Companies usually hire a foreign national who requires visa sponsorship because they cannot find a U.S. worker with those skill sets, which is frequently in the STEM fields. However, visa sponsorship comes with significant costs to the employer. Employers may be able to recover a portion of the immigration sponsorship fees by implementing what are called “clawback” provisions into their employment agreements. Clawback provisions are terms in the employment agreements that, in the event of a resignation by the employee before a certain date, require the employee to reimburse the employer for a portion of the costs or fees associated with his or her visa sponsorship.
Not All Visa Fees Can Be Clawed Back
But first, it’s important to understand which sponsorship fees and costs are potentially recoverable and which are prohibited from being “clawed back.”
H-1B Petition: Because these visas have a prevailing wage set by the U.S. Department of Labor (DOL) a H-1B employer may not clawback any attorney fees or government filing fees used to obtain the H-1B petition approval by U.S. Citizenship & Immigration Services (USCIS).
Other Visas: The same restriction applies to the Australian E-3 visa and the Singapore/Chile H-1B1 visas as well as the H-2A, H-2B, and J-1 visas.
PERM Labor Certification Sponsorship for Permanent Residency: PERM Is the most common method for an employer to sponsor a foreign national employee for permanent residency (green card). It is done by conducting recruitment and proving to DOL that no qualified U.S. worker applied for the position. An employer is required to pay for all of the fees and costs associated with the PERM process.
I-140 Immigrant Petition: After DOL certifies the PERM application and agrees that no qualified U.S. worker is available, the employer must file an I-140 immigrant petition with USCIS. The attorney fees and costs for the I-140 may be clawed back. The purpose of the I-140 immigrant petition is for the employer to prove to USCIS that the foreign national has the required education, experience and special skills outlined in the PERM filing with DOL. In addition, the I-140 includes financial documents showing that the employer has the ability to pay the offered wage.
I-485 Adjustment of Status to Permanent Resident filing: The employer may clawback the fees and costs associated with the I-485 adjustment of status application (green card).
Practice Pointers
Still At Will: The clawback provisions should be in writing. It should also indicate that the employment is still at will, if applicable.
Final Paycheck: The majority of states, including California, do not allow an employer to deduct anything from a final paycheck without the express consent of the employee. This includes fees and costs pursuant to the clawback provision.
Deterrence: Given that an employer cannot clawback from the final paycheck and suing a former employee to collect the amount in controversy is not always practical, a clawback provision can be used as a deterrence for early departure.
Among the multiple executive actions the White House announced on June 18, 2024, was one stating it was taking steps to facilitate the process for certain Deferred Action for Childhood Arrivals (DACA) recipients to obtain work visas/status. DACA was created in 2012 by President Barack Obama as a means for immigrant youth who met certain eligibility requirements to qualify for work authorizations and obtain “deferred action.”
While DACA protection has enabled hundreds of thousands of individuals to legally work and live in the U.S., the program has faced considerable uncertainty since 2017, when the Trump administration initially sought to terminate the program, but was prevented from doing so in the federal courts.
The program continues to face legal challenges, and additional litigation before the U.S. Supreme Court is likely. Fundamentally, DACA is not a legal status – the reliance on “deferred action” simply reflects the U.S. Department of Homeland Security’s (DHS) decision not to bring immigration removal proceedings against a specific individual. While many DACA recipients and their employers have since sought to transition to a work visa or other legal status that Congress specifically established in the Immigration and Nationality Act (INA), the process for doing so is uncertain, expensive and cumbersome.
Since DACA recipients either entered without authorization or were out of status when they received DACA protection, they are typically ineligible for a transition to a lawful status within the U.S.
Instead, they are required under immigration law to “consular process” outside the U.S. and obtain a work visa at a U.S. consulate. The individual’s departure from the U.S. could trigger removal bars (similar to those described above), requiring the individual to obtain a temporary waiver of inadmissibility from the government. These waivers, known as “d3 waivers” based on the section of the INA to which they relate, can take months to obtain and the outcome of such a waiver is not certain. These cumulative issues have chilled the interest of many employers and DACA recipients in pursuing these waivers.
On July 15, 2024, the U.S. Department of State made changes to the Foreign Affairs Manual (FAM), which is controlling guidance for consular officers at U.S. Consulates on factors to consider when adjudicating waiver requests. The three primary changes that the DOS made to 9 FAM 305.4-3 are:
Expanding the factors that would have a positive effect on U.S. public interests in granting a waiver to include circumstances “where the applicant has graduated with a degree from an institution of higher education in the United States, or has earned credentials to engage in skilled labor in the United States, and is seeking to travel to the United States to commence or continue employment with a U.S. employer in a field related to the education that the applicant attained in the United States….” These changes noted in bold are clearly designed to benefit many DACA recipients.
The second change creates a mechanism for a waiver applicant whose request is denied by a consular officer to request State Department review in circumstances involving “significant public interest,” which in turn cross-references the factors above that are of particular benefit to DACA recipients.
The FAM was also updated to reflect the ability of DACA recipients who have graduated from an educational program in the United States or are seeking to reenter the U.S. with a visa as beneficiaries of an offer of employment to request an expedite of the waiver request. This change is particularly critical as one of the greatest challenges that DACA recipients face when seeking a waiver is the uncertain adjudication period, which often stretches for months.
Collectively, these updates are significant and will benefit several DACA recipients who are beneficiaries of employer sponsorship. These pathways also create a mechanism for U.S. employers to transition DACA recipients from DACA, with its increasing uncertainty, to a more stable work visa. DACA recipients should, of course, plan prudently if considering a departure from the U.S. to apply for such a waiver and should also apply for advance parole before departing the U.S. so as to provide a mechanism for reentering the U.S. if the waiver request is denied.
The statement outlines risks to competition that are present in the AI ecosystem and shared principles for fostering and protecting competition in this space.
The statement is silent on specific enforcement actions, but the release of the statement suggests potential future activity and increased scrutiny of AI competition by the enforcers.
On July 23, the top competition enforcers at the US Federal Trade Commission (FTC) and Department of Justice (DOJ), the UK Competition and Markets Authority (CMA), and the European Commission (EC) released a Joint Statement on Competition in Generative AI Foundation Models and AI products. The statement outlines risks in the AI ecosystem and shared principles for protecting and fostering competition.
While the statement does not lay out specific enforcement actions, the statement’s release suggests that the top competition enforcers in all three jurisdictions are focusing on AI’s effects on competition in general and competition within the AI ecosystem—and are likely to take concrete action in the near future.
A Shared Focus on AI
The competition enforcers did not just discover AI. In recent years, the top competition enforcers in the US, UK, and EU have all been examining both the effects AI may have on competition in various sectors as well as competition within the AI ecosystem. In September 2023, the CMA released a report on AI Foundation Models, which described the “significant impact” that AI technologies may have on competition and consumers, followed by an updated April 2024 report on AI. In June 2024, French competition authorities released a report on Generative AI, which focused on competition issues related to AI. At its January 2024 Tech Summit, the FTC examined the “real-world impacts of AI on consumers and competition.”
AI as a Technological Inflection Point
In the new joint statement, the top enforcers described the recent evolution of AI technologies, including foundational models and generative AI, as “a technological inflection point.” As “one of the most significant technological developments of the past couple decades,” AI has the potential to increase innovation and economic growth and benefit the lives of citizens around the world.
But with any technological inflection point, which may create “new means of competing” and catalyze innovation and growth, the enforcers must act “to ensure the public reaps the full benefits” of the AI evolution. The enforcers are concerned that several risks, described below, could undermine competition in the AI ecosystem. According to the enforcers, they are “committed to using our available powers to address any such risks before they become entrenched or irreversible harms.”
Risks to Competition in the AI Ecosystem
The top enforcers highlight three main risks to competition in the AI ecosystem.
Concentrated control of key inputs – Because AI technologies rely on a few specific “critical ingredients,” including specialized chips and technical expertise, a number of firms may be “in a position to exploit existing or emerging bottlenecks across the AI stack and to have outside influence over the future development of these tools.” This concentration may stifle competition, disrupt innovation, or be exploited by certain firms.
Entrenching or extending market power in AI-related markets – The recent advancements in AI technologies come “at a time when large incumbent digital firms already enjoy strong accumulated advantages.” The regulators are concerned that these firms, due to their power, may have “the ability to protect against AI-driven disruption, or harness it to their particular advantage,” potentially to extend or strengthen their positions.
Arrangements involving key players could amplify risks – While arrangements between firms, including investments and partnerships, related to the development of AI may not necessarily harm competition, major firms may use these partnerships and investments to “undermine or coopt competitive threats and steer market outcomes” to their advantage.
Beyond these three main risks, the statement also acknowledges that other competition and consumer risks are also associated with AI. Algorithms may “allow competitors to share competitively sensitive information” and engage in price discrimination and fixing. Consumers may be harmed, too, by AI. As the CMA, DOJ, and the FTC have consumer protection authority, these authorities will “also be vigilant of any consumer protection threats that may derive from the use and application of AI.”
Sovereign Jurisdictions but Shared Concerns
While the enforcers share areas of concern, the joint statement recognizes that the EU, UK, and US’s “legal powers and jurisdictions contexts differ, and ultimately, our decisions will always remain sovereign and independent.” Nonetheless, the competition enforcers assert that “if the risks described [in the statement] materialize, they will likely do so in a way that does not respect international boundaries,” making it necessary for the different jurisdictions to “share an understanding of the issues” and be “committed to using our respective powers where appropriate.”
Three Unifying Principles
With the goal of acting together, the enforcers outline three shared principles that will “serve to enable competition and foster innovation.”
Fair Dealing – Firms that engage in fair dealing will make the AI ecosystem as a whole better off. Exclusionary tactics often “discourage investments and innovation” and undermine competition.
Interoperability – Interoperability, the ability of different systems to communicate and work together seamlessly, will increase competition and innovation around AI. The enforcers note that “any claims that interoperability requires sacrifice to privacy and security will be closely scrutinized.”
Choice – Everyone in the AI ecosystem, from businesses to consumers, will benefit from having “choices among the diverse products and business models resulting from a competitive process.” Regulators may scrutinize three activities in particular: (1) company lock-in mechanisms that could limit choices for companies and individuals, (2) partnerships between incumbents and newcomers that could “sidestep merger enforcement” or provide “incumbents undue influence or control in ways that undermine competition,” and (3) for content creators, “choice among buyers,” which could be used to limit the “free flow of information in the marketplace of ideas.”
Conclusion: Potential Future Activity
While the statement does not address specific enforcement tools and actions the enforcers may take, the statement’s release suggests that the enforcers may all be gearing up to take action related to AI competition in the near future. Interested stakeholders, especially international ones, should closely track potential activity from these enforcers. We will continue to closely monitor and analyze activity by the DOJ and FTC on AI competition issues.
The Federal Law for the Protection of Industrial Property, in force since the 5th of November of 2020, is distinguished from its predecessor, among other things, by the particularities in the claims of a compensation for damages caused by the infringement of industrial property rights.
Currently, individuals may claim a compensation for damages through the administrative venue, before the Mexican Institute of Industrial Property (IMPI), or through the civil venue before the corresponding Courts in the matter. This implies that the holder of infringed exclusive rights may opt for two procedures and authorities of different nature, which has its benefits and disadvantages.
Before the IMPI, the compensation action is exercised in an ancillary proceeding, provided that such authority has previously issued a declaration of administrative infringement that is enforceable. Alternatively, it is still possible for the action to be brought directly before the Civil Courts, once the resolution from IMPI is final.
Although the exercise of the action for compensation before the administrative authority implies that a specialized authority in the matter is to hear the case, it has the disadvantages that its ancillary proceeding requires the prior prosecution of an administrative infringement claim before the same administrative authority (IMPI) and the lack of experience to quantify damages and losses. Additionally, the time required for the enforcement of the resolution issued by the IMPI before the Federal Courts in Civil Matters must be added to the time required for the substantiation of the action.
Thanks to the entry into force of the new Law, individuals may also resort directly to the civil Courts to claim infringement of their industrial property rights and compensation for damages, without the need for a prior declaration of infringement by the IMPI. This implies that a Judge, an expert in civil law, will have to delve into complex, specialized and technical issues, specific to industrial property.
Additionally, it is provided that the proceeding of the civil action will be suspended if an invalidity claim is filed before the IMPI against the right basis the civil claim, as long as the administrative authority does not issue a final resolution to such nullity action. This counteracts the advantage of a civil proceeding whose resolution may be quicker than before IMPI.
The new landscape for the claim for damages requires a careful study of the particularities of each specific case to determine the suitability of each route, since this is influenced, among other factors, by the complexity, the sophistication of the counterparty, the causes and technical considerations of the violation caused, among others.
Cross-cultural differences and the misunderstandings that often arise from them play a powerful role in how businesses build relationships and conduct their commercial and legal affairs. At a time of expansive growth in transnational business, trade, and investment, a lack of knowledge about local culture, values, and customs in business and legal dealings are leading to ever more complex and tense international legal disputes.
As lawyers and arbitrators, it is critical to foster a deeper understanding of how cultural and emotional factors along with behavioral tendencies impact business decisions and the practice of arbitration worldwide. Addressing these issues in the context of business-to-business (B2B) relationships, a recent report by the International Chamber of Commerce, Jus Connect, and McCann Truth Central found that a new set of principles—based on emotional intelligence, cultural awareness, and cultural fluency—is required to create a cross-cultural playbook for arbitration and re-imagining dispute outcomes.
Global leaders surveyed said that arbitration is still the preferred way to resolve cross-border disputes over litigation. If a contract fails, 60% prefer arbitration to legal proceedings in a court. Overall, arbitration has increased significantly over the past decade, reaching an estimated $80 billion in 2022. Some 37,000 new cases were registered between 2018 and 2022, an increase of nearly 30% between 2013 and 2017. While this represents a mere fraction of the $121 trillion in international trade in 2022, arbitration is growing twice as fast as global trade as clients recognize the speed, efficiency, transparency, and flexibility it offers to resolve disputes compared to traditional litigation.
Cultural Miscues
In my travels as President of the ICC International Court of Arbitration, I have heard countless stories about the influence of cross-cultural differences on business and legal affairs, including arbitration. And with good reason: every country has unique and often contrasting attitudes about dispute resolution and misunderstanding them can add layers of difficulty during legal proceedings for both general counsel and arbitration lawyers.
Based on extensive interviews and quantitative data, the ICC report divides cultural attitudes and approaches into four generalized categories and suggests which countries fit into each one. The Innovative Explorer, for example, including France and Saudi Arabia, seeks collaboration and co-creation, looks for emotional chemistry, and tends to stretch goals. For their part, India and Nigeria can be seen as a Strategic Balancer, eager for collaboration and co-creation, along with emotional chemistry, and ready to stretch goals.
Brazil and Mexico are among the countries regarded as a Decisive Custodians, in that they tend to value structure and contracts as part of a more direct, yet discrete approach and in addition, prefer working with senior partners. Finally, as the name indicates, the Pragmatic Realist—including the U.K. and Switzerland—takes a reasoned and practical approach, with an appreciation for clear expectations meeting agendas, and giving parties a second chance.
These attitudes are reflected in the different approaches that countries have toward contracts. Some want a clear scope, set in stone. Others put more focus on outcomes and fluidity in delivery. For instance, while Mexico and Brazil prefer structured approaches in contract agreements, India and Saudi Arabia are open to collaboration and co-creation in a scope of work. France and China prefer to stretch sometimes-unrealistic goals, but India and Nigeria, want realistic and achievable ones.
Chameleon U.S.
Digging deeper into the analysis shows that in some ways, the U.S. has a lot in common with Brazil and China when considering the role of hierarchy and discretion in a business situation. If someone in business makes a mistake, Americans prefer to promptly resolve disputes, even if a party might get offended and are also unlikely to copy their boss on an email.
These categories help explain many business decisions and actions and can guide teams to recognize and overcome cultural differences. But they don’t always tell the whole story: cultural nuances add even more complexity to cross-border business and legal dealings.
The U.S., for example, can be described as a chameleon or shapeshifter that doesn’t always neatly fit any descriptor. In my experience, U.S. business representatives will typically revise their approach depending on what the customer or counterparty needs. This flexibility is likely due to the presence of diverse and multicultural U.S. business teams compared to some other countries. As one senior arbitrator said in the report, “In the U.S., the common denominator is understanding what the customer needs.”
Small Behavior, Big Impact
Mapping the world by culture rather than geographic positioning offers valuable insights that can improve cultural fluency and ensure that geography alone does not influence expectations and approaches. The report showed how small behaviors point to larger cultural priorities. Teams from France and Saudi Arabia don’t necessarily need an agenda to attend a meeting, but those from India and Nigeria would usually prefer a detailed agenda. Acknowledging these cultural differences, however small and seemingly inconsequential, provides a framework for anticipating and resolving friction and helping teams adapt.
One of the most interesting aspects of the study is that business teams and leaders say they want lawyers involved earlier in the B2B process—and more deeply integrated into the journey—with a focus on win-win outcomes. This is consistent with the changing role of in-house counsel, particularly in the U.S., where in house counsel work more closely with business teams to develop strategy and structure the deal. Given the growing complexity of today’s global regulatory environment, business teams can no longer negotiate the deal first and then bring the terms to the in-house team to document.
While the study focused on cultural differences, it also found a commonality across cultures: a growing preference for non-legal dispute resolution. Some 77% favored an amicable, interest-based resolution—through internal or contract review, or direct negotiations between legal teams—compared to 52% favoring a rights-based resolution using arbitration or legal proceedings in a court. Only about one-third chose a so-called power-based resolution, such as a canceled contract, a report to a regulator, a post on social media, or a leak to the press.
Key Truths
Understanding the diverse world of business culture reveals several truths about B2B relationships. One is that emotion and culture have a significant impact on business—perhaps more than many realize—because the B2B journey comprises the human experience. Contrary to the commonly held perceptions that B2B interactions are largely transactional or purely functional, and free of emotions, the report found that they are emotionally charged, from initial engagement with parties and contracts to long-term partnerships.
I have experienced this firsthand when representing a multinational company in a very complex arbitration involving the calculation of damages. I needed to prepare the CEO for cross-examination. Yet his analysis was not entirely data-driven decision-making: emotions were also a big part of his thinking. When describing his approach and his meeting with his CEO counterpart, he just kept telling me, “This is so emotional.”
Another truth is that by effectively navigating cultural differences and overcoming communication barriers, we can improve business relationships. In this context, business attitudes toward particulars such as contracts and meeting styles reflect cultural priorities and offer relevant cultural cues. At first, these may appear to be minor details but unveil deeper cultural attitudes concerning hierarchy, orderliness, adaptability, and creativity.
When I was in China earlier this year, I was surprised by the number of back-channel conversations that took place to determine how many people we could bring to a meeting and the level of seniority so that the Chinese delegation would have the same. There were also discussions about attire—including whether men should wear a tie—so that nobody would feel out of place.
Cross-Cultural Playbook
With these truths in mind, a new cross-cultural playbook for global arbitration should include the following actions. First, integrate legal teams as early as possible into the process and keep them engaged via partnerships with business teams. Train teams to understand emotional intelligence and be more culturally aware so they can become more adept at relationship building and managing shifting emotions during the B2B journey. Ensure teams can interpret subtle behavioral and cultural cues to make informed decisions and improve communications. Equally important, prioritize direct negotiation channels for dispute resolution, reserving legal action for failed negotiations.
More than ever, we must emphasize the role of emotion and human interaction in business and how important it is in building trust: the report noted that half of all B2B disputes are likely caused by the breakdown of human interaction rather than solely by contractual issues. With heightened sensitivity to cultural differences, we can better understand the complexities of the B2B journey, minimize business and legal disputes, and successfully apply these truths to resolving conflicts through arbitration.
This series will examine the issues stakeholders need to consider in connection with deep-sea mining. We first provide an introduction to deep-sea mining and its current status. Future articles will consider in greater detail the regulatory and contractual landscape, important practical considerations, and future developments, including decisions of the ISA Council.
POLYMETALLIC NODULES
Current technology for the generation of wind and solar power (as well as the batteries needed to store such power) requires scarce raw materials, including nickel, manganese, cobalt, and copper. The fact that these minerals are found in the millions of polymetallic nodules scattered on areas of the ocean floor gives rise to another debate on whether the deep-sea mining of these nodules should be pursued.
This issue attracted considerable attention over the summer of 2023, when the International Seabed Authority (ISA) Assembly and Council held its 28th Session and, in January 2024, when Norway’s parliament (the Storting) made Norway the first country to formally authorise seabed mining activities in its waters.
INTERNATIONAL REGULATION OF DEEP-SEA MINERALS: UNCLOS AND ISA
The United Nations Convention on the Law of the Sea (UNCLOS) provides a comprehensive regime for the management of the world’s oceans. It also established ISA.
ISA is the body that authorises international seabed exploration and mining. It also collects and distributes the seabed mining royalties in relation to those areas outside each nation’s exclusive economic zone (EEZ).
Since 1994, ISA has approved over 30 ocean-floor mining exploration contracts in the Atlantic, Pacific, and Indian oceans, with most covering the so-called ‘Clarion-Clipperton Zone’ (an environmental management area of the Pacific Ocean, between Hawaii and Mexico). These currently-approved contracts run for 15 years and permit contract holders to seek out (but not commercially exploit) polymetallic nodules, polymetallic sulphides, and cobalt-rich ferromanganese crusts from the deep seabed.
UNCLOS TWO-YEAR RULE AND ISA’S 28TH SESSION
Section 1(15) of the annex to the 1994 Implementation Agreement includes a provision known as the “two-year rule.” This provision allows any member state of ISA that intends to apply for the approval of a plan of work for exploitation of the seabed to request that the ISA Council draw up and adopt regulations governing such exploitation within two years.
In July 2021, the Republic of Nauru triggered the two-year rule, seeking authority to undertake commercial exploitation of polymetallic nodules under license. That set an operative deadline of 9 July 2023.
At meetings of the ISA Assembly and ISA Council in July 2023, the ISA Council determined that more time was needed to establish processes for prospecting, exploring, and exploiting mineral resources, and a new target was set for finalising the rules: July 2025.
The expiration of the two-year rule in July 2023 does allow mining companies to submit a mining license application at any time. However, the above extension gives the ISA Council direct input into the approval process, which will make approval of any application difficult.
NORWAY’S DEEP-SEA MINING PLAN
State legislation regulates deep-sea mining in different EEZs. Norway is one of the only countries that has its own legislation (the Norway Seabed Minerals Act of 2019) regulating the exploration and extraction of deep-sea minerals.
In December 2023, Norway agreed to allow seabed mineral exploration off the coast of Norway, ahead of a formal parliamentary decision. The proposal was voted 80-20 in favour by the Storting on 9 January 2024.
The proposal will permit exploratory mining across a large section of the Norwegian seabed, after which the Storting can decide whether to issue commercial permits.
The decision initially applies to Norwegian waters and exposes an area larger than Great Britain to potential sea-bed mining, although the Norwegian government has noted that it will only issue licenses after more environmental research has been done.
The Norwegian government has defended the plan as a way to seize an economic opportunity and shore up the security of critical supply chains. However, there is concern that this will pave the way towards deep-sea mining around the world. Green activists, scientists, fishermen, and investors have called upon Oslo to reconsider its position. They cite the lack of scientific data about the effects of deep-sea mining on the marine environment, as well as the potential impact on Arctic ecosystems. In November 2023, 120 European Union lawmakers wrote an open letter to Norwegian members of the Storting, urging them unsuccessfully to reject the project, and in February 2024, the European Parliament voted in favour of a resolution that raised concerns about Norway’s deep-sea mining regulations. This resolution carries no legal power, but it does send a strong signal to Norway that the European Union does not support its plans.
In May 2024, WWF-Norway announced it will sue the Norwegian government for opening its seabed to deep-sea mining. WWF-Norway claim that the government has failed to properly investigate the consequences of its decision, has acted against the counsel of its own advisors, and has breached Norwegian law.
METHODS OF POLYMETALLIC NODULE EXTRACTION
Should Norway, or any other nation, initiate commercial deep-seabed mining, one of the following methods of mineral extraction may be employed:
Continuous Line Bucket System
This system utilises a surface vessel, a loop of cable to which dredge buckets are attached at 20–25 meter intervals, and a traction machine on the surface vessel, which circulates the cable. Operating much like a conveyor belt, ascending and descending lines complete runs to the ocean floor, gathering and then carrying the nodules to a ship or station for processing.
Hydraulic Suction System
A riser pipe attached to a surface vessel “vacuums” the seabed, for example, by lifting the nodules on compressed air or by using a centrifugal pump. A separate pipe returns tailings to the area of the mining site.
Remotely Operated Vehicles (ROVs)
Large ROVs traverse the ocean floor collecting nodules in a variety of ways. This might involve blasting the seafloor with water jets or collection by vacuuming.
Recent progress has been made in the development of these vehicles; a pre-prototype polymetallic nodule collector was successfully trialed in 2021 at a water depth of 4,500 metres, and in December 2022, the first successful recovery of polymetallic nodules from the abyssal plain was completed, using an integrated collector, riser, and lift system on an ROV. A glimpse of the future of deep-sea ROVs perhaps comes in the form of the development of robotic nodule-collection devices, equipped with artificial intelligence that allows them to distinguish between nodules and aquatic life.
Key to all three methods of mineral extraction is the production support vessel, the main facility for collecting, gathering, filtering, and storing polymetallic nodules. Dynamically positioned drillships, formerly utilised in the oil and gas sector, have been identified/converted for this purpose, and market-leading companies active in deep-water operations, including drilling and subsea construction, are investing in this area. It will be interesting to see how the approach to the inherent engineering and technological challenges will continue to develop.
THE RISKS OF DEEP-SEA MINING
As a nascent industry, deep-sea mining presents risks to both the environment and the stakeholders involved:
Environmental Risks
ISA’s delayed operative deadline for finalising regulations has been welcomed by parties who are concerned about the environmental impact that deep-sea mining may have.
Scientists warn that mining the deep could cause an irreversible loss of biodiversity to deep-sea ecosystems; sediment plumes, wastewater, and noise and light pollution all have the potential to seriously impact the species that exist within and beyond the mining sites. The deep-ocean floor supports thousands of unique species, despite being dark and nutrient-poor, including microbes, worms, sponges, and other invertebrates. There are also concerns that mining will impact the ocean’s ability to function as a carbon sink, resulting in a potentially wider environmental impact.
Stakeholder and Investor Risks
While deep-sea mining doesn’t involve the recovery and handling of combustible oil or gas, which is often associated with offshore operations, commercial risks associated with the deployment of sophisticated (and expensive) equipment in water depths of 2,000 metres or greater are significant. In April 2021, a specialist deep-sea mining subsidiary lost a mining robot prototype that had uncoupled from a 5-kilometer-long cable connecting it to the surface. The robot was recovered after initial attempts failed, but this illustrates the potentially expensive problems that deep-sea mining poses. Any companies wishing to become involved in deep-sea mining will also need to be careful to protect their reputation. Involvement in a deep-sea mining project that causes (or is perceived to cause) environmental damage or that experiences serious problems could attract strong negative publicity.
INVESTOR CONSIDERATIONS
Regulations have not kept up with the increased interest in deep-sea mining, and there are no clear guidelines on how to structure potential deep-sea investments. This is especially true in international waters, where a relationship with a sponsoring state is necessary. Exploitative investments have not been covered by ISA, and it is unclear how much control investors will have over the mining process. It is also unclear how investors might be able to apportion responsibility for loss/damage and what level of due diligence needs to be conducted ahead of operations. Any involvement carries with it significant risk, and stakeholders will do well to manage their rights and obligations as matters evolve.
As an accompaniment to our biweekly series on “What Every Multinational Should Know About” various international trade, enforcement, and compliance topics, we are introducing a second series of quick-hit pieces on compliance best practices. Give us two minutes, and we will give you five suggested compliance best practices that will benefit your international regulatory compliance program.
Conducting an international risk assessment is crucial for identifying and mitigating potential risks associated with conducting business operations in foreign countries and complying with the expansive application of U.S. law. Because compliance is essentially an exercise in identifying, mitigating, and managing risk, the starting point for any international compliance program is to conduct a risk assessment. If your company has not done one within the last two years, then your organization probably should be putting one in motion.
Here are five compliance checks that are important to consider when conducting a risk assessment:
Understand Business Operations: A good starting point is to gain a thorough understanding of the organization’s business operations, including products, services, markets, supply chains, distribution channels, and key stakeholders. You should pay special attention to new risk areas, including newly acquired companies and divisions, expansions into new countries, and new distribution patterns. Identifying the business profile of the organization, and how it raises systemic risks, is the starting point of developing the risk profile of the company.
Conduct Country- and Industry-Specific Risk Factors: Analyze the political, economic, legal, and regulatory landscape of each country where the organization operates or plans to operate. Consider factors such as political stability, corruption levels, regulatory environment, and cultural differences. You should also understand which countries also raise indirect risks, such as for the transshipment of goods to sanctioned countries. You also should evaluate industry-specific risks and trends that may impact your company’s risk profile, such as the history of recent enforcement actions.
Gather Risk-Related Data and Information: You should gather relevant data and information from internal and external sources to inform the risk-assessment process. Relevant examples include internal documentation, industry publications, reports of recent enforcement actions, and areas where government regulators are stressing compliance, such as the recent focus on supply chain factors. Use risk-assessment tools and methodologies to systematically evaluate and prioritize risks, such as risk matrices, risk heat maps, scenario analysis, and probability-impact assessments. (The Foley anticorruption, economic sanctions, and forced labor heat maps are found here.)
Engage Stakeholders: Engage key stakeholders throughout the risk-assessment process to gather insights, perspectives, and feedback. Consult with local employees and business partners to gain feedback on compliance issues that are likely to arise while also seeking their aid in disseminating the eventual compliance dictates, internal controls, and other compliance measures that your organization ends up implementing or updating.
Document Findings and Develop Risk-Mitigation Strategies: Document the findings of the risk assessment, including identified risks, their potential impact and likelihood, and recommended mitigation strategies. Ensure that documentation is clear, concise, and actionable. Use the documented findings to develop risk-mitigation strategies and action plans to address identified risks effectively while prioritizing mitigation efforts based on risk severity, urgency, and feasibility of implementation.
Most importantly, you should recognize that assessing and addressing risk is an ongoing process. You should ensure your organization has established processes for the ongoing monitoring and review of risks to track changes in the risk landscape and evaluate the effectiveness of mitigation measures. Further, at least once every two years, most multinational organizations should be updating their risk assessment periodically to reflect evolving risks and business conditions as well as changing regulations and regulator enforcement priorities.
WEBINAR – Registration Is Open For “Harmonizing TSCA Consent Orders with OSHA HCS 2012”: Register now to join The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®) for “Harmonizing TSCA Consent Orders with OSHA HCS 2012,” a complimentary webinar covering case studies and practical applications of merging the requirements for consent order language on the Safety Data Sheet (SDS). In this webinar, Karin F. Baron, MSPH, Director of Hazard Communication and International Registration Strategy, Acta, will explore two hypothetical examples and provide guidance on practical approaches to compliance. An industry perspective will be presented by Sara Glazier Frojen, Senior Product Steward, Hexion Inc., who will discuss the realities of managing this process day-to-day.
SAVE THE DATE – “TSCA Reform — 8 Years Later” On June 26, 2024: Save the date to join Acta affiliate B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health for a day-long conference reflecting on the challenges and accomplishments since the implementation of the 2016 Lautenberg Amendments and where the Toxic Substances Control Act (TSCA) stands today. This year, the conference will be held in person at the George Washington University Milken Institute School of Public Health (and will be livestreamed via YouTube). Continuing legal education (CLE) credit will be offered in select states for in-person attendees only. Please check ELI’s event page in the coming weeks for more information, including an agenda, CLE information, registration, and more. If you have questions in the meantime, please contact Madison Calhoun (calhoun@eli.org).
AUSTRALIA
Changes To Categorization, Reporting, And Recordkeeping Requirements For Industrial Chemicals Will Take Effect April 24, 2024: The Australian Industrial Chemicals Introduction Scheme (AICIS) announced regulatory changes to categorization, reporting, and recordkeeping requirements will start April 24, 2024. For the changes to take effect, the Industrial Chemicals (General) Rules 2019 (Rules) and Industrial Chemicals Categorisation Guidelines will be amended. According to AICIS, key changes to the Rules include:
Written undertakings replaced with records that will make compliance easier;
Greater acceptance of International Nomenclature of Cosmetic Ingredients (INCI) names for reporting and recordkeeping;
Changes to the categorization criteria to benefit:
Local soap makers;
Introducers of chemicals in flavor and fragrance blends; and
Introducers of hazardous chemicals where introduction and use are controlled; and
Strengthening criteria and/or reporting requirements for health and environmental protection.
AICIS announced final changes to the Industrial Chemicals Categorisation Guidelines that will take effect April 24, 2024. According to AICIS, the changes include:
Refinement of the requirement to check for hazardous esters and salts of chemicals on the “List of chemicals with high hazards for categorisation” (the List);
Provision to include highly hazardous chemicals to the List based on an AICIS assessment or evaluation;
Expanded options for introducers to demonstrate the absence of skin irritation and skin sensitization; and
More models for in silico predictions and an added test guideline for ready biodegradability.
AICIS states that it will publish a second update to the Guidelines in September 2024 due to industry stakeholders’ feedback that they need more time to prepare for some of the changes. It will include:
For the List: add chemicals based on current sources and add the European Commission (EC) Endocrine Disruptor List (List I) as a source; and
Refined requirements for introducers to show the absence of specific target organ toxicity after repeated exposure and bioaccumulation potential.
CANADA
Canada Provides Updates On Its Implementation Of The Modernized CEPA: As reported in our June 23, 2023, memorandum, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, received Royal Assent on June 13, 2023. Canada is working to implement the bill through initiatives that include the development of various instruments, policies, strategies, regulations, and processes. In April 2024, Canada updated its list of public consultation opportunities:
Discussion document on the implementation framework for a right to a healthy environment under the Canadian Environmental Protection Act, 1999 (CEPA) (winter 2024);
Proposed Watch List approach (spring/summer 2024);
Proposed plan of chemicals management priorities (summer 2024);
Draft strategy to replace, reduce or refine vertebrate animal testing (summer/fall 2024);
Draft implementation framework for a right to a healthy environment under CEPA (summer/fall 2024);
Discussion document for toxic substances of highest risk regulations (winter 2025); and
Discussion document on the restriction and authorization of certain toxic substances regulations (winter/spring 2025).
EUROPEAN UNION (EU)
ECHA Checks More Than 20 Percent Of REACH Registration Dossiers For Compliance: The European Chemicals Agency (ECHA) announced on February 27, 2024, that between 2009 and 2023, it performed compliance checks of approximately 15,000 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations, representing 21 percent of full registrations. ECHA states that it met its legal target for dossier evaluation, which increased from five percent to 20 percent in 2019. ECHA notes that for substances registered at quantities of 100 metric tons or more per year, it has checked compliance for around 30 percent of the dossiers.
According to ECHA, in 2023, it conducted 301 compliance checks, covering more than 1,750 registrations and addressing 274 individual substances. ECHA “focused on registration dossiers that may have data gaps and aim to enhance the safety data of these substances.” ECHA sent 251 adopted decisions to companies, “requesting additional data to clarify long-term effects of chemicals on human health or the environment.” ECHA states that during the follow-up evaluation process, it will assess the incoming information for compliance. ECHA will share the outcome of the incoming data with the EU member states and the EC to enable prioritization of substances. ECHA will work closely with the member states for enforcement of non-compliant dossiers. Compliance of registration dossiers will remain a priority for ECHA. In 2024, ECHA will review the impact of the Joint Evaluation Action Plan, aimed at improving REACH registration compliance, and, together with stakeholders, develop new priority areas on which to focus. More information is available in our March 29, 2024, blog item.
Council Of The EU And EP Reach Provisional Agreement On Proposed Regulation On Packaging And Packaging Waste: The Council of the EU announced on March 4, 2024, that its presidency and the European Parliament’s (EP) representatives reached a provisional political agreement on a proposal for a regulation on packaging and packaging waste. The press release states that the proposal considers the full life-cycle of packaging and establishes requirements to ensure that packaging is safe and sustainable by requiring that all packaging is recyclable and that the presence of substances of concern is minimized. It also includes labeling harmonization requirements to improve consumer information. In line with the waste hierarchy, the proposal aims to reduce significantly the generation of packaging waste by setting binding re-use targets, restricting certain types of single-use packaging, and requiring economic operators to minimize the packaging used. The proposal would introduce a restriction on the placing on the market of food contact packaging containing per- and polyfluoroalkyl substances (PFAS) above certain thresholds. The press release notes that to avoid any overlap with other pieces of legislation, the co-legislators tasked the EC to assess the need to amend that restriction within four years of the date of application of the regulation.
EP Adopts Position On Establishing System To Verify And Pre-Approve Environmental Marketing Claims: The EP announced on March 12, 2024, that it adopted its first reading position on establishing a verification and pre-approval system for environmental marketing claims to protect citizens from misleading ads. According to the EP’s press release, the green claims directive would require companies to submit evidence about their environmental marketing claims before advertising products as “biodegradable,” “less polluting,” “water saving,” or having “biobased content.” Micro enterprises would be exempt from the new rules, and small and medium-sized enterprises (SME) would have an extra year to comply compared to larger businesses. The press release notes that the EP also decided that green claims about products containing hazardous substances should remain possible for now, but that the EC “should assess in the near future whether they should be banned entirely.” The new EP will follow up on the file after the European elections that will take place in June 2024.
On April 3, 2024, a coalition of industry associations issued a “Joint statement in reference to ‘the ban of green claims for products containing hazardous substances’ in the Green Claims Substantiation Directive (GCD).” The associations “fully support the principle that consumers should not be misled by false or unsubstantiated environmental claims and share the EU’s objective to establish a clear, robust and credible framework to enable consumers to make an informed choice.” The associations express concern that the proposed prohibition of environmental claims for products containing certain hazardous substances “will run contrary to the objective of the Directive to enable consumers to make sustainable purchase decisions and ensure proper substantiation of claims.” According to the associations, for a number of consumer products, “the reference to ‘products containing’ would encompass substances that would have intrinsic hazardous properties,” implying that there would be a ban of making any environmental claim(s), “even if such trace amounts of unavoidable and unintentional impurities and contaminants are present in these products.” The signatories include the International Association for Soaps, Detergents and Maintenance Products; the European Brands Association; APPLiA; the Association of Manufacturers and Formulators of Enzyme Products; CosmeticsEurope; the European Power Tool Association; the Federation of the European Sporting Goods Industry; the International Fragrance Association; LightingEurope; the International Natural and Organic Cosmetics Association; Toy Industries of Europe; Verband der Elektro- und Digitalindustrie; and the World Federation of Advertisers.
ECHA Clarifies Next Steps For PFAS Restriction Proposal: ECHA issued a press release on March 13, 2024, to outline how the Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will progress in evaluating the proposal to restrict PFAS in Europe. As reported in our February 13, 2023, memorandum, the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted a proposal to restrict more than 10,000 PFAS under REACH. The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks. Following the screening of thousands of comments received during the consultation, ECHA states that it is clarifying the next steps for the proposal. According to ECHA, RAC and SEAC will evaluate the proposed restriction together with the comments from the consultation in batches, focusing on the different sectors that may be affected.
In tandem, the five national authorities who prepared the proposal are updating their initial report to address the consultation comments. This updated report will be assessed by the committees and will serve as the foundation for their opinions. The sectors and elements that will be discussed in the next three committee meetings are:
March 2024 Meetings
Consumer mixtures, cosmetics, and ski wax;
Hazards of PFAS (only by RAC); and
General approach (only by SEAC).
June 2024 Meetings
Metal plating and manufacture of metal products; and
More information is available in our March 18, 2024, blog item.
ECHA Adopts And Publishes CoRAP For 2024-2026: On March 19, 2024, ECHA adopted and published the Community rolling action plan (CoRAP) for 2024-2026. The CoRAP lists 28 substances suspected of posing a risk to human health or the environment for evaluation by 11 Member State Competent Authorities. The CoRAP includes 11 newly allocated substances and 17 substances already included in the previous CoRAP 2023-2025 update, published on March 21, 2023. For 11 out of these 17 substances, ECHA notes that the evaluation year has been postponed, mainly to await submission of new information requested under dossier evaluation. Of the 28 substances to be evaluated, ten are to be evaluated in 2024, 13 in 2025, and five in 2026. The remaining substance of the 24 substances listed in the previous CoRAP was withdrawn as its evaluation is currently considered to be a low priority. According to ECHA, for this substance, a compliance check is needed first. ECHA states that the substance can be placed in the CoRAP list again, if after the conclusion of the dossier evaluation process, concerns remain beyond what can be clarified through dossier evaluation. ECHA has posted a guide for registrants that need to update their dossiers with new relevant information such as hazard, tonnages, use, and exposure.
Comments On Proposals To Identify New SVHCs Due April 15, 2025: A public consultation on proposals to identify two new substances of very high concern (SVHC) will close on April 15, 2024. The substances and examples of their uses are:
Bis(α,α-dimethylbenzyl) peroxide: This substance is used in products such as pH-regulators, flocculants, precipitants, and neutralization agents; and
Triphenyl phosphate: This substance is used as a flame retardant and plasticizer in polymer formulations, adhesives, and sealants.
UNITED KINGDOM (UK)
HSE Publishes UK REACH Work Programme For 2023/24: In February 2024, the Health and Safety Executive (HSE) published its UK REACH Work Programme 2023/24. The Work Programme sets out how HSE, with the support of the Environment Agency, will deliver its regulatory activities to meet the objectives and timescales set out in UK REACH. Alongside these activities, HSE and the Environment Agency will engage with stakeholders. The Work Programme includes the following deliverables and target deadlines:
Topic
Deliverable
Target
Substance evaluation
Evaluate substances in the Rolling Action Plan (RAP)
Evaluate one
Authorization
Complete the processing of received applications within the statutory deadline (this includes comments from public consultation and REACH Independent Scientific Expert Pool (RISEP) input)
100 percent
SVHC identification
Undertake an initial assessment of substances submitted for SVHC identification under EU REACH during 2022/23 and consider if they are appropriate for SVHC identification under UK REACH
Assess up to five
Regulatory management options analysis (RMOA)
Complete RMOAs initiated in 22/23
Initiate RMOAs for substances identified as priorities
Up to ten
Up to five
Restriction
Complete ongoing restriction opinions
Begin Annex 15 restriction dossiers
Initiate scoping work for restrictions
Two
One
Two
HSE Opens Call For Evidence On PFAS In FFFs: HSE is working with the Environment Agency to prepare a restriction dossier that will assess the risks of PFAS in firefighting foams (FFF). HSE will propose restrictions, if necessary, to manage any significant risks identified. To help compile the dossier, HSE opened a call for evidence. HSE states that it would like stakeholders to identify themselves as willing to engage in further dialogue throughout the restrictions process. In particular, it would like to hear from stakeholders with relevant information on PFAS (or alternatives) in FFFs, especially information specific to Great Britain (GB). Regarding relevant information, HSE is interested in all aspects of FFFs, including:
Manufacture of FFFs: Substances used, process, quantities;
Import of FFF products of all types: Quantities, suppliers;
Use: Quantities, sector of use, frequency, storage on site, products used;
Alternatives to PFAS in FFF: Availability, cost, performance in comparison to PFAS-containing foams, barriers to switching;
Hazardous properties: SDSs, new studies on intrinsic properties and exposure, recommended risk management measures;
Environmental fate: What happens to the FFF after it is used, where does it go;
Waste: Disposal requirements, recycling opportunities, remediation; and
Standards: Including product-specific legislation, performance, certification.
HSE states that the call for evidence targets companies (manufacturers, importers, distributors, and retailers) and professional users of FFFs, trade associations, environmental organizations, consumer organizations, and any other organizations and members of the public holding relevant information. HSE intends to publish the final dossier, including any restriction proposals, on its website in March 2025. Interested parties will also then be able to submit comments on any proposed restriction.
New GB BPR Data Requirements Will Apply To Applications Submitted In October 2025:The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024, which update the data requirements in Annexes II and III of the GB Biocidal Products Regulation (BPR), were laid in Parliament on March 13, 2024, and came into force on April 6, 2024. The legislation updates some of the data requirements to reflect developments in science and technology. These include the use of alternative testing approaches to determine some hazardous properties that previously relied on animal testing. HSE held a public consultation on the proposed changes in 2023 and has posted a report on the outcome of the consultation. The new data requirements will apply to applications received 18 months after the legislation came into force (October 6, 2025) and do not apply to existing applications. HSE will provide further guidance on the changes in the future.
Welcome to the UK Regulation Round Up, a regular bulletin highlighting the latest developments in UK and EU financial services regulation.
Key developments in March 2024:
28 March
FCA Regulation Round-up: The FCA published its regulation round-up for March 2024.
26 March
AIFMD II: Directive (EU) 2024/927 amending the Alternative Investment Fund Managers Directive (2011/61/EU) (“AIFMD”) and the UCITS Directive (2009/65/EC) (“UCITS Directive”) relating to delegation arrangements, liquidity risk management, supervisory reporting, provision of depositary and custody services, and loan origination by alternative investment funds has been published in the Official Journal of the European Union (“EU”). Please refer to our dedicated article on this topic here.
ELTIFs: The European Commission published a Communication to the Commission explaining that it intends to adopt, with amendments, ESMA’s proposed regulatory technical standards (“RTS”) under Regulations 9(3), 18(6), 19(5), 21(3) and 25(3) of the Regulation on European Long-Term Investment Funds ((EU) 2015/760) as amended by Regulation (EU) 2023/606.
Financial Promotions: The FCA published finalised guidance (FG24/1) on financial promotions on social media.
Cryptoassets: The Investment Association (“IA”) published its second report on UK fund tokenisation written by the technology working group to HM Treasury’s asset management taskforce.
25 March
Cryptoassets: ESMA published a final report (ESMA75-453128700-949) on draft technical standards specifying requirements for co-operation, exchange of information and notification between competent authorities, European Supervisory Authorities and third countries under the Regulation on markets in cryptoassets ((EU) 2023/1114) (“MiCA”).PRIIPS Regulation: the European Parliament’s Economic and Monetary Affairs Committee (“ECON”) published the report (PE753.665v02-00) it has adopted on the European Commission’s legislative proposal for a Regulation making amendments to the Regulation on key information documents (“KIDs”) for packaged retail and insurance-based investment products (1286/2014) (“PRIIPs Regulation”) (2023/0166(COD)).
Alternative Investment Funds: The FCA published the findings from a review it carried out in 2023 of alternative investment fund managers that use the host model to manage alternative investment funds.
AIFMD: Four Delegated and Implementing Regulations concerning cross-border marketing and management notifications relating to the UCITS Directive and the AIFMD have been published in the Official Journal of the European Union (here, here, here, and here).
22 March
Smarter Regulatory Framework: HM Treasury published a document on the next phase of the Smarter Regulatory Framework, its project to replace assimilated law relating to financial services.
21 March
Market Transparency: ESMA published a communication on the transition to the new rules under the Markets in Financial Instruments Regulation (600/2014) (“MiFIR”) to improve market access and transparency.
Retail Investment Package: ECON published a press release announcing it had adopted its draft report on the proposed Directive on retail investment protection (2023/0167(COD)). The proposed Directive will amend the MiFID II Directive (2014/65/EU) (“MiFID II”), the Insurance Distribution Directive ((EU) 2016/97), the Solvency II Directive (2009/138/EC), the UCITS Directive and the AIFMD.
19 March
ESG: The Council of the EU proposed a new compromise text for the Corporate Sustainability Due Diligence Directive, on which political agreement had previously been reached in December 2023.
FCA Business Plan: The FCA published its 2024/25 Business Plan, which sets out its business priorities for the year ahead.
15 March
Customer Duty: The FCA announced that it is to conduct a review into firms’ treatment of customers in vulnerable circumstances.
PRIIPS Regulation: The Joint Committee of the European Supervisory Authorities published an updated version of its Q&As (JC 2023 22) on the key information document requirements for packaged retail and insurance-based investment products (“PRIIPs”), as laid down in Commission Delegated Regulation (EU) 2017/653.
14 March
FCA Regulatory Approach: The FCA published a speech given by Nikhil Rathi, FCA Chief Executive, on its regulatory approach to deliver for consumers, markets and competitiveness and its shift to outcomes-focused regulation.
11 March
AML: HM Treasury launched a consultation on improving the effectiveness of the Money Laundering, Terrorist Financing and Transfer of Funds (Information on the Payer) Regulations 2017 (SI 2017/692). The consultation runs until 9 June 2024 and covers four distinct areas.
08 March
ESG: The IA published a report on insights and suggested actions for asset managers following the commencement of reporting obligations of climate-related disclosures under the ESG sourcebook.
ESG: The House of Commons Treasury Committee published a report on the findings from its “Sexism in the City” inquiry.
Cryptoassets: The EBA published a consultation paper (EBA/CP/2024/09) on draft guidelines on redemption plans under Articles 47 and 55 of the MiCA.
AML: The FCA published a Dear CEO letter sent to Annex I financial institutions concerning common control failings identified in anti-money laundering (AML) frameworks.
ESG: The European Commission adopted a delegated regulation supplementing the Securitisation Regulation ((EU) 2017/2402) with regard to regulatory technical standards specifying, for simple, transparent and standardised non-ABCP traditional securitisation, and for simple, transparent and standardised on-balance-sheet securitisation, the content, methodologies and presentation of information related to the principal adverse impacts of the assets financed by the underlying exposures on sustainability factors.
CRD IV: The European Commission adopted a Commission Implementing Regulation that amends Commission Implementing Regulation (EU) 650/2014 containing ITS on supervisory disclosure under the CRD IV Directive (2013/36/EU) (“CRD IV”).
01 March
Alternative Investment Funds: The FCA published a portfolio letter providing an interim update on its supervisory strategy for the asset management and alternatives portfolios.
Corporate Transparency: The Economic Crime and Corporate Transparency Act 2023 (Commencement No. 2 and Transitional Provision) Regulations 2024 (SI 2024/269) have been made and published.
Financial Sanctions: The Treasury Committee launched an inquiry into the effectiveness of financial sanctions on Russia.
EMIR: The FCA published a consultation paperin which it, together with the Bank of England, seeks feedback on draft guidance in the form of Q&As on the revised reporting requirements under Article 9 of UK EMIR (648/2012).
FCA Handbook: The FCA published Handbook Notice 116 (dated February 2024), which sets out changes to the FCA Handbook made by the FCA board on 29 February 2024.
FCA Handbook: the FCA published its 43rd quarterly consultation paper (CP24/3), inviting comments on proposed changes to a number of FCA Handbook provisions.
Amar Unadkat, Sulaiman Malik & Michael Singh also contributed to this article.
After extensive negotiations, the European Parliament, Commission, and Council came to a consensus on the EU Artificial Intelligence Act (the “AI Act”) on Dec. 8, 2023. This marks a significant milestone, as the AI Act is expected to be the most far-reaching regulation on AI globally. The AI Act is poised to significantly impact how companies develop, deploy, and manage AI systems. In this post, NM’s AI Task Force breaks down the key compliance timelines to offer a roadmap for U.S. companies navigating the AI Act.
The AI Act will have a staged implementation process. While it will officially enter into force 20 days after publication in the EU’s Official Journal (“Entry into Force”), most provisions won’t be directly applicable for an additional 24 months. This provides a grace period for businesses to adapt their AI systems and practices to comply with the AI Act. To bridge this gap, the European Commission plans to launch an AI Pact. This voluntary initiative allows AI developers to commit to implementing key obligations outlined in the AI Act even before they become legally enforceable.
With the impending enforcement of the AI Act comes the crucial question for U.S. companies that operate in the EU or whose AI systems interact with EU citizens: How can they ensure compliance with the new regulations? To start, U.S. companies should understand the key risk categories established by the AI Act and their associated compliance timelines.
I. Understanding the Risk Categories
The AI Act categorizes AI systems based on their potential risk. The risk level determines the compliance obligations a company must meet. Here’s a simplified breakdown:
Unacceptable Risk: These systems are banned entirely within the EU. This includes applications that threaten people’s safety, livelihood, and fundamental rights. Examples may include social credit scoring, emotion recognition systems at work and in education, and untargeted scraping of facial images for facial recognition.
High Risk: These systems pose a significant risk and require strict compliance measures. Examples may include AI used in critical infrastructure (e.g., transport, water, electricity), essential services (e.g., insurance, banking), and areas with high potential for bias (e.g., education, medical devices, vehicles, recruitment).
Limited Risk: These systems require some level of transparency to ensure user awareness. Examples include chatbots and AI-powered marketing tools where users should be informed that they’re interacting with a machine.
Minimal Risk: These systems pose minimal or no identified risk and face no specific regulations.
II. Key Compliance Timelines (as of March 2024):
Time Frame
Anticipated Milestones
6 months after Entry into Force
Prohibitions on Unacceptable Risk Systems will come into effect.
12 months after Entry into Force
This marks the start of obligations for companies that provide general-purpose AI models (those designed for widespread use across various applications). These companies will need to comply with specific requirements outlined in the AI Act.
Member states will appoint competent authorities responsible for overseeing the implementation of the AI Act within their respective countries.
The European Commission will conduct annual reviews of the list of AI systems categorized as “unacceptable risk” and banned under the AI Act.
The European Commission will issue guidance on high-risk AI incident reporting.
18 months after Entry into Force
The European Commission will issue an implementing act outlining specific requirements for post-market monitoring of high-risk AI systems, including a list of practical examples of high-risk and non-high risk use cases.
24 months after Entry into Force
This is a critical milestone for companies developing or using high-risk AI systems listed in Annex III of the AI Act, as compliance obligations will be effective. These systems, which encompass areas like biometrics, law enforcement, and education, will need to comply with the full range of regulations outlined in the AI Act.
EU member states will have implemented their own rules on penalties, including administrative fines, for non-compliance with the AI Act.
36 months after Entry into Force
The European Commission will issue an implementing act outlining specific requirements for post-market monitoring of high-risk AI systems, including a list of practical examples of high-risk and non-high risk use cases.
By the end of 2030
This is a critical milestone for companies developing or using high-risk AI systems listed in Annex III of the AI Act, as compliance obligations will be effective. These systems, which encompass areas like biometrics, law enforcement, and education, will need to comply with the full range of regulations outlined in the AI Act.
EU member states will have implemented their own rules on penalties, including administrative fines, for non-compliance with the AI Act.
In addition to the above, we can expect further rulemaking and guidance from the European Commission to come forth regarding aspects of the AI Act such as use cases, requirements, delegated powers, assessments, thresholds, and technical documentation.
Even before the AI Act’s Entry into Force, there are crucial steps U.S. companies operating in the EU can take to ensure a smooth transition. The priority is familiarization. Once the final version of the Act is published, carefully review it to understand the regulations and how they might apply to your AI systems. Next, classify your AI systems according to their risk level (high, medium, minimal, or unacceptable). This will help you determine the specific compliance obligations you’ll need to meet. Finally, conduct a thorough gap analysis. Identify any areas where your current practices for developing, deploying, or managing AI systems might not comply with the Act. By taking these proactive steps before the official enactment, you’ll gain valuable time to address potential issues and ensure your AI systems remain compliant in the EU market.
