Articles by mjlst

Permissionless Innovation or Precautionary Principle: the Policy Menu of the Future

October 31, 2016
3-D Printing, EU Law, New Technology, Public Safety, Regulatory

Ethan Konschuh, MJLST Staffer

In their recent paper, Guns, Limbs, and Toys: What Future for 3D Printing?, published in the Minnesota Journal of Law, Science, and Technology Volume 17, Issue 2, Adam Thierer and Adam Marcus discussed the potential regulatory frameworks for technological innovations that could spur what they call “the next great industrial revolution.”  They believe that 3D printing, one such innovation, could offer such great benefits that it could significantly enhance global welfare.  However, they worry that preemptive regulations on the technology could undermine these benefits before giving them a chance to be realized.  The paper advocates for a method of regulation called “permissionless innovation,” as opposed to regulations following the “precautionary principle.”  While there are many pros to the former, it could leave unchecked the risks curtailed by the latter.

“Permissionless innovation refers to the notion that experimentation with new technologies and business models should generally be permitted by default.”  It follows from the idea that unless a compelling case can be made that a new invention will bring serious harm to society, innovation should be allowed to continue unabated, and problems, should they arise, can be addressed later.  The authors point to numerous benefits of this approach with respect to emerging technologies.  One of the most obvious benefits is that this type of regulatory framework does not prematurely inhibit potential benefits.  “Regulatory systems based on precautionary thinking focus on preemptive remedies that aim to predict the future and its hypothetical problems. But if public policy is rooted in fear of hypothetical worst-case scenarios, it means that best-case scenarios will never come about.”  It would also preserve the modern startup culture where “just about anyone can afford to launch a business.”  Implementing a framework based on the precautionary principle will create barriers to entry and raise the cost of innovation.  This would also reduce the ability to maximize competitive advantage through trial and error, which refines the technology and efficient allocation of resources for development.  As an example of the potential detriments to competitive advantage from preemptive regulation, the authors point to the different policies of the Europe and the U.S. in the mid-nineties internet explosion where the former preemptively regulated and the latter allowed for permissionless innovation, resulting in the U.S. being a global leader in information technologies and Europe lagging far behind.

An alternative regulatory approach discussed in the article is based on the precautionary principle, which generally refers to the belief that new innovations should be curtailed or disallowed until it can be proven that they will not cause harm.  This approach, while posing problems of its own discussed above, would solve some of the problems arising under permissionless innovation.  While there are many economic and social benefits to permissionless innovation as the bedrock on which policy rests, it inherently allows for the “error” half of “trial and error.”  The whole concept is rooted in the idea of ex post regulation, creating policy to correct for problems that have already occurred.  While traditionally, as shown through the internet regulation difference and outcome between Europe and the U.S., the risk of error has not outweighed the benefits that result, new technologies pose new risks.

For example, in the realm of 3D printing, one of the hot topics is 3D printed firearms.  Current laws would not make 3D printed guns illegal, as most regulations focus on the sale and distribution of firearms, not creation for personal use.  The reasons why it might be more prudent to adopt a precautionary principle approach to regulating this technology are obvious.  To adopt an ex post approach to something that could have such dire consequences could be disastrous, especially considering the amount of time required to adopt policy and implement regulations.  Permissionless innovation could thus become a sort of self-fulfilling prophecy in that major tragedies resulting from 3D printing could result in exactly what advocates of permissionless innovation seek to prevent in the first place: strict regulation that undermines the development of the technology.

The debate will likely heat up as technology continues to develop.  In the era of self-driving cars, private drones, big data, and other technologies that continue to change the way that humans interact with the world around them, 3D printing is not the only area in which this discussion will arise.  The policy decisions that will be made in the next few years will have far reaching consequences that are difficult to predict.  Do the economic and social benefits of being able to manufacture goods at home outweigh the risks of legal, discrete self-armament and its consequences?  The proverbial pill may be too large for some to swallow.

Industry Giants Praise FDA Draft Guidance on Companion Diagnostics

October 26, 2016
FDA, Personalized Medicine, Pharmaceuticals

Na An, MJLST Article Editor

In July 2016, the US Food and Drug Administration (FDA) published a draft guidance document titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.”  The new draft guidance aims to serve as a “practical guide” and assist sponsors of drugs and in vitro diagnostics (IVD) in developing these two products simultaneously.  So far, FDA has received six public comments on the draft guide which are mostly positive, with Illumina calling the document “worth the wait,” and Genentech claiming it “crucial for the advancement of personalized medicine.”

A companion diagnostic includes a medical device, in this case an in vitro device, which provides safety and efficacy information of a corresponding drug or biological product.  It is a critical component of precision medicine, the cornerstone of which is the ability to identify and measure biomarkers indicative of the patient’s response to a particular therapy.  Approximately, a quarter of new drugs approved over the past two years were a drug-IVD companion.  However, the codevelopment process is complicated by the fact that these two products may be developed on different schedules, subject to different regulatory requirements, and reviewed by different center at the FDA.  The long-awaited draft guidance was in the works for more than a decade and intended to help sponsors and the FDA reviewers navigate these challenges.

In this draft guidance, FDA reiterates its general policy that IVD devices should receive marketing approval contemporaneously with the authorization of the corresponding therapeutic product.  FDA states that “the availability of an IVD with ‘market-ready’ analytical performance characteristics . . . is highly recommended at the time of initiation of clinical trials intended to support approval of the therapeutic product.”  FDA also recommends: “Using an analytically validated test is important to protect clinical trial subjects, to be able to interpret trial results when a prototype test is used, and to help to define acceptable performance characteristics for the development of the candidate IVD companion diagnostic.”  The new draft guidance provides much more information about the technical and scientific aspects of the development process.  For example, the draft guidance details the use of IVD prototype tests for the purpose of testing the drug early in the development, considerations for planning and executing a therapeutic product clinical trial that also includes the investigation of an IVD companion diagnostic, the use of a prospective-retrospective study approach, the use of training and validation sample sets, and the use of a master file for the therapeutic product to provide data in support of the IVD companion diagnostic marketing application.

The draft guidance has received high marks from industry giants. Illumina said the draft “has been a long time coming, eagerly anticipated, but worth the wait.”  Yet, the gene sequencing giant also seeks more clarity from FDA on risk assessments and expectations for analytical validation prior to investigational IVD use in trials.  “There is an opportunity here for FDA to add clarity on this important decision making process. We suggest this discussion on significant risk versus nonsignificant risk determinations be expanded and put into an appendix with examples. This is a unique opportunity for FDA to help sponsors get this process right,” Illumina says.  On a similarly positive note, Genentech called the draft “crucial for the advancement of personalized medicine,” and supplementary to two previous guidance documents on next generation sequencing.  In addition, Genentech notes that the scope of this IVD and drug co-development draft guidance “is limited, and therefore it does not address the requirements for development of complementary diagnostics or the challenges of co-development using high-throughput technologies such as Next-Generation Sequencing (NGS) based test panels, which are an increasingly attractive tool for both developers and providers.”  AstraZeneca, on the other hand, seeks more clarity on guidance on complementary diagnostics and clarifying between “patient enrichment” and “patient selection” and the resulting considerations on determination of significant risk uses of investigational devices.

We eagerly wait for FDA’s view of these comments and impacts of the guidance on the codevelopment of a drug-IVD companion.

Dastardly Dementor Dad Dupes Daughter

October 26, 2016
Uncategorized

Tim Joyce, Editor-in-Chief, Volume 18

Between last week’s midterm exams and next week’s Halloween shenanigans, the Forum proudly presents some light-hearted and seasonally-appropriate issue spotting. In this week’s issue: Drone Dementors!

This story has been going around recently, of a Wisconsin man who pranked his daughter hard by retrofitting his unmanned aircraft (aka, a “drone”) with fishing line and some well-positioned strips of black cloth (video here). Apparently she’s a big fan of the Harry Potter books and films, and so we’re sure she recognized it immediately as a real-life incarnation of the soul-sucking guardians of the Wizard prison known as Dementors. Undoubtedly, the fact that it was hovering around her backyard elicited some kind of hilarious reaction. Twitter (*strong language alert*) is still guffawing, but we’re pretty sure not everyone would instantly have recognized this as a joke.

While it’s at least arguable that this flight complies with many/most of the FAA’s recently finalized drone regs, let’s take a moment to examine some more creative theories of potential liability behind this prankster parent’s aerial antics:

  1. Negligent Infliction of Emotional Distress. First, let’s admit that there are probably much more effective ways to punish your dad for scaring you than a lawsuit. But, for an exceedingly litigious daughter of average sensitivities, the argument could be made that dad should have known better. In other words, Cardozo’s proximate cause “foreseeability” analysis from Palsgraf rears its ugly complicated head once again! We’ll admit that the eggshell plaintiff argument might provide a decent defense for pops, but it sure seems risky to wait until after the claim to invoke it.
  1. Intentional Infliction of Emotional Distress. See above, except now dad knows what he’s doing. To the extent that it’s sometimes harder to prove intent than negligence, a plaintiff might want to avoid this particular type of claim. On the other hand, an intentional actor is definitely a less sympathetic defendant, and particularly so if the jury is full of those darned Harry Potter-loving Millenials. Of course they’ll have time to serve jury duty, what with all that free time gained from “choosing to” live at home, and their generally lax work ethic.
  1. Copyright Infringement. Trademark infringement doesn’t apply when you’re not using the good in commerce. But Section 106 of the Copyright Act gives an exclusive right to control derivative works. This drone-decoration does look an awful lot like the movies, and it’s pretty clear that no one affirmatively granted permission to use the characters in real life. Given the rightsholders’ propensity to vigorously protect the brand / expression, dad would be wise to cool it on the backyard joyrides. On the other hand, he could probably make some kind of fair use argument, arguing something along the lines of “transformative use” — again, much simpler to avoid the issue altogether.
  1. Some crazy-attenuated products liability claim. You can imagine a situation where the drone clips the tree, or the puppet gets tangled in the branches, and then spirals out of control, injuring a bystander. Should the drone manufacturer then be liable? Extending the chain of causation out to the drone assembly factory seems a bit tenuous, but should strict liability apply nonetheless? Does this situation violate the FAA’s prohibition on “careless or reckless operations” or “carriage of hazardous materials?” Should that fact make a difference?

Everyone with half a brain seems to agree that this is just a really great one-time use scenario. But there are real issues to consider with this, as with any, new technology. Plaintiffs may have to get creative when arguing for liability, at least until courts take judicial notice of the power of a Patronus Charm. From those of us here at MJLST, have a fun and safe Halloween!

EmDrives: The End of Newtonian Physics?

October 25, 2016
New Technology, Patents, Space Law

Peter Selness, MJLST Staffer

The EmDrive has been the center of much controversy over the past decade, and rightfully so.  But what exactly is an EmDrive, and why does it have the scientific community at odds with one another over the underlying science behind it?  The EmDrive is a type of propulsion system that was first designed by Roger Shawyer in 2001.  Essentially, it is a RF resonant cavity thruster that relies on electro magnetic radiation projected into the cavity of a cone to produce thrust.

The EmDrive was met with no small amount of criticism when first proposed because it is what is known as a propellantless propulsion system in that it consumes no fuel when producing thrust.  Not only does it consume no fuel, however, it also appears to only produce force in one direction, thus contradicting Newton’s third law of “for every action there is an equal and opposite reaction.”  Such a proposition has been compared to standing on the deck of a sailboat and pushing on the mast to propel it across a lake, or the old adage of “pulling yourself up by your bootstraps.”  The implications of such a device means that our understanding of physics as it relates to Newton’s third law (which has been relied upon for centuries) is either not entirely understood yet by humanity, or is completely wrong; which is largely why the EmDrive has received such criticism from the scientific community.

And yet, there are multiple confirmed reports of EmDrive testing resulting in this unexplainable thrust that have arisen independently from Roger Shawyer.  Even NASA conducted testing on EmDrives in 2014 and reported measuring a thrust produced by the device.  A similar experiment was then carried out by NASA again in 2015 to correct for some reported errors from the first test, but thrust was surprisingly recorded again despite the corrections.  Also, an EmDrive paper has finally been accepted by peer review by the American Institute of Aeronautics and Astronautics, granting the technology more authority from critics.

Interestingly enough, legal developments have also granted significant legitimacy to the EmDrive.  Roger Shawyer currently has three patents granted on the EmDrive, while two more are still going through the patent process.  Being granted three patents from the UK IP Office means that the physics behind the EmDrive has been thoroughly examined and was found to not violate the laws of physics, as such a violation would inevitably have lead to the patent applications being denied.  Furthermore, Shawyer’s most recent patent, as of October 12th, was filed more than 18 months ago, allowing the patent office to disclose the information contained to the public.  Such a public disclosure should in turn allow for greater scrutiny of Shawyer’s more recent efforts in developing the EmDrive.

The implications of the EmDrive being accepted as a legitimate technology are immense.  First of all, a working propellantless propulsion system would allow for future space craft to be much lighter and cheaper without requiring large amounts of rocket fuel for each take off.  It also would allow for much faster space travel, possibly allowing humans to reach the outer limits of our solar system in a matter of years and Mars within only a few months.  Furthermore, outside its space propulsion systems applications, there’s really no limit to what it may be applied to.

Despite passing several hurdles in recent years, however, the EmDrive is still a long way from leading us to interstellar travel.  The testing conducted by NASA, while showing positive results, also recorded thrust of a force just slightly higher than the magnitude of error for the experiment.  Also, while this positive result allowed it to pass peer review, that does not necessarily mean that the technology is sound and will not later be found to have flaws.  In all likelihood, the chances of a new technology being discovered that, for the first time, violates the laws of physics as we have known them for hundreds of years is a far less likely result than finding some sort of experimental error in the technology.  But maybe, just maybe, this could be the end of Newtonian physics as we know it.

A New Option for Investors Warry of High Frequency Trading

October 24, 2016
Administrative Law, Regulatory, Securities Law

Spencer Caldwell-McMillan, MJLST Staffer

In his recent paper, The Law and Ethics of High Frequency Trading, which was published in the Minnesota Journal of Law, Science, and Technology Issue 17, Volume 1, Steven McNamara examined the cost and benefits of a high frequency trading (HFT) on stock exchanges. He observed that problematic practices such as flash orders and colocation can provide HFT firms with asymmetrical information compared to retail or even sophisticated institutional investors.

In June, a new type of exchange was approved by the Securities and Exchange Commission (SEC). IEX Group Inc. was granted exchange status from the SEC. Before this designation the firm was handling less than 2% of all equity trades, with this new designation the exchange is likely to see volume increase as orders are routed to the exchange. IEX uses 38 miles of looped fiber optic cable to combat some of the information asymmetry that HFT firms exploit. IEX uses this coil to slow incoming orders down by about 350 microseconds. This is roughly half the time a baseball makes contact with a baseball bat. While this may seem like an insignificant amount of time, the proposal proved extremely controversial. The SEC asked for five revisions to IEX application and released the decision at 8 PM on a Friday.

This speed bump serves two purposes: to stop HFT firms from taking advantage of stale prices found on IEX orders and to prevent them from removing liquidity on other exchanges so that IEX’s customer are unable to fill their orders. Critics of this system claim that the speed bump violates rules that requires exchanges to fulfill orders at the best price. However, IEX pushes back on these points to arrangements like colocation that allows firms to pay for faster access to markets by buying space on the servers of the stock exchanges. These policies allow HFT firms to get information faster than even the most sophisticated investors because of their proximity to the data. IEX began operations as an exchange in August and time will tell whether it can generate profits without compromising their pro-investor stance.

This debate is likely to continue long after public attention has faded from HFT. Institutional investors are the most likely beneficiaries of these changes, in fact, in a letter to the SEC the Teacher Retirement System of Texas, claimed that using IEX to process trades could save the fund millions of dollars a year. More recently, Chicago Stock Exchange has submitted a proposal to include a similar speed bump on its exchange. Taken together these two exchanges would represent a small fraction of the order volume being processed by U.S. exchanges but these changes could have a lasting impact if they drive institutional investors to change their trading behavior.

Solving the “Patent Troll” Problem

October 21, 2016
Litigation, Patents

Travis Waller, MJLST Managing Editor

“Dovre: What’s the distinction between troll and man?

Peer: So far as I know, there is none, by my score.

The big want to roast you, the small ones to scratch you; —

same as with us, if they dare but catch you.”

Henrik Ibsen, Peer Gynt, Act II, ll. 903–06 (John Northam, trans., 2007) (1876).

In recent events, internet “trolling” has become something of a hot issue. This discussion will not address internet trolling (even tangentially), but will instead endeavor to shed light upon a different, often craftier member of troll-kind: the patent troll.

To begin, what is a “patent troll?” The term has taken a somewhat expansive usage since its original appearance in a 1990’s educational video released to corporations. Today, the term can refer to a broad range of practices, but most commonly is understood as the practice of an individual or corporation (sometimes with a large patent portfolio) that abusively uses the threat of enforcement litigation for overly broad, and probably invalid, patents that it has acquired to essentially extort licensing agreements from companies (often quite small) that do not necessarily have the resources to devote to patent litigation, and are likely not even infringing on the “trolls” patented invention to begin with.

Since that was a mouthful, let me provide an example:

Company A (the “troll”) purchases a patent on invention A3;

Company B independently creates invention ABC123, and acquires a patent;

Company A claims that patent A3 reads on patent ABC123, because it claims elements A3 are contained in Company B’s patent ABC123;

Company A sends a letter to Company B demanding that it licenses patent A3, or will face a “prompt” litigation action.

In this example, Company B, fearing that Company A may actually be within it’s legal rights, agrees to pay Company A the fee to license patent A3 for fear of Company A filing expensive patent litigation against Company B, even though a court would almost certainly find that invention ABC123 is nothing like patent A3, and therefore that Company B is not infringing on Company A’s rights (for a few “real world” examples, as well as a dash of technology industry gossip, see this article by Business Insider).

The question arising from situations like this that many courts and lawmakers have hemmed and hawed over is this: who is right? On the one hand, federal patent law strives to protect the rights of the legitimate inventor, and incentivize the very “progress of the useful arts”. On the other hand, how can the law protect companies and individuals like Company B from being bullied by the aggressive assertion of patent rights by companies like Company A?

The answers have manifested themselves mostly through federal and state law making, starting first with the enactment of the Lahey-Smith America Invents Act (the “AIA” for those in the know). This Act modified existing US patent law to allow for a process called “post-grant opposition,” which essentially allows individuals to challenge the validity of a patent after it has been issued by the USPTO, but without having to set foot in a courtroom (theoretically creating a much cheaper option than trial for individuals seeking to invalidate broad patents) (for more info on the process, see here).

The AIA is still relatively new (enacted in 2012), and it is hard to say for certain how this procedure has affected the act of “patent trolling”, however some have made the claim that the AIA has not had the effect of “starving patent trolls” that the lawmakers hoped it would (see here for more discussion on this point).

As such, individual states have taken the fore in this fight against the patent troll, and it is often the case that state consumer protection agencies make up the front lines, by way of various state unfair trade practice laws. However, many state legislatures have taken a much more targeted strategy, and have begun to arm their agencies with the ability to specifically bring actions against individuals and corporations for the “bad faith assertion of patent rights” (as of 2016, Minnesota became one such state).

This action gives state agencies a huge benefit in targeting “troll-like” behavior in the patent industry, but at what cost? Federal patent law preemption issues aside for right now (and yes, they are out there), how exactly will an agency define what “trolling” is? How will state agencies determine that the assertion of the patent right was “in bad faith?” Moreover, how will this effect an otherwise uniform protection that patent holders have across the US?

These questions, and many more, will no doubt need to be addressed by states adopting the “bad faith assertion of patent rights” statutes. For now, since I don’t have an answer off-hand to this incredibly intricate legal and policy question, I will simply eco the words of Henrik Ibsen: “what is the distinction between troll and man?” What is the distinction between patent troll, and legitimate inventor? And finally, are these definitions really something we want to leave in the hands of state agencies, which may or may not be relatively unsophisticated in the intricacies of federal patent law?

My initial impression is one of skepticism, but if the willingness of a great deal of state legislators to adopt such measures can be taken as some indication of a nationwide public demand for a new way to address these issues, maybe this is the start of a conversation that should have happened some time ago.

Crossing the Offensive Line

October 18, 2016
Constitutional Law, Trademark Law

Quang Trang, MJLST Managing Editor

In my opinion, Autumn is easily one of the top four seasons of the year. It is a season where pumpkin becomes a spice, the leaves change colors, I wear cardigans, and of course FOOTBALL. And yeah, the Supreme Court of the United States becomes a thing again.

During its next term, the Supreme Court of the United States will hear Lee v. Tam, a case that may determine the constitutionality of the U.S. Patent Office’s (“USPTO”) authority to refuse a trademark. The USPTO threw a yellow flag and refused to trademark the name of a band called “The Slants” after finding the name crossed an offensive line against Asians. The Slants threw a red flag challenge to have the decision reviewed. Under review, the Federal Circuit reversed the ruling on the field citing First Amendment protection. The USPTO Hail Mary’d the Supreme Court of the United States to protect its authority to reject offensive trademarks.

Under Section 2 of the Lanham Act (15 U.S.C. § 1052(a)), the U.S. Patent Office may refuse to register a trademark that “[c]onsists of or comprises a . . . matter which may disparage . . . persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt, or disrepute.” However, granting the USPTO such authority may violate the First Amendment, which states that “Congress shall make no law . . . abridging the freedom of speech.” The Federal Circuit found the band’s name to be private speech, and thus entitled to First Amendment protection.

At this point you may be wondering “why is Quang making all these football puns?”, “Does Quang think his puns are funny?”, and “will he stop making bad puns?”

A Supreme Court decision in Lee v. Tam may intercept a case in the Fourth Circuit. The Fourth Circuit is currently reviewing the USPTO’s refusal to trademark the Washington Redskins after finding the name offensive and disparaging to Native Americans.

If the Supreme Court finds Section 2 of the Lanham Act unconstitutional, then the Fourth Circuit must overturn the USPTO’s refusal to trademark the Washington Redskins. However, if the Supreme Court limits its decision in Lee v Tam to the facts of the case or if the court affirms the USPTO’s ruling, then the Washington Redskins’ challenge may be sacked for good.

If the Washington Redskins loses its challenge, the organization may still keep the name and seek state trademark protection. The team would still be financially impacted if it loses federal protection against copycat merchandising. Changing the team name may then become a financial decision.

The “Fourth Industrial Revolution”: Queue Chaos and Disarray

October 17, 2016
Economy, New Technology, Tax Law

Rhett Schwichtenberg, MJLST Staffer

We are all familiar with Hollywood’s drastic miscalculations when predicting the future. In Timecop, which took place in 2004, time-travel was the conventional means of transportation. In the world of Marty McFly, 2015 marked the year where hoverboards were the standard means of transportation. In 2001: A Space Odyssey, the moon was colonized by 2001. The list goes on. While we [unfortunately] see none of this today, perhaps Hollywood was not too far off.

Today, robots are shaping the way we live and have contributed a world of good to society. While Google Glass might have been an utter failure, Google’s Self-Driving Car Project is making fast advances to provide the world with hand-free, piece-of-mind driving. Taxi giant, Uber, has also entered the self-driving market with the implementation of self-driving Uber vehicles in the Pittsburgh market. Self-driving technology has the ability to eliminate the extreme and unnecessary amount of traffic deaths occurring every day in addition to providing a reliable mode of transportation for individuals that cannot operate a vehicle. Apart from the transportation industry, robots are growing rapidly in nearly every industry including the agriculture, food service, manufacturing, military, and rehabilitation industries.

Earlier this year, the EU made a proposal calling for the classification of autonomous  robots as “electronic persons.” If codified, this proposal could bestow legal rights upon robots, require companies to pay a social security tax for using them, and impose a liability insurance upon companies using robots in order to protect against any harm they might cause. While ridiculed by many, is there no merit in this proposal?

The age of robotics that is currently among us is being referred to as the “fourth industrial revolution” by economists. The first industrial revolution introduced steam power, the second, electric power, and the third, electronics and information technology. While the past three industrial revolutions have advanced at a linear rate (occurring approximately one-hundred years apart) the current revolution is advancing exponentially. Previous technology has threatened blue-collar jobs, but has never caused us to question whether jobs will even exist in the near future. With the implementation of quantum computing looming, the professionals in scientific and medical fields might experience issues of job security.

Alan Manning, leading author in labor economics and professor at the London School of Economics, seems to remain calm, cool, and collected when tasked with answering the question of how autonomy will affect the labor market. He strongly opines that such technology should not be taxed. Implementing the proposed tax will slow the advancement and use of such technology. Instead, Manning expects investment in modern technology to increase productivity and, at worst, leave the labor market where it currently stands. Manning believes the expert prediction that 47% of jobs will be threatened by autonomic robots is just that, a mere prediction. He retorts that such a prediction is grounded in ignorance rather than educated measures. Manning states that the entire job market must be looked at, not just the specific occupations that will see job reduction. Looking at the job market as a whole, Manning admits that jobs will be lost in some areas, but trusts that new jobs will arise due to an increase in companies’ spending power through the use of autonomic robotics.

So given that autonomic robotics and advanced computing technology is already written in our future, what are the implications of such technology? The simple answer is: we must wait and see.

Copycats to Copycows: The Cloned Livestock Industry Emergence

October 17, 2016
Biotechnology, Ethics, New Technology

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 here, here, 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

October 15, 2016
3-D Printing, Biotechnology, Food and Agriculture

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.

Home | Contact Publishing Services | My Account