Governing Technology: “Nanotechnology Risk Management and Public Health Protection Act” A Harmonized Approach to Promoting Innovation While Protecting Global Health

III GHS: Successful Precedent Protecting Global Health and Advancing Commerce

History shows that innovation can thrive when there is a superstructure that consistently operationalizes precautionary principles across jurisdictions, because enterprises and economic actors, (including governments in their employment capacity) cannot be held liable when obeying the law23. On the contrary, legal principles that support obeying the law create an “affirmative defense”: when a defendant has obeyed the law with the result that harm arises from acts that are legally in compliance with the relevant law, then the fault lies in weak laws, not bad acts. The linchpin of an affirmative defense, however, is that the defendant accused of creating liability has obeyed the relevant law, not merely any old law that they choose. A flexible framework can laser focus its terms on a particularly problematic aspect of nano-enabled applications to the greater society, using the priorities that stakeholders want and those legislative drafters believe will work best [6]. Many well-intended and widely accepted nongovernmental sources of nanotechnology standards, guidelines and consensus documents, so-called “soft law” have been generated to address nanotechnologies. Soft laws may be more attuned to the needs of users or more aligned with the needs of a particular interest group, but lack power; soft laws cannot provide the protection that compliance with laws provides against liability in the event of harm. The resulting admixture of guidance and government- empowered regulations, with new laws springing up like mushrooms24.

One outstanding model for coherent and efficient harmonization of laws is the Global Harmonization of Chemical Safety, (GHS) 25 which is respected worldwide and followed by hundreds of nations. Even in the case of the USA, which does not typically ratify the major global treaties, the government has seen fit to create an end-run around the typical treaty ratification process, by creating an interagency entity with oversight to monitor compliance with GHS under the auspices of over 100 agencies ranging from US Department of State, Food and Drug Administration (FDA) Occupational Safety and Health Administration (OSHA) and Homeland Security. Under GHS suppliers, distributers and end users meet their globally shared need predictable laws and consistency. Requirements to pass forward the information about toxicity nanotoxicity, adverse health effects and possible hazards in the context of other materials are embodied in the Safety Data Sheets (SDS) that travel the world and often can be found on the web. Furthermore the goals of information transmittal are operationalized by requirements for labelling under a new universal code of pictograms and requirements for training in the use of SDS, the use of materials, safe handling methods and detailed explanations for clean-up in the event of spills or unplanned exposures. All sectors and across all job descriptions, employer entities, including government entities acting in their capacity as employers, are required to offer this information free of charge and update it annually in training. Many nations including the USA have incorporated these requirements by reference into their existing laws about occupational health and safety and therefore fulfilling these requirements is a subject of national enforcement, subject to inspection, fines, abatement requirements or penalties such as closing down the facilities involved. These precepts are also included in unexpected places such as university experimental facilities and government labs around the world. As a result, GHS provides pre-emptory protection for the health of the general public and buffers participants against liability. GHS is inherently transparent because any participant in the process, including end-users (whether consumers or an enterprise incorporating final products into their new product) is entitled to trace back along the supply chain to obtain detailed information [7, 8, 9, 10, 11].

Suppliers, distributers and end users need predictable laws and consistency and they need reliable information when purchasing goods from abroad or shipping their goods from their home country. Therefore GHS has been viewed by many companies as a sigh of relief, ending previous confusion regarding labeling and the right of companies to know the accurate information from their suppliers, regarding chemicals that are shipped around the world and used in thousands of different applications in international trade. Providing consistent and predictable data from manufacturers and suppliers to downstream users is central to the GHS rationale. Each link in the supply chain must operationalize the right to know by providing training about materials and attaching that information to products, by using a unified template called Safety Data Sheet (SDS). Plugging-in data they used and then passing that information along to the next link in the chain of commerce enables each participant in the chain of commerce to enjoy the right to know about relevant health hazard information.

Therefore, GHS has been viewed by many companies as a sigh of relief, ending previous confusion regarding labelling and the right of companies to know the accurate information from their suppliers, regarding chemicals that are shipped around the world and used in thousands of different applications in international trade. Under GHS suppliers, distributers and end users have the opportunity to enjoy predictable laws and consistency and they need reliable information when purchasing goods from abroad or shipping their goods from their home country. Providing consistent and predictable data from manufacturers and suppliers to downstream users is central to the GHS rationale. Each link in the supply chain must operationalize the right to know by providing training about materials and attaching that information to products, by using a unified template called Safety Data Sheet (SDS). Plugging-in data they used and then passing that information along to the next link in the chain of commerce enables each participant in the chain of commerce to enjoy the right to know about relevant health hazard information. GHS process is inherently transparent because any participant in the process, including end-users (whether consumers or an enterprise incorporating final products into their new product) is entitled to trace back along the supply chain to obtain detailed information about products that are in use, whether already in the workplace or the subject of possible purchase [12, 13, 14].

GHS is Self-Enforcing Rather than Subject to Inspections

GHS is widely accepted and subject to detailed training and certification in schools of public health, programs for industrial hygiene or occupational hygiene and its international scope includes training by UNITAR, (United Nations Institute for Training and Research). Its impact has clearly become a pre-emptory strike against long negotiations about whether a product is safe or how to characterize its risks when starting negotiations for purchase or sale, thus saving money time and staffing resources from the outset of any commercial negotiation regardless whom is the purchaser or the supplier.

GHS operationalizes a legal theory called “Stepwise analysis”. The stepwise approach is a lock and key theory, wherein each step unlocks a series of questions, and those questions determine whether the next step of analysis is required26. False information and missteps can be easily discovered by the next partners in the supply chain, and any resulting harm caused by inaccurate disclosure can result in liability. The notion that the next entity in the supply chain will accept responsibility and possible liability for adverse health impacts following use or exposure to toxic and hazardous substances is an important underpinning of the stepwise analysis triggered by accepting materials that have an SDS, and therefore the next user in the supply chain will always need reliable information when purchasing goods from abroad or shipping their goods from their home country [15].

Each recipient of information has a burden to confirm the information disclosed to them is correct, in order to avoid potential liability when passing forward the same data. This does not require specific standards or arbitrary language to ensure the quality of data, which remains the responsibility of those who send the information, because of the so- called “garbage in, garbage out” risk of stepping incorrectly. Implementing GHS therefore favors candid selfevaluation before disclosure. Missteps produce mistakes; inaccurate disclosure causing harm is traceable, so that the source of the error becomes accountable for consequences. Stepwise, but step carefully, with due diligence supporting decisions about unquantifiable risks! [16].

Precedents for Harmonization of Laws Across the Globe

Harmonization across jurisdictions is not a new challenge; but acceptance of a harmonized regime for nanotechnology requires that governments forsake a piece of their sovereign power in order to bend to the will of other governments so that a nanoregulatory process can emerge with one unified law [17].

Therefore harmonization of the existing and emerging

nanotechnology laws requires a hierarchical superstructure set forth in the framework proposed here to meet civil society’s need for predictability in trade, to meet the private and public need for data collection regarding risks, to answer the universal need for consistent requirements regarding risk communication within industry and among industrial users and consumers of nanotechnology applications and to provide risk communication to directly impacted and secondary passive exposed populations. Tools for benchmarking, data collection, archiving data and synthesizing data from several sources with a view to protecting health is toooften misunderstood as a needless restraint on industry and not the invaluable resource for establishing commerce and industry that regulation has proven to be. A threshold need for clear mechanisms to encourage harmonization of conflicting nanotechnology laws swiftly takes centre stage in order to reconcile conflicts of law. Without a framework to guide application of diverse standards and guidelines, global nanoregulation can be a jungle hampering future development and use of nanotechnology in commerce regardless how logical, popular or well-intended these nanoregulations and parallel commercial or public health laws may be. This process is unlikely to be completed quickly, but inevitably some laws will take center stage and others will stay in the periphery as societal needs change. In order to facilitate trade and protect global health, governments relinquish sovereignty, thereby bowing to international law. If realized however, this structure could meet civil society’s need for predictability in trade, the private and public need for data collection regarding risks, answer the universal need for consistent requirements regarding risk communication, including a clear transfer path for risk communication [18].

Key Points: “Nanotechnology Risk Management and Public Health Protection Act”

The goal of our overarching superstructure is to design a package for the tools that already exist in law and the science of risk management, A strong and clear framework can organize the relationship between existing laws, existing guidelines and standards and indicate the gaps where new laws may be required. This also helps to harmonize the already large and unwieldy body of nanoregulations by bringing clarity to priorities [19].

Compliance with Existing Global Systems

27Embedding the existing body of well-respected established GHS law into a new legislative framework enables the new law to have benchmarks from the time of its effective date, even if those benchmarks are modified at a later time. A central feature of our proposed structure is a commission or governance council with (a) power of oversight for bioethical issues in the applications of nanotechnology (b) procedures for investigation and (c) redress to consumers and the general public in the event of explosions, spills or emergencies. A proposed structure embedded within the Model Act embraces data generation, risk evaluation and related management by creating compliance oversight structure across the life cycle of products that contain nanomaterials or self-styled “nano” products in order to enable products sale and distribution to flow across the chain of commerce throughout each product life cycle while safeguarding the environment and without sacrificing health. These provisions are enforceable because Section 9 enables individual citizens to trigger enforcement by petition with clear and convincing evidence to the Commission. The last sections address penalties, a legislative “Saving Clause” in case part of the law is repealed or deemed unenforceable and Effective Date [20].

New Model for Risk Communication to the Public

Nanotechnology information for all is a fundamental tenet of this proposed legal initiative28. This notion of Nanotechnology information for all is inspired by the practical reality that nano-enabled products are ubiquitous in society: nanotechnology has become a foundational methodology for several new disciplines including AI (artificial intelligence) big data collection and use, genetic manipulations (such as CRSPR mRNA vaccines) and a host of products for packaging, transport, food, drugs, cosmetics, housing construction materials, instant clothing, communication by telephone and internet, and novel consumer objects that everyone encounters every day.29 Innovation in nanotechnology is a catalyst for prosperity that can both innovate to bring economic benefits and overcome environmental challenges, if managed correctly30. Response to the multifaceted problems of informing workers and their families about risks associated with nanomaterials in the workplace requires a new paradigm for risk communication within the context of risk management31. Countless nanotechnology guides and sets of best practices are available [21].

There is global health precedent for this approach, but it is not found in hard law. The World Health Organization (WHO) without regulatory authority has nonetheless issued a well-respected set of guidelines about workplace exposure to nanomaterials after several years of careful expert consultations. Similarly, the USA National Institute of Occupational Safety and Health (NIOSH), also well respected worldwide without regulatory authority to inspect workplaces or enforce occupational health standards, has generated accessible information and guidelines about the use of nanomaterials such as titanium dioxide and also general guidelines.32 Many of the same experts worked on these guidelines so it is not surprising that their texts dovetail nicely, but these words are not enforceable under law and are not accountable to the public under principles of transparency or delegation of authority33.

Section 1 of the Model Act Framework for Nano Risk Governance

This section sets forth the importance of advancing a culture of innovation while protecting environment and health safety across the lifecycle of nano-enabled commercial products [21].

The background description of the economic and public health problems addressed in the proposed Model Act embraces steps from data generation to the actual risk evaluation and related management, positive incentives for inhouse compliance programs and an oversight commission. Finding that use of a flexible framework enables targeting broader societal and environmental concerns, the Model Act allows for a mechanism to generate responsible nanotechnology research and use consistently, across cultures and jurisdictions. The findings that justify the framework recognize the interdisciplinary character of nanotechnology research and applications, which generates the need for stakeholders to be heard, while reflecting perspectives from the general public and the media, legal theory and good science by Zooming in on nanoregulation decisionmaking: the center of the interface between public health, emerging technologies and international laws [22]. Purposes in Section 2 Target Broader Societal and Environmental Concerns This includes to construct a regulatory framework: To Anticipate, Recognize, Evaluate, Control, and Confirm risks to human health and the environment on a case-by-case basis, that applies precautionary principles to control and manage risks and communicate those risks when applying nanotechnology [23]. To require and develop ongoing regulatory mechanisms for oversight and monitoring of communication about risk, safe handling and projected long term health effects of nanotechnology products and, their biological fate the ecosystem and human beings [24].

To provide positive incentives for compliance with requirements for risk communication Section 3 Definitions include: “Corporate Criminal Sanctions” For Violations, “Due Diligence”; “Risk Management”, “Risk Mitigation”, and “Inhouse Compliance”

Definitions found in the Model Act explain to whom the legislature has granted authority, limit the scope of jurisdiction and clarify the roles of key players in the implementation of the new law. Clearly written definitions therefore enable consistent interpretations. For example, “Due diligence” is the fundamental concept for crafting and implementing effective in-house management systems. Our proposed Act therefore offers details about how t construct compliance programs, which in turn offer concrete proof of due diligence, ultimately allowing an entity to enjoy a presumption that activities are reasonable although the limits for preventing harm are unknown. The scope of the Model Act in Section 4 applies to end-use impacts of engineered or manufactured nanomaterials without regard to size, including materials in commerce that self-characterize as “nanomaterials”, “using nanotechnology” or listing “nano” among product features in labelling, publicity or using “nano” in trade names [25]. Section 5 Creating A “Commission for Bioethical Oversight of Nanotechnology Risk Communication in the Department of Health” is the Heart of the Model Act This central structure provides a reasonable alternative to the present chaos created by inconsistent laws with varying degrees of efficiency and conflicting jurisdiction. These components of the proposed framework will enable predictable oversight that will enable products to flow across the chain of commerce throughout the product life-cycle while safeguarding the environment and without sacrificing health. Oversight for risk communication embraces fairness, informed consent, and human health parameters of any applications of nanotechnology. The Commission can act as a conduit for monitoring and oversight, confirming ongoing free flow of information from the manufacturers, industrial consumers and product distributors of applications of nanotechnology to workers, consumers, the general public and end-users. It has power to: hear complaints from organizations and individuals regarding the failure to disclose required risk communication, authorize remedies to correct failures; set (or waive) penalties or fines; and create an accessible bi-annual report about best practices for maximizing benefits of nanotechnology, while minimizing risk [26]. Section 6, “Rewards For Proven Due Diligence In Risk Management” Enables The Commission To Offer “Positive Incentives” For Compliance With Requirements For: Disclosure; Risk Management; Risk Communication And Risk Mitigation. The Key Components For Operationalizing These Tasks Are Detailed In Section7, “Risk Management To Promote Responsible Development Of Nanotechnology” Setting

forth: components of risk management systems; data to Hazard analysis, quality-controlled, remotely accessible, searchable archives of comparable characterization, toxicological exposure information, methods for exposure assessment, and risk communication, with ongoing discourse between the Commission, regulated entities and stakeholders. Due diligence is required for auditing and periodic reviews about compliance; the Commission could require an entity to rewrite their risk management plan in the event of system failure leading to harm. Section 8, GHS applies an ancient legislative drafting technique called incorporation by reference Embedding the existing body of well-respected established GHS law into a new legislative framework enables the new law to have benchmarks from the time of its effective date, even if those benchmarks are modified at a later time. Section 9 enables individual citizens to trigger enforcement by petition with clear and convincing evidence to the Commission. The final sections address penalties, “Saving Clause” and Date for taking effect [27]. Can Law Govern EHS Issues for Applied Nanotechnology to Prevent Liability and Harm? Harmonization across jurisdictions is not a new challenge, but acceptance of a harmonized regime for nanotechnology law must be bottomed on more than consensus-- achieving harmonization requires that governments forsake a piece of their sovereign power in order to bend to the will of other governments so that a nanoregulatory process can emerge with one unified law. Therefore harmonization of the existing and emerging nanotechnology laws, requires a hierarchical superstructure set forth in the framework proposed here to meet civil society’s need for predictability in trade, to meet the private and public need for data collection regarding risks, to answer the universal need for consistent requirements regarding risk communication within industry and among industrial users and consumers of nanotechnology applications and to provide risk communication to directly impacted and secondary passive exposed populations. This process is unlikely to be completed quickly, if at all. Inevitably some laws will take center stage and others will stay in the periphery once there is a framework with clear priorities. It is not to expect that governments will relinquish sovereignty or that any administration responsible for public and environmental health would give up its power, thereby bowing to international law [28]. While plenty of global efforts for harmonisation exist, there is no clear indication which harmonized body of nanoregulations will become the most important. Simultaneously, well intended researchers in academia and governments and private industry are nonetheless filling the regulatory void with scientific guidance and guideline development aiming for a risk testing framework In sum, the rapidly changing nanoregulatory situation cries out for harmonization, transparency and consistency across hundreds of possible jurisdictions that are home to legitimate and enforceable laws. Regarding the substantive steps to be followed, risk management, employing best practices and exposure assessment and tools for risk communication provides the best answer to the problem of avoiding liability and forseeable harms, and for anticipating problems that cannot be predicted at the time of its writing. Therefore a base is needed to ensure the flow of data throughout the process of nanotechnology commercialization ensuring sound and replicable risk management: exposure assessment, risk assessment34, followed by education and training that will ensure the ongoing flow of data for stakeholder feedback in a cyclical process [29].

Harmonization is Key and a Commission is Needed to Traffic the Process

Historically, law and science have successfully partnered together throughout the 20th century to take on ”Big science” projects that were fraught with risk, and succeeded in harnessing atomic energy and decoding the human genome without blowing up the world or unleashing mutant monsters. Each of those endeavors undertook innovative projects that were fraught with risk, promoted new industries and ameliorated the quality of life for humanity. And, each of those projects had strong overarching legal frameworks to guide their discovery and provide oversight for their compliance with law. Therefore, a vast field of long and often inconsistent text governing commercialization of nanoenabled processes already exists. Regulations are the detailed rules created under laws by the administrative agency that has been delegated the authority by a duly elected legislature to create the fine-tuning of achieving the goals and mission of the law. It is enforce required and not subject to dispute. But, when scientists develop various regulatory minded nano-risk framework they often are not aware of that such a framework will operate under various laws in different jurisdictions, laws covering many different related issues. Thus, the plethora of nanoregulations and laws that exist without a hierarchy to prioritize them becomes an immediate obstacle to sound international commerce because obeying one law does not ensure than another, competing law has also been obeyed. The complex area of jurisprudence concerning the questions about which law applies involves resolving conflicts of law. A threshold need for clear mechanisms to encourage harmonization of conflicting nanotechnology laws swiftly takes center stage in order to reconcile conflicts of law. Without any proposed framework to guide application of diverse standards and guidelines, global nanoregulation becomes a jungle hampering future development and use of nanotechnology in commerce regardless how logical, popular or well-intended these nanoregulations and environmental, commercial or public health laws may be. Legal analysis of these rules within the larger superstructure can also yield important policy benefits by indicating gaps where new laws may be required, but also can demonstrate where duplicative or useless provisions can be removed [30].

The world needs nanotechnology and therefore, it is not surprising that its application across all industrial sectors and throughout commerce has become ubiquitous, as its proponnents in the previous century envisioned. The resulting plethora of nanoregulations, an admixture of statutory laws, treaties, private contracts and soft law, leaves many gaps and many overlapping areas of conflicting jurisdiction.

While plenty of global efforts for harmonisation exist, there is no clear indication which harmonized body of nanoregulations will become the most important. Simultaneously, well intended researchers in academia and governments and private industry are nonetheless filling the regulatory void with scientific guidance and guideline development aiming for a risk testing framework In sum, the rapidly changing nanoregulatory situation cries out for harmonization, transparency and consistency across hundreds of possible jurisdictions that are home to legitimate and enforceable laws. Regarding the substantive steps to be followed, risk management, employing best practices and exposure assessment and tools for risk communication provides the best answer to the problem of avoiding liability and forseeable harms, and for anticipating problems that cannot be predicted at the time of its writing. Therefore a base is needed to ensure the flow of data throughout the process of nanotechnology commercialization ensuring sound and replicable risk management: exposure assessment, risk assessment, risk mitigation through education and training, and to ensure the ongoing flow of data for stakeholder feedback in a cyclical process.

Oversight by a Commission comprised of an admixture of experts and novices gives a wide range of relevant perspectives for open discussion of technical points so that regulators have clarity regarding swiftly changing benchmarks, such as the Integrated Approaches to Testing and Assessment (IATA). Ultimately the result of these long discussions will enable manufacturers, employers including government entities, and consumers to know where they stand in relation to information about risk management when making choices about products that deploy nanotechnologies or nano-enabled offshoots of baseline nanotechnology [31].

The proposed Nanotechnology Risk Management and Public Health Protection Act does not override or repeal any of those laws or rewrite guides for best practices. Instead it offers an overarching superstructure to prioritize rules, to sort out the useful wheat from the chaff of duplicative, politically biased or otherwise flawed risk management analysis, and to clarify the roadmap for implementing nanotechnology information for all so that every stakeholder can become aware of and enable sound practices that foster innovation and protect global health across the legal landscape. Consequently, a commission created under a “Nanotechnology Risk Management and Public Health Protection Act” offering oversight of communication; following the blueprint of the GHS treaty; and incorporating by reference its terms as a start-up source for benchmarks can provide accountability for self-enforcing responsibility among those who send the information to protect the work health and survival of civil society and posterity [32, 33, 34, 35, 36].