CAse Study APA format in text citations -synthetic biology three pages

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Course Learning Outcomes for Unit VII Upon completion of this unit, students should be able to:

1. Outline important environmental problems and debates. 1.1 Summarize arguments for and against synthetic biology.

7. Recommend solutions for environmental problems.

7.1 Discuss the issues associated with the testing and regulation of potentially toxic chemicals. 7.2 Summarize the controversy regarding the use of Bisphenol-A.

Reading Assignment Unit 5: Hazardous Releases, pp. 251–277

Unit Lesson Synthetic Biology In Unit VI, you read about genetically modified organisms and crops. These crops are created by inserting some genes from one organism into another. What if we could just create the genome we want instead of taking pieces and parts from existing genomes? It turns out that we can. In 2010, scientists at the Craig Venter Institute successfully transplanted a genome that had been generated on a computer and “printed” on a DNA synthesizer into a recipient cell. The recipient cell’s DNA had been destroyed, so the only DNA in the cell was the synthesized DNA. The cell was able to fully function and could even self-replicate. Some scientists declared the bacterium a new kind of life form, while others asserted that it was not truly synthesized life, since it used a pre-existing cell as a sort of shell for the synthesized DNA. Whether it is a new life form or not, the technology’s potential is enormous. What could we do with synthetic biology? At this point of the technology’s development, we can do things like synthesize drugs with greater ease and efficiency. For example, the drug Artimisinin has been used to treat malaria for years, because it is derived from a plant, the manufacture of the drug depended on the plant’s growth cycle, supplies, and prices. With synthetic biology, yeast was implanted with genes which code for the metabolic pathway that produces a chemical precursor to Artimisinin. The yeast produced the precursor, and the drug could be synthesized in the lab from there. Synthetic biology is also being used to more efficiently produce antibiotics. The manufacture of Cephalexin requires a 13-step chemical process. DSM, a Life and Materials Sciences company, implanted enzyme-encoding genes into a penicillin-producing microbe. This microbe produced a precursor to Cephalexin in one step. The chemical precursor could then be converted into Cephalexin in only two steps, which allowed DSM to produce the antibiotic with a “significant cost and energy savings” (Biotechnology Innovation Organization, 2011). These examples of current uses are just the tip of the iceberg. As the technology becomes more well understood, the possibilities are endless. Craig Venter envisions microbes that are programmed to eat pollution and excrete harmless byproducts. When their jobs are done, they can be programmed to

UNIT VII STUDY GUIDE

Synthetic Biology and Bisphenol-A

Craig Venter (Chemical Heritage Foundation, 2011)

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self- destruct. Some microbes could be programmed to produce fuel or food. How about natural lighting from glowing plants? Perhaps it sounds far-fetched, but there is currently a project collecting funding to create these plants by using DNA from fireflies (Garthwaite, 2014). Projects such as these bring up some of the potential dangers of synthetic biology covered in this unit’s articles. If the genes from the glowing plants were to make their way into the environment at large, what would happen? In their testimony to the U.S. House of Representative Committee on Energy and Commerce, Thomas, Hoffman, and Hanson (2010/2016) call for Congress to see the progress made by Venter’s lab as a warning bell. They argue that Congress should put a moratorium on the use and release of synthetic organisms and should institute review processes for all synthetic biology projects. They use Venter’s own claims of the potential of the technology to produce millions of new synthetic species a day to argue that no country is prepared to assess the ecological and human health consequences of these organisms (Thomas et al., 2010/2016). Kaebnick (2010/2016) acknowledges that the concerns with synthetic biology are legitimate and should be assessed. However, he does not believe the concerns warrant a moratorium on the technology. Although Thomas et al. do not address the moral concerns of synthetic biology, Kaebnick (2010/2016) points out that some people believe there are ethical concerns about the nature of life and its sacredness that are brought up by the use of synthetic biology. Some may believe it is not right to create life at all, but Kaebnick argues that synthetic biology is not creating life from nothing, so synthetic biology is not “playing God.” Synthetic biology is fundamentally different from creating life in the sense that life is being synthesized from existing materials (Kaebnick, 2010/2016). More practically, there are biosafety concerns with synthetic biology. If a microbe can be programmed to cure disease, it could also be programmed to cause it. Kaebnick (2010/2016) believes that this type of deliberate misuse can be prevented by having controls placed on the people and companies who use the technology. As for the consequences of accidental release, synthetic life can be programmed with failsafe mechanisms to ensure that they do not survive in the wild (Kaebnick, 2010/2016). This debate about the potential promise and consequences of synthetic biology brings us back to our discussion of the precautionary principle from Unit I. Synthetic biology is in the early stages of development, and there are many unanswered questions about how the technology could affect human health and the environment. There may be serious consequences if we are not careful about how we use this technology. However, given the environmental issues we face in the current century, the consequences of not using the technology could be even higher. As you read this unit’s articles, think about the application of the precautionary principle to synthetic biology. Should we allow the technology to proceed and try to put policies and safeguards in place as we go, or should we wait till we are certain that no harm is done by the technology before we allow its use? What are the costs of taking either path? Is BPA a Health Threat? Often, the word chemical brings to mind something unnatural, industrial, or even dangerous. Such adjectives can certainly apply to some chemicals, but in reality, everything is made of chemicals. Some chemicals are what might be categorized as natural, such as the vitamin C in oranges, the chlorophyll in green plants, or the DNA in our cells. Other chemicals are made by humans and are categorized as synthetic. Although many people think of natural chemicals as safer than synthetic, neither synthetic nor natural chemicals are more or less toxic as an overall category. For example, melatonin, which is a chemical that helps to regulate sleep, can be produced in a lab. One can purchase synthetic melatonin or melatonin that was extracted from pineal glands of animals, which is the naturally derived version of melatonin. Every day, there are media reports about the dangers of one chemical substance or another. Sometimes, the threat is real. Lead-based paint was widely used before 1978, when it was banned because of the devastating effects lead exposure has on children. However, the toxicity of other chemicals is not so clear, making the decision to ban them a difficult and contentious process. Such is the case for bisphenol-A (BPA). BPA has been used since the 1950s to harden plastics. You can find it in the linings of canned goods, in plastic cups and bottles, in dental sealants, on receipts, and in CDs and DVDs. BPA belongs to a class of chemicals known as endocrine hormone disrupters. Endocrine hormone disrupters are “an exogenous agent or mixture of agents that interferes with or alters the synthesis, secretion, transport, metabolism, binding action or elimination of hormones that are present in the body and are responsible for homeostasis, growth, neurological signaling, reproduction and developmental processes” (Schettler, 2010/2016, p. 210). Because these chemicals interfere with reproduction and developmental processes, they can be especially

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toxic during embryonic development and childhood. These effects can apply not only to humans, but also to wildlife. Due to the ubiquitous use of endocrine hormone disrupters in manufacturing, they are found in the water and soil in even the most remote locations. Studies have reported effects from endocrine hormone disrupters on bird, amphibian, reptile, and mammalian development (Schetteler, 2010/2016). The Endocrine Society, which is comprised of over 14,000 researchers and doctors in the field of endocrinology, believes that the scientific evidence for the effects of endocrine disrupting chemicals on human health are strong (Schetteler, 2010/2016). Despite the evidence, the EPA has been slow to implement the recommendations of the Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), which the EPA itself formed in 1998. The only action taken by the EPA based on EDSTAC’s recommendations was to implement only a basic screening program in 2009, leaving thousands of chemicals untested for endocrine disrupting properties (Schetteler, 2010/2016). Even though BPA has long been considered to have endocrine disrupting properties, Jon Entine (2010) does not believe we should be concerned about its use. Both the National Cancer Institute and the National Toxicology Program have cleared BPA as a possible carcinogen. The FDA concluded BPA was safe in 2010, and the European Union (EU) declared it safe in 2006. The EU review is notable because the EU chemical review process adheres to the precautionary principle, which you may recall from Unit I calls for shifting the burden of proof to the proponents of activity when there is not a scientific consensus regarding the safety of that activity. If BPA is so safe, why are there so many media reports regarding the dangers of BPA? Entine (2010/2016) claims that the Environmental Working Group publicizes and sensationalizes its own misinterpretations of serious studies on BPA. These reports are then repeated without critical evaluation by activists and the media. For example, some articles reported that “BPA leached from plastic and showed a laboratory response on estrogen-responsive cancer cells” (Entine, 2010/2016, p.271). However, there are many substances that have similar effects on the endocrine system such as soy and tofu. Entine (2010/2016) also points out that only a few studies on BPA indicated any toxic or hormonal effects on rodents, and even those results are questionable for several reasons. First, the studies injected the BPA into the rodents. Humans ingest BPA, where it is detoxified in the gastrointestinal tract and in the liver into a harmless substance. Second, differences in biochemistry and metabolism in humans may make the effects of BPA very different in humans. Third, the studies showed effects in rodents at levels at least 500,000 times greater than humans consume (Entine, 2010/2016). In addition to calling into question the evidence for BPAs effects on humans, Entine (2010/2016) also cites a study that indicates BPA’s classification as an endocrine disruptor may not be accurate because its estrogenic activity is so low. In the study by L. Earl Gray Jr. and colleagues, “BPA was found to be so weak that even at levels of exposure 4,000 times higher than the maximum exposure of humans in the general population, there were no discernible effects” (Entine, 2010/2016). Although there are dangers to ignoring evidence that a chemical is causing harm, there is also danger in banning chemicals based mainly on fear. There are no good substitutes for BPA, tens of millions of dollars have been spent on the study of BPA. If it is safe, as Entine (2010/2016) and many other scientists believe, those dollars would have been much better spent on other research that would address more immediate and dangerous concerns.

References Biotechnology Innovation Organization. (2011). Current uses of synthetic biology. Retrieved from

https://www.bio.org/articles/current-uses-synthetic-biology Chemical Heritage Foundation. (2011, October 28). Photograph of Craig Venter [Image]. Retrieved from

https://commons.wikimedia.org/wiki/File:J._Craig_Venter_crop_2011_CHAO2011-49.jpg Entine, J. (2016). The troubling case of bisphenol A: At what point should science prevail? In T. A. Easton,

Taking sides: Clashing views on environmental issues (16th ed. expanded, pp. 270–275). New York, NY: McGraw-Hill Education. (Reprinted from The American Enterprise, 1–7, March 2010)

Garthwaite, J. (2014, September 25). Beyond GMOs: The rise of synthetic biology. The Atlantic.

http://www.theatlantic.com/technology/archive/2014/09/beyond-gmos-the-rise-of-synthetic- biology/380770/

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Kaebnick, G. E. (2016). Testimony to the House Committee on Energy and Commerce. In T. A. Easton, Taking sides: Clashing views on environmental issues (16th ed. expanded, pp. 258–261). New York, NY: McGraw-Hill Education. (Reprinted from U.S. House of Representatives, May 27, 2010)

Schettler, T. (2016). Testimony before Senate Committee on Environment and Public Works hearing on

“EPA’s efforts to protect children's health” In T. A. Easton, Taking sides: Clashing views on environmental issues (16th ed. expanded, pp. 266–269). New York, NY: McGraw-Hill Education. (Reprinted from U.S. House of Representatives, March 17, 2010)

Thomas, J., Hoffman, E., & Hanson, J. (2016). Offering testimony from civil society on the environmental and

societal implications of synthetic biology. In T. A. Easton, Taking sides: Clashing views on environmental issues (16th ed. expanded, pp. 256–257). New York, NY: McGraw-Hill Education. (Reprinted from U.S. House of Representatives, May 27, 2010)

Suggested Reading To access the resources below, you must first log into the myCSU Student Portal and access the Academic Search Complete database within the CSU Online Library. This article provides an interview with Craig Venter, a pioneer in the field of synthetic biology. Marshall, A. (2009). The sorcerer of synthetic genomes. Nature Biotechnology, 27(12), 1121–1124. To access the resources below, you must first log into the myCSU Student Portal and access the GreenFILE database within the CSU Online Library. This article discusses the safety of endocrine hormone disruptors. Safe, S. H. (200). Endocrine disruptors and human health--is there a problem. An update. Environmental

Health Perspectives, 108(6), 487–493.