Team:Manchester/HP/Silver
Human Practices
Beyond the bench, the world educates us on ethics, sustainability, social justice, safety, security, environmental impact and intellectual property rights - information which further shapes the direction of our research. We have engaged with experts from different fields to make sure that our project and its execution can be responsible, safe and sustainable. Click here to our gold Human Practice page to see specific interactions from stakeholders that have directly impacted and shaped different parts of our Phosphostore project!
Achievements:
1. Discussed with experts from various different water companies to determine whether our project or other synthetic biology approaches would be taken up in the water industry
2. Investigated intellectual property rights from experts to determine whether granted patents associated with our project will have any influence on the iGEM competition and the execution of our project in real life
3. Explored the possibility of scaling-up our project in an industrial scale and made a rough estimation on the production cost with guidance and resources from an expert
4. Gained an understanding of GMO regulation and the application procedure for commercial use of GMOs to ensure safety for public through a conference call with DEFRA
Exploring Human Practices 08/06/2017 & 20/06/2017
To start off with human practices, we talked with Dr. Robert Meckin and Dr. Andrew (Andy) Balmer to discuss and learn about Human Practices and the social implications of synthetic biology. From the start, we wanted to explore the possible areas to implement the project. We thought that the water industry, specifically water treatment plants where phosphate is removed would be a good target market. Another possible area is for bioremediation purposes within eutrophic lakes or water bodies.
Throughout our team discussions, we agreed that we would need to approach companies in the water industry to understand the feasibility of our project. In addition, discussion with Robert brought up the idea of innovation in water treatment companies, in particular to answer the question: what drives water companies to adopt a new technology? The answer to this question would be important to determine whether these companies would be willing to adopt new technology such as the application of synthetic biology for water treatment. One interesting point which came up during our discussion with Andy was how we might apply our project at a large scale after iGEM and to take this into consideration when designing our product. This challenged us to think about the project’s feasibility and how it would be implemented in a real world/business scenario.
Water Industry
To determine the feasibility of our project, we had a number of detailed discussions with the water industry. Our aim in these talks was to discover how innovation works in the water industry. The answer to this question would be important to determine whether water companies would be willing to adopt new technology such as synthetic biology to treat water. By talking to various experts, we were able to understand the background of the water industry in innovation and the requirements our synthetic biology device would need to meet in order to successfully sell it to water companies. We summarized all our findings here, check it out!
Interviewing an Expert - Water Innovation (Dr. Duncan Thomas) 05/07/2017
We wanted to understand the water industry further, especially after Robert brought up an interesting point regarding innovation. We set out to interview Dr. Duncan Thomas from the Manchester Institute of Innovation in the University of Manchester that researches water technology and innovation policies.
From our interview, we learned a few important points about innovation in the water industry:
1. The UK’s water companies are heavily privatized. Each company in the water industry is very different and thus, our technology will have to fit with the different existing frameworks on a case-by-case basis. This will mean assessing the following criteria for each company/regional treatment facility:
-Current treatment methods
-Do they have a phosphate problem?
-Do they specialize in removing phosphate?
-What methods are they using to remove them?
-Are current methods chemical or biological?
Therefore, in order to see the feasibility of our project, a performance and cost analysis would need to be done based on these questions for each company so that we can successfully sell our technology to them.
2. Innovation in the water industry is quite hard and slow, not always because of the costs but because of the way that companies prioritize things.
a. For example, water companies will definitely prioritize reaching the standard qualifications set by the government or other national authority. Since the government does not regulate the way the companies treat their water, water companies would choose to adopt whichever technology is readily available to them. Therefore, a completely new innovation may not be appealing to them because it requires a risky investment of money and a restructure of their existing process. To convince them we would have to show a cost analysis, which proves that our technology can be cheaper in the long term than an already existing process. Rather, an innovation that increases the efficiency or solves the problem of an already existing technology within the company may be more attractive for them.
b. In addition, safety would also be the main priority of a water company. They would not want to adopt a new technology if it has possible risk of contaminating the water as it would affect thousands of people within the area. This is why water companies often act as a ‘second adopter’ and would only adopt new technology when its risks have been assessed and it has proven to work in a different place.
3. However, the reasons above may only apply to the UK, because the industry in the UK is more mature (have better technology/infrastructure already). Therefore, it would probably be better to pitch the idea in countries where there is a lack of innovative technologies for water treatment and where meeting regulatory standards is still a struggle.
4. The government’s role in water treatment is only in establishing standard regulations, but not necessarily in deciding the way to treat water.
5. Brexit is a huge uncertainty that may put off water companies from adopting new innovations. The current regulations for the water industry is the Water Framework Directive which is created by the European Commission. It is uncertain whether the new UK law will adopt the same regulations or create a new one. If they adopt the same existing regulation, not much will change. However, there is a possibility of higher standard regulations that will have to be prioritized and addressed before adopting any new technology.
In addition to these findings, Dr. Thomas also challenged us to think beyond the water industry and to come up with other business plans, such as selling our technology directly to the customers. These customers may be farmers that may appreciate our technology to take up phosphate from the rivers for fertilizers or other companies (chemical, agricultural) that treats their own waste water to save money (avoid “penalties” for untreated heavily polluted waste water).
*Interview was conducted by Owen, Adam, and Theodore*
Interviewing Yorkshire Water - Professor Issy Caffoor 07/07/2017
To confirm the information gathered during our interview with Dr. Thomas, we set out to contact several water companies. Dr. Andrew Balmer helped us to reach out to Professor Issy Caffoor, who is an Ex-Innovation Manager with decades of experience in Yorkshire Water. We contacted him via e-mail with questions relating to innovation and adoption of new technology in Yorkshire Water. The key points from our contact can be seen down below.
Three ways Yorkshire Water adopt new innovation/technology for water treatment:
1. Through its R&D activities where equipment may be codeveloped with universities or manufacturers and tested in water company operations before being commercialized by a manufacturer and sold to water companies
2. May be offered by a design and build company as a cost saver or performance enhancer as part of the whole treatment plant offering
3. May be offered within a framework agreement by a supplier if it provides significant benefits over other solutions
Factors that are involved in determining strategic innovation and treatment procedures of water companies:
1. The treatment type is never a mandatory regulatory requirement but the end of pipe limit is often set either by the Drinking Water Inspectorate (DWI) for drinking water and Environment Agency (EA) for wastewater
a. If the technology comes into contact with drinking water Drinking Water Inspectorate has to approve the materials used
b. Similarly if it involves contact and release into wastewater Environment Agency needs to approve
2. If it involves GMOs in any way, Health and Safety Executive (HSE) approval is required
3. If it is likely to offend the public (religion, custom and practice etc) then local groups and the Consumer Council for Water (CCW) should be consulted
Lastly, numerous solutions that are involved in phosphate management have been tried. Some involving biology and chemistry but none that involve synthetic biology
Skype call with an iGEM Alumni - Dr. Ben Reeve from CustoMem 17/07/2017
We wanted to know the steps required to develop our project into a real business so we reached out to CustoMem, a spin-out company from iGEM (Imperial 2014) that specializes in developing a membrane for water filtration. We talked to Dr. Ben Reeve, an ex-iGEM team member and supervisor that works within CustoMem. He shared a lot of his experience with iGEM and CustoMem and we gained some useful feedbacks and comments in regards to our project and its implementation in real life. In addition, we also discussed legislative issues surrounding iGEM and received some tips and advice about the competition.
Key point summary of our talk can be seen down below:
1. Municipal water treatment is very conservative about trying new technologies. It is difficult to get into municipal water treatment and selling our project idea to them if it were to be implemented into a business. Therefore, the market for water treatment would be around industrial water treatment. It is easier to get into the market for industrial water treatment because different industries have different waste. In this case, our customer will be companies from different industries that handle their own waste water.
2. Selling our idea: It will be great if we can provide a proof of concept to the water companies, specifically a lab proof of concept using wastewater from each specific water company. Water companies also like the technology to be tested on site. Perhaps we can use their wastewater to design some simple experiments. People will be interested in our project if we can prove that it is able to treat phosphate with minimum space and time more efficiently than existing processes.
3. Legislation: CustoMem are using parts that are in the BioBrick registry but they do not patent the BioBrick. Everything that is in the wiki or presented in the Jamboree cannot be patented. If we were to patent our project, it will be on the specific process and application of the parts that are not disclosed through the competition. At this point, we should not be worried about any possible patent issues in our project.
4. Business Development: Business models often change through interactions with different stakeholders. CustoMem were made more aware of the problem specifications that they are trying to address through stakeholder interaction. It’s important to consider how to scale up the business from the lab into an industrial scale. For our project, we would have to think of the solutions to some questions: What concentration of phosphate comes out of the waste water? How quickly can our bacteria reduce this concentration of phosphate?
*Interview was conducted by Owen and Adam*
Interview with Jonathan Abra - Knowledge Transfer Network 19/07/2017
Dr. Andy Balmer helped us in contacting Jonathan Abra, the Knowledge Transfer Manager with responsibility for water and wastewater at Innovate UK, the UK government’s innovation agency. We wanted to confirm the things we learned from our interview with Dr. Duncan Thomas and throughout our discussion, we realized that there were indeed a lot of things that coincide with our previous findings. However, we also learned that there were new challenges to existing methods that we were not aware of. One of the important things that we learned is that the government is trying to push water companies to be more innovative and that there may be a role for synthetic biology in the water industry.
Key points from our discussion can be seen below:
1. UK water regulation is regulated in a non-competitive environment. There are three regulators:
a. Drinking Water Inspectorate (DWI), which is responsible in overseeing drinking water
b. Environment Agency (EA), which is responsible in looking at water in the environment
c. Ofwat, which is responsible in determining the amount of money that water companies can charge their customers
2. Ofwat is the main regulator that water companies have to address to. Ofwat regulates the water industry through a periodic review process every 5 years. As part of this review, water companies have to produce a business plan to cover the following 5 years. This business plan is now evaluated on 3 criterias: value for money, innovation and ambition.
3. Until now, it has been very difficult to get any novel new technology into the UK water industry and water companies have not been innovative in the past years. The target of success for water companies is to avoid getting punished by Ofwat and therefore, they are simply ‘ticking boxes’ and only doing what is necessary. This is no longer acceptable and there is now an incentive set by the government to push water companies to be more innovative (not only in technology but also in different ways of working i.e. different business models). If water companies do not demonstrate innovation, the government is going to punish them financially.
4. There is another new change which called to total expenditure (Totex) by Ofwat. In the past, water companies could spend lots of capital on building new treatment works and new assets instead of new technology. This increases the value of the company by improving the capacity but not the performance. With Totex, companies are now allowed to include the cost of operations expenditure (long term running cost) within their calculations in their business model. This means that by considering the cost of running a technology over 15-20 years, new technology that are more expensive in the short term (cost of setting up new equipment) can have its expenditure justified if water companies can demonstrate that the cost of running it is lower than existing technology.
5. It takes around 10-12 years for technology to come to the market in the water sector. The technology can be really attractive if it can replace an existing technology and save a lot of cost.
6. The government has no role in deciding the method to treat water; it is up to the individual companies as long as they can demonstrate that they can do it effectively and are not affecting public health.
7. Brexit is still a huge uncertainty although it is unlikely that they will change the existing Water Framework Directive. This is because it has been shown that the WFD have dramatically improved water quality across Europe.
8. Genetically modified organisms have not been used but it is not because they are being avoided.
*Interview was conducted by Owen and Adam*
Interview with Dr. Benjamin Tam - Isle Utilities 01/08/2017
We got into touch with Dr. Benjamin Tam from Isle Utilities after being referred by Jonathan Abra. We confirmed most of our findings regarding innovation in the water industry with Dr. Tam and also discussed the possibility of applying our technology for remediation purposes in the environment. Although we were skeptical about the idea of using our technology for remediation purposes due to financial limitations, Dr. Tam advises us that it is still possible and just because there are no direct consumers that would pay for the service, it does not mean that the market is not there.
“At the moment, reducing phosphate levels within the environment is limited in terms of available technology”
- Dr. Benjamin Tam
We were also introduced to current ways of remediating phosphate in the environment, which are usually chemical. To tailor this into our project, he told us that it would be more interesting if our technology can pull out dangerous chemicals in addition to phosphate. However, we were told that public reception on GMOs being released into the environment may be something to worry about. He agreed with us that perhaps it is best to pitch our technology to water companies or other companies where it will be in a contained and controlled environment instead of implementing it directly in the environment. We came to this conclusion after considering the application procedure and fee that we previously discussed with DEFRA.
*Interview was conducted by Owen, Maciej and Adam*
Interview with Dr. David Tompkins and PhD student Katie Ward - Aqua Enviro 04/08/2017
We got into touch with Dr. David Tompkins and Katie Ward, a PhD student currently interning at Aqua Enviro. We discussed thoroughly about the market and competitors that we’ll have to address in order to successfully pitch our project. We were introduced to Ostara, a company that is similar to our project in the way they do phosphorus precipitation as struvite following biological phosphorus removal and is currently implementing their technology at commercial scale in the UK. Also, we were introduced to Microvi, a company that has a phosphate removal technology in which specific microorganisms are cultivated in special beads that provide optimal living conditions.
In addition, we were told that current phosphate removal methods are mostly chemical dosing in the UK to achieve 0.1-1 ppm phosphorus in the effluent discharge to surface water.
“Biological phosphate removal has not been taken up very widely in the UK; perception being, it is not as efficient as chemical dosing. The discharge consent that people are looking at are difficult to achieve with biological approaches.”
- Dr. David Tompkins
Chemical dosing seems to be the preferred route in the UK because it can guarantee the final concentration needed. The downside to this technology is that the dosing agent has to be purchased and the result of chemical dosing is sludge which needs to be processed further. While biological approaches also normally produce sludge that requires treatment, water companies perceive that they are more difficult to use and does not guarantee the removal of phosphorus to its required final concentration. That means that we’ll have to consistently prove that our project would be able to remove phosphate in a predictable and consistent manner to successfully sell our project.
*Interview was conducted by Owen, Maciej, Amber, and Alice*
Site Visit to Davyhulme Treatment Works - United Utilities 23/08/2017
We scheduled a site visit to Davyhulme Treatment Works, the biggest wastewater treatment works in North West England run by United Utilities. Sara Lyons, the technical officer in Davyhulme, led us on a tour around the treatment plant. From the tour, we were introduced to the basic process of water treatment and the different stages that the water have to go through, from separation of sludge to water treatment through biological means.
Throughout the tour, we gained a lot of insight and information that we would not have known otherwise. In Davyhulme and other water treatment plants, the system works 24/7 every single day and there will always be workers in the site regardless of time. We realized that a lot of energy must have been used up by the plant every single day. We noticed that Davyhulme had solar panels to try and reduce the energy cost. In addition, the treated water were checked with a microscope in the laboratory each day to ensure that there are no abnormalities or foreign microorganisms present in the processed water.
Although we did not have time to visit the sludge process, we were told that sludge from the treatment is processed and converted to fertilizers which are given away for free to farmers. This was an interesting point because we also thought about harvesting our phosphate accumulating bacteria and to sell the phosphate as fertilizers to reduce cost. We learned from Davyhulme that the fertilizers are given away for free because they have no use for it and eventually would have to get rid of them. We were told that it was much cheaper for them to give them for free than to throw them away in a landfill or store them somewhere else.
We also discussed our project with Sara and talked about its possible implementation at Davyhulme. Sara suggested to think about other ways our project can be used outside of the treatment plant. She explained to us how most of the phosphate usually originates from detergents and perhaps it might be more feasible if we can reduce the phosphate levels of the wastewater before it reaches the treatment plant and before it gets mixed up by other wastes. We discussed this with the rest of the team and thought about doing some experiments to test the viability of this idea. Check out our experimental page to see what we did!
In addition, we also learned that Davyhulme does not treat phosphate in the facility. We asked Sara whether it would be possible for us to obtain phosphate level data from Davyhulme in the last 12 months. We figured that the phosphate level in Davyhulme will be a reflection on the phosphate level we can expect in wastewater. After asking for permission to the people in charge, Sara was able to send us the data through e-mail the following day. We were able to use this information in the other parts of our project. Check out our modelling page to see how we use this data to estimate the production cost of our bacteria!
*Owen, Maciej, Amber, and Alice came to the site visit*
Intellectual Property
As the paper that we based our project on cited a granted patent, we wanted to explore intellectual property in more detail to determine how this may influence our project. As none of our team members have any experience in intellectual property rights, we consulted experts in the field to seek guidance and answers. We contacted Dr. Rick Watson from the University of Manchester Intellectual Property office and Dr. Linda Kahl from the BioBrick Foundation. Through e-mail exchanges and a phone call discussion, the details of the intellectual property surrounding our project became much clearer. This directly impacted the development of our business plan and consequently shaped our experimental ideas. Click here to read our full report on intellectual property!
E-mail Exchange with Dr. Rick Watson - University of Manchester Intellectual Property (UMIP)
We wanted to know whether our project would be viable for a patent. To understand this, we reached out to Dr. Watson from the University of Manchester Intellectual Property (UMIP). Through e-mail, Dr. Watson gave a very thorough explanation that helped us to understand the patent situation of our project.
We were told that a granted patent is different than a patent application because if the patent has not yet been examined, we do not know for certain which of the claims are approved as written by the applicant, or which of them may be modified or refused as part of the examination process. In addition, we learned that holding a patent in a certain territory will give a monopoly not only over that territory but it also stops products created outside from being imported into those territories.
If we were to commercialize and patent our project, we learned that we will have to consider all previous patents and all previous scientific literature known as the ‘prior art’. This is because to be patentable, our invention would have to pass four basic tests:
1. Is it novel? Has our idea been thought of before, and put into the public domain by either us, or someone before us? - if our idea is not novel then it fails this test and we cannot patent it
2. Our project will have to have an ‘inventive step’ that is different from other previous patents - and not just an obvious thing to do for someone who has the average level of understanding of our subject area
3. Is it industrially relevant? Will our idea be commercially useful?
4. Is it excluded? Some types of invention are not patentable due to the ethics involved, including many biotechnology related ‘inventions. Also, one cannot simply patent a pure scientific discovery
In addition to checking whether our invention can be patented, we will also have to balance out the commerciality of our project. If we were to patent this project, would it only cover a very narrow scope of protection? If so, could competitors easily ‘get around’ our patent without infringing us by producing a similar system with slightly altered components? Would the invention ultimately have a good chance of making us or our company more income to cover the cost of developing the idea and protecting it? If not, there would be no point in spending time and money on the patent in the first place.
Phone Call with Dr. Linda Kahl - BioBricks Foundation 29/07/2017
We wanted to confirm our understanding on the Intellectual Property side of our project in the context of the iGEM competition and the use of BioBricks. We then reached out to Dr. Linda Kahl, Senior Counsel & Director of Ownership, Sharing and Innovation for the BioBrick Foundation.
From our call, we gained some information regarding the BioBrick Public Agreement and what it means for Users and Contributors. We learned that the User and Contributor agreement only protects users against the claims by the person who signs the Contributor agreement and it would not protect users from any third party claims. This means that if a User submitted a patented part into the iGEM Registry and the patent owner does not sign the Contributor agreement, the User would be liable for a patent infringement lawsuit.
We realize that this may possibly have had happened in the past with previous iGEM teams that are unaware of IP issues. However, Dr. Kahl explains that it costs at least 3 million dollars to pursue a patent infringement lawsuit. Therefore, it is highly unlikely for anyone to file a lawsuit against iGEM or the BioBricks Foundation unless there is 3 million dollars or more worth of damages.
We then briefly discussed the Intellectual Property rights in the context of our business plan. Dr. Kahl advised us to consider the patent landscape to see who else is working in our field of interest. We were also advised to carefully examine the claims of the issued patents and see whether parts of our project are covered by the patent.
Lastly, we talked about iGEM and learned that the reason why anything we disclose in the Jamboree (wiki/presentation) cannot be patented is because patent laws generally say anything disclosed in public is already in the public domain and cannot be patented. There is, however, a one-year grace period after public disclosure where the inventor can still file a patent application, but this grace period is available only in the US and a few other countries.
*Phone call was conducted by Owen, Adam, and Theodore*
Industrial Scale
We wanted to explore how to implement our project in real life. This includes figuring out how to produce our bacterial product in a large industrial scale. Upon our initial research, we thought about producing our bacteria in a continuous culture system but in reality, we do not know whether this would be financially viable or not. We had a lot of questions regarding production cost in an industrial scale. Therefore, we sought out to contact John Liddell from the Centre Process of Innovation to answer some of our questions. Through a phone call, we were able to obtain information and resources that enabled us to estimate the production cost of our system through a mathematical model.
Phone call with John Liddell from the Centre for Process Innovation (CPI) 24/07/2017
To get a better understanding of expanding our project in an industrial scale, we contacted John Liddell from the Centre for Process Innovation, a UK based technology innovation centre that helps companies to develop, prove, prototype and commercialize products and processes.
One of the main things we learned is that it’s hard to accurately estimate the cost of production as there are a lot of different factors that will have to be considered: the type of bioreactor used, the size of the bioreactor, the type and amount of medium used, growth rate of organism and various utility cost (cost to sterilize and maintain). We initially thought that growth medium would be one of the biggest factor for cost. However, John explained to us that for E. coli, the medium may be about £1000 in a batch system using a 1000L tank. But again, he told us that this will depend on the type of medium and said that molasses and glycerol are among the cheapest sources of glucose.
We briefly discussed our idea of culturing our E. coli bacteria in a continuous culture system. John suggested that if we were to consider starting up a business, the idea of using a batch culture is probably best during the initial stages. As the business expands and the demand of our product has increased, only then it is advisable to proceed to move and invest on a continuous culture system. He reasons that the bioreactor might be quite expensive for an initial investment and recommends us to rent an existing bioreactor from a manufacturer which would be cheaper in the short period of time.
Nonetheless, he challenges us to try our best to estimate the cost of our production in a continuous culture system to see whether our project can be financially feasible. He gave us some books and resources that would help in cost estimation. Through those resources, we were able to find a rough estimation cost which we used in our modelling and business plan.
*Interview was conducted by Owen, Amber, Adam, Theodore*
Legislation
In envisioning our project in real life, safety and GMO legislation is inevitably one of the most important factors we have to consider. After some initial research on the UK GMO legislation, we contacted the Department of Environment, Food and Rural Affairs (DEFRA) to answer some of our questions about the legislation in the context of our project. Through a conference call, DEFRA explained to us the procedures that one will have to go through for any commercial use of GMOs.
Conference Call with Department of Environment, Food and Rural Affairs (DEFRA) 25/07/2017
*To respect privacy, the names of those in the call are kept anonymous*
In envisioning the implementation of our project in real life, we wanted to understand the regulation and legislation process that we would have to address. We had a conference call with DEFRA to discuss this issue. We explained to DEFRA how we envision our project to work in real life. We would grow large cultures of bacteria and then place them in panels covered by a membrane that allows water to pass through but keeps the bacteria inside.
One of the things we discussed was regarding the different legislation between ‘contained use’ and deliberate release of GMOs. We were not sure whether our project would fall under ‘contained use’ since our engineered bacteria is still exposed to the environment so we briefly talked about the application process for deliberate release of GMOs. DEFRA advised that it could not provide specific guidance in this case because it would require further details of the nature of the activity (species of bacterium, exact genetic modification, containment measures etc). However, theoretically it could be argued that similar activities might be regulated under ‘contained use’ if the environmental risk assessment demonstrates that the GM bacteria are effectively contained.
Key points from our talk can be seen below:
1. Applicants will have to determine whether they apply on deliberate release or the contained use of GMOs. For our project, we will have to prove that our device (panel and membrane) is robust enough to keep our bacteria in when placed in the environment to argue for applying to ‘contained use’.
2. Guidance and regulation of non-plant releases of GMO is currently geared towards clinical trials. In clinical trials, they look at the level of attenuation of any pathogens that is used and the level of biological containment. When it comes to experimental releases, they will consider biological containment as well as physical containment measures. A kill switch could come into the category of biological containment but even a kill switch would be quite a new application. Regulators would expect a lot of detail in the environmental risk assessment.
3. In a deliberate release of GMOs, DEFRA will publish the application online on gov.uk (previous applications are recorded there as well). The applicant is also required to state an advertisement of their intended use in a national newspaper (such as the Times, Telegraph, or Metro). DEFRA will also invite representation for public consultation where the public can make comments on the safety or any environmental/human health risk that may occur due to the release of GMO. Only scientific concerns/comments are accepted and considered by the Advisory Committee on Releases to the Environment (ACRE) as part of their deliberation.
4. Although decision about the legislation of research into GMOs can be taken in a national level, decisions on the commercialization of GMOs have to be taken at a European level at the moment (while the UK is still in the EU). Anything beyond the EU will depend on the GMO legislation in whichever country the applicant would like to commercialize in. However, some third world countries may not have any GM regulatory system at all. In this case, then it is possible that these countries may require the applicant to gain approval in the EU first which has a well-respected GM regulation.
*Conference call was conducted by Owen, Amber, Alice, Theodore*
