Revision as of 17:48, 28 October 2017

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Experimental Design

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Regulation Research

To understand if synthetic biology products and cell-free systems were regulated around the world, we researched relevant legislation. Table 1 is an overview of the regulations that we could find that are implemented in the four legal systems used as was suggested to us by Ian Andrews (link to silver). We concluded that some legal systems have more concrete regulations for the use of products derived using biotechnology. Most countries have in place some form of assessments to ensure that any products will not have detrimental effects on the environment and human health.

Table 1. Overview of regulations related to the implementation of biotechnology and organismal based devices in society by legal system.

Legal System	Civil	Common	Mixed	Religious
Laboratory Safety	General guidelines implemented, national frameworks being updated	General guidelines implemented in regulations, committees in place to oversee concerns	General guidelines implemented in regulations, committees in place to oversee concerns	National biosafety frameworks in the process of being developed, have signed the Cartagena Protocol
GMO Regulations	In place, appropriate labelling required in most cases to identify GMO status Generally strict regulations in place (EU, JPN)	In place, usage differs depending on country though most countries allow (notable exception: NZ)	Dependent on country: some follow EU regulations and restrict access while others are in the process of developing legislation with minimal regulations currently	In place, only allow certain crops, need proper labelling to identify GMO status
Environmental Regulations	Environmental impact assessments used to determine effect on biological diversity, environmental release addressed	Environmental impact assessments used to determine effect on biological diversity, environmental release addressed	Environmental impact assessments used to determine effect on biological diversity, some countries have in place environmental release stipulations	Environmental impact assessments used to determine effect on biological diversity, developing more specific legislation for environmental release
Agricultural Regulations	Regulations mostly relate to field trials	Must be approved by regulatory body to not cause a negative impact on the environment	Dependent on country: some have strict regulations on crops that can be planted while others have regulations in place, but allow a greater crop diversity	Regulations relate to type of crops that can be planted
Health Regulations	Must be approved by governing authority to not have negative impacts	Must be approved by governing authority to not have negative impacts	Must be approved by governing authority to not have negative impacts, some countries are still in the process of developing legislation	In development with the growth of biotechnology, general regulations state that new materials generated must be approved

We looked further into the regulations of biotechnology products in Canada and the United and tried to find any piece of legislation that mentioned the regulations of cell-free systems. Within Canada and the United States, both countries do not regulate the methodology of how products are made; they focus on the end materials. While we could not find any specific mention of "cell-free", Ian told us that this may not mean that cell-free systems are not included within the regulations. He suggested that the direct mention of cell-free systems is just out-of-scope of current legislation. However, the closest piece of legislation that we could find that was the most associated with our project is the Assisted Human Reproduction Act in Canada as it prohibits transplanting human-based materials into non-human life forms.

Table 2. Canadian and American Regulation Comparisons for Cell-Free Systems.

Regulation Area	Canada	United States
Health	Assisted Human Reproduction Act (HC): Focus on IVF and new technologies that can aid in reproduction Transplantation into a non-human life form is prohibited	Federal Food, Drug, and Cosmetic Act (FDA) Public Health Services Act (FDA): All biological products must go through licensing process before introduction
Environment	Canadian Environmental Protection Act (EC and HC): Focus on environmental release and new organism activity Environmental assessment required and notification of agencies	National Environment Policy Act (EPA: Requires environmental assessments to determine the impact on the environment
Food/Pharmaceuticals	Food and Drugs Act (CFIA): Focus on labelling and notification of marketing Director must receive notification of intent to sell modified products including an extensive report	Federal Food, Drug, and Cosmetic Act (FDA) Public Health Service Act (FDA) : Must be approved by FDA if food is an additive, but mislabelled food is prohibited New Drug Application submitted for approval to go to marker
Agriculture	Seeds Act (CFIA) Canada Agricultural Products Act (CFIA): Planting, importation, and transportation regulated Must have proof to not cause harm to humans or the environment	Agricultural Act Federal Seed Act (APHIS) Plant Protection Act (APHIS) : Planting, importation, and transportation regulated Must have approval before plant is introduced
Pests	Pest Control Act (PMRA): Accepted if there is proof that no human health will not be affected or will have long term effects on the environment	Federal Insecticide, Fungicide, and Rodenticide Act (EPA): Registration process detailing proof no harm to the environment
Microorganisms	Canadian Environmental Protection Act (EC and HC): Undergo screening assessment to identify potential harm to humans and the environment	Toxic Substances Control Act (EPA): Must submit notice of use with information on organism
Animals	Health of Animals Regulations (CFIA): Prohibited to introduce substances without permit	New Animal Drug Application (FDA): Focusses more on drug use Must fill out application detailing effects on the animal and the environment
Pathogens and Toxins	Human Pathogens and Toxins Act (PHAC): Regulates Risk Group 2-4 organisms Prohibited from producing toxins and pathogens within Schedules without a licence	Toxic Substances Control Act (EPA): Does not classify toxic and non-toxic chemicals Chemicals not on list are prohibited from being produced

System Safety Features

The exploration of our plan on how to address the genetic re-coding aspect of our project continues more in depth on our software page. We consider it to be a major part of our human practices, but to explain it as in depth as it requires, we felt it deserved its own page.