Current Regulatory Practices Research Articles

Legal Regulation of Methane Emissions and Its Role in Supporting the Goal of the Paris Agreement: General Issues

This article explores the current legal and regulatory practices on lowering atmospheric methane, the main short-lived gaseous pollutant, adopted by the world’s largest methane emitters. In 2021, many countries joined the Global Methane Pledge (GMP), a joint international initiative, which has since been the guiding framework for estimating and reducing global methane levels. The GMP’s primary task is to support the goal of the Paris Agreement on climate change. Due to methane’s short life and the phenomenon referred to as the methane paradox, it has become clear that abandoning hydrocarbons completely would not guarantee a swift decrease in the radiative forcing of the lower troposphere. Reduction of aerosol emissions will lead to more intense warming during the first ten years, as aerosols are rapidly removed from the atmosphere. The only way to mitigate this effect is to curb short-lived methane emissions. Our findings reinforce previous conclusions and stress the critical need for developing legally binding regulations, both national and international, on greenhouse gas emissions.

Are Exposure Recommendations for QT Evaluation Being Fulfilled?

Pharmaceutical companies have several options to evaluate drug-induced QT prolongation, often referred to as QT pathways, during clinical development. Current regulatory practices recommend achieving high clinical exposure (HCE) for conventional thorough QT (TQT) studies. An alternative to the TQT study, commonly known as the Q&A 5.1 pathway, recommends a two-fold HCE as the exposure margin for concentration-corrected QT(C-QTc) analysis. To assess the impact of these recommendations, we analyzed the exposure margins of 166 new active substances approved in Japan since 2015. Among these, 28.3% of substances in conventional TQT studies (n = 92) did not achieve HCE, and 50.0% of substances in the C-QTc analysis (n = 22) did not achieve two-fold HCE. In the integrated risk assessment, C-QTc analysis, often incorporated into first-in-human studies, is recommended to cover HCE for substances showing no QT prolongation risks in both in vitro and in vivo non-clinical studies, and we analyzed whether the Cmax achieved in single-ascending dose (SAD) and multiple-ascending dose (MAD) studies reached HCE. The result showed that 51.1% and 47.7% of substances did not achieve HCE in SAD and MAD studies, respectively. Our findings highlight the need for dose-ascending strategy targeting two-fold therapeutic exposure to ensure HCE. Insufficient exposure may lead to failure to waive the TQT study, and delays in development timelines. To address these challenges, we propose strategies for optimizing early clinical study designs to meet the exposure recommendations and reduce the risk of additional requirements from the regulatory authorities at a later stage.

Neonicotinoid pesticides in African agriculture: What do we know and what should be the focus for future research?

This review provides a comprehensive overview of the direct and indirect effects of neonicotinoid pesticides (NEO-P) within African agricultural ecosystems and identifies research gaps, particularly in the monitoring and regulation of pesticide use. We observed a decline in the numbers of NEO-P studies conducted in Africa since 2019 with 40.7% of the countries reporting at least one study to date. Imidacloprid (33.5%), acetamiprid (23.3%), and thiamethoxam (25.0%) are the most reported NEO-P across the continent with concentrations range from 9.0×10-5 to 7.2×107mgkg-1, 1.7×10-5 to 2.1×103mgkg-1, and 1.0×10-5 to 4.7×104mgkg-1, respectively. NEO-P have been reported in honey, water, vegetables, fruits, and staple foods in most countries and in 92-100% of human urine samples collected in Ghana and Cameroon. This widespread presence indicates a potential food safety and public health concern, warranting further study. Studies on NEO-P interactions with bees have emanated mainly from North Africa (35.3% published studies) while Central/Middle, and Southern Africa accounted for 11.8% each of these studies, all of which were conducted in Cameroon and South Africa, respectively. It is important to have contextual evidence to understand neonicotinoids-pollinator interactions across specific African regions and countries; however, literature regarding the extent of NEO-P toxicities/effects on pollinators is required in 44 African countries. The environmental persistence of NEO-P and their broad-spectrum impact necessitate a re-evaluation of current regulatory practices and adoption of more sustainable pest management strategies across the continent. Furthermore, future studies should focus on investigating the long-term exposure to NEO-P, advanced computational methods in ecological risk assessments and eco-friendly alternatives to NEO-P.

Regulating robo-advice for consumers’ financial decisions: The interplay between algorithm quality & digital choice architecture

Rapid advances in digital interfaces, the quality of predictive algorithms, and the availability of high-speed internet are allowing firms to offer robo-advice: automated online guidance about which financial products are suitable for a consumer. At their best, robo-advisors feature algorithms that accurately predict which financial products are the optimal match for a given consumer’s needs and use digital choice architectures (that is, ways of presenting the product recommendations online) that are designed to strongly guide consumers to those best-fit products. Yet when algorithms lack great accuracy, strong guidance in favor of products incorrectly predicted to have the best fit could lead consumers to select options that do not meet their needs well. The possibility that strong guidance results in different financial outcomes depending on the quality of the algorithms has important implications for regulating robo-advice. We propose that, consistent with current regulatory practice for human advisors, regulators should require any firm wishing to implement a robo-advisor for its clients to demonstrate both that the robo-advisor is honest (that is, it works in the best interests of the client) and that its algorithms meet some established level of accuracy. In addition, regulators should require any firm offering a robo-advisor to demonstrate that the strength of the guidance provided by the digital choice architecture aligns with the predictive accuracy of the advisor’s algorithms. We offer several practical suggestions for implementing such a regulatory strategy. The need for regulations is becoming increasingly urgent because many robo-advisors now use artificial intelligence (AI) to make predictions. AI has made robo-advisors more powerful and easier to use, which is likely to expand their adoption—and, by extension, the harm that would be caused if subpar robo-advisors are allowed on the market.

Neurofeedback: potential for abuse and regulatory frameworks in the United States.

Neurofeedback is a brain-training technique that continues to develop via ongoing innovations, and that has broadening potential impact. Once confined primarily to clinical and research settings, it is increasingly being used in the general population. Such development raises concerns about the current regulatory mechanisms and their adequacy in protecting patterns of economic and political decision-making from the novel technology. As studies have found neurofeedback to change subjects' preferences and mental associations covertly, there is a possibility it will be abused for political and commercial gains. Current regulatory practices (including disclaimer requirements, unfair and deceptive trade practice statutes and undue influence law) may be avenues from which to regulate neurofeedback influence. They are, however, limited. Regulating neurofeedback will face the line-drawing problem of determining when it induces an unacceptable level of influence. We suggest experiments that will clarify how the parameters of neurofeedback training affect its level of influence. In addition, we assert that the reactive nature of the traditional models of regulation will be inadequate against this and other rapidly transforming technologies. An integrated and proactive regulatory system designed for flexibility must be adopted to protect society in this era of modern technological advancement. This article is part of the theme issue 'Neurofeedback: new territories and neurocognitive mechanisms of endogenous neuromodulation'.

Reputation, commitment, and financial market regulation

This paper explores the interplay between reputation mechanisms, pre-commitment strategies, and financial market regulation. Through a theoretical model, we analyze how repeated interactions between market participants, combined with regulatory oversight, can lead to improved compliance and market efficiency. The study demonstrates that reputation mechanisms serve as powerful self-regulatory tools, as negative reputational feedback exerts a stronger influence on market behavior than positive feedback, particularly when the cost of non-compliance is high. Additionally, we investigate the role of pre-commitment in promoting market cooperation and separating equilibria, where high-quality suppliers distinguish themselves from lower-quality competitors. However, in the absence of stringent regulatory enforcement, pre-commitments may be exploited by low-quality suppliers, leading to market inefficiencies. Our findings suggest that a reputation-based, tiered regulatory framework can optimize resource allocation and enhance the effectiveness of financial market regulation. The paper concludes with policy recommendations for integrating these mechanisms into current regulatory practices and outlines areas for future research.

Повторный лизинг как необходимая юридическая фикция

The article explores the issue of implementing the concept of re-leasing in Russia and examines the main fea-tures of the current regulatory and law enforcement practice concerning transactions that are currently used by civil turnover participants instead of this construct. The main obstacles preventing the direct extension of finan-cial lease regulation to this category of transactions without the introduction of legal fiction have been studied. The article evaluates the key advantages and, consequently, the market’s demand for such a construct in leas-ing services, as confirmed by judicial practice and the position of the Supreme Court of the Russian Federation. Additionally, the article considers methodological aspects of financial accounting and the differentiation of re-leasing as a subtype of financial leasing from rental (operational leasing), and offers proposals for amending the current legislation based on the Ministry of Economic Development’s draft law, with revisions that take into account the protection of the rights and legitimate interests of all parties to the re-leasing agreement.

The Evolution of Futures and Options Markets: From Agricultural Roots to High-Frequency Trading

The evolution of futures and options markets from simple agricultural hedging tools to complex financial instruments has been marked by significant technological advancements, particularly the advent of electronic trading and high-frequency trading (HFT). This paper traces the development of these markets, highlighting key milestones and innovations that have shaped their current form. High-frequency trading, while enhancing liquidity and reducing transaction costs, has also introduced significant challenges, including increased market volatility, the potential for market manipulation, and systemic risks, as seen in events like the 2010 Flash Crash. This research provides a comprehensive analysis of the legal and regulatory frameworks governing futures and options markets, with a focus on both Indian and international contexts. It examines the effectiveness of existing regulations in addressing the challenges posed by modern trading practices and explores the need for continuous adaptation in regulatory approaches. Through a detailed review of relevant case laws, statutory provisions, and scholarly literature, the paper identifies gaps in current regulatory practices and proposes recommendations to enhance market transparency, fairness, and stability. The study concludes that while the evolution of futures and options markets has brought undeniable benefits in terms of efficiency and risk management, these markets must be carefully regulated to mitigate the risks associated with high-frequency and algorithmic trading. Adaptive regulatory frameworks, enhanced transparency measures, and international cooperation are essential for ensuring that these markets continue to contribute positively to the global financial system.

Regulatory compliance and efficiency in financial technologies: Challenges and innovations

This study explores the integration of Regulatory Technology (RegTech) within dynamic regulatory frameworks tailored to the financial services industry, addressing the critical challenge of aligning fast-paced technological innovations with more traditionally static regulatory environments. The core purpose of this research is to develop adaptable regulatory frameworks that support the implementation of advanced technological tools, ensuring compliance while enhancing the efficiency of regulatory supervision. Utilizing a blend of qualitative and quantitative research methods, this paper analyzes the effectiveness of proposed frameworks through real-world application within financial institutions. Results indicate that integrating RegTech solutions streamlines compliance processes, significantly reduces operational costs, and improves real-time risk management. Interpretations of these findings suggest that adaptive regulatory frameworks facilitate a more proactive regulatory approach capable of supporting continuous technological advancements without compromising the integrity or stability of financial systems. The conclusion drawn from this study advocates for a systematic reevaluation of current regulatory practices, emphasizing the need for regulations that are as dynamic and innovative as the technologies they aim to govern. This approach promises to safeguard against emerging risks and foster an environment conducive to technological advancement within the financial sector.

The Post-Public Sphere and Neo-Regulation of Digital Platforms

This article discusses the post-public sphere and the regulation of platforms that have had disruptive effects on democracy. Platformisation means that the normative ideals for a political public sphere set out by Jürgen Habermas face a distinctive challenge. “Neo-regulation” is an evolving adaption by states that reflects the urgent need to address platformisation and digitalisation more generally. In conditions of geopolitical competition, notably between the China and US, attempts by various states and the EU to establish a neo-regulatory order has developed a significant national security dimension, which is highly relevant for the regulation of digital communication. Policing borders and content is an ever-present focus in all political regimes, whether characterised as democratic or authoritarian. Applying Pierre Bourdieu’s field theory to internet regulation, the argument is illustrated by reference to current British regulatory practice. At the level of the state, the “regulatory field” is shaped by national and global forces. Although the British case has specific characteristics, the underlying analysis has general relevance for comparative research.

Macroprudential Policies in the Light of the Development of Information Technologies: A Synthesis on the Effective Early Warning Signals

In response to recent recurrent crises, innovative macroprudential policies (MaPs) have been framed and implemented to address the weaknesses of market-led microprudential mechanisms and enhance the stabili­ty of financial systems. However, the effectiveness of the tools used to implement MaPs remains a critical research question. Early warning signals (EWS) serve as indicators of potential future crises. This paper explores approaches for identifying EWS to optimize the impact of MaPs, particularly in light of advances in information technology. It provides a comprehensive review of academic studies that identify effective EWS by analyzing numerical data through econometric and machine learning (ML) methods or by extracting economic insights from text using deep learning (DL) techniques — innovative methods for financial supervision and regu­lation. The findings, considering current regulatory practices, highlight the benefits of ML-based approaches for processing large sets of numerical data and the growing potential of text-based methods for assessing economic expectations.

Sectoral Asset Concentrations and Insurance Solvency Regulation

Historical evidence, like the global financial crisis from 2007–2009, highlights that sectoral asset concentrations can play an important role in the solvency of insurers. Yet, current regulatory frameworks, such as the U.S. risk-based capital (RBC) framework, neglect sectoral asset concentrations in the determination of capital requirements, potentially underestimating the asset portfolio’s systematic loss exposure and reducing incentives for corresponding risk mitigation. By creating a detailed data sample of U.S. insurers’ asset holdings from 2009 to 2018 by means of their statutory filings, we find that insurers concentrate their assets particularly toward the financial, public, and real estate sector and that sectoral asset concentrations toward the public sector are associated with improved solvency, while concentrations toward the real estate sector weaken solvency. Our findings can serve as a starting point to revise current regulatory practices, particularly in terms of creating proactive incentives for insurers to mitigate the accumulation of systematic risk exposures associated with sectoral asset concentrations.

Regulatory measures when implementing a new medical device into the cosmetic surgery industry. A case example: Macrolane

Over the past two decades, the cosmetic surgery industry has experienced significant global growth. This expansion has piqued the interest of healthcare professionals and product manufacturers, both aiming to enhance accessibility to surgery for a broader demographic. This manuscript presents the case example of “macrolane” hyaluronic acid. This product was introduced into the cosmetic surgery industry in 2007 and then removed from the market in 2012 by the manufacturer. The manuscript also presents and discusses the regulatory measures that were enacted following the introduction of macrolane into the European market. Specifically, these regulatory measures involved: insurance, professional qualifications and training, clinician representatives, sanitation, safety, cooling-off periods, informed consent, and advertising. Within the manuscript, it is also highlighted that interests from different stakeholders can create tension in the cosmetic industry, specifically: 1. clients might ask for a product, and they need to be protected; 2. healthcare providers are seeking a profit, and are subject to liability; 3. product’s manufacturers, who are seeking to expand their market, need to pass through regulatory processes. In conclusion, we wish to raise awareness of the ethical issues related to the regulatory measures implemented by European regulatory agencies responsible for public health, especially during the launch of a new product. These ethical considerations encompass several aspects: establishing accountability for validating research authenticity, delineating the functions of compensatory systems, overseeing educational processes, and supervising advertising and marketing practices. It should be noted that the comprehensive exploration of these ethical matters falls outside the scope of this manuscript, as they pertain more to public affairs rather than the realm of cosmetic surgery itself. Therefore, the discourse on these matters is better suited for engagement by experts in political and social ethics. Level of Evidence: Level V, analysis of current regulatory practices.

FINANCE REFLECTED BY FUNHOUSE MIRRORS

Money is money, securities are securities, and banking is banking. Their fundamentals are not changed by whether technology rails are centralized (classic) or pseudo-decentralized (virtual assets) – the song remains the same. As such, this paper does not reinvent the wheel on why we should regulate cryptoasset centralized exchanges (CEXs), as there is enough bibliography from today to the XVII century to go around on that. Instead, we focus on how to regulate the CEXs, which comes into play in a world where their distributed ledger technology (DLT) rails are off-the-grid and hinder regulators from: (i) collecting market data (information asymmetry); and (ii) practical enforcement (technology/operational asymmetry). After revising current regulatory practices from various countries, we identify grounds for a practical approach – we propose that regulators might enforce full trading/financial intermediation obligations on the CEXs by enacting an indirect regulation/gatekeeper scheme, as inspired by the U.S. Foreign Account Tax Compliance Act (FATCA). In this model, regulators would restrict traditional institutions (i.e., banks, broker-dealers, clearings, funds) from transacting with CEXs which do not provide adequate evidence of material compliance with their trading/financial intermediation obligations. On a final remark, we narrate a growing movement which aims to insulate non-compliant crypto from the financial systems altogether, avoiding risks of contagion.

Mixture risk assessment and human biomonitoring: Lessons learnt from HBM4EU.

Unintentional chemical mixtures that are present in the environment are of societal concern as the (environmental) chemicals contained therein, either singly or in combination, may possess properties that are hazardous (toxic) for human health. The current regulatory practice, however, is still largely based on evaluating single chemical substances one-by-one. Over the years various research efforts have delivered tools and approaches for risk assessment of chemical mixtures, but many of these were not considered sufficiently mature for regulatory implementation. This is (partly) due to mixture risk assessment (MRA) being very complex because of the large number of chemicals present in the environment. A key element in risk assessment is information on actual exposures in the population of interest. To date, information on actual personal (internal) mixture exposures is largely absent, severely limiting MRA. The use of human biomonitoring data may improve this situation. Therefore, we investigated within the European Human Biomonitoring Initiative (HBM4EU) various approaches to assess combined exposures and MRA. Based on the insights and lessons learnt in the context of the HBM4EU project, conclusions as well as recommendations for policy development regarding chemical mixtures and for further research were drafted. These conclusions and recommendations relate to both exposure and adverse health effects in humans. The recommendations were discussed with stakeholders in a workshop held in October 2021. There was considerable support and agreement with the spirit, scope and intention of the draft recommendations. Here we describe the lessons learnt on mixture risk assessment through the HBM4EU project and present the final recommendations. Overall, HBM4EU results demonstrated the potential of human biomonitoring as an instrument to obtain insight into the real-life mixtures the human population is exposed to. Also, HBM4EU results demonstrated that chemical mixtures are of public health concern. In the majority of the cases, it was possible to identify risk drivers, i.e. chemicals that contribute more strongly than others to the health risk. The novel approaches to identify co-occurrence patterns demonstrated clusters of co-occurring chemicals; chemicals in these mixture clusters are regulated independently under different legislative frameworks. Moreover, HBM4EU data and expertise can support a science-based derivation of a Mixture Assessment Factor and gauge potential impacts on the population's exposure to chemicals. While further expansion is needed on various aspects of the mixture activities carried out in the context of HBM4EU, application of available methodologies for mixture risk assessment should already be implemented to the degree possible.

QMRA of beach water by Nanopore sequencing-based viability-metagenomics absolute quantification

The majority of the current regulatory practices for routine monitoring of beach water quality rely on the culture-based enumeration of faecal indicator bacteria (FIB) to develop criteria for promoting the general public's health. To address the limitations of culture methods and the arguable reliability of FIB in indicating health risks, we developed a Nanopore metagenomic sequencing-based viable cell absolute quantification workflow to rapidly and accurately estimate a broad range of microbes in beach waters by a combination of propidium monoazide (PMA) and cellular spike-ins. Using the simple synthetic bacterial communities mixed with viable and heat-killed cells, we observed near-complete relic DNA removal by PMA with minimal disturbance to the composition of viable cells, demonstrating the feasibility of PMA treatment in profiling viable cells by Nanopore sequencing. On a simple mock community comprised of 15 prokaryotic species, our results showed high accordance between the expected and estimated concentrations, suggesting the accuracy of our method in absolute quantification. We then further assessed the accuracy of our method for counting viable Escherichia coli and Vibrio spp. in beach waters by comparing to culture-based method, which were also in high agreement. Furthermore, we demonstrated that 1 Gb sequences obtained within 2 h would be sufficient to quantify a species having a concentration of ≥ 10 cells/mL in beach waters. Using our viability-resolved quantification workflow to assess the microbial risk of the beach water, we conducted (1) screening-level quantitative microbial risk assessment (QMRA) to investigate human illness risk and site-specific risk patterns that might guide risk management efforts and (2) metagenomics-based resistome risk assessment to evaluate another layer of risk caused by difficult illness treatment due to antimicrobial resistance (AMR). In summary, our metagenomic workflow for the rapid absolute quantification of viable bacteria demonstrated its great potential in paving new avenues toward holistic microbial risk assessment.

Exploring risk governance deficits of maritime Search and Rescue in Canada

Maritime Search and Rescue (SAR) is an essential component of ensuring the safety of life at sea. Canadian SAR regions comprise vast sea areas, posing challenges to incident response. A wide range of maritime activities takes place, each having a different risk profile. The multitude of national and international regulatory commitments, rightsholder and stakeholder interests, and the need for efficient SAR response in changing climatic conditions, point to the need for effective societal risk governance. This article provides insights in shortcomings and improvement opportunities of maritime SAR risk governance in Canada, as understood by experts from responsible maritime authorities. The relevant current regulatory context and governance practices are described first, giving particular focus to the legal basis, roles and responsibilities, engagement processes with rights- and stakeholders, and the applied risk assessment tools to support decision-making. Subsequently, an exploratory research methodology based on interviews with federal civil servants and literature is performed to understand risk governance deficits, using a set of commonly found deficits identified by the International Risk Governance Council. The results indicate that the main deficits pertain to the lack of organizational capacity and dealing with dispersed responsibilities. Furthermore, deficits are identified in terms of obtaining factual knowledge of the risk, dealing with risk perceptions, understanding complex systems, and adequately involving rights- and stakeholders in risk assessment. The results serve as an initial basis to develop policy and management strategies for alleviating the identified deficits. Acknowledging the limitations of the exploratory study, several avenues for future research are outlined.

Systems and processes for regulation of investigational medical devices in Uganda.

In many parts of the world, medical devices and the processes of their development are tightly regulated. However, the current regulatory landscape in Uganda like other developing countries is weak and poorly defined, which creates significant barriers to innovation, clinical evaluation, and translation of medical devices. To evaluate current knowledge, systems and infrastructure for medical devices regulation and innovation in Uganda. A mixed methods study design using the methods triangulation strategy was employed in this study. Data of equal weight were collected sequentially. First, a digital structured questionnaire was sent out to innovators to establish individual knowledge and experience with medical device innovation and regulation. Then, a single focus group discussion involving both medical device innovators and regulators to collect data about the current regulatory practices for medical devices in Uganda. Univariate and bivariate analysis was done for the quantitative data to summarize results in graphs and tables. Qualitative data was analyzed using thematic analysis. Ethical review and approval were obtained from the Makerere University School of Biomedical Sciences, Research and Ethics Committee, and the Uganda National Council for Science and Technology. A total of 47 innovators responded to the questionnaire. 14 respondents were excluded since they were not medical device innovators. Majority (76%) of individuals had been innovators for more than a year, held a bachelor's degree with a background in Engineering and applied sciences, and worked in an academic research institute. 22 of the 33 medical device innovators had stopped working on their innovations and had stalled at the proof-of-concept stage. Insufficient funding, inadequate technical expertise and confusing regulatory landscape were major challenges to innovation. The two themes that emerged from the discussion were "developing standards for medical devices regulation" and "implementation of regulations in practical processes". Legal limitations, lengthy processes, and low demand were identified as challenges to developing medical device regulations. Efforts have been taken by government to create a pathway for medical device innovations to be translated to the market. More work needs to be done to coordinate efforts among stakeholders to build effective medical device regulations in Uganda.

Cancer patient management: Current use of next-generation sequencing in the EU TOP4

BackgroundNext-generation sequencing (NGS) is recognised by a growing audience of medical professionals as a functional diagnostic tool in oncology. However, adoption in clinical routine proceeds haphazardly in Europe. MethodsA semi-structured interview survey was administered to 68 cancer care professionals in four EU countries between June-August and November-December 2021. Pre-screening questionnaires assessed sufficient NGS expertise, diverse geographical distribution, and professional roles. ResultsOur findings provide a better understanding of current clinical, regulatory, and reimbursement practices for NGS in four EU countries. ConclusionsDespite the impending European In-vitro Diagnostic Medical Devices Regulation (IVDR), tortuous national guidelines implementations and limping reimbursement policies are common traits across surveyed countries and produce disparity in access to advanced healthcare services amid regional distinctions. Policy summaryThe evident information gap between involved parties and demand for consistent national guidelines could be filled by health economics analyses tailored to local specifics to provide factual leverage for a structured adoption of NGS testing.

A framework for the oversight and local deployment of safe and high-quality prediction models.

Artificial intelligence/machine learning models are being rapidly developed and used in clinical practice. However, many models are deployed without a clear understanding of clinical or operational impact and frequently lack monitoring plans that can detect potential safety signals. There is a lack of consensus in establishing governance to deploy, pilot, and monitor algorithms within operational healthcare delivery workflows. Here, we describe a governance framework that combines current regulatory best practices and lifecycle management of predictive models being used for clinical care. Since January 2021, we have successfully added models to our governance portfolio and are currently managing 52 models.