Biotechnology

Happy Mother’s Day to all the Moms!: Law, Science, Technology and Beagles

Angela Fralish, MJLST Guest Blogger

Beagles are well-known as a quintessential family dog because they love humans and listen to their owners (most of the time). What is less known, is that those same traits are the primary reasons they are used in 95% of canine medical experimentation. Although, beagles are not biologically comparable to humans, they are compliant people-pleasers, making them ideal subjects for scientific experiments.

This reality is a hard pill to swallow for animal lovers and scientists alike. To scientists, research beagles are a necessary evil decreasing the pain and suffering of humans. To advocates, beagles are victims of unspeakable cruelty.

One law bridges the divide between these opposing views to help the beagles. The Beagle Freedom Bill, created by the Beagle Freedom Project (BFP), forges a compromise between animal rights lawyers, scientists and medical technologists. The Bill asks that ”tax-payer funded laboratories offer up the “experimentally-spent” dogs and cats for public adoption through rescue organizations.” In other words, once the beagle is no longer used for research, the dog is given a home instead of euthanasia. Minnesota was the first state to sign the Bill into law in 2014, and since then, 5 more states have joined. Currently, 5 additional states are considering adopting this law as well.

In addition to legislative measures, the BFP has found other ways to help research beagles. They have created new technology such as the Cruelty-Cutter app which helps shoppers easily scan products for humane animal testing, and sued the USDA demanding restoration of scrubbed animal records. The Beagle Freedom Project is a leader in animal science law and a great example of how lawyers, scientists and technologists can work together for the greater good of both humans and animals.

Scientists are working to replace this “necessary evil” as well. According to Dr. Teresa Arora’s article Substitute of Animals in Drug Research: An Approach Towards Fulfillment of 4Rs, research methods are being developed that are “superior to using animals to learn about human disease or predict the safety of new drugs [and include] stem cells, microdosing, DNA chips, microfluidics chips, human tissue, new imaging technologies, and post-marketing drug surveillance.” There is even a Center for Alternatives to Animal Testing at John Hopkins University and the NC3R in the UK.

For an employee of medical research looking to carve out meaning in their every day workweek, helping research animals through new collaborative measures is one way to answer the call. As a lawyer, scientists or technologist, you can help develop policy, arbitrate between groups, hold violators accountable, assist in medical technology development, vote for the Beagle Freedom Bill or adopt a research beagle. According to Congressman Earl Blumenauer, “members of Congress are realizing that protecting animals is not just the right thing to do, it’s also developing to become potent politically.” Congress will need help understanding the relationship between animal models and science in order to make improvements. That help will come from people who work in these fields on a daily basis.

The Beagle Freedom Bill highlights the plight of animals languishing in labs and promotes cruelty-free lifestyle choices everyone can make. Now that BFP has opened the door, it is time for all of us to show a little gratitude to the beagles for their sacrifice in advancing medical science such as chemotherapy and insulin. We can do this in our own unique ways, and although we can’t change the world for all beagles, for some beagles, we can change the world.

As Mahatma Ghandi stated, “The greatness of a nation and its moral progress can be judged by the way its animals are treated.” I hope ours is one of progress.


Is there a Reasonable Pot of Gold at the End of the Rainbow?: Legal Ethics, Brain Stimulation and Neuroprosthetics

Angela Fralish, MJLST Invited Blogger

As expert bioethicist Dr. Walter Glannon remarks, “Interventions in the brain raise general ethical questions about weighing the potential benefit of altering neural circuits against the potential harm from neurophysiological and psychological sequelae.” Laws governing human subject research for these interventions mandate that “risks to subjects are reasonable in relation to anticipated benefits.” Modern brain technologies in neuroprosthetics make the harm/benefit analysis challenging because there are many unanswered questions surrounding neuroprosthetic implementation.

So what is a neuroprosthetic? Neuroprosthetic devices use electrode muscle and nerve stimulation to produce muscle contraction and restore motor function. Basically, since the brain controls the body, a device is put on the brain telling it to make the body work. Through neuroprosthetics devices, a person may restore movement by bypassing nervous system damage which allows greater independence in daily living. To someone whose dependence is caused by non-working body parts such as blindness, Parkinson’s or spinal cord paralysis, this technology holds great potential for a higher quality of life.

However, the use of a neuroprosthetic may involve negative side effects. Some are more behavioral such as gambling and addiction while others are biological like pain from overstimulation. For instance, Steffen K. Rosahl discusses how “relatives and friends sometimes complain of personality changes in the patient, ranging from transient confusion and bradyphrenia to euphoria or depression.” Further, implanting the device is not an exact science and if done incorrectly, a completely different result may occur such as loss of speech or other unknown changes. Research also indicates that an autonomy-capable neuroprosthetic can influence the brain if its actions go unchecked, making it a threat to the user and his or her surroundings. There are serious risks and concerns associated with the use of neurprosthetic technology.

The juncture of law, science and research is especially prevalent in modern neurological research. The cochlear implant is one such example. While the implant has allowed many children all over the world to hear for the first time, it has also led to shock and convulsions. In Sadler v. Advanced Bionics, Inc., the plaintiffs won a $7.25 million verdict in a negligence action when the manufacturer failed to adequately test or obtain approval for a new material in one of their implant designs. The unanswered legal questions in this case evolved around product recalls for implants, overcoming federal preemption, regulatory laws governing research submissions and product liability. Exactly how does a business recall an implant in someone’s brain!?

Clearly, legal-science partnerships are in high demand in advancing neurological research. Scientists need to understand the law and lawyers need to understand science. This principle is critically important when research institutions weigh the risks and benefits to subjects before that device ever hits the market. As Stephen Breyer, associate justice of the U.S. Supreme Court, stated, “In this age of science, we must build legal foundations that are sound in science as well as in law. Scientists have offered their help. We in the legal community should accept that offer.”


Bet on Science: Transplantation Without Human Donation

Rhett Schwichtenberg, MJLST Staffer

There is no question that the American organ donor process is flawed. An individual makes the selfless decision to become an organ donor, but upon death their organs remain in their body.  Although the law states that the donor is the only person that can revoke an anatomical gift, hospital practice will almost never harvest an organ without the family’s consent. A recent article published in the Minnesota Journal of Law, Science & Technology has proposed a solution to the 120,000 Americans waiting for organs: paying the donor $5,000 per organ. This solution could have many positive impacts, but many negative ones as well.

First, this solution will have a strong influence on the socio-economically poor, as an individual could make up to $40,000 for their family by donating the eight organs currently eligible for donation (not including hands and face, added in 2014). This amount of money would put low-income families in a horrible position where they might choose to forego medical treatment in order to provide for their family. This reward manages to take the decision away from the socio-economically poor by incentivizing death. Though middle-class individuals might also elect to choose money over treatment, the decision is based more on want than on need.

Second, with advancing technologies, organs harvested from fatalities will become less frequent. Take, for instance, the new technology of self-driving cars. In the near future, self-driving cars will dominate the automotive industry. Given that in 2016, 13.6 percent of organ donors died in a road accident, the number of available organs will only decrease in years to come. In a very recent article, Elon Musk stated that nearly all new cars will be self-driving within ten years.

Although self-driving cars might be farther down the road than Musk declared, scientists have made a major breakthrough in the biological field. Researchers have successfully used an enzyme to integrate human stem cells into developing pig embryos. This technology makes it possible to edit a pig’s DNA sequence coding for a certain organ, and insert code that would “theoretically grow a human organ for patient transplantation.” Artificially creating human organs would single-handedly eliminate the need for organ donation.

In addition to biological advancements, the tech industry has been a major player in organ creation. The use of 3D printing in the medical industry was instantly commercialized for its ability to create prosthetics and fake organs to practice surgical procedures. Today, Wake Forest Institute for Regenerative Medicine has developed a 3D printer capable of “print[ing] tissues and organs by utilizing cells as the main filament or component of the 3D printer.” Using an individual’s own cells to 3D print new organs for them would also eliminate the need for organ donation.

With such large advancements in science and technology, I do not believe there is a need to incentivize organ donation. This would result in a disparity between rich and poor and create situations where an individual has to choose between life or death for all the wrong reasons. Until science reaches the point where human organs can be created, individuals who wish to donate their organs upon death need to take steps to ensure their wish is fulfilled. Such steps include preparing an advance directive or a living will, signing a donor card, obtaining a health care power of attorney, and informing family members of their decision. Paying someone for their organs is simply not the solution.


Exploring the Final Frontier—The Relevance of Brain Imaging in Litigation

Mary Riverso, MJLST Staffer

Human curiosity and technological advancements have led to the exploration of the ends of the earth, the deep seas, even outer space. We have learned so much about the animals we live amongst, the nooks and crannies of planet Earth, and our role in the universe. But as we continue to explore farther and farther outward, we often overlook how little we actually know about ourselves.

The human brain remains predominantly mysterious and unknown. Neuroscientists continue to attempt to map the brain, to assign different functions and behaviors to the different regions of the brain supposedly responsible for them. However, a thorough understanding remains nearly impossible given the intricate circuitry of brain functioning. While certain areas of the brain are sometimes responsible for discrete tasks, complex functions are not exclusively localized. It is more accurate to think of the brain as composed of neuron circuits – the different regions constantly connecting with one another via neuron circuits to work together to process information and complete tasks. Technological advancements now allow for many groundbreaking and non-invasive means of observing the functioning brain. For example, devices administering scans for functional magnetic resonance imaging, or fMRI, monitor blood flow to detect areas of activity. Whereas an electroencephalogram, or EEG, is a test that measures and records the electrical activity of your brain. Finally, magnetoencephalography, or MEG, captures the magnetic fields generated by neural activity. As the capacity and means to monitor brain functioning expand, the potential for successful brain mapping increases. As a result, using brain images resulting from these scans as evidence in litigation becomes more tempting.

The potential for brain imaging to be used as expert evidence in litigation is already being explored. Criminal defendants, such as Herbert Weinstein, want to use the results from brain scans and tests to show that they are not responsible for their criminal actions due to a physical mental disease or defect. Other defense teams see the potential of brain imaging to aid in assessments of truth-telling. Physicians who administer the tests must be willing to testify as expert witnesses to the results and their medical conclusions. Often times, the physicians probe brain function and analyze energy utilization of the brain and then administer tests of human behavior and mental representations to provide a basis for their medical conclusions. However, a major hurdle for potential neuroscientific evidence is its relevance under Federal Rule of Evidence 401 (“FRE 401”). FRE 401 demands that before such evidence be admitted, it must have a tendency to make a fact of consequence more of less probable. But because the brain remains so misunderstand, it is difficult, or arguably impossible, to draw any exact conclusions that a physical disease or defect in fact caused a behavioral or mental defect.  As a result, courts have come out on either side of the threshold issue in FRE 401 – some have found that the neuroscientific evidence is appropriate for consideration by a jury who can decide what inferences to draw from it, while others find that this kind of evidence is too prejudicial while being only minimally probative and exclude the evidence under FRE 403, and still others allow the evidence but only for limited purposes, such as the sentencing phase of proceedings instead of the guilt phase. As technology continues to advance and neuroscientists continue to learn more about brain functioning, this kind of evidence may become commonplace in litigation. But for now, the admissibility decision seems to be fact-and-circumstance dependent, based on the case, the expert, the evidence, and the judge.


Genetically Modified Foods And The Consumer Quest For Disclosure

Nicholas Ratkowski, MJLST Staffer

In 2000, the Minnesota Journal of Law, Science, and Technology (MJLST) proudly published its first issue, spanning a variety of issues between Patent Protection of Computer Programs to an analysis of the First Amendment through the lens of Jesse Ventura. One Note addressed how genetically modified foods (GMOs) should be labeled, if at all. In the seventeen years since MJLST’s inception, much has changed – how has the landscape of GMO labeling progressed?

In 2000, the principal argument was whether or not GMOs should be specially labeled as such; the author references unexpected concomitant protein allergies and environmental effects as prime concerns. As of 2000, scientists had not identified any negative effects from consuming GMOs. The Note notes different approaches between Europe and the United States, with the former relying on strict disclosure requirements, and the latter ignoring the issue (for the most part). At the time of authorship, “[m]ore than 4,500 GM plants ha[d] been tested, and at least 40 ha[d] passed government reviews” and “as much as 70% of processed foods contain[ed] GM components. The Note “propose[d] that the most appropriate method of resolving the labeling issue involves developing a new, international, voluntary labeling standard for products that have not been developed through genetic engineering techniques or do not contain genetically engineered ingredients.”

Now to the fun part – has anything changed? The short answer is not really. In 2013, Connecticut became the first state to “successfully enact a law requiring food containing genetically modified ingredients to be labeled as such, though it comes with the unusual requirement that four other states must pass similar legislation.” As of 2017, more than 70 bills across 30 states have been proposed in an effort to require labeling of GMOs. Only two states (Vermont and Maine) have joined Connecticut’s lead in forcing disclosure of genetically modified foods. Maine’s disclosure law requires disclosure, but is subject to a litany of exceptions. Vermont’s seems a bit more stringent, but is also easily circumvented. See §3043(d) and §3044 (for example, “Any processed food that would be subject to subsection 3043(a) of this title solely because it includes one or more materials that have been produced with genetic engineering, provided that the genetically engineered materials in the aggregate do not account for more than 0.9 percent of the total weight of the processed food”).

It is perhaps surprising then that GMOs remain mostly invisible to the average consumer in the United States, considering “[m]ore than 70 percent of Americans say they don’t want genetically modified organisms in their food” and “92 percent of Americans want genetically modified foods to be labeled,” according to a 2014 Consumer Reports survey. I’m not smart enough to tell you whether or not eating GMOs has any effect on health, much less whether that effect would be positive or negative. I can, however, posit a theory to explain this paradox, albeit not a novel one – the Pro-GMO lobby is simply too powerful for states to butt heads with in the courts on the taxpayers’ dime. With Monsanto leading the charge, the pro-GMO lobby has spent tens of millions of dollars to fight state-level labeling initiatives. In 2013, lobbyists spent $9,300,000 to prevent GMO disclosure requirements. In just the first quarter of 2014, lobbyist spent another $9,000,000. How can states compete?

If the U.S. ever makes the policy decision to implement widespread labeling requirements for GMOs, doing so will require federal legislation; states have been shown to lack the resources necessary to fight the purveyors of incomplete information that are GMO lobbyists. On the other hand, would labeling have any discernable effect on consumers? Maybe not, but I believe consumers should have the choice to pick what they eat, and how their food is sourced.


Broad Inst. Inc. v. Regents of the Bd. of the Univ. of Cal: PTO to Decide CRISPR Gene Editing Ownership

Jeffrey Simon, MJLST Staffer

The Broad Institute and the University of California will argue claims related to ownership on Patents relating to CRISPR (clustered regular interspaced short palindromic repeats) gene editing technologies. The arguments will be heard on Dec, 6 by the Patent Trial and Appeals Board.

CRISPR technology utilizes prokaryotic DNA segments to confer immunity to foreign genetic elements. CRISPR editing technology has the potential to alter human DNA sequences by removing existing genes or inserting new ones. Moving forward, CRISPR technology has the potential to develop into a form of gene therapy, whereby the human genome can be edited to fortify one’s immune system against infectious diseases or other hereditary issues. CRISPR technology raises ethical concerns, especially relating to the potential use in altering the genes of human embryos.

Although CRISPR technology has been understood for over a decade, the current case revolves around an improvement using cas9 protein that splices DNA at a specific locus. The Broad Institute asserts that patents filed on behalf of the Massachusetts Institute of Technology and Harvard University Researchers (Broad Institute being the eventual assignee of the patents) maintain priority over those owned by University of California. However, the relevant patents have been asserted pre-AIA. Therefore, priority date will be established by date of the invention rather than under the AIA standard of application date. The Patent Trial and Appeals Board (PTAB) initially maintained that the date of invention was properly asserted prior to the patents upon which the challenge was brought. If the decision of the PTAB is upheld, the University of California patents will invalidate the patents held by MIT and Harvard. It’s important to note that both parties are asserting priority date to a previous University of California patent relating to CRISPR technology. The PTAB may determine that both parties failed to prove priority date ahead of the US Patent Application No. 13/842,859, thus invalidating both parties claims.

The Broad Institute is a research institute associated with MIT and Harvard University. It’s unclear how the decision will affect CRISPR technology moving forward. CRISPR technology has attracted lucrative investments from government agencies and private entities alike. Additionally, since the initial patenting of CRISPR, University of California has licensed out the use of CRISPR technology to numerous firms interested in its applications.


The GIF That Keeps on Giving: The Problem of Dealing with Incidental Findings in Genetic Research.

 Angela Fralish, MJLST Invited Blogger

The ability to sequence a whole genome invites a tremendous opportunity to improve medical care in modern society. We are now able to prepare for, and may soon circumvent, genes carrying traits such as Alzheimer’s, breast cancer and embryonic abnormalities. These advancements hold great promise as well as suggest many new ways of looking at relationships in human subject research.

A 2008 National Institute of Health article, The Law of Incidental Findings in Human Subjects Research, discussed how modern technology has outpaced the capacity of human subject researchers to receive and interpret data responsibly. Disclosure of incidental findings, “data [results] gleaned from medical procedures or laboratory tests that were beyond the aims or goals of the particular laboratory test or medical procedure” is particularly challenging with new genetic testing. Non-paternity for example, which has been found in up to 30% of participants in some studies, result in researchers deciding how to tell participants that they are not biologically related to their parent or child. This finding could not only impact inheritance, custody and adoptions rights, but can also cause lifelong emotional harm. Modern researchers must be equipped to handle many new psychosocial and emotional variables. So where should a researcher look to determine the proper way to manage these “incidentalomas”?

Perspectives, expectations, and interests dictating policies governing incidental finding management are diverse and inconsistent. Some researchers advocate for an absolute ban on all findings of non-paternity because of the potential harm. Others argue that not revealing misattributed paternity result in a lifetime of living with inaccurate family health history. These scenarios can be difficult for all involved parties.

Legal responsibility of disclosure was indirectly addressed in Ande v.Rock in 2001 when the court held that parents did not have property rights to research results which identified spina bifida in their child. In 2016, an incidental finding of genetic mutation led a family to Mayo Clinic for a second opinion on a genetic incidental finding. The family was initially told that a gene mutation related to sudden cardiac death caused their 13-year-old son to die in his sleep, and the gene mutation was also identified in 20 family members. Mayo Clinic revealed the gene was misdiagnosed, but the decedent’s brother already had a defibrillator implanted and received two inappropriate shocks to his otherwise normal and healthy heart. Establishing guidance for the scope and limits of disclosure of incidental findings is a complex process.

Under 45 C.F.R. §§ 46.111 and 46.116, also known as the Common Rule, researchers in all human subject research must discuss any risks or benefits to participants during informed consent. However, there is debate over classification of incidental findings as a risk or benefit because liability can attach. Certainly the parents in Ande v. Rock would have viewed the researchers’ decision not to disclose positive test results for spina bifida as a risk or benefit that should have been discussed at the onset of their four-year involvement. On the other hand, as in the Mayo Clinic example above, is a misdiagnosed cardiac gene mutation a benefit or risk? The answers to these question is very subjective.

The Presidential Commission for the Study of Bioethical Issues has suggested 17 ethical guidelines which include discussing risks and benefits of incidental finding disclosures with research participants. The Commission’s principles are the only guidelines currently addressing incidental findings. There is a desperate need for solid legal guidance when disclosing incidental findings. It is not an easy task, but the law needs to quickly firm-up a foundation for appropriate disclosure in incidental findings.


Recent Ninth Circuit Ruling an Important One for State and Local Governments Seeking to Regulate Genetically Modified Plants

Jody Ferris, Note & Comment Editor

Genetically modified plants (GMOs) are and have always been a hot topic in agriculture and food policy.  Since they were first developed, groups have been lobbying at various levels of government to impose regulations on how they are grown or to have them banned outright. A noteworthy decision has come down for those following legal challenges to GMO regulation. In Alika Atay et al. v. County of Maui et al., the Ninth Circuit court in Hawaii has ruled that state and local governments may regulate the production of GMOs in their jurisdictions.

The original suit was filed by GMO proponents after the County of Maui enacted a ban on genetically modified crops.  The court held that federal regulation of GMOs does not preempt state and local regulation after the variety is commercialized. This means that the United States Department of Agriculture holds jurisdiction over all GMO varieties prior to commercialization, which is the period during development and testing before the variety is sold on the market. According to the Ninth Circuit, after the variety is commercialized, however, state and local governments are free to enact regulations, including outright bans of GMO production, without the need to worry about federal preemption.

Interestingly, the county regulations in Hawaii that were at issue in the suit were nonetheless stricken down by the court because the State of Hawaii already has a comprehensive regulatory scheme which the court held to preempt county GMO regulations.  This outcome disappointed local environmental and anti-GMO groups due to their support of the new county level GMO restrictions.  However, the decision will help clarify the respective regulatory responsibilities between individual counties and the State of Hawaii. Despite the disappointment of these groups, the decision that there is no federal preemption on regulation of commercialized GMO varieties is an important one for many of the states in the Ninth Circuit, as there are counties in Washington and California, for example, which have also enacted bans on GMO production.

This decision will likely be an encouraging one for states wishing to enact their own regulations for how GMO varieties are grown and handled.  It is also encouraging for individual counties who wish to enact GMO bans or county level regulations, should state level regulations not be preemptive.  It will certainly be interesting to follow how state and local governments structure any future regulatory activities in light of this ruling.


Copycats to Copycows: The Cloned Livestock Industry Emergence

Ryan Dowell, MJLST Staffer

In the two decades since Dolly, a comically named sheep, animal cloning has remained little more than fiction to the average person. Behind the scenes, however, the field has progressed tremendously.  Success rates today are estimated to be 70% or higher, compared to less than half a percent when cloning Dolly and her siblings. As the technique has been perfected, the obvious result has occurred: animal cloning has become a nascent industry.

Cloning has long been present in human society, in a form that many people may not recognize: plants. From simple home-garden cutting & replanting to industrial-scale cultivation from tissue samples; these techniques produce genetically identical individuals (i.e. clones) used as floral cultivars, tree planting, and especially foods. A large number of plants grown for human consumption are clones—which means that you, dear reader, have probably eaten a clone. Plant cloning has not encountered the same scrutiny as that with animals, perhaps due to its natural occurrence or millennia-long history of human use.

Dolly was merely the proverbial ‘dipping our toe into’ animal cloning. True to the writings of Michael Crichton (or the movies, if one so prefers), it didn’t take long for Jurassic Park-esque attempts to clone endangered and extinct animals. Cloning was not limited to such an idealistic use—a market emerged. Grieving pet owners could, at significant cost, get clones of their beloved pets. Despite the cost (still a five-digit price tag), a market for such services has continued to develop. Further demonstrating the human capacity for expensive animal-keeping hobbies, equine cloning has emerged as a means to “insure that prized horse and its unique qualities.” If one were to stop here, cloning seems to be a niche market for the wealthy.

The emerging cloning industry has not stopped at pets and exotic creatures. With the science complete and industrial production moving forward, livestock cloning is set to erupt in the coming years. A ‘cloning factory’ is opening in China. This factory is intended to produce not only pets and horses, but also prime beef cattle and drug-sniffing dogs. Following the same reasoning underlying farming’s predilection for plant clones, elimination of genetic variations could significantly improve farming techniques—maximizing yield, minimizing labor and resource inputs, matching strains to specific regions, and so on. In a world with mounting concern over the meat sustainability, improvements to production are key and cloning provides the means to significantly advance the field.

In many emerging fields, law and regulation react to the development and often impede progress. Fortunately, the issue of animal cloning has already been addressed—the FDA regulates the field & was essentially prescient. In 2008, the FDA released a guidance stating “meat and milk from cow, pig, and goat clones and the offspring of any animal clones are as safe as food we eat every day.” The FDA examined cloning (also known as somatic cell nuclear transfer or SCNT), under the umbrella of assisted reproductive technologies (ART), which have long been utilized by farmers. The analysis noted that these animals would have essentially identical genetics to the source, unless reprogramming occurred (which can be done with other ARTs); that risk associated with the cloned animals is no different than the source organism. It was noted that cloned offspring have higher risk of adverse health issues early in life compared to offspring from other ARTs. However, none of these issues are unique to clones and other than early-life issues, clones are as healthy as non-clones. Livestock cloning has passed FDA scrutiny  and manufacturing infrastructure is in place; it is poised to develop rapidly.

Public opinions may prove to be the final hurdle for livestock cloning. If one tells a fruit-eater that he or she is eating a clone (or as a botanist might put it the ovary of a clone), the fruit-eater will likely be unaware of this fact and less than pleased that his or her enjoyment of that fruit has been disrupted by the interjection. Alternatively, a substantial portion of the population believes GMOs are not safe for them to consume, which is untrue (see herehere, here, here, and here). A similar scenario to either of these might present itself here: (1) everyone blissfully consumes food without the need for nitty-gritty detail of its origin (since there is no discernable or material difference), or (2) misinformation is allowed to spread and ‘poison the well.’ The deciding factor will likely be education; the current state of affairs presents the opportunity to preemptively educate the public on the FDA’s findings and regulations.

Livestock cloning is poised to expand rapidly in the future and now we face a crucial time in its acceptance: a public educated on the issue will be equipped to fairly determine whether such livestock should be consumed, without a torrent of pseudo-science obscuring the decision. The FDA has examined clones and found them to be nearly identical to non-clones (pun very much intended) in regards to human consumption.

 


Food “Hot Off the Printing Press”: Insights into 3-D Printed Food

Theodore Harrington, MJLST Managing Editor

Would you food hot off the 3D printing press? In Jaspers Tran’s article, 3-D Printed Food, he explores the potential legal issues surrounding the commercialization of 3D printed food. (see here).

The article suggests that “. . . the 3D printer may become the fundamental daily appliance in every household . . . .” The pros are easy to see—As the demand for food increases at an exponential rate, the ability to create food quickly and avoid the current environmental impacts caused by food production would be a game-changer. The benefits here are fairly obvious and easy to wrap our heads around. However, large barriers still remain.

A tougher point for me to grasp is Tran’s suggestion that 3D printing will solve issues related to malnutrition, particularly over-nutrition, or obesity. Tran seems to leap from personalized nutritional food (tailored to an individual’s exact nutritional needs) to an obesity solution. This reminds me of the old adage, “you can lead a horse to water, but you can’t make him drink.”

Even if 3D printers end up in every household, my gut-feeling is that it will be a very long time before people are accepting of the idea of eating food that was just spit out of a machine (although there is a large amount of processing in today’s food, it goes on behind closed doors. Ignorance is bliss.). As Malcolm Gladwell suggests in his book Blink, the way we taste food is as much psychological as it is physical (see example of declining sales in a pork product when a life-like pig was placed on packaging instead of a cartoon pig).

Something to chew on.