to confirm that the country's laws align with our project and that we have all necessary
approval. Unfortunately, in many parts of Africa, where schistosomiasis is most common, there are no laws that address the use of
synthetic biology. Because it could potentially be harmful to the environment and its people, most developing countries are reluctant
about risky new technology. However, synthetic biology and biosafety conferences are being held and we are optimistic that countries
will take this step in implementing synthetic biology.
Because there are only synthetic biology laws in Nigeria, South Africa, and Kenya, we will be mainly focusing on laws in these
countries, in hopes that other African countries will have similar synbio laws in the future.
In Nigeria, we would have to get our project approved by the National Biosafety Management Agency (NBMA), established in 2015 by the
Nigeria Biosafety Bill. Their core belief is that synthetic biology may help solve poverty issues, and have already implemented
agricultural biotechnology to improve food security. The new regulations state that any project involving gene drive, gene editing,
and synthetic biology must gain approval from the Agency to best minimize adverse effects. After submitting an application to the
Agency, an internal review must be conducted with the possibility of additional information requests. Within 21 days, the project can
be approved, indicating a relatively quick time frame from application to implementation. Since our final product contains recombinant
DNA, it must also undergo a GMO regulation process.
As discussed throughout our review of schistosomiasis policy, many countries in which schistosomiasis is prevalent have agencies
responsible for public health and water management with specific regulations and rules regarding project approval. However, durations
for this vary due to numerous political and social considerations that we could potentially encounter in countries of interest.
One of the primary hindrances to the approval of SchistoGONE in many countries studied is the lack of state funding and investment
into schistosomiasis related causes, or an unwillingness to financially support initiatives with potential economic and environmental
consequences if unsuccessful. For instance, Nigeria has been condemned by public health academics both within and internationally due
to their relative inaction, exacerbated by the emergence of COVID-19. Despite commitments to the London Declaration and many WHO
initiatives throughout the last 20 years, Nigeria has observed little to no changes in their schistosomiasis mortality rate. As
discussed by Professor Oyeyemi at the University of Medical Science in Ondo State, the Nigerian government is only willing to invest
in low-risk, low-liability plans with minimal economic commitment, which contrasts with the nature of our project. As a result, a
meticulous process involving a solidified proof of concept and environmental analysis would be required in order to meet this
criteria, which would require many years to conduct. However, other schistosomiasis-afflicted countries have demonstrated promising
actions in order to tackle the disease. For instance, Kenya has implemented a deworming initiative which provide children with free
deworming treatments. However, like Nigeria, Kenya and many other nations face other limiting factors.
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