Tag Archive | "x-y pair"

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We Need Worldwide Regulation of Synthetic Biology

Posted on 11 March 2015 by Jerry

Following the thought of the creation of new nucleotides, the x-y pair (see Synthetic Biology Advances With No Oversight, 7/15/14), synthetic biologists at Yale and a separate group at Harvard have constructed genetically altered organisms that require special synthetic amino acids to live.  Synthetic biologists reason this makes the synthetic organisms safer since they would die if released into the environment that lacks the amino acid.

This breakthrough would eventually allow synthetic organisms to be raised in laboratories for use in experimentation.  According to an article in the January 22, 2015 volume of Nature entitled Safety boost for GM organisms “The microbes also do not swap their engineered DNA with natural counterparts because they no longer speak life’s shared biochemical language.”  The article continued with a quote from a Yale synthetic biologist, Farren Isaacs who said, “Establishing safety and security from the get-go will really enable broad and open use of engineered organisms.”

While this does provide another layer of security to the development of synthetic organisms, it still begs the question of when there will be proper regulation of synthetic biology.  This is not to say there is no regulation today, for there is.  It is as if we have a bedspread that has been pulled in many different directions as we try to cover a synthetic biology spot by expanding existing coverage of a wide array of bureaucratic organizations each of which are designed to respond to other priorities.

This is like stating that in an environment where everyone is responsible, no one is.  The closest anyone comes to directly regulating this area is the National Institute of Health (NIH).  The law requires that any entity that receives money for research from the NIH must adhere to its guidelines that cover synthetic biology.  Everyone else is free to follow the guidelines or not, or worry about another governmental agency with a regulatory role that can be extended to synthetic biology.

The Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), the Food and Drug Administration (FDA), the Commerce Department and the Department of Health and Human Services (HHS) all have overlapping responsibility for Synthetic Biology.  It is doubtful that any of them has been given any additional budget to extend their regulation to include synthetic biology.  Let us reiterate that when all are responsible, no one is responsible.

There is a thorough description of the patchwork quilt of regulation of synthetic biology which can be found by accessing “synberc.org/safety-and-security-resources” and selecting the “The Regulation of Synthetic Biology: A Guide to U.S. & European Regulations, Rules & Guidelines.”

Synthetic biologists are working to solve humanity’s problems.  Today they are largely self-regulated.  This must change.  There must be regulation but it should be one regime that is worldwide (maybe from the U.N.) and assures that humans will not unleash a foreign organism into the world’s environment.

Use the following sites to gain additional information or access the original documents that were used to generate this article.

http://www.iamaguardian.com/category/protect/synthetic-biology/

http://www.nature.com/nature/journal/v518/n7537/full/nature14095.html

http://www.nature.com/nature/journal/v518/n7537/full/nature14121.html

Access “synberc.org/safety-and-security-resources” and select the “The Regulation of Synthetic Biology: A Guide to U.S. & European Regulations, Rules & Guidelines.”

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3554958/

 

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Synthetic Biology Advances With No Oversight

Posted on 15 July 2014 by admin

Scientists have now created a self-replicating organism that can pass its uniqueness to subsequent generations.  All species of life on Earth from bacteria and viruses to human beings use the same genetic code.  This consists of four types of chemicals in DNA, A, C, G, and T.  The sequence of these chemicals, nucleotides or bases, determine which proteins each cell makes.

According to a New York Times article appearing on May 7, 2014 researchers have created two new nucleotides in addition to the original four, an X-Y pair.  They have put the new X-Y pair into a common bacterium, E. coli. In a unique way, “the bacteria were able to reproduce normally, through a bit more slowly than usual, replicating the X and Y along with the natural nucleotides.  In effect, the bacteria have a genetic code of six letters rather than four, perhaps allowing them to make novel proteins that could function in a completely different way from those created naturally.”

Each organism had only one X-Y pair and we don’t know if it would function with many of the new combinations.  We don’t know how long such a bacteria would survive retaining the foreign code.  In other words there is more we do not know than what we do know.

The uniqueness of this progress lies in the ability to get the X-Y pair to successfully duplicate as the E. coli cell splits.  Also, it is the ability of successive generations to copy the six-letter genetic code exactly.

This progress in synthetic biology may be why a recent conference attracted representatives from the Federal Bureau of Investigation and the Department of Homeland Security.  The Pentagon’s Defense Advanced Research Projects Agency (DARPA) recently created the Biological Technologies Office, with Dr. Alicia Jackson from MIT named as deputy director.

Dr. Neil Gershenfeld, a physicist from MIT was quoted in a New York Times article as saying, “The new abilities, he noted, raised ethical questions that are as yet unanswered.  When the ability to convert biology to data and data into biology becomes that cheap, that agile, that easy to do, what are the consequences?  The most exciting and frightening thing I saw this morning was a slide talking about designing and synthesizing genomes next to a slide describing a human being.”

This progress is attracting many of the same players who make genetically modified foodstuffs and drugs.  MIT announced its Synthetic Biology Center has just inked a three-year collaboration agreement with Pfizer to advance synthetic biology discovery and development.

There still is no governmental oversight or regulation of synthetic biology.  With incremental progress of synthetic biology’s efforts, the fear grows that there will ultimately be success.  In fact, the ultimate concern is that some alien life form will find itself loose in our environment.

A May 7,2014 New York Times article quotes Jim Thomas of the ETC Group, a Canadian advocacy organization as saying, “The arrival of this unprecedented ‘alien’  life form could in time have far reaching ethical, legal and regulatory implications.  While synthetic biologists invent new ways to monkey with the fundamentals of life, governments haven’t even been able to cobble together the basics of oversight, assessment or regulation for this surging field.”

Even with known procedures and strict security with known dangerous materials, mistakes will be made that will compromise our DNA.  An example is the recent admission that the Centers for Disease Control mislabeled and mishandled samples of deadly pathogens, including anthrax, smallpox, botulism bacteria, and a virulent bird flu virus.  These errors were committed in five occasions over the last decade.

These failures raise concerns that even the U.S. government, in its most closely watched environments, cannot safely store and transport dangerous microbes.  These include live samples of decades old vials of smallpox that killed hundreds of millions of people before being eradicated in the 1970s and 1980s.  A bioterrorist expert was most concerned about the distribution of a bird flu virus that was contaminated.  What should have been a safe strain of bird flu virus became a deadly H5N1 virus.

No one is advocating trying to put the genie back in the bottle.  Synthetic biology is here to stay.  In Beyond Animal, Ego and Time it was suggested synthetic biology should be taken out of the start-up stage of business where the profit motive is the reason venture capitalists are invested and returned to basic science.

In this case we would go backward from applied science to pure science by denying all patents on the grounds that life is the basis of these discoveries so there is insufficient novelty.  Denying patents would remove all economic incentive and return the field to scientists.

Now we must admit the moment has passed for this single step or for industry self-regulation.  On this basis there should be federal oversight established in four governmental departments; Centers for Disease Control, Environmental Protection Agency, the Federal Drug Administration and Homeland Security.   All of these departments should be engaged in drafting a law to be submitted by the Administration to Congress for action.

In addition, they should begin immediate oversight and regulation of the science consistent with their normal focus on our behalf.  This is an industry that is using the genetic code we all share for its own gains without thought to the continued integrity of our genetic code or to protection of the citizenry or environment we all share.   It has fought all efforts to seek self-regulation and now needs to be controlled.

Our government needs to stop looking at synthetic biology as a future opportunity for the U.S. to once again be a leader in a technology.  It needs to get serious about synthetic biology and recognize the threats it poses.

Use the following links to gain more information or access the source documents for this article.

http://www.nytimes.com/2014/05/08/business/researchers-report-breakthrough-in-creating-artificial-genetic-code.html?_r=o

http://www.nytimes.com/2014/05/09/science/a-synthetic-biology-conference-lures-an-intriguing-audience.html?_r=o

http://www.nytimes.com/2014/-5/08/business/researchers-report-breakthrough-in-creating-artificial-genetic-code.html?_r=0

http://newsoffice.mit.edu/2014/mits-synthetic-biology-center-collaborates-with-pfizer-to-advance-synthetic-biology-research-in-drug-discovery-and-development

http://news.yahoo.com/forgotten-vials-smallpox-found-storage-room-160303452.html

http://news.nationalgeographic.com/news/2014/03/140327-functional-designer-chromosome-synthetic-biology/

http://www.nature.com/nature/journal/v509/n7500/abs/nature13314.html

 

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