Genetically modified organisms and byproducts are not just found in food. They may be in your home right now; in your household cleaners, cosmetics, scents, flavorings, or medications. Youd know if you were buying genetically engineered products, wouldnt you? No, actually, youd probably have no idea because its not on the label.
How do you define natural?
Genetic modification enters consumer products through synthetic biology. What is synthetic biology? Thats a good question and complex to answer because there is no single agreed upon definition of synthetic biology. Dozens of definitions exist, at a conservative estimate. At its core, synthetic biology is engineering applied to biology to deliberately (re)design and construct biological systems. Put another way, tailored biological systems are produced for specific purposes using a great degree of manipulation.
How? One method of synthetic biology is to create digital DNA sequences and insert them into living cells. Natural genes are replaced by computer generated genes to create new biological systems. For example, algae are genetically manipulated in a lab to produce a specific type of algal oil. That algal oil is then used in cleaning and cosmetic products. The oil-producing algae and specific algal oil would never be found in nature; they exist solely through engineering.
Although you may not have previously heard of synthetic biology, the concept itself is not new. Beginning as a process for creating biofuels, synthetic biology has evolved in the last 20 years into a multi-sector use technology. Also called synbio or syn-bio, it is labeled in friendlier terms as nature-identical, fermentation-derived, optimized, renewable and sustainable for consumer products when engineered components are included, if any indication of genetic manipulation and synthetic biology can be found. Products containing synbio components may even be labeled as all natural when, without a lab, they would not and could not exist. How do you define natural?
Rapid Change and Regulation
There is no current regulation for labeling synthetic biology products.
Synthetic Biology is a rapidly evolving field. Regulation and policy also evolve, though not at the same pace. In the United States, the federal agencies which have historically overseen regulation of genetic engineering have been the Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency. As technologies evolve, newer technologies used in synthetic biology can fall outside established regulations.
What does this mean for the future regulation of synthetic biology? As the synbio industry grows, the current regulatory system may be flooded and overwhelmed by new microbes developed for commercial use.
Commercial and Environmental Use
What does the future of synthetic biology in consumer products looks like? Companies like Ecover and Unilever are already using synbio products commercially, and other companies are investing large amounts of money in synbio. Proponents claim synbio products can replace standard product ingredients like palm oil, making synbio products a sustainable and renewable resource and lessening land impacts. Synbio products are created in labs, however, and without both monetary and physical investment they are neither sustainable nor renewable. Synbio involving algae and yeast requires large amounts of sugar for the algae and yeast to consume, creating a need for large amounts of sugarcane. Increase in demand for sugarcane production should be considered as a potential land impact.
Investment and interest in synbio is strong, as is advocacy for a precautionary approach when bringing synbio organisms out of the lab. Concerns over potential ecological and health effects, largely due to the lack of risk assessment and information on synbio organisms, have been raised by environmental, consumer, civil society, social-justice and non-profit organizations and foundations internationally.
In June 2014, the Subsidiary Body on Scientific, Technical and Technological Advice to the UN Convention Biological Diversity recognized potential benefits and risks of synthetic biology. The Subsidiary Body recommended a precautionary approach, including establishing risk assessment, management and regulatory procedures. Recommendations also included a moratorium on field testing and environmental and commercial release of synthetic biology organisms and products until an international and legal regulatory framework is put into place, including the consideration of environmental, socio-economic and cultural impacts.
The United States of America signed the UN Convention on Biological Diversity in 1993 but never ratified it, and as such is not party to any binding measures. Even so, the case for using a cautious approach in addressing the unknowns of synbio is reasonable, appropriate, and the best option for mitigating established, unforeseen, and as yet unknown risks.
Practicing Precaution
Why should we be cautious? There are many cause and effect relationships which are not fully understood despite technological advancement and scientific prowess. Consider the case of synthetic chemicals. Synthetic chemicals are approved for production and usage with the expectation the chemicals will remain within the limits of the risk assessments performed during regulatory processes. Despite this, there is evidence numerous synthetic chemicals cause disruption in the endocrine system. The endocrine system is the system in the human body dealing with hormones and glands, regulating all biological processes in the human body. Endocrine disruption impacts human health by affecting immunity, behavior, reproduction, and development.
The Environmental Protection Agency is currently testing chemicals to find endocrine disruptors, but while this happens the chemicals remain in production and usage. The testing process is slow and the test design ensures testing of chemical effects on only the most well understood hormones, which account for less than 10% of known hormones. Knowledge and testing gaps are the result, and chemicals which are known or suspected to cause harmful human health impacts remain in use.
As evidence indicates, a lack of information and/or understanding does not constitute proof of safety. This is why synbio should be treated with a precautionary approach.
What is precaution? Precaution is action taken in advance of an event or decision to prevent detrimental effects. Anticipating detrimental effects or the possibility of detrimental effects when dealing with unknowns may seem like a common sense measure, but when dealing with complexity it is not always a common approach. In addressing synbio, exercising a precautionary approach allows the opportunity for more information to be gathered on how new biological organisms will act outside of the lab environments in which they are created. A precautionary approach allows regulators the opportunity to consider the complex nature of synbio and to compose the complex questions they must ask in order to establish frameworks and risk management guidelines to address not only environmental and consumer safety, but any potential far-reaching impacts this rapidly evolving technology may bring.
Further information:
ETC Group: 17 Groups call on Ecover and Method to drop extreme genetic engineering plans
Institute for Agriculture and Trade Policy: Synthetically modified organisms arent natural at all
International Center for Technology Assessment: Synthetic Biology
Corporate Europe Observatory: Synthetic biology is not natural
Friends of the Earth: Hagen-Dazs says no to synbio
