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A large portion of the burden of creating and maintaining order at the regional or global level will fall on the United States. This is inevitable for several reasons, only one of which is that the United States is and will likely remain the most powerful country in the world for decades to come. The corollary to this point is that no other country or group of countries has either the capacity or the mind-set to build a global order. Nor can order ever be expected to emerge automatically; there is no invisible hand in the geopolitical marketplace. Again, a large part of the burden (or, more positively, opportunity) falls on the principal power of the day. There is more than a little self-interest at stake. The United States cannot remain aloof, much less unaffected by a world in disarray. Globalization is more reality than choice. At the regional level, the United States actually faces the opposite problem, namely, that certain actors do have the mind-set and means to shape an order. The problem is that their views of order are in part or in whole incompatible with U.S. interests. Examples would include Iran and ISIS in the Middle East, China in Asia, and Russia in Europe.

It will not be an easy time for the United States. The sheer number and range of challenges is daunting. There are a large number of actors and forces to contend with. Alliances, normally created in opposition to some country or countries, may not be as useful a vehicle in a world in which not all foes are always foes and not all friends are always friendly. Diplomacy will count for a great deal; there will be a premium on dexterity. Consultations that aim to affect the actions of other governments and their leaders are likely to matter more than negotiations that aim to solve problems.

Sujai Shivakumar, “Securing Global Standards for Innovation and Growth,” Center for Strategic and International Studies, 01-27-2022, https://www.csis.org/analysis/securing-global-standards-innovation-and-growth

Standards are indispensable to innovation, providing shared platforms for industry participants to work together to bring new technological solutions to the marketplace. Securing the integrity of fair and broad-based frameworks that establish accurate and workable standards for technology adoption and interoperability is therefore critical for accelerating innovation and promoting fair global competition in all fields essential to commerce.

The increasing power of technology could produce novel existential threats to humankind. One technology is synthetic biology. Humans, like all species, are vulnerable to bacteria and viruses. When lethality and communicability align, pandemics can be catastrophic, such as the plague that struck Europe in 1341–1347 (“Black Death”), killing between 30 and 50 percent of the population; the influenza virus in 1918–1921 (“Spanish Flu”) that killed between 50 and 100 million people, potentially more than World War I and II combined; or smallpox in the Americas, which contributed to the collapse of the Aztec and Incan civilizations during the Spanish “Conquista.” Yet natural selection mitigates the existential risks of pandemics, since lethality and communicability tend to work against each other—the more lethal a pathogen, the more likely it will kill its host, giving it less opportunity to spread (Rees 2003; Posner 2004).

However, advances in synthetic biology could make it possible for humans to design pathogens to increase the destruction capacity of pandemics. The ability to take the genetic blueprints of pathogens and manipulate them to increase virulence opens up the possibility of “designer viruses” that are both highly communicable and lethal (Leslie 1996; Rees 2003; Posner 2004; Torres 2017). In theory, a pathogen could be designed to be highly contagious, but with a slow incubation period to maximize the time for its spread and minimize the possibility of detection, and then overcome the human immune system and exploit the absence of defenses from vaccinations or antibiotics (Rees 2003, 50–7; Posner 2004, 75–6). The “gain-of-function” research to make pathogens more virulent is indicative of the danger (Selgelid 2016). One controversial experiment in 2012 involved the genetic alteration of H5N1 avian influenza to be transmissible by air between ferrets (Herfst et al. 2012), which one virologist described as “probably one of the most dangerous viruses you can make” (Enserink 2011). In another experiment in 2017, researchers reconstituted the horsepox virus from DNA ordered by mail, which one virologist explained, “If it’s possible with horsepox, it’s possible with smallpox” (Kupferschmidt 2017). While synthetic biology could bring enormous benefits, bioengineered pathogens could pose an existential threat to humanity.

Jurgen Altmann, professor of experimental physics at the University of Dortmund, Germany, International Handbook on Regulation Nanotechnologies, Ch. 17, Military Applications: Special Conditions for Regulation, 2010, pg. 380-382

There are also military uses of nanotechnology which are mostly specific and which would not be developed for a civilian market. Some of these, however, once developed in a military context and made cheap by mass production, may find their way into civilian society and have negative impacts there, for example, by being used by non-state actors for illegal activity. Variable camouflage would not pose a big problem if it were used in the civilian context. However, many uses of nanotechnology for specific military application may pose serious security risks if they became available to civilians. For example, small, cheap sensors to be scattered over the battlefield could also be used for private or economic espionage, or smaller conventional weapons with highly precise guidance systems, in particular very small missiles, could be used for terrorist attacks. The same applies for firearms and munitions using nanofibre composites, which, without any metal, would be difficult to detect at security checkpoints. Soldier systems for monitoring body status from the outside, forming compresses and administering therapeutic agents if needed. are not problematic. However, implants or other body manipulation, such as a brain-machine interface or modification of the human biochemistry, may create problems for civilian society. Here the military could act as a door-opener, preempting a broad societal debate about the acceptability of non-therapeutic body modification.

Nanosciences and nanotechnologies are set to transform the global industrial landscape, but the debate on how to regulate environmental, health and safety risks is lagging behind technological innovation. Current regulatory efforts are primarily focused on the national and regional level, while the international dimensions of nanotechnology governance are still poorly understood and rarely feature on the international agenda. With the ongoing globalization of nanosciences and the rapid expansion of international trade in nanomaterials, however, demand for international coordination and harmonization of regulatory approaches is set to increase. However, uncertainty about nanotechnology risk poses a profound dilemma for regulators and policy-makers. Uncertainty both creates demand for and stands in the way of greater international cooperation and harmonization of regulatory approaches. This paper reviews the emerging debate on nanotechnology risk and regulatory approaches, investigates the current state of international cooperation and outlines the critical contribution that a global governance approach can make to the safe development of nanotechnologies.

Introduction

Moreover, courts and commentators have long realized that agencies possess comparative institutional advantages over Congress that surpass the mere application of expertise. By shifting policymaking responsibility outside of the legislative branch, Congress is also able to avail itself of the greater agility of administrative agencies in responding to changed circumstances or adapting to new [*1028] policy concerns. Legislation is costly and time-consuming to enact, and Congress cannot always rapidly change course when confronted with novel problems or the imminent obsolescence of old solutions. n15 Agencies are more willing and able than Congress to tweak their policy agendas. Especially in the high-technology areas, this alacrity is invaluable to agencies' ability to act in the public interest.

In order to act effectively, then, agencies must possess flexibility not only in the substantive sense described above, but also in the "temporal" sense: They must be free to alter policies over time and adapt to changes in relevant technologies and markets. n16 Much like substantive flexibility (deference, really), temporal flexibility (which I will refer to simply as "flexibility") is the lifeblood of successful agency operation. Even minor changes in technology or markets can obsolete pre-existing regulatory regimes, and it likely would be prohibitively costly for Congress to respond to every minor circumstance by amending an agency's authorizing legislation. n17 Agencies need the authority to adjust policies in order to maintain their currency and efficacy, n18 and unwise judicial doctrines that deny agencies all significant policy flexibility would undoubtedly lead to regulatory stagnation. n19

Emily S. Bremer, “On the Cost of Private Standards in Public Law,” Kansas Law Review, https://kuscholarworks.ku.edu/bitstream/handle/1808/20310/5-Bremer_FinalPDFSheridan.pdf?sequence=1

One consequence of the predominantly private character of the U.S. standards system is that public standards are—and long have been— significantly outnumbered by private standards.166 A recent study suggests that there are at most 114 federal agencies,167 while as of 2004, there were more than 600 standards development organizations in the United States.168 There is significant diversity among these private organizations, although the most common are trade associations, professional societies, standards organizations, international organizations, and consortia.169 It is estimated that there are currently more than 100,000 private standards actively in use in the United States.170 In any given sector, such as consumer products or pipeline transportation, the output of the private standards developers typically far outstrips that of the relevant public counterpart. Thus, in 1990, one scholar noted that while the Consumer Product Safety Commission (CPSC) had created about a dozen standards since its creation in 1973 (several of which had been challenged in court), UL had over five hundred published standards.171 A similar phenomenon is observable in the modern pipeline context. Although approximately 73% of PHMSA’s incorporated standards are developed by just three organizations,172 those incorporated standards represent just 3.7%,173 one-tenth of 1%,174 and 2%,175 of those organizations’ respective standards portfolios. This imbalance pervades the U.S. standards system—the thousands of private standards incorporated by reference into federal regulations represent just a tiny fraction of private standards actively in use in the United States.176

National Fire Protection Association, “Benefits of Standards Development Organizations,” NFPA, 04-18-2024, https://www.nfpa.org/for-professionals/codes-and-standards/standards-development/the-value-of-standards-development-organizations/benefits-of-sdos#

SDOs marshal the vast expertise, diverse perspectives, and technical resources that are available outside the government in order to develop health, safety and environmental standards that are made available for government use at virtually no tax-payer cost. In addition, government use of standards decreases the burden of regulation and the costs of enforcement by conforming regulatory requirements to voluntary, user accepted standards that are already widely looked to for best practices and private self-regulation. Finally, the savings from standards can be seen in many areas of the economy.

Arnold E. Brown, II, Kenneth Wilton, Intellectual Property Attorney at Seyfarth, J.D. from the University of California College of the Law, Joseph Myers, Director of Innovation for the Intellectual Property Practice Group at Seyfarth, J.D. from Vanderbilt University, “The District of Columbia Court of Appeals’ Recent Significant Legal Precedent Carries Implications for Standards Organizations,” Seyfarth, 12-19-2023, https://www.seyfarth.com/news-insights/the-district-of-columbia-court-of-appeals-recent-significant-legal-precedent-carries-implications-for-standards-organizations.html

1. Under what conditions are technology standards that are published by standards organizations likely to be subject to the public’s right to freely access them?

John Burroughs, “Incorporated Standards and Fair Use: Remaining Uncertainties Set the Stage for Further Litigation,” The University of Chicago Business Law Review, https://businesslawreview.uchicago.edu/online-archive/incorporated-standards-and-fair-use-remaining-uncertainties-set-stage-further

An additional ambiguity lies in the precise scope of the fair-use defense under the D.C. Circuit’s holding: when a standard that is incorporated by reference into law itself references another standard that is not so incorporated, would a fair-use defense protect the publishing of this second standard? While the court did say that “Public Resource may not copy unincorporated standards—or unincorporated portions of standards only partially incorporated,”35 the court also stated:

Emily S. Bremer, “Technical Standards Meet Administrative Law: A Teaching Guide on Incorporation by Reference,” Notre Dame Law School Scholarship, https://scholarship.law.nd.edu/law_faculty_scholarship/1406/

The copyright issue is intimately related to the matter of funding the standard-setting process. As previously noted, the revenue model most SSOs have adopted relies heavily on the revenue generated from the sale of standards. Copyright protects this model. When you think of counterfeit products, you generally think of things like Louis Vuitton handbags. But standards get counterfeited, too! For example, the National Fire Protection Association (NFPA) has had problems with people selling counterfeit copies of the National Electric Code. 73 NFPA's ability to enforce its copyright protects the SSO's primary funding source and helps to prevent the dissemination of potentially erroneous copies of its standards.

National Fire Protection Association, “Benefits of Standards Development Organizations,” NFPA, 04-18-2024, https://www.nfpa.org/for-professionals/codes-and-standards/standards-development/the-value-of-standards-development-organizations/benefits-of-sdos#

Consensus-based and user-accepted

Sean McGrath, “Standards Development Organizations – The Future Revenue Model,” Propylon, 05-13-2021, https://propylon.com/standards-development-organizations-future-model/

These are challenging times for Standards Development Organizations (SDOs). Standards-making has always been an expensive undertaking – especially for accredited, consensus-based standards – yet revenue streams to fund the process are under unprecedented levels of threat in the digital age.

Kevin J. Hickey, “Copyright in Standards Incorporated by Reference into Law and the Pro Codes Act,” Congressional Research Service, 09-26-2023, https://sgp.fas.org/crs/misc/R47656.pdf

Applying its rule, the majority in Georgia v. PRO found that because Lexis made the annotations under an agreement with an “arm” of the Georgia state legislature, the annotations were authored by the legislature in the course of its legislative duties. 86 The Court thus held that the annotations were not copyrightable.87

Kevin J. Hickey, “Copyright in Standards Incorporated by Reference into Law and the Pro Codes Act,” Congressional Research Service, 09-26-2023, https://sgp.fas.org/crs/misc/R47656.pdf

Despite decades of decisions, courts have not reached consensus on whether technical standards remain protected by copyright after they are incorporated into law. Various U.S. Courts of Appeals for different regional circuits reached seemingly conflicting conclusions on that question in the 1980s–2000s. Following a 2018 decision by the D.C. Circuit in American Society for Testing and Materials v. Public.Resource.Org (ASTM v. PRO I), the case law has increasingly focused on whether copyright’s fair use doctrine permits public-access groups to make IBR standards available online. Following ASTM v. PRO I and the Supreme Court’s 2020 decision on a related issue in Georgia v. Public.Resource.Org, recent cases have typically ruled against SDOs’ copyright infringement claims, mainly on fair use grounds.

Antibiotic resistance, prompted by the overuse of antimicrobial agents, may arise from a variety of mechanisms, particularly horizontal gene transfer of virulence and antibiotic resistance genes, which is often facilitated by biofilm formation. The importance of phenotypic changes seen in a biofilm, which lead to genotypic alterations, cannot be overstated. Irrespective of if the biofilm is single microbe or polymicrobial, bacteria, protected within a biofilm from the external environment, communicate through signal transduction pathways (e.g., quorum sensing or two-component systems), leading to global changes in gene expression, enhancing virulence, and expediting the acquisition of antibiotic resistance. Thus, one must examine a genetic change in virulence and resistance not only in the context of the biofilm but also as inextricably linked pathologies. Observationally, it is clear that increased virulence and the advent of antibiotic resistance often arise almost simultaneously; however, their genetic connection has been relatively ignored. Although the complexities of genetic regulation in a multispecies community may obscure a causative relationship, uncovering key genetic interactions between virulence and resistance in biofilm bacteria is essential to identifying new druggable targets, ultimately providing a drug discovery and development pathway to improve treatment options for chronic and recurring infection.

1. Introduction

In 2003 a doctor with SARS unknowingly infected several guests while staying at a Hong Kong hotel, and overnight the virus reached across the globe. China is currently battling a bird flu that kills nearly half of the people infected. If Ebola, which transmits through fluids, were spread by air, or if Zika, which has reached over 50 countries, were as deadly as Ebola, we would be facing an unprecedented catastrophe. An uncontrolled outbreak or bioterror attack could result in a contagion that kills over 30 million people.

We fear it is only a matter of time before we face a deadlier and more contagious pathogen, yet the threat of a deadly pandemic remains dangerously overlooked. Pandemics now occur with greater frequency, due to factors such as climate change, urbanization, and international travel. Other factors, such as a weak World Health Organization and potentially massive cuts to funding for U.S. scientific research and foreign aid, including funding for the United Nations, stand to deepen our vulnerability. We also face the specter of novel and mutated pathogens that could spread and kill faster than diseases we have seen before. With the advent of genome-editing technologies, bioterrorists could artificially engineer new plagues, a threat that Ashton Carter, the former U.S. secretary of defense, thinks could rival nuclear weapons in deadliness.

Tatsujiro Suzuki, “Pandemic Futures and Nuclear Weapon Risks: The Nagasaki 75th Anniversary pandemic-nuclear nexus scenarios final report,” Journal for Peace and Nuclear Disarmament, https://www.tandfonline.com/doi/full/10.1080/25751654.2021.1890867

The Challenge: Multiple Existential Threats

Scott Cadzow and Suno Wood, “The role of SDOs in developing standards for ICT to mitigate the impact of a pandemic,” European Telecommunications Standards Institute, 05-xx-2020, https://standict.eu/sites/default/files/2020-10/etsi_wp33_eHealth_standard_role_pandemic%281%29.pdf

COVID-19 (Corona Virus Disease 2019) is a particularly aggressive form of coronavirus discovered in 2019 that has rapidly spread across the human population of the planet, becoming classified by the World Health Organisation as a Public Health Emergency of International Concern on 30 January 2020 (in short it was recognised as a pandemic in late January 2020 only 1 month after its official recognition). The virulence of COVID-19 is 2 to 2½ times more than that of seasonal flu and its mortality rate is significantly higher, with a hospitalisation rate an order of magnitude higher again. This is not a mild pandemic, it is a serious, often lethal, health condition, the impact of which is seriously detrimental to social and economic life across the world.

Ilan Noy and Tomáš Uher, “Four New Horsemen of an Apocalypse? Solar Flares, Super-volcanoes, Pandemics, and Artificial Intelligence,” Economics of Disasters and Climate Change, https://link.springer.com/article/10.1007/s41885-022-00105-x

Misaligned Artificial Intelligence