An Overview of the Dangerous Technology System (HTS)
Hazardous Technology Systems (HTS) encompass a broad range of systems, from thermostats to industrial ovens. Such devices, which impact safety, are increasingly controlled by IT systems and software. Many HTS have specific implementation criteria or requirements intended to safeguard their risks associated with their use. Industry-specific regulations and standards (of an old and new origin) have been developed to regulate the use and eligibility of such technology. New technology not only generates new risk, but also generates discussions amongst authorities and regulators as to who has responsibility for ensuring that such risks are mitigated . This includes whether the correct agency is responsible for ensuring conformity with requirements for the devices, from batteries to software updates. Because HTS are subject to regulation on the state and federal level, not unlike other forms of critical devices such as nuclear plants, or health related devices such as implanted medical devices, it is important to understand the regulatory landscape in order to ensure that your technology conforms with applicable requirements.
Federal Statutes Governing HTS
Several federal laws apply to hazardous technology systems. The Clean Air Act applies to HTS when an affected facility emits an air pollutant or are potentially hazardous. The Occupational Safety and Health Act (OSHA) is an important federal law that regulates many types of workplaces, including those that use various types of hazardous equipment, processes, and materials. There are a number of different kinds of federal regulations that can apply to HTS.
Environmental Protection Agency (EPA) regulations under the federal Clean Air Act govern the emissions from facilities that burn hazardous waste designed to reduce toxicity or volume. Specifically, EPA regulations govern the terms of a permit to burn hazardous waste. The terms generally include record keeping and reporting requirements, and monitoring emissions that are discharged into the air. The permits required under the EPA’s regulations for burning hazardous waste also apply to HTRW that, although not treated as hazardous waste may be so treated. If the HTRW contains metals in concentrations that may be hazardous, EPA regulations require monitoring and mitigation of the metals.
The Occupational Safety and Health Administration (OSHA) has promulgated standards pursuant to the Occupational Safety and Health Act, which are applicable to many workplaces and particular processes, substances, and equipment. For example, OSHA regulates the use of x-ray related equipment. Similarly, the National Institute for Occupational Safety and Health (NIOSH) is part of the U.S. Department of Health and Human Services, which has developed regulations and standards for many potentially hazardous operations. NIOSH and OSHA are two government agencies with regulations that apply to many types of industrial workplace operations, including among other things transportation, storage, use, and disposal of such things as chemicals, flammable liquids or vapors, and x-ray equipment.
State Statutes applicable to HTS
Beyond federal exploration of regulations governing HTS, the flip side to the balance of power between federal and state governments is states’ rights. Many states have enacted or are enacting laws pertaining to hazardous technology systems. An overview of these regulations is below.
In addition to the federal laws discussed above, a few states have enacted laws regulating hazardous technology systems.
Minnesota
S.F. 4538 was passed by the Minnesota legislature in March 2014 after having been painstakingly drafted and debated for many months. The bill went through at least a dozen versions before being passed. It received bipartisan support, and received no "no" votes in committee or on the floor. The measures in S.F. 4538 provide regulatory protection for the citizens of Minnesota from risks associated with hazardous (and many non-hazardous) systems.
Ohio
In Ohio, practically every HTS is now covered by regulation. The Ohio Department of Natural Resources will now regulate any electronic communications facility which breaks rock. A small electronic equipment vault or buried cable may be covered by general permitting. An "electronic communications facility" includes all facilities used to electronically transfer information and associated accessory uses to the land. The regulation was adopted on February 18, 2014 and became effective on March 24, 2014.
Hawaii
Hawaii is the only state in the country to have yet addressed hazardous technology systems in its regulations. This makes sense, as the state has not had any problems with HTS in the past, and there are very few HTS on the islands. However, both Hawaii and Alaska seem to be heading in the direction of covering HTS under existing regulations. Citing the precedent set in Minnesota and Ohio, Hawaii may yet be next to regulate hazardous technology systems.
Challenges to HTS Operators
Operators of hazardous technology systems (HTS) face compliance challenges that stem from the complex interplay of federal and state laws. The federal hazardous air pollutions requirements are an important part of the regulatory framework for hazardous technology systems, but states impose additional requirements that vary considerably in both scope and application. All classified HTS are subject to these overlapping regulations, which create a complicated compliance landscape in addition to a complicated regulatory environment.
Below are some of the most commonly problematic compliance issues faced by operators of hazardous technology systems:
Applicability of Federal PM Emissions Standards Because both federal and state governments regulate classified HTS, it is critical to distinguish between the two levels of laws that may apply. Permits issued by the U.S. Environmental Protection Agency (USEPA) will incorporate federal emission standards as well as monitoring, recordkeeping, and reporting requirements. However, the applicability of any federal emissions standards is often much more difficult to determine, especially in light of the changes made to the National Emissions Standards for Hazardous Air Pollutants (NESHAP) standards in 2015, since it can be unclear whether such standards even apply. Determining what standards apply requires a careful analysis of each process and material used.
Application of State Laws Compliance with state laws, and therefore state permitting, is generally based on when the system becomes operable, as opposed to when the system is put to use. In many cases, if the system has received a permit issued before 2004, the system will no longer have to comply with a state’s hazardous air pollutants emissions standards and will have certain exemptions from permitting requirements, upon request. However, "if such existing source_commences construction of new or additional facilities or installation of equipment in excess of thirty percent (30%) of the generating capacity of the existing facility, the facility is subject to the permitting requirements and emission standards as they apply to new facilities." Even once HTS operators determine the hazardous air pollutants standards to which they are bound, federal and state methods for monitoring, recordkeeping, and reporting requirements may differ, necessitating separate compliance plans.
Therefore, when a known listed hazardous air pollutant is identified in a new process design, it is important to map out for that process the appropriate federal emissions standards, the state emissions standards that might apply based on the design’s capacity, and USEPA and state hazardous waste regulations. Often times, this exercise will lead to the determination that there is not a one-size-fits-all permit that covers the entire facility and that each unit must be designed to accommodate these differences after determining its applicable standards.
Role of Technology in Regulatory Compliance
Technology has become an increasingly important component in complying with the legal requirements imposed on HTS. Newly developed systems can aid in reporting requirements and monitoring to ensure that the HTS remains compliant with governing legal requirements. For example, the Common Rule [45 CFR 46.101(b)(2)] requires certain records be retained for three years after research ends. Certain innovations exist in the form of records management systems that assist with compliance to this requirement by tracking and storing relied upon citations, study records, and prior reviews. Technologies such as these alleviate certain administrative burdens that would otherwise distract from the core work of research possible. Further , data management systems can allow authorized users to easily input milestones and notify other authorized users upon milestone completion. These milestones and notifications assist in compliance with legal requirements that impose deadlines upon HTS. Such systems can also be designed to facilitate other compliance measures, such as requiring re-authorization of users or training completion before granting access to integral components of HTS. For example, a system could be set up to require a user be current in their training on subject matter of an HTS before they are permitted to perform any tasks.
Future Directions for HTS Regulation
As the landscape of hazardous technology systems continues to evolve at a rapid rate, so too does the need for a corresponding shift in regulatory frameworks. With the increasing integration of artificial intelligence, autonomous systems, and smart infrastructure, regulators must adapt their approaches to ensure the safe and responsible deployment of these technologies. In the future, we can expect to see more comprehensive guidelines and nuanced regulations that address not only the safety and efficacy of these systems but also ethical considerations, liability issues, and the socio-economic impact on communities.
One of the more imminent changes likely to occur in the near future is the potential expansion of federal authority to regulate a wider array of hazardous technology systems. As the federal government examines and updates current legislation governing technologies such as drones and autonomous vehicles, new inclusions are expected not only to increase the jurisdiction of federal agencies but also to establish a consistent regulatory environment to address the challenges posed by these emerging technologies. Moreover, we can expect to see state governments complementing and augmenting federal regulations with their own localized rules and standards.
Another developing trend is the formation of multi-stakeholder partnerships between government, industry, and academia to address regulatory challenges. As various sectors become involved in the examination of new technologies, inclusive dialogue can yield a more complete understanding of the potential issues and solutions. Such collaboration stimulates the drafting of recommendations for the federal government, not only with respect to safety and technology, but also in the areas of policy, economics, and education.
Additionally, public awareness of the risks presented by hazardous technology systems has increased dramatically in recent years, with grassroots initiatives and activist groups now having a pronounced impact on decision-makers. The push for policy change in this area is likely to become a "movement" unto itself, with more organizations and larger numbers of citizens advocating for stricter oversight of hazardous technology systems. Furthermore, as the populace becomes increasingly well-informed, more individuals will enter the government or private sector with the requisite specific expertise on these matters.
Throughout the next decades, government regulators will grapple with the juxtaposition of protecting the public safety, health, and welfare while also fostering innovation. As such, the issue of balancing these competing interests will be the fulcrum on which policymakers will pivot their determinations. Whether the result is more legislative power for the federal government or local autonomy for states, one thing remains certain: the regulatory landscape governing hazardous technology systems will continue to grow in complexity and demand the attention of all involved stakeholders.
Closing Thoughts on Navigating HTS Regulations
It should now be well understood that the Hazardous Technology System (HTS) regulations (if applicable to a firm) have three essential components: (1) The HTS subject to the regulations are specifically identified in the regulations, (2) the regulations provide explicit requirements and protocols that must be adopted for the safe design, construction and operation of the HTS, and (3) the regulations also require a firm to "obtain the prior approval of the [CSB] pursuant to guidelines established by the [CSB]" for the design, construction and operation of the HTS.
In addition, the regulations require a firm to:
It is also important to keep the following points in mind: This article has provided an introduction to some important aspects of the federal laws and regulations setting standards for the management of safety and health risks to the public associated with the transportation, sale, manufacturing and use of hazardous technology systems. The article has also identified the fundamental importance of HTS regulations and compliance in those states covered by the CSB regulations. If you are a local government or state agency, it is critically important to understand the legal implications of the federal and state HTS regulations. A fundamental understanding of the scope and intent of the federal and state regulations is also essential when developing or revising any regulations applicable to the design, manufacture, sale, transportation and operation of any potentially hazardous information technology systems. For both public and private sector compliance obligations, no less than knowing where obligations may arise under state and/or federal laws , it is also important for state and local officials to understand the specific legal requirements that may be imposed under HTS regulations. Compliance obligations can be very technical and detailed, as exemplified by the Master Equipment File (MEF) detailing the design and operational specifications incorporated into the applicable operational descriptions of the higher risk Tier 1, Tier 2A and Tier 2B facilities subject to certain federal regulations.
In addition, compliance with such requirements generally requires the generation of a significant volume of engineering, construction, operational, training, and maintenance data along with the preparation and distribution of appropriate reports to affected local, state and federal agencies. Finally, arguably the most important takeaway from this article is the need for affected organizations to focus on achieving effective compliance under federal and state laws and regulations governing Hazardous Technology Systems. As indicated above, compliance obligations can vary with respect to the details of: (1) the HTS regulatory jurisdiction; (2) applicable design codes; (3) documentation requirements; (4) application requirements; (5) training regime requirements; (6) monitoring and reporting of charges; (7) safety and maintenance equipment; (8) safety and maintenance procedures and protocols; (9) the inspection or audit of records; (10) the approval of changes in circumstances (including a change in technology, institution, ownership or control); and (11) standards, guidelines and qualifications of test and maintenance personnel (among other details). It is also critical to remember that compliance can involve the legal rights, powers, duties, liabilities and responsibilities of private, state and local government organizations as well as domestic and foreign government organizations and entities.