Erwinions

Integrated Human Practices

Overview

Tec-Chihuahua is sure our project is integral with the legal, economic and social aspects. We know the most important thing is how the international society can influence our project, and vice versa; that's why we've ensured a biosafety, responsible, viable and environmentally friendly project. Everytime that we were approaching to our desired biocontrol, we took feedback from experts, governmental institutions, and leading international companies. Consequently, we were able to design a genetic system that meets their biosafety expectations and that is legally supported by the creations of our Official Mexican Norms and Mexican Law. Nevertheless, we believed that none of our work was completed if we don’t make biotechnology products available to everyone. Therefore, we created a public policy that establishes guidelines Mexico must follow to address hunger and starvation. Complementarily, the entrepreneurship sector analyzed the project's viability with the current government´s economy transforming it into a tangible solution for the world.

How did everything started?

As we described at the Design tab, one of the biggest problems we encounter when designing Erwinions was: if we prove that our solution works, then how are we going to apply it?. Our problem was not only the application per se but its implication for the world. To begin with, the whole team knew that we needed to integrate our solution with the necessities from the those who were primarily affected. This how we started our Integrated Human Practices.

During four different visits to Cuauhtemoc, Chihuahua, the team interviewed about 16 different producers and farmers that gave us first handed information about how they, for years, have been trying to solve this problem with different solutions; antibiotics, improvised solutions and/or biocontrols. It is important to highlight that what all interviews had in common where that none of the interviewed had found an effective solution and that they were desperate to. Therefore, we started talking about our project and how we thought it could be applied; as a biocontrol or a transgenic fruit. To be honest, most of the farmers and the producers didn't care about what they were going to apply or use as long as it was effective. Nevertheless, one agricultural engineer, Rafael Quevedo, told us what we implemented as our application.

Mr. Quevedo was updated in several biotechnology topics and gave us the example of the greenfly as an idea from which we could base our project. He asked us:

**“Why don't you, somehow, make your modified bacteria to interact with wild Erwinia so that they create offsprings with the modification?”**

Also he told us:

“I believe that it's going to be more troublesome if you pretend that the final product ends being consumed by a human [referring to a transgenic], on the other hand, if it is a product that you are gonna apply, sprinkle or protect … but it is not going to be an intrinsic part of [the plant], then the product may even have a product life meaning that it will inactivate before the consumption…”

After this interview, the whole team gathered and started planning what ended up being Erwinions. Thanks to this stage of our Integrated Human Practices, we were able to establish this edition project as a biocontrol which the main component is modified/sterile Erwinia. We took the Sterile Insect Technique as an idea were the sterilization means that Erwinia has lost all of his virulence factors. We decided to, instead of doing a plasmid insertion, modify the chromosome of the bacteria to ensure that its daughter cells are going to have the modification. Our bacteria will be applied right before the blossoming season

In our way to a biosecure product

Facts: Did you know that the production in 2016 of the Rosaceae in the whole world was of one hundred thirteen millions of tons? Or, Have you thought about how this production has relevance with the economic sector in each country? Better, Did you know that the apple is one of the most consumed ailments in the whole world? Apples are in the first 20th products most consumed in the world, and its whole production produced 43 billions of dollars last year (Hummer, 2009).

Therefore, it was of our concern a big problem the apple presents in all countries who produce it: Fire blight. The lab work of Erwinions gave a solution to this big problematic issue, using genetic engineering and molecular biology; nevertheless, as an Integrated Human Practices team, we were concerned about the safeness of the project, and, the legality of it.

As it has been told, our concern of the environment and people's safety was real. Genetic engineering and molecular biology in the wrong hands can be lethal and can destroy years of evolution. So, the big question was:

What we must do to make a responsible and viable project?

Once we knew that the most viable product, we could make was a biocontrol that did not affect the microbiota, we wanted to make sure that our it complied with every piece of environmental safety regulation in Mexico. In our investigation, while trying to accomplish this, we realized that there was a big void in the Mexican Legislation regarding genetically modified organisms. The principal Mexican law in this matter, the “Biosafety Law of Genetically Modified Organisms”, doesn`t contemplate at all general or specific rules and guidelines one must follow in order to develop modified organisms like our biocontrol safely, nor there were applicable Official Mexican Norms (NOM`s) which are general coercible norms issued by the executive branch of the Government.

Because of that, we weren't going to be able to correctly develop our project within the accurate standards and procedures nor does anyone in Mexico interested in genetically modified organisms, this directly led us to the basic concept of our legal Human Practices, “in order to develop our biocontrol we need to create a Mexican Official Norm that establishes a specific procedure to genetically modify an organism, that is environmentally safe” we thought that by creating this NOM we could validate our project and also create a protocol to be reviewed by the Mexican Government to fill this existing legal void in our country.

As a result, we were able to create the “Project of Mexican Official Norm PROY-NOM-000-SAGARPA/SEMARNAT-2017. Good Practices for Genetic Transformation of Risk 2 Microorganisms by Conventional Methods” based on the Federal Law on Metrology and Standardization which establishes the general rules in the making of a NOM. Once we were able to create the NOM correctly, we knew that it wouldn´t have legal value unless we made sure that it didn´t contradict any other Mexican regulation and more importantly that it complied with the international legal standards in the matter. Because of that, we redacted a validation paper, that contrasted what we stipulated in the NOM with national and international regulation like:

The General Law of Ecological Equilibrium and Protection to the Environment: specifically on its section of sustainable development, by making sure that the NOM complied with the environmental impact assessment mentioned in the law.
Biosecurity Law of Genetically Modified Organisms: as mentioned before this is the main regulation in Mexico when it comes GMO´s, so we adapted its risk evaluation segment to our NOM in order for them to be compatible.
General Health Law: which establishes that the specifications related with the process, characteristics and labeling of biotechnological products that are not mentioned in the law will be regulated in Mexican Official Norm like the one we made.
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity: by making sure our NOM complied with the articles 15, 16 and annex III that regulate everything related with risk assessment when performing genetic modifications, which we adapted to our NOM.

The complete Official Mexican Norm that established a biosecure protocol and recomendations for genetic transformation can be visualized here:

Project of Mexican Official Norm PROY-NOM-000-SAGARPA/SEMARNAT-2017. Good Practices for Genetic Transformation of Risk 2 Microorganisms by Conventional Methods

Also, we have translated all the adaptation of our Norm to the standards established by the InterMexican and International legislation. This file was the one that was reviewed by the governmental entities.

ADAPTATION OF MEXICAN OFFICIAL NORMS INTO INTERMEXICAN AND INTERNATIONAL LEGISLATION

After the development of our NOM, it was clear to us that it wasn't enough to academically create a general and mandatory norm because, at the end of the day, it´s only the Mexican government whose authorized to issue Official Norms like ours. Because of that, we set a meeting with Chihuahua's Delegate, Engineer Isaac Zepeda Romero, head of the regional office of the Ministry of Agriculture, Cattle Raising, Rural Development, Fisheries and Food (for its acronym in Spanish “SAGARPA”). Also, the secretary of the mentioned dependency, Engineer Luis Raúl Cano del Val, attended for them to give us feedback and validate our project in the governmental sphere. During our meeting, we presented our whole lab project and how we tried to complement it with the creation of the NOM, and they were impressed with it but also had a few observations for us to make it more integrated with the Mexican legal environment. Their recommendations, which later translated in 4 pivotal changes in our project were:

When we presented SAGARPA our NOM the first thing they told us is that they thought it was great to create a particular protocol that everyone had to follow to perform genetic modifications to risk two microorganisms. But they told us that we were only contemplating a lab protocol and leaving behind another kind of criteria that the scientific community in Mexico should take into account when performing genetic transformations that could have an impact on the environment and general health. We were asked about the ethical aspect of our project.
At this point, they were very concerned that we had our lab project almost done and we haven't managed to protect ethics on biotechnology. ¿How could they know, that if approving our projects of norms, everyone who accesses will have an ethical conduct? ¿is it even ethical or legal not to regulate human´s conduct? They made emphasis in the ethical considerations everyone should follow, so as a direct effect of that we implemented in our NOM, the creation of a Bioethical Committee. That committee would be formed by various governmental agencies like The national institute of forestry, agricultural and livestock research (for its acronym in Spanish “INIFAP”) The Center for Research and Advanced Studies of the National Polytechnic Institute (for its acronym in Spanish “CINVESTAV”) and important national universities like UNAM. Our solution consists in the creation of a bioethical committee that would evaluate the process of any person who is using GMO´s and it's looking forward to releasing it to the environment. As well as, the attribution to evaluate the ethical considerations and viability of any synthetic biology product involving risk two microorganisms that are developed in Mexico. So it is matter in the next section to explain the conclusions at which we arrived to give a tangible solution to this ethical problem the delegate planted us in the meeting.
Click here for more info!

Bioethical Committee Proposal

Another topic we discussed with the people of SAGARPA was the scientific development in synthetic biology in the recent years and how it will affect the way we perceive the world , specifically how will the system CRISPR-CAS9 and its crescent implementation will have an impact in society with Mexico not being the exception. As a result of this conversation, we thought that it would validate our work to create a second NOM where we would implement the protocol established in our first NOM to the chromosomal insertion of risk two microorganisms by CRISPR-CAS9. This relatively new method was discussed as a solution to the fact that, if we transformed with plasmidic vectors our bacteria, there could be conjugation between wild strains. Nevertheless, a chromosomic insertion could be a great solution to this problem. So after a few weeks of hard work, we were able to create our second NOM called: “Project Of Mexican Official Norm PROY-NOM-000-SAGARPA / SEMARNAT-2017. Good practices for the chromosomal insertion of risk two microorganisms by CRISPR-CAS9.” which provides the technical generalities of experimental development for genetic modification using the system CRISPR-Cas9. As modified Erwinia amylovora will be released, we have to take into consideration this protocol to create our genetic design. (The CRISPR guide RNA design).

Project Of Mexican Official Norm PROY-NOM-000-SAGARPA / SEMARNAT-2017. Good practices for the chromosomal insertion of risk two microorganisms by CRISPR-CAS9.

While we were presenting our lab project, we mentioned that we were transforming Erwinia amylovora using plasmid vectors whose selection gene confers the ability to grow in an environment with antimicrobial compounds. In response to that, they told us that performing such transformations is one of the reasons why the non-scientific community somehow “fears” GMO´s, because of the small but existing risk of this ability being naturally transmitted to other bacteria or microorganisms once the GMO is freely interacting with the environment. Because of that, we decided to implement in our NOMs a particular requirement for anyone who wants to create a GMO whose final intention is the release to the environment, and that is that it should only be done through the insertion of a cloning or expression vector with positive selection. More importantly because of this interaction with SAGARPA we ourself implemented this technique by transforming Erwinia amylovora through the insertion of cloning and expression vectors with positive selections.You can review it as well in the Applied design section. This feedback ensures that the whole process of creation of Erwinions is BIOSECURE.

One of the final propositions they gave us was that because of the importance they saw in our project and the lack of real governmental interest in regulating genetic transformation like our NOM´s do, they recommended and offered to help us present our NOM´s project to the executive branch of the government specifically to the National Normalization Commission which is the only organ with faculties to approve a NOM project. All this in order to give real legal life to the regulations we created, validated, and applied in the laboratory so our project would actually influence every other that involves genetic modification.

Erwinions for Everyone

While we were designing the basic concepts in our project and what exactly did we wanted to achieve, a crucial question came up that latter reverberated in a significant way in our whole project, “How will we make sure that everybody in Mexico will have access to your product and be benefited by it?”. Honestly we didn't have any concrete response to that question, in fact, we realized that although we were creating this incredible product we couldn't be sure that it would benefit the people that struggle the most and maybe the ones that need it more like people in marginalized communities in the State of Chihuahua. In consequence to that, we went back and decided we needed to expand our reach by developing a “Public Policy” that became the third sector in our Human Practices.

Erwinions' Public Policy

This Public Policy we developed is divided into three pivotal sections, the first one outlines the importance of the apple production industry in Mexico and specifically in Chihuahua which produces almost 82% of the total production in the country (Servicio de Información Agroalimentaria y Pesquera, 2017), and how does the production impacts all levels of its society and more in certain communities like Cuauhtemoc. The second one being the justification of our policy within national parameter, it´s mainly based the right to food which is derived from the health right consecrated in the Mexican Constitution on its article four. Also with international regulation we discuss the importance of the Human Right to enjoy the benefits of scientific progress and its applications, established by the Special Relator of the United Nations Farida Shaheed that this right is interrelated with other Human Rights such as Right to Health, Right to education, and many others that belong to the International Covenant on Economic, Social and Cultural Rights (OHCHR, 2017). Finally, the third section is about the specific proposals we think the Mexican government should implement on a national scale in order to secure that everybody in Mexico will be able to benefit from Erwinions and be able to have access to nutritional food that guarantees their health right.

Our specific proposals shaped in the public policy were:

Promotion and application of Biotechnology on the agricultural practices.
Promotion and implementation of GMO’s on mexican agricultural production.
Promotion of Biotechnology on elementary and middle school.
Reduction of governmental taxes and implementation of financial aids to productors implementing GMO’s on their production techniques.
Set antecedents on Official Mexican Norms of Biotechnological processes.
Elevate mexican rosaceas to international competitive level.

These proposals were fixed to Mexican legal necessities, especially those that have direct relationship with Biotechnology and its processes, in order to promote, integrate and apply legal mechanisms to impulse Mexican agricultural production processes and the implementation of GMOs, so that it is in order with international standards. It also was adapted to the possibilities that the government has so our project is not just a utopia; we considered to establish this proposal based on other public policies regarding different subjects such as the abolition of hunger, the basic ones being the promotion, so people start seeing biocontrols in a friendlier way.

You can review our whole social proposal by clicking on the link below:

Economic

As a complement to the social and legal aspects, we developed a complete entrepreneurship project as an approach to the economic perspective. What we sought to accomplish was the creation of a viable and affordable product so that it could be implemented in the Public Policy, plus to have the point of view of leading companies in the edible Rosaceus Market. We are happy to state that we have achieved this and much more. You can read the complete overview and key outcomes on the entrepreneurship tab.

References

Hummer (2009) Rosaceae: Taxonomy, Economic Importance, Genomics. may 31, 2017, de US Department of Agriculture Sitio web: https://hort.purdue.edu/newcrop/janick-papers/rosaceae.pdf

Servicio de Información Agroalimentaria y Pesquera. (2017). Manzana: México produjo 716,930 toneladas en 2016. Mayo 15, 2017, de Gobierno de México Sitio web: https://www.gob.mx/siap/articulos/manzana-mexico-produjo-716-930-toneladas-en-2016?idiom=es

OHCHR (2017). El derecho a gozar de los beneficios del progreso científico y sus aplicaciones.. Mayo 15, 2017, de UNESCO Etxea Sitio web: http://www.unescoetxea.org/dokumentuak/Derecho_progreso_cientifico.pdf