Biosafety & DIY Bio

DIY Bio

Introduction

In this year, the death of the infamous “biohacking” practitioner, Aaron Traywick, a showman of unapproved “cures” and the man who had openly injected into his bare left thigh an experimental herpes treatment developed by his company, brought the DIY-bio communities in grey area into the spotlight [1]. The safety problems of DIYbio were highlighted, division within the community were observed, and discussion soon followed. But what is DIY-bio, how has it developed, and what should we do? In line with these questions, we conducted an online investigation of DIY-bio, and proposed ways of addressing the associated risks.

Definition and distribution

DIY-bio is a global movement which disseminates the use of biotechnology beyond traditional academic and industrial institutions and into the lay public [2]. DIY-bio is widespread. Its practitioners include a broad mix of amateurs, enthusiasts, students, and trained scientists. According to the movement’s main association — the DIYbio.org website — the movement currently involves 26 local groups in Europe, 35 in the United States and Canada, and 11 in Latin America, Asia and Oceania [2]. And yet, this may only represent the tip of iceberg. In a conference of Chinese iGEM teams in 4 Oct, an insider told us that there are up to 100,000 in DIY-bio in China alone, though most of them are likely only doing rather trivial experiments like a simple analysis of environmental microbes. With this in mind, it is obvious that there may be more Traywicks that has not yet dared to venture into the public.

Origins

The DIY-Bio movement has developed under the influence of at least four related movements. First, of course, is the do-it-yourself movement that became popular in the 1990s; Second, DIY-Bio is part of the citizen science movement, but that DIY-Bio projects are not initiated and supervised by scientists within academic institutions, rather having a genuinely bottom-up character; Third, DIY-Bio represents a direct translation of free software and hacking practices into the realm of genes and cells, and it has largely adopted the general principles of the hacker ethic such as sharing, openness, decentralization, free access to tech, and world improvement; Fourth, DIY-Bio has affinity with the maker movement that represents an expansion of the hacker culture and ethics from software to hardware development[2].

Difference and indifference

And yet even this is not the whole story. DIYbio is far from a homogenous activity, and the characters of a given DIYbio community also depend on the particular social cultural environment. For example, in America, where hacker and maker culture are more prevalent, the codes on diybio.org are a considerably weaker ethical framework and leaves biohackers with a much more open maneuvering space compared to its European counterpart. In the US there is a strong focus on biosecurity (including bioterrorism), while in Europe the focus is much more on biosafety. Another different concern about DIY-medicine appears: whereas North American groups attempt to develop an alternative to the established health care practices, European groups rather focus on helping people in developing countries. And as a result, amateur biologists in Europe are more than their North American counterparts focused on collaboration with artists and designers [2]. It is yet uncertain how such a divide will pan out in other regions like Asia or Africa [2], but may these already have one or more distinct biohacking community/ies, for instance the one that operates in a starkly distinct cultural setting in China?

Yet regardless of their particular characters, DIY-bio represents a safety and security risk. We attempted to buy the carcinogenic dye used for electrophoresis, Ethidium bromide, and it was easily purchased, even distributed, from the Chinese online shopping website Taobao. Even more alarming, and a real public threat, is that we discovered flu viruses artificially injected into guinea pigs to promote mutations on sale in the same website. It really seemed to be one step forward before true bioweapons can be made and yet sold.

How to tackle such threats? To find some idea, we conducted interviews with relevant persons as below.

Episode

Interview was not only applied to investigation of biosafety, but also models in dry lab. When we first started modelling our project, we attempted to simulate the production rate inside the fermenter. However, we gave up on this idea after discussing with Jianwen Ye for the following reasons.

1) The production rate depends on the specific product that the bacteria produce.

2) The production rate is also related to the type of the bacteria i.e obligate aerobes, anaerobes, and facultative anaerobes.

In our project, we didn't choose a specific product. Therefore, it would be unrealistic for us to make a model like this.

Biosafety

Introduction on Biosafety

One of the most important matters in biology experiments is biosafety. As a high school team, we interviewed a prestigious figure in the Chinese biosafety government authority. From the interview with the director of Chinese Center for Disease Control and Prevention in Heilongjiang, Jilin, Liaoning Provinces, we pointed out that the issue of biosafety has long been a matter of concern to society in the global classification because the leakage of biological agents or pathogens is far more harmful than weapons in some degree and is very likely to destroy the ecosystem without any way of control in case of emergency. Contemplating on the influence of our project, the director expressed support for the students to do such work.

Environmental pollution has a great impact on the public. The problem of environmental pollution has attracted intense international attention since 1991. Environmental pollution should be kept at the lowest level. By causing water pollution, biological pollution, and noise pollution, economic construction will have strong negative effects on the environment and might lead to various health problems. Enacting policies which promote development of systematic construction is a major issue all over the world. After all, pollution control cannot be simply implemented or solved by lectures.

On the other hand, the pollution involves whole ecological environment problems. The indigenous attention to environment is essential for limiting the environmental pollution problems and effectively controlling infectious diseases in a manageable range. The transportation of biological reagents should be under a series of strict examinations operated by governments so that pathogens used in research or spread in the hospitals cannot enter into the atmosphere, water. As far as possible, avoid environmental pollution caused by biosafety.

Disease Control

In order to control diseases, preventing the leakage of the system is very necessary. This is a very vital problem. Pathogens are lethal threats to human beings during the development of biotechnology, and safety problems will lead to a serious of catastrophes once leakage occurs. Especially, when pathogens are not well studied or fully understood, there is no effective response to that kind of exigent situation.

Methods to cope with potential hazards

From this point of view, the country and the place are trying to develop some methods and legislate for potential dangers. Pre-treatment before the spill and cautionary measures after the spill, are pivotal. Medical institutions are divided into physical and chemical aspects. From the perspective of laboratory biosafety, local authorities need to be highly concerned about the importance of the management of the labs. The experiments are under strict legal supervision. For example, there are a whole series of systems inside the disease lab, including the training of basic operation and emergence scheme. In recent years, the biosafety awareness of medical institutions has been highly valued, but due to the wide range of experiments, medical institutions still need to consummate laboratory safety and cannot afford to any slack.

Impact on civilians

During the years from 1980 to 2018, more and more countries have joined the big party of biosafety. The research in gene reforming field is unavoidable. For example, in recent years, genetically engineered drugs and genetically modified food are involved in safety issues, which will be involved in daily production and life. In some countries, genetically modified rice is thought to increase yields at first, but it caused an allergic reaction among those who ate them. As a result, this product was proved unfeasible.

Biosecurity involves a wide range of fields, including ecological, animal, plant. It is indeed possible that a new drug will be developed when we meet a new problem. However, some problems will not be discovered until a few years later.

Biological research should have a bottom line of biosafety, and all the professors need to pay full attention in this research. As aforementioned, EB is a highly toxic reagent that we found on Taobao website and that could be purchased and delivered to home. The professor said that toxic reagents are graded by the law and there was a whole set of processes involved in the production, storage, transportation and use of reagents. The reagent can only be obtained by submitting application forms. The reagent can be controlled through effective management as long as the purchase of toxic reagent is made online under the control of relevant national policies.

Awareness of biosafety in hospitals

Medical institutions are divided into physical and chemical departments. The administrative organizations are under strict legal supervision, and there is a whole set of systems inside the hospital, including plenty of training and exercises. In recent years, the biosafety awareness of medical institutions has been highly valued, but due to the wide range of coverage, medical institutions are always on the road to laboratory safety and cannot afford to slack off.

Laws

Background

Ethidium Bromide (EtBr), a fluorescence tag in molecular and micromolecular labs, is widely used by biology majoring students to accomplish procedures like agarose gel electrophoresis. Under ultraviolet light, it shows bright orange color with combined DNA, thus playing an imperative role in electrophoresis.

Though it has capacious markets in the field of biology and is well accepted by laboratory staffs, EtBr can impose severe consequences on human. Since EtBr can be inserted into DNA, and cause malposition of nitrogenous bases, it functions as a mutagen. Besides, through inhalation, ingestion or skin absorption, EtBr can be absorbed by human body readily, therefore causing irritation of the mouth, respiratory tract, skin, and eyes. [1][2]

Inhalation symptom	Cough, methemoglobinemia (dizziness, drowsiness, headache, shortness of breath, cyanosis, rapid heart rate, chocolate-brown blood)
Eye symptom	Redness
Ingestion symptom	Sore throat, gastrointestinal irritation with nausea, vomiting and diarrhea

Story

This summer, we ordered EtBr online through one of the biggest e-commerce platform Taobao, which functions similarly as Amazon.

On the official website, users can search EtBr and related products easily. No notification is shown there, and there are also many merchants selling similar toxic products.

We were expecting requirements from the merchant and had prepared for failure in purchase EtBr online. However, the official website and the merchant didn’t send any warning. Besides, our receiving address is a high school campus, but the express delivery did nothing to prevent dangerous package being delivered to school campus.

After receiving EtBr, neither did we receive official form to fill in our purpose of purchasing, nor did the merchant record our intention of using it. Also, there was no warning sign on the surface of the package to inform the property of the substance, or to point out that this package contained dangerous chemical substances.

Is it proper for buyers like high school students to access biological substances like EtBr through such a simple procedure? Are there any laws required for the sellers and the buyers to obey for the public safety? Or what should people improve on if the current version of laws functions ineffectively?

Evaluation

According to China Measures for the Administration of Lot Release of Biological Products, when biological products are applying for lot release, there are many certificates and materials that should be handed in, for example the certificate on drug approval, lawful production, post-marketing modification, related raw components of the product. However, there’s no strict and specific law that regulates the retail of such biological products in free market. From the origin of the trade——the seller (or supplier), to the transport, and the end at buyer’s hands, there is no clear regulation to guarantee the proper use of toxic products and to monitor the flow of them.

What are other countries’ laws with the aim of protecting biosafety? How could we enhance the efficiency of China’s law?

Comparison

India

In The Guidelines on Good Distribution Practices for Biological Products[3], the Indian government clearly defines the regulation of the distribution of biological products in the market.

• 1) The activities of persons or entities involved in the distribution of products shall be regulated by applicable national legislation.
  This rule ensures that in terms of legislation, the sellers are under the monitor of government, which simultaneously helps control the flow of products to unsuitable crowds, like high school students or ordinary buyers.
• 2) Biological products distributors or their agents shall obtain their supplies of biological products from persons or entities authorized to sell or supply such products to a distributor and shall supply biological products only to persons or entities which are themselves authorized to acquire such product either in terms of an authorization to act as a distributor or to sell or supply products directly to a patient or to his or her agent.

With this requirement, both suppliers and customers trade with proper, match partner. It restricts both sides but allows the market to be more ordered.

European Union

In the Annex I Analytical, Pharmacotoxicological and Clinical Standards and Protocols In Respect of the Testing of Medicinal Products, EU has explicit rules for the finished medicinal products.

• 1) A description of the finished medicinal product and its composition shall be provided. The information shall include the description of the pharmaceutical form and composition with all the constituents of the finished medicinal product, their amount on a per-unit basis, the function of the constituents.

In this regulation, EU focuses on a different aspect of biological products. Medicinal products need to have a clear illustration and instruction for the users, with all essential information and warning about the products. This helps consumers avoid misuses.

US

Comparing to other countries, US has the strictest and most elaborate laws, working together to protect the biosafety of the countries as well as US citizens’ personal safety.

In the US Public Health Act, there’s a set of rules to enhance the control of dangerous biological agents and toxins:

• 1) The Secretary shall consider the effect on human health of exposure to the agent or toxin; the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans; the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting
• 2) The Secretary shall by regulation provide the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure—
  • (A) proper training and appropriate skills to handle such agents and toxins; and
  • (B) proper laboratory facilities to contain and dispose of such agents and toxins.
  • (C) appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.

Also, in the Regulations of Biological Products, it states very specific requirements:

1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless——

• (A) a biologics license under this subsection in effect for the biological product, and
• (B) Each package of the biological product is plainly marked with——
• (i) the proper name of the biological product contained in the package;
• (ii) the name, address, and applicable license number of the manufacturer of the biological products; and
• (iii) the expiration date of the biological product.

Besides rules presented above, there are also many laws in different countries, which restrict non-laboratory access, transfer, use and possession of toxin and other listed agents. In general, it emphasizes that the users must master professional skills, working in a suitable place with daily records. The real-name system and product package requirements enable the users and suppliers to maximize their goals bidirectionally and under safety control.

Conclusion

Though China have laws to regulate imports and market of biological products, it lacks specific regulations that control different dangerous variables more effectively. Viewing from both transportation and packaging, to the proper use and achievement of users and suppliers, China’s laws still have potentials to improve.

First of all, we need laws to monitor the action of the suppliers and demanders in the market, record the flow of biological products, and therefore control the general market of toxins and other biological products. Secondly, there should be laws that restrain the users of listed biological products. Users must master a certain level of professional skills and have proper laboratories to conduct experiment with the listed products. Thirdly, every listed products, biological substances and toxins should be distributed with proper using instructions and essential information to earn the attention of users.

With supplementary regulations above, our biological products market will be more regulated and highly reduce potential risks of the trading and experimental processes.