Written: Jun 9, 2006
Put Online: Oct 1, 2006
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Why Small Tech Is Such a Big Deal:

The Control And Regulation of Bio And Nanotechnology

Contents

Executive Summary

Antisense Drugs

How Antisense Drugs Work Proteins
Nucleic Acids
Protein Synthesis
Transcription
Translation
Blocking Protein Synthesis Problems And Concerns Specificity
Toxicity
Antisense Therapy Backfiring Control And Regulation Specificity
Toxicity
Preventing Antisense Therapy From Backfiring Bibliography

Genetically Modified Foods

How to Genetically Modify an Organism Gene Identification
Restriction Enzymes
Insertion of DNA
Alternate Methods of DNA Insertion
Current Applications Problems and Concerns Health Problems
Societal Problems
Environmental Problems Control and Regulation Current U.S. Regulations
Current European Union Regulations
Amendments to Current Regulations Bibliography

Genetic Testing

Implementation And Usage Applications
Process Problems And Concerns Genetic Discrimination
Fetal Selection Control And Regulation Current Anti-Discrimination Regulations
Potential Anti-Discrimination Regulations
Fetal Selection Conclusion
Bibliography

Nanoparticles

Current Nanoparticle Products
Problems And Concerns Exposure And Hazards
Asbestos Case Study
Testing Environments For Nanoparticles
Improper And Unfair Use Control And Regulation Considerations Of Regulation
Future Uses
Correct Use
Misconceptions And Embracing The Future Bibliography

Quantum Computing

What Is Quantum Computing? Operations Of A Quantum Computer Problems And Concerns Cryptography Public Key Cryptography Factorization Control And Regulation Bans Quantum Cryptography Regulations Bibliography

Glossary

Executive Summary

We investigate five emerging technologies in the disciplines of biotechnology and nanotechnology and explain the fundamental principles of how they work, the concerns and problems they pose as well as how they should be controlled and regulated to avoid potentially harmful situations.

Antisense Drugs

Antisense drugs promise to fight viral diseases as well as cancer by selectively disabling a cell's ability to produce certain disease causing proteins. Important issues regarding the safety and effectiveness of this new type of medication include the specificity and toxicity of these drugs. Another danger is that an overly successful antisense drug may actually help a disease spread. Carefully designed methods of testing must be employed to ensure that antisense drugs are safe and actually combat a disease, and not just suppress it.

Genetically Modified Foods

Genetically Modified Foods are a product of recombinant DNA technology, where a specific gene is inserted into an organism to give the organism a desired trait. The ethical issues surrounding Genetically Modified crops are a danger to human health, lack of informed consent and genetic pollution. The control and regulations necessary to ensure safety to consumers are: increased research for health effects, labeling of all Genetically Modified Foods and better methods for containment.

Genetic Testing

Genetic testing is the process where an individual's genetic material is analyzed in order to gather genetic information about that individual. This information can be used to determine the existence of hereditary diseases and to discover inclinations towards developing late-onset genetic diseases. Because of the predictive power of this information, individuals may be discriminated against because they possess certain genetic traits or potential health conditions. In order to prevent genetic discrimination, regulations must be enforced to protect the privacy and prohibit the inappropriate use of genetic information.

Nanoparticles

The properties of nanometer sized particles and structures are of concern because their unique toxicological properties are not currently regulated. Also, the encouragement of global benefits prevents the exclusive use of future nanotechnologies by individuals that could stigmatize those that could not afford to do the same. Laws can not be put into place to prevent catastrophes due to misuse in the future, it is possible to encourage the most productive use of nanotechnologies rather than a complete loss of control for economic gain.

Quantum Computing

With ever-shrinking electronics, inevitable are quantum computers utilizing the bizarre laws of physics at such small sizes to provide enormous computing power. Quantum computing poses a danger to current information, financial, and privacy security. Instead of banning such quantum technology, embracing solutions that rely on quantum computing can defend against these very threats while fostering the benefits of quantum computing.

Antisense Drugs

Antisense drugs prevent a cell from producing a specific protein. This new class of drug therapy, because of its ability to precisely block the disease-causing behavior of cells, promises a cure to human illnesses such as cancer and AIDS. Currently, the FDA has approved an antisense drug to fight cytomegalovirus in AIDS patients (Isis, 2006) while other antisense drugs targeting cancer are undergoing clinical trials (Oncogenex, 2006). To explain the how antisense drugs work, the basic genetic mechanisms that a cell uses to synthesize proteins must first be explained.

How Antisense Drugs Work

Proteins

The human body contains approximately 32,000 different proteins, each designed to fulfill various functions which include providing cellular structural support, regulating the flow of materials in and out of cells, transmitting signals between cells and within a cell as well as controlling protein production activity (Lodish, 2003). Proteins are the basic building blocks of human biology, accounting for the majority of the mass in a human body after only water, and are formed of only 20 different amino acids. They are nothing but long, folded chains of amino acids, whose function is ultimately dependent on the amino acids it contains and the order in which they are linked. Synthesized within the cytoplasm of a cell, the genetic information needed to assemble a protein from amino acids is completely contained within a cell's DNA.

Nucleic Acids

Deoxyribonucleic acid, or DNA, is also a long, chain-like organic molecule, but unlike a protein, it is composed of nucleotide bases connected by a sugar-phosphate backbone. The four nucleotide bases found in DNA are adenine, guanine, cytosine and thymine; which are represented by A, G, C and T respectively. DNA typically forms a two-strand double-helix structure, each strand being composed of a sugar-phosphate backbone spiraling around the exterior and complimentary nucleotide bases facing inward. The complementary nucleotide base pairs, A bonding exclusively with T and G bonding exclusively with C, that are formed between the two strands comprise the glue by which the two strands hold together and form one cohesive molecule. A living organismÕs entire genetic library is contained within these molecular databases situated in the nucleus of most of the organism's cells. Furthermore, this genetic information is subdivided into relatively small sequences of base pairs called genes, where each gene holds the DNA that is needed to properly synthesize a single protein.

An additional nucleic acid, ribonucleic acid or RNA, plays crucial roles in protein synthesis. RNA is very similar to DNA except that the nucleotide thymine is replaced by the nucleotide uracil, represented by U. Also, although DNA molecules may be on the order of several hundred million nucleotides in length, RNA molecules range from only tens to thousands of nucleotides in length. Finally, it is not uncommon for certain RNA molecules to occur as a single strand rather than as a double helix. This is the case with messenger RNA, or mRNA, for instance.

Protein Synthesis

Protein synthesis occurs in two steps: transcription, where a gene's sequence of nucleotides is copied into an mRNA molecule; and translation, where the mRNA genetic code is interpreted in order to assemble the correct sequence of amino acids.

Transcription

At the beginning of each gene in human DNA is a special sequence of base pairs which form what is called a promoter sequence. An enzyme called RNA polymerase is able to attach itself to the DNA at these promoter sequence sites. The RNA polymerase then moves down the DNA molecule temporarily unwinding the DNA to expose the nucleotide bases of a single strand of DNA. At the same time, it copies the A, G, C and T code of the DNA into the equivalent A, G, C and U code of mRNA. These two codes are identical except that T is replaced by U. At the end of the gene the RNA polymerase encounters a sequence of nucleotide bases in the DNA that form a terminating sequence, at which point the RNA polymerase separates itself from the DNA and releases the completed single stranded mRNA. Other RNA such as transfer RNA, tRNA, and ribosomal RNA, rRNA, are formed in very similar processes.

Translation

After transcription, the mRNA molecule enters the cytoplasm to begin the translation phase of protein synthesis with the help of two other key molecules; tRNA, and ribosomes. These three molecules perform translation in the following manner: the mRNA contains the genetic code that determines the ordering of amino acids in the protein; tRNA is used to decide which amino acids correspond to which nucleotide sequences in the mRNA; and finally ribosomes are used to bring the entire operation together. In other words, the mRNA contains the untranslated message in the form of nucleotides, the tRNA forms the bilingual dictionary used to translate individual words from the nucleotide language to the amino acid language, and the ribosomes are the linguists who read the untranslated message, look up individual words in the bilingual dictionary and produce the final translated message.

The untranslated message, or nucleotide sequence, found in the mRNA strand is encoded in codons, which are groups of three adjacent nucleotides. Since each nucleotide can be either A, G, C or U there are a total of 64 possible codons. Of these, 61 correspond directly to one of the 20 amino acids while the remaining 3 are stop codons that mark the end of the protein sequence.

tRNA molecules are folded RNA strands with one end attached to an amino acid and the other containing an anticodon. An anticodon is a sequence of three complimentary nucleotides that form base pairs with its corresponding codon. For example the codon AAG forms a base pair with the anticodon UUC. Thus, tRNA fulfills its role as the mechanism for matching a codon to its respective amino acid.

Ribosomes play the final part in translation and protein synthesis. They synthesize proteins one amino acid at a time by traveling along the mRNA strand codon by codon and matching each codon with a tRNA that contains the matching anticodon. For every codon-anticodon pair that is successfully matched, an amino acid is added to the growing protein chain. Finally, when the ribosome reaches a stop codon, it releases the fully formed protein as well as the mRNA strand.

Blocking Protein Synthesis

The antisense mechanism thwarts the protein synthesis in the translation stage by introducing antisense oligodeoxynucleotides, or oligos, into the cytoplasm which bind to mRNA and prevent ribosomes from successfully translating the mRNA strand. These oligos can be thought of as artificially manufactured RNA strands in that they are sequences of A, G, C and U nucleotide bases held together by some engineered backbone. The term "antisense" is given to these oligo strands because of their complementary nature to mRNA, which is labeled as the "sense" strand. The extraordinary property of antisense therapy is its ability to block the production of a single, specific protein, based on the nucleotide sequence of the oligo, while leaving the production of all other proteins completely unhindered. This is possible because only a near-perfect Watson-Crick pairing between the nucleotides of the oligo and the mRNA will produce a bond strong enough to halt protein synthesis of that mRNA.

The two common strategies in targeting the mRNA are either to design the oligos to bind to the coding region of the mRNA or to design them to bind to the region surrounding the initiation codon, also called the start codon, of the mRNA. Binding an oligo to the coding region of the mRNA produces a roadblock for any ribosomes attempting to travel down the mRNA because of the increased size of the bonded mRNA-oligo section. In contrast, targeting of the initiation codon of the mRNA has the effect of shielding it from ribosomes. Since ribosomes seek to first attach to the initiation codon of an mRNA before traveling its length, the shielding effect of the oligo effectively prevents a ribosome from ever attaching itself to the mRNA.

Apart from determining the correct oligo nucleotide sequence, the backbone of the oligo must be properly engineered as well. Desirable properties of the backbone include the ability to survive within the body, which means that it must not be quickly broken down by enzymes or any other common agents. Not only does the backbone need to be stable, but an additionally desirable quality is that cells must be willing to take in oligos without immune response.

Problems and Concerns

The two principal dangers surrounding the use of antisense therapeutics are specificity and toxicity. Additionally, the success of some antisense drugs may lead to unexpected complications as well.

Specificity

Specificity refers to the ability of the antisense drug to accurately suppress the production of a single protein while leaving the production of all other proteins completely unaffected. This is a direct consequence of the antisense oligoÕs ability to bind to the correct mRNA strands and only to those strands. Expectedly, this is primarily accomplished by producing an oligo with a nucleotide sequence that exactly complements the targeted mRNA sequence. Apart from having a complementary nucleotide sequence, the length of the oligo also plays an essential role in its specificity.

The length of an oligo typically has both a lower bound of 14 nucleotides and an upper bound of 25 nucleotides. Intuitively, the shorter an oligo is, the less specific one would expect it to be. This is because it becomes significantly easier to find a complementary sequence to a sequence shorter than 14 nucleotides long. However, there is also a danger in using oligos longer than 25 nucleotides because sufficiently large subsections of the oligo may be capable of binding to non-targeted mRNA. For example, one can consider a 30 nucleotide long oligo to be a superposition of five 25 nucleotide long oligos, each capable of forming unwanted bonds with other mRNA strands.

Toxicity

Toxicity is always an issue when foreign material is introduced into a human being. Of primary concern are adverse immune system responses to antisense agents. For instance, it was shown that sufficiently large injections of antisense material into monkeys resulted in cardiac problems as well as a decrease in blood pressure (Galbraith, 1994).

Insufficient purity of the antisense drug leading to toxic side effects occur because the toxic chemicals used to synthesize the oligos are not sufficiently purified from the final drug. These chemicals include acetonitrile, trichloroacetic acid as well as methylene chloride. To avoid introducing these chemical agents into the body along with the antisense drug various purification techniques must be performed.

Antisense Therapy Backfiring

In light of the success of an antisense drug, a different danger presents itself. The danger is that antisense drugs may actually encourage the spread of the disease that it has been designed to fight against. To elucidate this thought, let us consider a hypothetical antisense drug that treats HIV.

The HIV virus works by entering a cell and inserting genes into its DNA that instruct it to produce copies of the HIV virus. A successful antisense treatment would effectively suppress the expression of these inserted genes. The result would be a band-aid solution where although carrying infected DNA, the patient would not experience the symptoms associated with the virus. The problem is that the root of the disease, which is the hijacked DNA, has not been destroyed, although the patient has seemingly been cured. This may actually encourage the spread of the virus itself as more people are able to live a normal lifestyle while carrying a deadly disease. The severity of HIV may diminish so as not to be considered life threatening and, in an extreme case, it may be normal for the typical human to carry the virus in their DNA.

Control and Regulation

The control and regulation of antisense drugs should focus on specificity and then consider the issues of toxicity and other social effects.

Specificity

Specificity is the key control and regulation issue because it is what makes antisense drugs a completely new class of medication. Because of its unique nature and function, antisense drugs should also be tested in uniquely appropriate ways.

Specifically, when tested in vitro, investigators must not only perform standard experiments designed to test a drugÕs effectiveness but they must also study the degree to which certain proteins are suppressed. This can be an intimidating task when one considers the tens of thousands of different proteins produced by the human body; however, with some simplifying assumptions the task can be made tractable. In vitro testing usually involves adding antisense drugs to a cell culture in a Petri dish and comparing it against control cases. A common sign that the antisense drug was effective is whether or not cell growth has stopped.

In vivo testing may be carried out in a typical manner with increased attention to long term side effects. Once again, this is especially true in this case because antisense drugs are a new class of drugs whose properties and behavior are not yet completely understood, and therefore, whose long term effects cannot be accurately predicted.

Toxicity

The toxicity of antisense drugs can be regulated through careful control of the method of administration as well as the manner in which the antisense drug is produced and purified. Previously, in the case where monkeys developed cardiac problems after being administered antisense drugs, it was shown that smaller, more frequent doses avoided those problems. Thus the dosage quantity and frequency must be tightly controlled in order to ensure a safe administration of the drug to the patient.

Regarding the presence of toxic chemical agents, the purity of antisense medication must be monitored and standards should be set that clearly define the limit to which chemical byproducts may be found in antisense medication. These kinds of regulations are familiar to the pharmaceutical industry and should not be difficult to implement.

Preventing Antisense Therapy from Backfiring

Lastly, in order to avoid a scenario in which antisense drugs actually encourage the spread of a disease, they must be employed in tandem with another mechanism that actually attacks the source of the illness. In other words, antisense drugs should be used defensively to contain an illness, while a complementary force should be used offensively to destroy the illness. Fortunately, todayÕs current therapeutic strategies as well as the natural processes of the immune system may already be suited to fulfill this complementary offensive role. For instance, chemotherapy and radiotherapy may be significantly more effective in fighting a cancer if its malignant spread can first be stopped using antisense drugs. Also, the bodyÕs immune system may be able to cope and eventually rid itself of a viral infection if its spread can first be stabilized. Nevertheless, these mechanisms must first be in place in order to be able to effectively use antisense drugs.

Bibliography

Galbraith et al, Complement activation and hemodynamic changes following intravenous administration of phosphoronthioane oligonuceotides in the monkey, Antisense Res. Dev. 4(3), 1994.

Isis Pharmaceuticals, Vitravene, [http://www.isispharm.com/vitravene.html] . Acessed April 23 2006.

Lodish, Harvey, et al, Molecular Cell Biology, 5^th ed., New York, W. H. Freeman and Company, 2003.

Oncogenex, Antisense Technology, [http://www.oncogenex.ca/documents/Antisense.pdf] . Accessed June 8 2006.

Schlingensiepen et al, 1997, Antisense - From Technology to Therapy, Vienna: Blackwell Wissenschaft Berlin

Genetically Modified Foods

Genetically Modified Foods can be both plants and livestock; this paper will focus on genetically modified plants. Genetically modified plants are a product of recombinant DNA technology. The essence of recombinant DNA technology is the ability to take DNA from a foreign source: plant or animal and then insert this piece of foreign DNA into another plant or animal. The region of the DNA that is copied codes for a gene or a set of genes that will give a desired trait to the organism accepting the DNA insert. The benefit in Genetically Modified plants is this ability to alter the DNA of the plant to produce a desired trait, which is passed on to future generations. Essentially controlling the process of evolution and selecting desired traits rather than allowing natural selection to take place. The benefit to genetically modifying foods is that it can add desired traits such as: insect or herbicide resistance; quicker grow time; increased yield and increased temperature tolerance. Before delving into what Genetically Modified Foods have been successful at the present time, it is important to understand what it means to Genetically Modify an organism.

How to Genetically Modify an Organism

Gene Identification

Genetically Modified organisms are created by isolating a fragment of DNA and then using recombinant DNA technologies to incorporate the DNA fragment into a vector, which can then be taken up by cells in the target organism and the DNA insert in the vector will be transcribed to mRNA and then translated into protein using the host organisms own machinery. The process of genetically modifying an organism can be broken down into a few steps: identifying the gene that contains the desired trait, using a restriction enzyme or enzymes to isolate a DNA fragment and create an opening in the plasmid, then insertion of the DNA fragment into the organism. This insertion can take different forms: using a vector with a DNA ligase and then transferring vector to target organism, which leads to uptake of extrachromosomal DNA in the form of a plasmid or directly into host organism genome for permanent change (Lodish, 2003, pp. 360-370).

In order to identify a gene that contains the desired trait from a cDNA library an oligonucleotide probe is used. An oligonucleotide probe is a chain of nucleotides that can be anywhere from 10-100Õs of base pairs long. The way an oligonucleotide probe is chosen is based on partial protein sequences, and it must be long enough for its sequence to occur uniquely only in the clone of interest. A cDNA library contains DNA copies of all the DNA that codes for proteins, because it is made using reverse transcriptase which produces DNA from mRNA. The process of transcription, which includes removal of non-coding regions of DNA called introns, results in mRNA, which is a copy of only exons - regions of DNA coding for proteins. Therefore cDNA is not a copy of the entire genome because it does not include non-coding regions of DNA. An oligonucleotide can be prepared to be a complementary match to a specific fragment of DNA that codes for a certain gene. The double stranded DNA that composes the cDNA library is denatured and attached to a filter. This filter, usually a nitrocellulose membrane, is then incubated with a radioactively labeled oligonucleotide probe that has a complementary fragment to the DNA of interest. The filter is then washed and undergoes autoradiography, to determine where the radiolabeled probe is bound to the filter. After the cDNA is found that has the protein sequence, the cDNA can be radioactively labeled and used as a probe against a genomic DNA library to get the entire gene, if necessary. The process of identifying a gene is basically a process of hybridization of complementary DNA and oligonucleotide fragments, in order to take a small sample of known protein and find DNA relating to that protein (Lodish, 2003, pp. 360-370).

Restriction Enzymes

Once the target gene is known, restriction enzymes are used to isolate the gene and then create a complementary opening in the plasmid vector. There are other ways of DNA fragment insertion that do not involve plasmids, however plasmid vectors are very common and the way they work is outlined in detail. Restriction enzymes work by cutting the phosphodiester bonds between certain base pairs depending on the type of restriction enzymes. Every type of restriction enzyme has a specific sequence of bases it always cuts, usually 4-8 base pairs long. The cut made by restriction enzymes produce restriction fragments with either "sticky ends or blunt ends." Sticky ends result when a restriction enzyme makes a staggered cut causing both sides of the newly spliced DNA to have "tails." The tails on the DNA are complementary to all other tails generated by the same restriction enzyme. These tails naturally form transient complementary base pairs with other "sticky ends," resulting in a new recombinant DNA that is a combination of DNA from two different sources. Blunt ends occur when the restriction enzyme cuts directly across both DNA strands in the same location, leaving no tail to complimentarily bind to. Once the sequence of the DNA is known any fragment of the DNA can be isolated by using the appropriate restriction enzyme or enzymes. More than one restriction enzyme is used to create fragments with tails that bind to different sticky ends. Restriction enzymes are also used to cut a snip in the circular plasmid, making space for the insertion. The restriction enzyme used to cut the plasmid needs to match the restriction enzyme that was used to prepare the DNA fragment, because the sticky ends need to complementarily bind to each other (Lodish, 2003, pp. 360-370).

After the sticky ends are transiently bound, a DNA ligase is used to covalently join the complementary ends of restriction fragments with plasmid DNA. The ligation proceeds in the standard 5Õ - 3Õ direction associated with DNA synthesis, and uses phosphodiester bonds as the method of connection. DNA ligase can be used to make transient associations between sticky ends permanent and to connect any two blunt ends together. This ligation completes the process of vector formation (Lodish, 2003, pp. 360-370).

Insertion of DNA:

A vector is the physical entity, such as a plasmid, that carries the insert and is able to clone a DNA fragment; this usually takes place in a bacterium (such as E. coli). There are many different types of vectors, but the most commonly used are plasmid vectors. A plasmid is extrachromosomal DNA that is circular and double stranded. Plasmids occur naturally in bacteria and lower eukaryotic cells, such as yeast, and they have either a parasitic or symbiotic

relationship with their host cell. Plasmid DNA is duplicated before every cell division and is passed on to each daughter cell. The three regions of a plasmid essential for DNA cloning are a replication origin, a marker that allows for selection, and a region where the insert DNA can reside. The replication origin is very important because it is the location that host cell enzymes look for in order to start plasmid replication. Once initiated it continues regardless of the nucleotide sequence. The marker that allows for selection is usually an antibiotic resistance gene. Selection is useful because it allows determination of plasmid uptake. If the cells are grown on a Petri dish that contains an antibiotic, such as ampicillin, then only the cells containing a plasmid with the specific antibiotic resistance, to ampicillin in this case, will live and continue to replicate, forming colonies of solely transformed cells. All of the cells that were not transformed, implanted with the plasmid containing recombinant DNA, will die due to the antibiotic. The third crucial element of a plasmid is a spot for the insert DNA to be incorporated into the plasmid; the easiest way to incorporate a fragment of DNA into a plasmid is by having a Polylinker in the plasmid. A Polylinker is a synthetically generated sequence located on the plasmid that has multiple recognition sites for several restriction enzymes that are not located anywhere else in plasmid, which makes it very easy for a restriction enzyme to create a useful opening in a plasmid. The result of this plasmid replication process is a Petri dish with multiple colonies of transformed E. coli cells; each colony is a set of clones from one original transformed cell. In this way, many vectors can be made all containing the same plasmid (Lodish, 2003, pp. 360-370).

The vectors are then applied to totipotent cells, cells which can form every part of a plant or organism. Every cell is totipotent in a plant, whereas in animals it only embryonic stem cells that can be transformed to create and entire transgenic organism. There are various processes used to transfer foreign DNA into totipotent cells, other than plasmid uptake. Regardless of method of insertion, these transgenic cells then replicate and reproduce like normal cells passing on foreign DNA as part of their genome, or as extrachromosomal plasmid. The result is an entire transgenic organism that has incorporated the DNA insert into the entire plant, or animal (Lodish, 2003, pp. 360-370).

Alternate Methods of DNA Insertion

Besides microbial vectors there are alternate methods of transfer including: electroporation, microprojectile bombardment, and microinjection. Electroporation is a process where cells are stripped of their cell walls creating protoplasts, and then an electric current is applied to weaken the cell wall and the DNA insert enters the cell. The transformed cell then reforms it cell wall and grows into a transgenic plant. Microprojectile bombardment is a process where microscopic pellets to which DNA is attached are shot at plant cells; this is used a lot with grains that are not easily transformed by vectors. Microinjection is where insert DNA is injected directly into anchored cells (Institute of Medicine, 2004, pp.28-30). Many methods are available to transform cells into transgenic cells; all methods have different pros and cons and depending on the plant a different method may be used. Once the DNA has been accepted by the host organism it will be passed on to future generations, as a permanent addition to the genetic lineage of the transgenic organism.

Current Applications

Now that the mechanism for producing GM foods is known it is important to realize that GM foods are abundant in the world that we live in, despite the ethical debate and safety concerns about their use. The first Genetically Modified Food to be accepted was the Flavr Savr tomato, which extended shelf life by down-regulation of a gene controlling ripening. Since the Flavr Savr tomato there has been many other genetically modified foods that have been approved for growth in the U.S. The U.S. is leading the biotech revolution owning 55% of global biotech area, with genetically modified crops including: soybean, maize, cotton, canola, squash and papaya. Genetically Modified Foods are increasing in popularity globally, with an 11% increase in approved acreage in 2004 (James, 2006). Even though genetically modified foods are increasing in popularity globally, the skepticism regarding safety of genetically modified foods the control and regulations governing genetically engineered food continue to increase as well.

Problems and Concerns

Health Problems

Potential health problems are numerous and mostly unknown. According to Dr. Mae Won Ho, the mechanism of plasmid uptake is considered imprecise, due to the fact that there is no control of how the gene is actually inserted (McDonagh, 2004, p. 74). There is the possibility of human gut bacteria accepting a DNA insert coding for a pest resistance gene that produces toxins. If human gut bacteria happened to recombine unfavorably with such a gene, there is the possibility that the gut bacteria will produce toxins inside the stomach of the individual, which can be very hazardous to human health. The unknown mechanism surrounding uptake is believed to have the potential of creating new pathogens (McDonagh, 2004, p. 74). Another health problem is transfer of allergens that are unexpected in different foods. One case when attempting to transfer a protein gene from the Brazil-nut into soybeans caused a transfer of allergenicity (GM Foods and Allergies, 2006). This is a serious health problem because someone who is allergic to Brazil-nuts would not expect to be affected by eating soybeans and as such there is no informed consent. There is also the possibility that antibiotic resistance can be transferred from the selection marker in the plasmid causing current medicine to be less effective (Yount, 2000, p. 9). Genetic modification of food in order to increase uptake of certain nutrients, can also increase uptake of unfavorable trace elements that may be toxic in large amounts, such as toxic heavy metals (Institute of Medicine, 2004, p.119). Overall the health issues are only beginning to be understood and much more research is needed on long term effects before this technology would be considered acceptable.

Societal Problems

There are few societal problems, and they mostly involve problems with informed consent. There are significant possible health problems; therefore, the public should be forewarned before eating a product that little is known about. There is a major problem in the regulation in the United States, which is once the Animal and Plant Health Inspection Service (APHIS) grants the genetically modified food the status of non-regulated article they no longer keep track of the GM food as distinct from normal food. After few years of testing, which cannot possibly show all long term effects the plant is considered safe and intermixed with normal food supply. Conversely, in the European Union genetically modified foods are constantly monitored and kept separate in order to deal with health problems as they arise. In the U.S. there is no current standard for labeling unless the genetically modified food product is proven to have allergens that may be a health risk, in which case it must be labeled. Another societal problem is using genetically modified food as foreign aid, because every country has very different regulations involving genetically modified foods. The U.S. has regulations that are very favorable to genetically modified foods, whereas many countries are much more skeptical. This difference between nations is a problem because the U.S. is a major exporter and exporting GM foods that little is known about the long term effects of is a dangerous practice that can lead to irreversible damage to the worldÕs ecosystem.

Environmental Problems

The most threatening long term problem is the effects of GM foods on the environment. The major environmental concern is genetic pollution, which is the unintended transfer of transgenes through cross-pollination. This is a serious problem because there is potential for "superweeds" to develop (Michaels, 2006). A superweed is a genetically modified hybrid plant that would out survive existing plant species based on an inserted trait, causing an irreversible loss of biodiversity. Once the trait is taken into the genome of a plant it is permanently incorporated. The danger is that if one genetic variant of a certain plant outlasts it predecessors, there is the possibility that a climate change or an increase in toxins in the plant would cause the plant to die or be inedible, respectively. Basically the danger associated with breaking the boundary of a species and creating organisms that are not possible through reproduction, puts control of evolution into hands of molecular biologists (McDonagh, 2004, p. 80).

Control and Regulation

The control and regulations necessary to ensure safety to consumers are increased research for health effects, labeling of all genetically modified foods and better methods for containment. The regulations in place currently are a good starting point to monitoring this new and potentially hazardous technology, but could be improved. The current regulations governing safe growth of GM foods depend on the country. Each country regulates GM foods differently, causing problems with international trade. What is accepted by exporting countries is not always accepted by importing countries. The two most prominent differences in policy regarding GM foods are exemplified by the EUÕs and USAÕs policies on growth of genetically modified foods.

Current U.S. Regulations

The United States takes the approach that a genetically modified food is safe until proven otherwise, while imposing mild regulation on technologies that are still in testing. The process of getting a genetically modified food commercialized in the U.S. is composed of a few simple steps: Pre-submission Discussions, Field Trials Approvals of Regulated articles, and the last step is Petitioning United States Department of Agriculture Agriculture's Animal and Plant Health Inspection Service (USDA-APHIS) for "non-regulated Status" (United States Department of State 2006). There are inherent problems in this system of open acceptance, such as pre-submission discussions being optional, so farmers can plant field tests at their discretion and then notify the APHIS. Once the APHIS is notified they then send inspectors and make the field testers follow stringent guidelines; however, lag due to increases in approved acreage and lack of inspectors could result in periods of completely unregulated growth. Once the petition to become a non-regulated article is submitted, after several years of field tests, the APHIS has the job of determining if the technology has the potential to cause damage to human health or the environment, a process that usually takes about ten months (United States Department of State 2006). If the status of non-regulated article is given, based on a few years of tests, the product is considered safe and is given free reign to be combined with the normal food supply and be sold without a label, in the U.S.

Current European Union Regulations

Restrictions in the EU are much stricter; however, enforcing a mandatory label on all GM foods in order to track problems and increase accountability for potential long term effects. "The EU views its all encompassing labeling and traceability regulations as critical to assuaging consumer concerns" (Cohen 2006). The European approach of skepticism to new technology makes for slower adapting to the future of agriculture, yet the unforeseen problems caused in Europe relating to GM foods will probably be much less due to the slow regulated growth of their genetically modified food industry. The current regulations are a good start, however with a field that evolves as rapidly as the GM food industry a number of unique problems arise, which must be considered.

Amendments to Current Regulations

The EU model for regulation of GM foods is much safer than the U.S. model. It is essential for the U.S. to adapt its model to be more skeptical about new GM foods. The new and improved U.S. regulations on GM foods should take into account longer testing periods to catch possible long term effects. Since it is not possible to test for every health risk or for extremely long periods of time due to practical and financial reasons, it is very beneficial to label all GM foods, so that consumers can decide. The labeling of GM foods makes them traceable and is almost like an extended test period, because if problems were to arise there could be a recall, something that would be impossible with current U.S. regulations. Traceability allows health effects to be monitored continuously effectively making the testing period a continual process rather than a short term that cannot possibly explore all possibilities. Other than traceability, labeling of all GM foods creates an environment of informed consent, so people have the choice of getting involved in the highly experimental field of GM foods. The next step to safely incorporate GM foods into the worldÕs agricultural framework is developing better containment methods, such as growth in safe room or growth with a special nutrient that can be removed in order to act as a kill switch. The truth about GM foods is that there is a lot that is unknown about the long term effects of genetically modified foods on human health and the environment. Increased testing periods, strict labeling guidelines and better containment methods is the first step in protecting public safety. Until more is known about GM foods the safest course of action is to separate and continue to monitor them, as public safety is the first priority and implementation of a new technology should not compromise that. Genetically Modified foods are the future of agriculture due to phenomenal increases in efficiency, and only with improved controls and regulations can this field grow safely and cause minimum disturbance to society.

Bibliography

Cohen, Stan, The EUÕs Biotech Regulatory System- WhoÕs Being Protected? 2005, [http://www.fas.usda.gov/gainfiles/200501/146118478.doc] . Accessed June 9, 2006.

Institute of Medicine and National Research Council of the National Academies, 2004, Safety of Genetically Engineered Foods: approaches to assessing unintended health effects, Washington, D.C.: The National Academies Press.

James, Clive, Global Status of Commercialized Biotech/GM Crops:2005, [www.isaaa.org] . Accessed June 9, 2006.

Lodish, Harvey, et al, 2003, Molecular Cell Biology, 5th ed., New York, W.H. Freeman and Company.

Mcdonagh, Sean, 2004, Patenting Life? Stop! UST Social Research Center: UST Publishing House.

Michaels, Patricia A, 2000, GMOÕs and the Escape Scenario, [http://greennature.com/article297.html] . Accessed June 9, 2006.

Michaels, Patricia A, 2001, GM Foods and Allergies, [http://greennature.com/article971.html] . Accessed June 9, 2006.

United States Department of State, Food Safety-Regulating Plant Agricultural Biotechnology in the United States, [http://greennature.com/article51.html] . Accessed June 9, 2006.

Yount, Lisa, 2000, Biotechnology and Genetic Engineering. New York, New York: Facts On File, Inc.

Genetic Testing

As bio and genetic technology continue to advance, the control scientists have over human genetics increases as well. As control increases, diagnosis and analysis of oneÕs genes become increasingly crucial. Consequently, many forms of genetic testing have emerged, allowing an individual to know their genetic traits. While there are definite medical benefits to genetic testing, there are also social and ethical concerns that must be considered.

Genetic testing is the analysis of genetic material to determine an individualÕs predisposition to particular health conditions or to confirm the presence of genetic diseases. As the genetic material of an individual is examined, important health and hereditary information becomes available. This information can be a powerful predictor of present and even future health conditions and tendencies. Genetic testing is widely used in health related diagnostic processes.

Implementation and Usage

Applications

One of the most common applications for genetic testing is carrier identification. This testing is usually done on a parent or a potential parent to determine whether that individualÕs genes carry certain genetic diseases, such as the Tay-Sachs Disease. Frequently, genetic diseases do not manifest themselves due to their recessive nature. Genetic diseases require a chromosome pair that carries itself on both strands to express the symptoms. Individuals are often not aware that they carry the genes for a genetic disease, since they exhibit no external symptoms. The danger for having this type of diseases is that they are hereditary, where the diseased genes can be passed on to oneÕs offspring, who will also become carriers of that disease.

It is possible that children will not become victims of their parentsÕ genetic diseases. If the section of DNA that carries the disease is on a sex chromosome -- one of the X chromosomes in a female or either the X or the Y chromosome on the male -- sometimes the egg and sperm will have the halves that do not have the disease. Many types of genetic diseases are unique to the Y chromosome in males, and without a complementary gene to suppress them, these diseases typically manifest in male carriers. Thus, parents should find out whether they carry certain genetic diseases or not, in order to avoid having children who will suffer from genetic diseases.

Another prevalent use of genetic testing is for prenatal analysis, which is done on unborn fetuses, usually with the intent to discover whether a baby would develop certain genetic diseases such as Down Syndrome, Sickle-Cell Anemia, and Cystic Fibrosis. Testing a fetus gives the advantage of knowing more about the health condition of a baby before nativity, so that diseases can be diagnosed and preventative measures performed. This advance knowledge would give parents time to decide on the best course of action for the fetus.

Similar to prenatal analysis, newborn screening is genetic testing on newborn babies. This postnatal analysis is useful for diagnosing diseases, illnesses, and disorders in newborn babies that may not become noticeable immediately. While this type of application is similar to prenatal analysis, that fact that the baby has been born limits the options parents have if the baby is diagnosed with certain diseases.

Another application of genetic testing is the identification of potential late-onset diseases, which include ParkinsonÕs, HuntingtonÕs, and Alzheimer disease. These diseases are called late-onset, because they manifest later in a personÕs life. Genetic testing can find the tendency an individual has to develop these types of diseases. Late-onset testing is a predictor of any individualÕs future health conditions. While this powerful information is useful for prevention, it can also become a basis for discrimination.

Process

DNA strands need to be isolated and processed for comparison and identification. Among the many techniques for DNA processing, the relatively new Polymerase Chain Reaction (PCR) method is the fastest and most accurate. First, DNA samples are obtained from an individualÕs blood, hair, or other bodily tissues. After separating the DNA from the containing cells, segments are selected for the testing process. Then the chosen DNA segments for examination are duplicated using the PCR method.

The PCR method creates copies of a DNA segment for testing and analysis. What is most useful about PCR is that it can quickly and accurately duplicate DNA. An older technique called Restriction Fragment Length Polymorphism (RFLP) was used before the invention of PCR. This technique uses enzymes to cut the DNA into smaller segments. Using an electrically charged agarose gel in a process called electrophoresis, the DNA segments are separated by their size and movement speed. The RFLP often takes a few days to perform, and although it is very discriminating it requires a large amount of pristine DNA, which may be difficult to obtain for purposes such as forensic investigations.

With the introduction of the PCR method in 1983 by Kary Mullis, DNA extraction and duplication became much faster, and this method required only a small starting sample (MSN Encarta, Genetics). Using primers, which are nucleic acid strands, the desired section of DNA is marked. Then the PCR process uses repeated heating and DNA polymerase cycles to copy the specified section of DNA both quickly and in large quantities. This technique is now more widely used than RFLP for duplication of a selected segment of DNA.

After getting copies of the desired DNA segments, a comparison can be made between the DNA samples and a database of DNA segments that have shown to increase the risk of developing certain diseases and disorders. A positive result means that segments of DNA from the patient has been found that may carry genetic diseases, while a negative result means that no match has been found. Although the analysis of DNA segments is difficult, much information can be extrapolated from genetic tests.

Problems and Concerns

Genetic Discrimination

Genetic information about an individualÕs propensity to develop certain genetic diseases and the likelihood of having some hereditary disorders can be obtained. This predictive power allows the use of genetic information to extrapolate an individualÕs future health condition. Even though this can be used to plan preventative measures to lower the chance these health issues will arise, genetic information can also become a basis for discrimination.

Genetic discrimination has been increasing ever since testing results became reliable. A middle-aged woman was denied health insurance because she was diagnosed with hereditary hemochromatosis, even though she was perfectly healthy at the time. A man was denied employment for a government agency because it became known that he was an unaffected carrier of the GaucherÕs Disease. Another woman was denied group health coverage at a new job because her daughter, having been successfully treated for phenylketonuria, was considered to have a higher health risk. Clearly, the issue of genetic discrimination from health insurance companies and employers is a real threat to genetic test patients. Health insurance companies feel that they will lose profits by insuring an individual if that individual will have a high chance to develop diseases and require costly treatment. Likewise, employers are not willing to hire an individual who has a good chance of needing medical treatment, which the employers will have to help cover while losing efficiency from an out-of-commission employee. Although this attitude is somewhat understandable, an individualÕs rights must be protected, and genetic discrimination violates the right of equality.

Fetal Selection

Besides becoming a basis for discrimination in health insurance and employment, genetic information is also becoming a criterion used by parents to select offspring with desirable traits. With advancements in the human genome project, the function of specific segments of DNA and the trait that it represents can be identified with greater accuracy. Using the test-tube fertilization method, a couple can select a particular sperm-egg pair that will produce a child with traits they desire. It is common for parents to try selecting a child with no detectable genetic diseases. If a fetus is diagnosed with a genetic disease, how should the parents deal with this information? Should the parents carry on and raise the child, even though the child may have a considerable disadvantage in life, or should the parents simply end the fetusÕ life to prevent the child from facing an insurmountable challenge? Does the fetus have the right to life? Do the parents have the authority to kill a fetus? These ethical issues are still passionately debated by proponents on both sides.

Now that selecting fetuses without diseases is possible, nothing prevents parents from selecting a child with particular traits, such as blue eyes, blonde hair, boy or girl, and other traits like these. Soon, genetic technology will allow genetic testing to distinguish the level of intelligence between several fetuses and other personality traits. With the power to select fetuses, parents can give their children significant advantages over other children.

Many ethical and religious groups oppose the idea of fetal selection, because the parents are essentially "playing God" by choosing their childÕs traits (Kalfoglou, 2006). They argue that actions that man naturally cannot do should not be done. Genetic testing has not been around until fairly recently, and fetal selection is most definitely not natural. By selecting only desirable traits, diversity will diminish, because a society usually has a common conception of desirability. As communication and transportation technologies advance, societies are now melding together ever so swiftly, with the boundaries between them disappearing. Soon everyone will look alike and have very similar traits, and the traits that are desirable will become commonplace.

Fetal selection can also introduce a social divide within a society and between societies. Genetic testing is not economical, and fetal selection is also an expensive process. As fetal selection becomes more popular, soon only the rich will have the privilege of hand-picking their child, while the poor must bear children the natural way. There will also be parents who refuse to select their child, even though they may be able to afford it. This would cause a divide between rich and poor countries, and even a divide in a society between those rich and willing and those poor or unwilling. This divide will create social stratification, where the rich become increasingly better off physically while the poor become comparatively disadvantaged.

Control and Regulation

Current Anti-Discrimination Regulations

In the past, legislators have attempted to prevent genetic discrimination by passing laws to prohibit health insurance providers from doing so. The Ethical, Legal and Social Implications (ELSI) Working Group of the Human Genome Project issued a report called "Genetic Information and Health Insurance" in 1993, in which the work group suggested that people should be eligible to receive health insurance regardless of their past, present or future health status. Two years after that, the ELSI Work Group, together with the National Action Plan on Breast Cancer (NAPBC), created guidelines for federal and state legislature to prevent genetic discrimination in health insurance. Their recommendations stressed that written authorization from an individual must be required for each separate disclosure of genetic information, and that the authorization should specify the recipient of the disclosed information (NHGRI, 2006).

Later, in 1996, the Health Insurance Portability and Accountability Act (HIPAA) became the first step in federal protection against genetic discrimination in health insurance. This act prohibited health insurance providers from "excluding individuals from group coverage due to past or present medical problems, including genetic predisposition to certain diseases" (NHGRI, 2006). Specifically, the act limited exclusions from group plans for preexisting conditions to 12 months and prohibited such exclusions for people previously covered for that condition for 12 months or more. Moreover, it established that having genetic information without proof that an individual actually having the illness does not determine a preexisting condition. This piece of legislature may seem comprehensive, but there are areas that it neglected to address.

While the law prohibited exclusion from coverage under certain circumstances, it did not prevent health insurers from raising the rates for individuals according to their genetic information. Also, nothing in the act prevented insurers from collecting genetic information or limit dissemination of genetic information to insurers. It did not prohibit insurers from requiring its insurance applicants to receive genetic testing (NHGRI, 2006). These loopholes made the act ineffective against unethical insurers who exploit these unaddressed issues in order to take advantage of insurance applicants. It was clear that more issues around genetic discrimination must be addressed.

When a bill, which would ban all health plans from denying coverage or raising rates based on genetic information, failed to pass Congress, President Bill Clinton issued an Executive Order in February, 2000 that prohibited federal agencies from collecting genetic information from employees or job applicants. The Executive Order also prevented hiring and promoting decisions from being based on individualsÕ genetic information. President ClintonÕs Executive Order used the federal government to set an example for taking genetic discrimination in employment seriously. Around this time and afterwards, numerous bills were proposed to Congress to prevent genetic discrimination both in insurance coverage and in the workplace. Thirteen bills were introduced between 1999 and 2003. During this time, 41 states passed laws to limit genetic discrimination in health insurance, and 31 states did the same for the employment context (NHGRI, 2006).

Potential Anti-Discrimination Regulations

It is clear from past legislation that more regulation and control need to be implemented to protect genetic test patientsÕ privacy. One effective way of limiting genetic discrimination is to make genetic information confidential. In this way, sensitive information can be contained, allowing the test patient to decide who can obtain their genetic information. Also, to undergo genetic testing and to disclose testing results would require informed consent from the patient. This process will increase confidentiality and the public confidence in the security of their genetic information, as well as the willingness for individuals to receive testing. Thus, an individualÕs genetic information can be controlled, allowing its use to be limited to counseling and treatment for those who already have genetic diseases or preventative measures for those with propensity towards certain genetic diseases.

Fetal Selection

While laws exist for issues regarding genetic discrimination, there are currently no legislation regarding prenatal analysis and fetal selection. Usually the parents are the ones deciding whether or not to undergo prenatal analysis or fetal selection. With the lack of formal regulation, these decisions become based on personal ethics and preferences. Since each individual has a different set of ethics and morals, it is hard to legislate on fetal selection without violating someoneÕs ethical concerns. Thus, perhaps the best course of action is to leave the decision up to the parents, because, after all, it is their child.

However, there is a possible solution to reduce the social stratification resulting from the uneven availability of the analysis and selection process due to price. The government could subsidize couples who want to choose their child, but are too poor to afford it. This way, at least those who want to select desirable traits for their children will be able to. Of course there will still be those who oppose fetal selection, but in their choice to oppose, they should already understand that selection will be commonplace sooner or later, and it is up to them to weigh the pros and cons for not selecting their children. By making the selection technology more available, the social stratification can be alleviated.

Conclusion

As new technologies and techniques continue to develop, ethical issues will always arise alongside them. It is impossible to avoid those issues, such as genetic information privacy and fetal selection in this case. Even though issues arise, that does not mean the technologies are bad. It simply means that society as a whole must be able to control and regulate these new technologies so that these issues can be resolved. Only then can these new technologies be the most effective in improving and benefiting society.

Bibliography

Berkeley Lab, What is Genetic Testing? [http://www.lbl.gov/Education/ELSI/genetic-testing.html] , Accessed May 28, 2006.

Council for Responsible Genetics, Genetic Testing, Discrimination, And Privacy, [http://www.gene-watch.org/programs/privacy.html] , Accessed June 7, 2006.

GeneTests, GeneTests Web Site, [http://www.genetests.org/] , Accessed May 28, 2006.

Genetic Health, Genetic Testing, [http://www.genetichealth.com/] , Accessed May 28, 2006.

Kalfoglou, Andrea L., et al, Opinions about New Reproductive Genetic Technologies: Hopes and Fears for Our Genetic Future, [http://www.dnapolicy.org/resources/OpinionsAboutNewRepro.pdf] , Accessed June 8, 2006.

Lodish, Harvey, et al, Molecular Cell Biology, 5^th ed., New York, W. H. Freeman and Company, 2003.

MSN Encarta, Genetics, [http://encarta.msn.com/encyclopedia_761563786_11/Genetics.html] , Accessed June 8, 2006.

National Human Genome Research Institute (NHGRI), Genetic Discrimination in Health Insurance, [http://www.genome.gov/10002328] , Accessed June 7, 2006.

National Institute of Health, Genetic Testing, [http://www.nlm.nih.gov/medlineplus/genetictesting.html] , Accessed May 28, 2006.

Thieman, William J., Palladino, Michael A., Introduction to Biotechnology, San Francisco, California, Pearson Education, Inc., publishing as Benjamin Cummings, 2004.

United States Department of Health and Human Services, Medical Privacy - National Standards to Protect the Privacy of Personal Health Information, [http://www.hhs.gov/ocr/hipaa/finalreg.html] , Accessed June 7, 2006.

Nanoparticles

Nanotechnology covers a broad range of smaller technologies and processes that focus primarily on building useful products at near nanometer size, typically 1 to 100 nanometers. To provide an idea of this size with relation to larger, well known objects, a single nanometer is approximately the length of 8 consecutive atoms, and the width of a human hair is 80,000 nanometers. Regulation of nano-sized particles must take into consideration the particle size. The danger of nanoparticles is not proportional to mass, as current regulations enforce. Due to their extremely small scale, nanoparticles may cause a greater danger than particles of significantlylarger size due to their greater relative surface area and other toxicological characteristics (Royal Society of Engineering, 2006).

Current Nanoparticle Products

The use of synthetic nanoparticles and nanotubes is relatively uncommon within the marketplace; however, some products contain these materials and the packaging does not reflect the contents. Currently, products such as anti-static packaging, self-cleaning surfaces, and most significantly, cosmetics, are sold without the disclosure of the harmful effects that may be contained within (Royal Society of Engineering, 2006). A product that is well known for its mysterious properties is stain-repellent clothing, which uses nanoparticles to defend against liquids in a manner similar to the raindrop deflecting surface of a peach (Nanotech Now, 2006).

Problems And Concerns

Exposure And Hazards

Ultra-violet sunscreens are currently sold as a cosmetic product, some containing nanoparticles that both do not fully fit within the correct category, and do not include ingredients that have been fully tested and assured safe. Should such cosmetics be applied to the skin, there is a danger whereby these particles could pass through the skin at a location of sun-damage. The exhaustive testing of nanoparticles requires that every possible use of the product be tested. Even if the use of nanoparticles within sunscreen does not cause dangerous particles to pass through the skin, there is still a danger caused by unexpected effects after the disposal of such materials. Concern having to do with exposure to nanoparticles and nanotubes is becoming an issue within workplace environment and academic research facilities (Royal Society of Engineering, 2006). Currently, the regulation of such nano-sized contaminants has been the responsibility of employers and not of any agency able to oversee and specify the specific requirements that must be obeyed in order to prevent health hazards.

In an article recently published by the University of California, Los Angeles, Dr. Andre Nel and his coworkers at the David Geffen School of Medicine described a technique for determining the potential risks of nanoparticles (UCLA Healthcare, 2006). Predictive Toxicology is the technique of exposing a sample of living cells to a specific set of nanoparticles and analyzing how the cells react. Using this process, a sample of nanoparticles can predict the likely effect in a full sized specimen. Nanoparticles must be tested in precaution to their effects on numerous organs, tissues, and fluids. To be assured that no danger is present, Predictive Toxicology is a method that can be used in large scale and in an efficient manner.

Exposure to larger contaminants is an easier process to regulate as the mass of the particle can be measured in less sophisticated manners. Contamination of nanoparticles and nanotubes due to either human error or equipment malfunction could cause contaminants to be airborne, and with diameters within 100 nanometers, this contaminant could both be unseen, and unknown to those exposed.

Asbestos Case Study

Asbestos fibers, found in building insulation, is a commonly known contaminant that causes mesothelioma (lung cancer) when inhaled into the lungs. Currently, asbestos is the only nano-sized fiber that is measured in terms of quantity rather than by mass. The size of asbestos fibers range from 73 nanometers and larger, though the greatest concern are fibers that are between 250 nanometers and 8000 nanometers (8 micrometers). This range is most likely to be both inhaled and cause the greatest damage once residing within the lung (Toomey, M, Heimlich, J, 2006). Asbestos was first considered a cause of death in England in 1889, 32 years after asbestos based products were introduced. It was not until August 1, 1984, that the Asbestos Regulations were enacted and put into practice, setting forth an effort to remove asbestos, rather than reducing exposure by primitive methods such as improved ventilation (London Hazards Centre, 1995).

Testing Environments For Nanoparticles

Modern technologies and methods for analyzing 100 nanometer structures and smaller such as electron microscopy are fully available for testing both the contamination of asbestos and nanoparticles. It is extremely important to prevent the 126 year timespan that was required in order to stop using and begin removing asbestos in England. The introduction of nanoparticles in mainstream products is a reasonable cause for concern if practiced without regulation. Should a product such as asbestos be introduced in today's society without proper consideration, the same effects would be realized in far less than 126 years, and without recall, would have global consequences far higher than could be imagined in 1857.

Other sources of nanoparticle contaminants in everyday life are not as obvious as they are common. Simply cooking can cause airborne contaminants on the nanometer scale that can be inhaled and cause various degrees of mild illnesses. In industry, the use of welding and soldering equipment is known to be toxic after long exposures, yet these large particles are measured on a mass scale (Royal Society of Engineering, 2006). The idea of adding nanoparticles directly within the food industry is not completely out of the question, as there may be benefits. The notion of consuming a food product that contains asbestos is surely unacceptable, but only after research and case studies have proved that a danger exists. With proper evaluation of possible effects caused by nanoparticles, it may be possible to consider some synthetic particles as being consumable and even beneficial.

Improper and Unfair Use

Without regulation and care for the good of mankind, society could choose to use nanotechnologies for profit, like a new product that is just begging for a market. The distant future is larger than the concept of selling a product; our future is the destiny of humanity itself, and any ethical individual would not choose to sell humanity to the highest bidder.

The notion of a stigmatization has been put forth whereby individuals without access to future technologies will be discriminated against, as though they were lesser beings (Royal Society of Engineering, 2006). Another ethical issue concerns an Olympic athlete's rights to use such technologies and whether it would be possible to ban such actions. In a society where medications are only accessible to those who have the financial means, others may be at a serious lifelong disadvantage. These however, are not problems of the future, but rather problems that we deal with today: only wealthy individuals can afford their own jet aeroplanes, the presence of performance enhancing drugs among Olympic athletes is an ongoing issue, and no one can honestly say that a liver has never been sold to the highest bidder. The truth is that the fears we have about the future are only scaled fears we have in the present, where we are only fearing we will not be able to solve the issues of today.

A concept that has been discussed for future of nanotechnology has to do with the order in which technologies are developed (Royal Society of Engineering, 2006). Should one company be able to market a new technology prior to a competing environmentally friendly company, a lack of haste may produce global failure. Without careful planning and consideration for the global effects of technologies entering the marketplace, products may be introduced that could prove to be more detrimental than useful. Should a single product be influential towards the misconstruction of consecutive products, nanotechnology could quickly jump into the marketplace with consequences incomparable to asbestos.

Control And Regulation

Considerations Of Regulation

Predicting how to regulate the use of nanometer sized objects is a difficult task at the present. Short term requirements are easier to regulate as the products in question have materialized. The rugulation of products that could exist half a century in the future is an extremely difficult talk to consider. Regulation can include the way in which materials are handled within the workplace, how they are used after purchase, and what becomes of them after they are no longer needed. No establishment is currently able to set forth laws for the distant future, as a lack of information prevents such laws from being put into placed.

Assuming for a moment that nanotechnology were both fully possible and perfectly safe, the question of what the first direction taken in order to better society becomes pertinent. Current environmental concerns would demand attention in the United States. In countries such as Zambia, where the AIDS virus tears countless families apart, the primary task is to simply stay alive. Lastly, if a businessman were asked what he would like nanotechnology to do for him, his response might not even involve the benefits for an entire country. Given the current state of the world and the current neglect to close the technological divide between various countries, the addition of nanotechnology to countries able to produce such materials has been said to create a nanodivide. Countries unable to produce products at the same complexity as the forerunners will be further separated by the nanodivide (Royal Society of Engineering, 2006). Since Nanotechnology enables additional benefits and the countries at the leading edge of technology will most certainly be reaping the rewards firstly (assuming there is sharing of knowledge), the ethical question is what the leaders of technology will choose to do with their success.

Future Uses

Nanotechnology is either the new science of technology, or a problematic field of technology, depending on supporting facts of the given opinion (Royal Society of Engineering, 2006). No matter the actual result, the truth is that the future has yet to occur, and the actions that might cause inexpressible good or unspeakable harm have yet to unfold. Although the specifics of how the technologies will function are not blueprinted, we are able to begin formulation of benefits we would like to see in the future. Ethical treatment of human life quickly comes into play while considering who should reap the rewards of technology in the future.

The military is looking forward to upcoming nanotechnologies in order to exploit new attributes in the battlefield. Currently, new textiles fibers are being developed by the US Army's Soldier Systems Center, Natrick, that will have higher durability and greater strength than previously available (Natrick Soldier Systems Center, 2006). Advances such as these will secure victory to armies able to develop and train soldiers with this new battle tactic. The US Air Force is currently conducting predictive toxicology research to determine the safety of nanoparticles within likely future environments for both soldiers and citizens that may be at risk (US Air Force Biosciences and Protection Division, 2006). The United States Air Force currently dedicates efforts in order to research the use and ramifications of Cellular Dynamics, Predictive Biotechnology, and Predictive Toxicology. The efforts of the Natrick Laboratory, the U.S. Air Force's Biosciences and Protection Division, and several other military funded institutions advance the public knowledge of nanotechnologies as a side effect of advancements in military strength.

Correct Use

Although the concept of defending one's country is a noble one, it can be seen as only assuring short term results when the need to deter war in the first place is a more pressing issue for the long term. In 1945 the United States used a newly developed technology to end a war with Japan. Since then, the control of nuclear technologies have been a fear that had yet to be resolved. The sophistication of chemistry, physics, and various sciences were at a point where if the United States had chosen not to create such a technology, another country surely would have. It is not simply possible to hide from the future like an ostrichÕs head in the sand; nor is it a question of who can develop the most advanced weaponry in order to destroy all others. The responsibility for the future is to create technologies that prevent war, that overcome hatred, and that can bring various groups of people together.

Efforts to improve the most important areas of society should be made first and foremost and the regulation of all products should be set forth in order to prevent misuse. In order to encourage long term positive effects, the most reasonable action would be to put into place global initiatives to support and encourage nanotechnologies that promote a global improvement in order for entrepreneurs to be encouraged to benefit a global society rather than seeking to satisfy a specific niche within a country. It is the global society that the most important beneficiary to future technologies and therefore the most logical goal to seek is the wellbeing of the entire planet. With careful planning, it is possible to help the individuals that need the most help in the long term, such as Zambia, and every other disadvantaged country.

Misconceptions And Embracing The Future

In a world destined to have a great increase of technology in everyday life, nanotechnology is seen as the ability to decrease the size of current electronics in a perhaps intrusive manner (Royal Society of Engineering, 2006). The issue of being tracked by means of future product identification should be no more alarming than the fact that supermarket club cards might be tracking buyer preferences today (Weise, E, 2000). The wish to remain completely anonymous during everyday actions does not cause individuals to want to regress to the middle ages, when their lives were completely isolated from the distant world. The desire is a limitation where the privacy of every individual is requested. An invasion of privacy is not being planned by the makers of new technologies, yet there is an issue within society, a fear that is completely independent of technology; a fear of information. If accusations involving privacy issues having to do with supermarket club cards is valid, than the worst that will result is that supermarkets are maintaining databases. Nanotechnology will not enable supermarkets to maintain any more detailed databases due to the fact that an authority would step in when supermarkets began making clearly intrusive efforts. Individuals suspicious of who might be able to find out that they purchased orange juice on many years earlier are misplacing their paranoia, which can be neither assisted nor prevented with the development of future technologies. On the other hand, individuals who fear that establishments are collecting information about their lives should be interested in resolving those specific privacy concerns rather than attempting to convince technologists of the evils of technology.

Technological advancements can not be prevented. The ability to engineer nanometer scale products at ever increasing complexity is the focus of numerous laboratories today. Rather than attempting to discover a logical way of denying the existence of future technology, we must embrace it. This, however, does not mean that we have no voice for future developments. While accepting that technology will arrive, we can focus on efforts for what human beings should do in order to best utilize these new advancements. Proper planning can allow for better realization of what is truly needed, and what efforts are required for those technologies to become reality.

Bibliography

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Nanotech Now, Current Nanotechnology Applications, [http://www.nanotech-now.com/current-uses.htm] . Accessed May 10, 2006.

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Accessed May 16, 2006.

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US Air Force Biosciences and Protection Division, HEPB Applied Biotechnology Branch, [http://www.hep.afrl.af.mil/HEPB/] . Accessed May 20, 2006.

Weise, E, 2000, "Itentity Swapping Makes Privacy Relative": USA Today (December 6, 2000).

Quantum Computing

What is Quantum Computing?

Quantum Computing applies the wave nature of quantum effects towards computation. Quantum phenomena start becoming significant as components reach nanometer scales, not necessarily subatomic sizes. While quantum computing promises vast computing power, classical electronic computers are still necessary to supplement the human-computer interface.

Computing devices are shrinking to ever smaller sizes. Electronics companies are already observing unwanted effects of quantum mechanics on smaller circuits.

Operations of Quantum Computer

The quantum bit, or qubit, is the fundamental unit of storage, or memory, of a quantum computer. Classical computers represent memory as an ordered sequence of 1's and 0's, the binary digit, or bit. A bit represents a distinct 0 or 1, and nothing more. A qubit also represents a 1 or 0, but instead of discretely representing a one or zero, the value of qubit represents a probability of being either 1 or 0, as strange as it sounds. Qubits can be implemented by any substance that exhibit quantum-like behavior. These substances can include subatomic particles, atoms, or large molecules.

Qubits collected into an ordered manner form registers that can represent larger numbers, capable of representing all its possible combinations of 1's and 0's in a probabilistic manner. This fusion of all its possible combinations, or states, is known as superposition. Quantum computing derives its immense computational power from this superposition of states -- a quantum computer is operating on all possible expressible numbers simultaneously.

Quantum gates provide the control mechanism for the changes in state of a quantum computer. In essence, a collection of quantum gates constitute a quantum computer's programming. The configuration of quantum gates guides the change of states in qubits towards the desired answer.

A quantum computing program starts with the device in a particular initial state, setting the initial probability values of the qubits. The quantum gates are applied to yield an end state that is read as the answer. Setting up the initial states may require other means, such as classical electronic computers.

Qubits hold a value indicating the probability of a 1 or a 0. Reading the value of a qubit means measuring its quantum state, at which point the wave functions collapse into either a 1 or 0. The probability aspect means that the measured value randomly yields a 1 or a 0, with a bias towards either depending its probability. While the answer yields a discrete value as an answer, the measured value is probably the answer, and not definitely the answer.

Classical computers can coordinate the results of quantum computing devices. The uncertainty of the result can be reduced by statistical sampling, running the same quantum program multiple times or by running the same program on multiple quantum computing devices at the same time.

In 2001, IBM constructed a functioning 7-qubit quantum computer that factored the number 15 into 3 and 5 (IBM, 2001). This experiment not only demonstrated the feasibility of quantum computing, but also validated Shor's algorithm, a factorization algorithm that requires a quantum computer.

Problems With Quantum Computing

The immense computational power afforded by quantum computing introduces problems particular to cryptography as a security mechanism. Most of cryptography relies on using mathematical operations where attempting to "break" the security becomes an intractably long task for classical computers completing one operation at a time. A quantum computer can perform all possible operations simultaneously at a time, defeating the "time barrier" cast by encryption.

Cryptography

Computer cryptography is a method of transforming one set of meaningful numbers into another set of otherwise meaningless numbers in a deterministic and reversible manner based on the input of another set of numbers, the key. This transformation into meaningless numbers is known as encrypting, while the inverse of transforming the meaningless numbers back into the original meaningful numbers is decrypting. Both encrypting and decrypting require the appropriate key, without which the inverse transformation, the decryption, yields a set of numbers just as meaningless without the key. Keeping the key secret is critical in ensuring that the original message, the meaningful numbers, are not revealed to inappropriate parties.

Cryptography is used in securing the contents of sensitive information. Such sensitive information include identification material, financial information (e.g. banks, stocks, loans), trade secrets, and military documents. Such types of information demand denial of access to unauthorized parties. Encryption ensures that even if unauthorized parties could get the particular sequence of 1's and 0's, the data remains meaningless without the key, which is presumably kept even more secure.

Public Key Cryptography

Public key cryptography relies on a set of asymmetric algorithms which utilize a pair of keys, one private and one public. The private key, designed to be kept secret and unshared, is used for signing any message and decrypting personal messages. The public key, designed to be shared without restriction, is used for verifying signatures and for encrypting personal messages intended for the private key holder. The asymmetric nature of the keys means that there is no direct way of obtaining the private key from the public, but the public key can be easily created from the private key.

The algorithms involved typically utilize functions that are relatively easy to calculate "forward", but very difficult to solve "backwards". One common algorithm is the multiplication of large prime numbers, since the inverse operation, the factorization of very very large numbers, cannot be solved easily. As there is no "clever" shortcut technique to factoring, the best solution to factoring still involves a technique known as "brute-force search" -- trying every single possible number, one at a time, until an answer is found.

Another algorithm utilizes discrete logarithms. The "forward" algorithm involves exponentiation, and the inverse operation, the discrete logarithm, is likewise difficult to solve, also depending on brute-force search.

The strength of encryption is its ability to remain uncompromised in the face of active attacks. In the two algorithms above, the strength relies on the fact that trying to solve the inverse operations is very difficult and that a brute-force search takes a very long time. For example, in the primes multiplication example, a binary number that is 1024 bits in length (roughly 300 digits in decimal form) would take several thousand years for even a decently fast contemporary computer to find the answer to compromise the security of the key. In most cases, increasing the key by one extra bit increases by a factor of two the potential key space, and thereby the time for searching. The infeasibily long time of a brute-force search ensures the integrity of encrypted data.

As cryptography is used in the dealings of human activities, the large time span involved compared to human lifespan means brute-force searching is pragmatically an impossible task.

Factorization

A quantum computer solves a factorization problem with its superposition of quantum states in a qubit. In short, many factorization operations occur simultaneously in the qubits. Quantum computers can calculate the factorization of a number in far fewer steps than a classical computer. The speed of factorization threatens the security of encryption schemes that rely on a multiplying large prime numbers. One proven algorithm for factorization on a quantum computer is Shor's Algorithm, which requires 2n qubits to factorize a key with n bits in one step. In comparison, a classical computer would need the full n bits and 2ⁿ steps to exhaustively search the key space.

The ability to compromise public key cryptography means the ability to discover the private key, and thereby the ability to masquerade as the key holder -- identity theft. Signature can be forged, sensitive information is no longer secured, and identity cannot be proven.

Control And Regulation

Through regulation, the beneficial aspects of quantum computing can be harnessed and used to benefit society via quantum cryptography. Banning a technology is a less effective method of regulation, but is a popular mechanism to attempt to limit dangerous or undesirable activities. Proper regulations can be used to restrict the potential consequences of activities for the short term. Inevitably as computing technology advances, quantum phenomena must be accommodated, and quantum computing exploits these phenomena for additional computing power. Attempting to squelch the progress of quantum computing threatens progress of computing technology, which would be detrimental to a world increasingly depending on information processing.

Quantum Cryptography

Instead of fighting quantum computing, it can be used to improve information security. The quantum mechanical nature of quantum computers can be used to secure communication channels. For example, the polarization of light can be encoded in such that any attempt to "eavesdrop" on the communication affects the polarization itself due to the uncertainty effects of measurement on quantum states. Simply attempting to eavesdrop disrupts the communication medium. The intended recipient can compare the measured signal against the expected signal, and detect an in-between eavesdropper if the comparison does not match.

Alternatively, a transmitted message can be encoded such that an attempt to read the message without the appropriate key results in complete destruction of the message. Quantum wave functions without proper guidance of the key would collapse to completely meaningless gibberish. Such a scheme is useful for highly sensitive material.

Banning

A typical legislative reaction to dangerous technology is a ban on either using or exporting such technology. Bans have been applied to nuclear technology (peaceful and military), supercomputers, and cryptography. Many of these bans typically fail over time, as loopholes are discovered and technology continues developing in other nations. As an example, while India was not permitted to purchase supercomputers from the USA, they still purchased large numbers of relatively weaker desktop computers and harnessed them all together into one large massively-parallel supercomputer, to be used in simulation of nuclear processes. The Rijndael cipher, ultimately adopted as the Advanced Encryption Standard (AES) used by the US government, was developed by Belgians.

The security of information and finances relies on strong encryption. As aging cryptographic systems are made obsolete by quantum computing, quantum computing devices themselves may be needed to secure these areas. Banning the export or use of quantum computing may hinder or compromise the integrity of critical services worldwide.

Regulation

Regulating in the sense of placing limits on the manufacture, use, and application of quantum computing would be a serious hindrance to potential benefits quantum computing could offer. One of the first suggested applications of quantum computers were in the simulation of quantum physics. Other areas of science and research could benefit from the computational boost afforded by quantum computers.

Regulations would only be good for the short term, slowing the spread of quantum computing, to provide some breathing room until more suitable policies are in place. While limiting the existence of quantum computing limits the detrimental side effects, restrictions would similarly limit beneficial effects. Quantum computing opens a new door to computational capabilities, just as the transistor did. At the time of the invention of the transistor, very few people could have anticipated the wide and varied uses for which it would be used. With proper regulation, quantum computing will soon initiate a paradigm shift which will permanently change the worldÕs concept of computing for the better.

Bibliography

A. J. Daley, J. I. Cirac and P. Zoller, "The Development of Quantum Hardware for Quantum Computing" [http://th-physik.uibk.ac.at/qo/news_items/200507_Quantum_DCZ/Quantum_DCZ.html] Accessed June 9, 2006

Center for Quantum Computer, Quantum Computing, [http://www.qubit.org/library/intros/comp/comp.html] . Accessed June 9, 2006.

Centre for Quantum Computing, Introductions and Tutorial, [http://www.qubit.org/library/introductions.html] . Accessed June 9, 2006.

Department of Atomic Energy, Government of India, Nuclear India, [http://www.dae.gov.in/ni/niaug01/niaug01.htm] . Accessed June 9, 2006.

IBM, IBM's Test-Tube Quantum Computer Makes History , [http://domino.research.ibm.com/comm/pr.nsf/pages/news.20011219_quantum.html] . Accessed June 9, 2006.

Nechvatal, J., 2001, "Report on the Development of the Advanced Encryption Standard", Journal of research of the National Bureau of Standards, v.106.3, pp 511-576.

Glossary

A:Abbreviation for Adenine

AES:Acronym for Advanced Encryption Standard

APHIS:Acronym for Animal and Plant Health Inspection Service

C:Abbreviation for Cytosine

cDNA:Abbreviation for Complementary Deoxyribonucleic Acid

DNA:Abbreviation for Deoxyribonucleic Acid

ELSI:Acronym for Ethical, Legal and Social Implications

EU:Acronym for European Union

G:Abbreviation for Guanine

GM:Acronym for Genetically Modified

HIPAA:Acronym for Health Insurance Portability and Accountability Act

NAPBC:Acronym for National Action Plan on Breast Cancer

Oligo:Abbreviation for Oligo Deoxynucleotide

PCR:Acronym for Polymerase Chain Reaction

Qubit:Abbreviation for Quantum Bit

RFLP:Acronym for Restriction Fragment Length Polymorphism

RNA:Abbreviation for Ribonucleic Acid

rRNA:Abbreviation for Ribosomal ribonucleic Acid

T:Abbreviation for Thymine

tRNA:Abbreviation for Transfer Ribonucleic Acid

U:Abbreviation for Uracil

UCLA:Acronym for University of California, Los Angeles

USDA:Acronym for United States Department of Agriculture