Public Urged to Use Encryption for Mobile Phone Messaging and Calls

On December 4, 2024, four of the five members of the Five Eyes intelligence-sharing group (the United States, Australia, Canada, and New Zealand) law enforcement and cyber security agencies (Agencies) published a joint guide for network engineers, defenders of communications infrastructure and organizations with on-premises enterprise equipment (the Guide). The Agencies strongly encourage applying the Guide’s best practices to strengthen visibility and strengthen network devices against exploitation by reported hackers, including those hackers affiliated with the People’s Republic of China (PRC). The fifth group member, the United Kingdom, released a statement supportive of the joint guide but stated it had alternate methods of mitigating cyber risks for its telecom providers.

In November 2024, the Federal Bureau of Investigation (FBI) and the U.S. Cybersecurity and Infrastructure Security Agency (CISA) issued a joint statement to update the public on its investigation into the previously reported PRC-affiliated hacks on multiple telecommunications companies’ networks. The FBI and CISA reported that these hacks appeared to focus on cell phone activity of individuals involved in political or government activity and copies of law enforcement informational requests subject to court orders. However, at the time of the update, these U.S. agencies and members of Congress have underscored the broad and significant nature of this breach. At least one elected official stated that the hacks potentially expose unencrypted cell phone conversations with someone in America to the hackers.

In particular, the Guide recommends adopting actions that quickly identify anomalous behavior, vulnerabilities, and threats and respond to a cyber incident. It also guides telecoms and businesses to reduce existing vulnerabilities, improve secure configuration habits, and limit potential entry points. One of the Guide’s recommended best practices attracting media attention is ensuring that mobile phone messaging and call traffic is fully end-to-end encrypted to the maximum extent possible. Without fully end-to-end encrypted messaging and calls, the content of calls and messages always has the potential to be intercepted. Android to Android messaging and iPhone to iPhone messaging is fully end-to-end encrypted but messaging from an Android to an iPhone is not currently end-to-end encrypted. Google and Apple recommend using a fully encrypted messaging app to better protect the content of messages from hackers.

The FBI and CISA are continuing to investigate the hacks and will update the public as the investigation permits. In the interim, telecom providers and companies are encouraged to adopt the Guide’s best practices and to report any suspicious activity to their local FBI field office or the FBI’s Internet Crime Complaint Center. Cyber incidents may also be reported to CISA.

NSA Wants Industry to Disclose Details of Telecom Hacks in Light of Chinese Involvement

On November 20, 2024, the director of the National Security Agency, General Timothy Haugh, urged the private sector to take swift, collective action to share key details about breaches they have suffered at the hands of Chinese hackers who have infiltrated US telecommunications.

Gen. Haugh said he wants to provide a public “hunt guide” so cybersecurity professionals and companies can search out the hackers and eradicate them from telecommunications networks.

US authorities have confirmed Chinese hackers have infiltrated US telecommunications in what Senator Richard Blumenthal, a Connecticut Democrat, this week described as a “sprawling and catastrophic” infiltration. AT&T Inc., Verizon Communications Inc. and T-Mobile are among those targeted.

Through those intrusions, the hackers targeted communications of a “limited number” of people in politics and government, US officials have said. They include Vice President Kamala Harris’ staff, President-elect Donald Trump and Vice President-elect JD Vance, as well as staffers for Senate Majority Leader Chuck Schumer, according to Missouri Republican Senator Josh Hawley.

Representatives of the Chinese government have denied the allegations.

“The ultimate goal would be to be able to lay bare exactly what happened in ways that allow us to better posture as a nation and for our allies to be better postured,” – Gen. Tim Haugh.

Proposed Disregarded Payment Loss Rules Create Traps for the Unwary

Be wary: The US Department of the Treasury’s proposed disregarded payment loss (DPL) regulations lay surprising new traps for multinational taxpayers – and those ensnared are unlikely to see what’s coming.

Under the proposed regulations, disregarded payments from a foreign disregarded entity to its domestic corporate parent can give rise to a US income inclusion without any offsetting deduction.[1] This phantom income can be substantial and because the inclusion results from payments that are disregarded as a matter of US tax law, it is sure to be an unwelcome surprise for some taxpayers.

Multinational taxpayers with US corporate entities that hold or acquire interests in foreign disregarded entities should understand the proposed regulations, determine their potential exposure, and consider steps to mitigate potential tax liabilities. This article provides a high-level overview of the proposed regulations and reviews the questions that multinational companies should ask themselves before the traps are sprung.

In Depth


The DPL rules are included in proposed regulations that were published on August 7, 2024.[2] The proposed regulations address, among other topics, how the Section 1503(d) dual consolidated loss (DCL) rules apply in the context of Pillar Two taxes. Though the proposed regulations include both DCL and DPL rules and the DPL rules use similar timing and concepts as the DCL rules, the DPL rules operate separately and apply to a different set of circumstances.[3]

While the DCL rules prevent taxpayers from deducting the same loss twice (once in the United States and once in a foreign jurisdiction), the DPL rules target “deduction/no inclusion” (D/NI) outcomes. In a D/NI scenario, a domestic corporation owns a foreign disregarded entity that makes payments to its domestic corporate parent. The payments are regarded for foreign tax purposes and may give rise to a foreign deduction or loss but are disregarded for US tax purposes, so there is no corresponding US income inclusion. Under foreign tax law, the foreign deduction or loss can be used to offset other foreign income and reduce foreign tax.[4]

To prevent D/NI outcomes, the proposed DPL rules identify certain foreign tax losses attributable to disregarded payments and then require the domestic corporate parent to include a corresponding amount of income for US tax purposes. However, the rules are extremely broad and may require US income inclusions where there is no D/NI outcome or potentially when the foreign disregarded entity is not actually in a loss position from a foreign tax perspective.[5]

As explained below, the rules (1) apply only to domestic corporations that are deemed to consent to their application, (2) may require domestic corporations to include a substantial “DPL inclusion amount” as ordinary income with no offsetting deduction, and (3) will require such inclusion whenever one of two triggering events occur, namely, a “foreign use” of the DPL or a failure to satisfy the rules’ certification requirements.

DEEMED CONSENT

The DPL rules apply only to consenting domestic corporations but set a low bar for what this “consent” requires. Essentially, a domestic corporation consents to the rules if it owns a foreign disregarded entity, with the applicability date depending on when the domestic corporation acquired or checked the box on the foreign disregarded entity.

First, a domestic corporation consents to the DPL rules if it directly or indirectly owns interests in a “specified eligible entity”[6] that makes a check-the-box election on or after August 6, 2024, to be a disregarded entity.[7]

Second, a domestic corporate owner is deemed to consent to the DPL rules if, as of August 6, 2025, the entity directly or indirectly owns interests in a disregarded entity and has not otherwise consented to the rules. To avoid such deemed consent with respect to a disregarded entity, the disregarded entity may instead elect to be treated as a corporation prior to August 6, 2025. Of course, the related consequences of such an election can be significant.[8]

THE DPL INCLUSION AMOUNT

Domestic corporations that consent to the rules may be required to include a DPL inclusion amount as income. For a specified eligible entity or foreign branch of a consenting domestic corporation (such specified eligible entity or foreign branch is referred to as a “disregarded payment entity”), the DPL for a given tax year is the disregarded payment entity’s net loss for foreign tax purposes that is composed of certain items of income and deduction that are disregarded for US tax purposes.[9] The notice of proposed rulemaking (NPRM) provides the following example:

[I]f for a foreign taxable year a disregarded payment entity’s only items are a $100x interest deduction and $70x of royalty income, and if each item were disregarded for U.S. tax purposes as a payment between a disregarded entity and its tax owner (but taken into account under foreign law), then the entity would have a $30x disregarded payment loss for the taxable year.

The DPL inclusion amount is the DPL amount reduced by the positive balance of the “DPL cumulative register.” The DPL cumulative register reflects the cumulative amount of disregarded payment income attributable to the disregarded payment entity across multiple years. The NPRM also provides the following example:

[I]f a disregarded payment entity incurs a $100x disregarded payment loss in year 1 and has $80x of disregarded payment income in year 2, only $20x of the disregarded payment loss is likely available under the foreign tax law to be put to a foreign use. As such, if a triggering event occurs at the end of year 2, then the specified domestic owner must include in gross income $20x (rather than the entire $100x of the disregarded payment loss).

Taxpayers who expect to benefit from the DPL cumulative register should keep in mind that the register only reflects disregarded payments that would be interest, royalties, or structured payments if regarded for US tax purposes. It reflects no other disregarded payments, and it reflects no regarded payments of any sort.

Notably, disregarded payment entities “for which the relevant foreign tax law is the same” are generally combined and treated as a single disregarded payment entity for purposes of the DPL rules. As a result, disregarded payments between entities formed in the same foreign jurisdiction generally should not give rise to DPL inclusions. However, this rule applies only where the entities have the same foreign tax year and are owned by the same consenting domestic corporation or by consenting domestic corporations that are members of the same consolidated group. Further, to ensure the items of foreign income and deduction net against one another within the combined disregarded payment entity, taxpayers should analyze the applicable foreign tax rules to confirm that these items accrue in the same foreign taxable year.

THE TRIGGERING EVENTS

Consenting domestic corporations will be forced to include the DPL inclusion amount as ordinary income if one of two triggering events occurs within a certification period. A certification period includes the foreign tax year in which the DPL is incurred, any prior foreign tax year, and the subsequent 60-month period. These certification periods and triggering events are somewhat similar to the ones used in the DCL rules. In the case of the DPL rules, however, there is no ability to make a domestic use election, as for US tax purposes there is no regarded loss that can be used to offset US tax.

The first triggering event is a “foreign use” of the DPL. A foreign use is determined under the principles of the DCL rules. Thus, a foreign use generally occurs when any portion of a deduction taken into account in computing the DPL is made available to offset or reduce income under foreign tax law that is considered under US tax law to be income of a related foreign corporation (and certain other entities in limited circumstances).

The second triggering event occurs if the domestic corporation fails to comply with certification requirements. Specifically, where a consenting domestic corporation’s disregarded entity has incurred a DPL, the domestic corporation must certify annually throughout the certification period that no foreign use of the DPL has occurred.

HYBRID MISMATCH RULES AND PILLAR TWO

The DPL rules provide that if a relevant foreign tax law denies a deduction for an item to prevent a D/NI outcome, the item is not taken into account for purposes of computing DPL or disregarded payment income. These so-called “hybrid mismatch rules” go some way toward softening the headache the DPL rules are likely to cause taxpayers.

However, foreign countries’ adoption of Pillar Two rules will exacerbate their impact. The rules make clear that for purposes of a qualified domestic minimum top-up tax (QDMTT) or income inclusion rule (IIR) top-up tax, foreign use is considered to occur where a portion of the deductions or losses that comprise a DPL is taken into account in determining net Global Anti-Base Erosion Rules income for a QDMTT or IIR or in determining qualification for the Transitional Country-by-Country Safe Harbor.[10] There is also a transition rule providing that, for this purpose, QDMTTs and IIRs are not taken into account for taxable years beginning before August 6, 2024.[11] This means that calendar year taxpayers who have not consented early to the DPL rules generally should not have a DPL inclusion amount in 2024 solely as a result of Pillar Two taxes, but, depending on their facts, could have an inclusion next year if proactive measures are not taken.

NEXT STEPS

Now is the time for multinational taxpayers to evaluate their risk under the DPL rules. Taxpayers with a domestic corporation in their structure should think carefully before making check-the-box elections to treat foreign entities as disregarded entities.[12] Moreover, taxpayers should determine whether their domestic corporations own any foreign disregarded entities or other specified entities that will cause them to be deemed to consent to the rules as of August 6, 2025.

Multinational taxpayers also should determine whether they have disregarded interest payments, structured payments, or royalties that fall under the purview of the rules. If so, they should consider whether they will be able to avoid future triggering events or if “foreign uses” of DPLs will be unavoidable. One should pay particular attention to Pillar Two, including the Transitional Country-by-Country Safe Harbor, when considering whether there could be a foreign use.

Taxpayers who cannot avoid triggering events should consider whether, and when, to take some defensive measures. Such actions might include winding up foreign disregarded entities that could be subject to the rules, eliminating disregarded payments that would result in DPL income inclusions,[13] or taking other restructuring steps (e.g., electing to treat certain foreign disregarded entities as associations, as the Treasury suggests). When determining whether to take defensive actions, taxpayers should consider the impact that DPL inclusions could have on their overall tax profile, including sourcing issues, foreign tax credits, and the Section 163(j) limitation on business interest deductions. In terms of timing, taxpayers also should consider whether they have until August 5, 2025, to unwind any arrangements subject to the DPL rules or whether it may be prudent to unwind any such arrangements before the end of the year.

Finally, taxpayers concerned about these rules should watch for news about whether they will be issued in final form. The results of the 2024 US presidential election call into question whether the proposed rules will be finalized or, conceivably, shelved.[14] These considerations further complicate the question of whether and when multinational taxpayers should act in response to the rules, particularly as the clock continues to tick toward the deemed consent date of August 6, 2025.

Endnotes


[1] The proposed regulations also can apply to payments made by a foreign disregarded entity to other foreign disregarded entities owned by the same domestic corporate parent.

[2] REG-105128-23.

[3] Although not analyzed in detail here, the proposed changes to the DCL rules are also significant and taxpayers should consider their impact.

[4] For example, the foreign deduction or loss can be used through a loss surrender or consolidation regime.

[5] For example, this may occur when a foreign disregarded entity makes a payment that is included in another foreign disregarded entity payee’s income for foreign tax purposes.

[6] A specified eligible entity is an eligible entity that is a foreign tax resident or owned by a domestic corporation that has a foreign branch.

[7] The rules also can apply to an entity that is formed or acquired after August 6, 2024, and classified without an election as a disregarded entity.

[8] For example, Section 367 may apply to a deemed contribution to the newly regarded foreign corporation.

[9] Generally, these are items of income and deduction from certain disregarded interest, royalties, and “structured payments” within the meaning of the Section 267A regulations.

[10] A limited exception is available in certain cases where the Pillar Two duplicate loss arrangement rule applies.

[11] This favorable transition rule is subject to an anti-abuse provision that can prevent it from applying.

[12] Taxpayers also should give careful thought to any internal restructurings involving foreign disregarded entities.

[13] Eliminating these payments may, of course, result in a corresponding increase in foreign tax liability.

[14] Commentators to the proposed regulations also have raised substantive invalidity arguments under the Loper Bright framework.

What U.S. Travelers to UK Need to Know About UK’s Electronic Travel Authorisation (ETA)

Americans traveling to the UK as tourists or business visitors are generally visa-exempt. Starting on Jan. 8, 2025, visa-exempt Americans traveling to the UK will need to use the new Electronic Travel Authorisation (ETA) scheme prior to travel. Americans will be able to apply for ETA starting on Nov. 27, 2024.

Like the U.S. ESTA (Electronic System for Travel Authorization), ETAs are digitally linked to the traveler’s passport, allowing smoother and more secure immigration processing.

Applying for an ETA costs ten pounds. The ETA expires either two years after issuance or when the individual’s passport expires – whichever is earlier. If an individual obtains a new passport, they must apply for new ETA.

The ETA allows:

  • Multiple entries
  • Stays for no longer than six months

The ETA is being rolled out in phases. It is already in effect for nationals from the Gulf States. On Jan. 8, 2025, approximately 50 other countries, including the United States, will be added to the list. ETA will be rolled out for European countries on April 2, 2025.

The application is online and through the UK ETA app. Every individual who is traveling will need a separate ETA application. It is best to apply early, although applications are usually processed within three working days.

The similar ETIAS program for travel to the European Union has been delayed, but it is expected to go into effect sometime in 2025.

Administration Action Could Unravel the De Minimis Exception for Goods From China

Many e-commerce retailers are closely monitoring increasing bipartisan criticism of the Section 321 de minimis program. This program, which provides an exemption for goods valued at $800 or less destined to a single person on a given day, allows these goods to enter the US duty and tax-free without formal entry.

While this expedited clearance process has been beneficial for many retailers, critics argue that it creates loopholes that can be exploited, particularly by foreign sellers, to bypass tariffs and import restrictions. Addressing US Congress’ inability to pass de minimis reform legislation, on September 13, the Biden-Harris Administration took decisive action to address these concerns. They announced a notice of proposed rulemaking aimed at reducing de minimis import volumes and strengthening trade enforcement through the following measures:

  • Limiting De Minimis Exemptions for Products Subject to Other Trade Remedies: Removal of the de minimis exemption for shipments that contain products subject to additional tariffs under Sections 201 and 301 of the Trade Act of 1974 and Section 232 of the Trade Expansion Act of 1962 (e.g., from China).
  • Increased Disclosure Requirements for De Minimis Shipments: Additional information would be required for de minimis shipments, including the 10-digit tariff classification and identification of the person claiming the exemption.
  • Compliance Requirements for the CPSC: All importers of consumer products must file Certificates of Compliance (CoC) with the US Consumer Product Safety Commission (CPSC).

It is unclear when the proposed rule will be published.

The Administration also calls on Congress to implement legislation to further reform the de minimis program. Earlier this year, the House Ways and Means Committee introduced H.R. 7979 – End China’s De Minimis Abuse Act, which would similarly limit the use of this program for products subject to Sections 201, 301, and 232 and require a 10-digit Harmonized Tariff Schedule of the United States declaration. There have been several other de minimis reform bills proposed however, Congress has struggled to pass comprehensive legislation to reform the program. This announcement may be the push Congress needs to pass legislation during the lame duck session, but we will see…

Although these measures are primarily aimed at restricting Chinese e-commerce giants like Shein and Temu, these government actions could have long-term implications for direct-to-consumer sales. Any changes to the program will impact other US retailers that benefit from Section 321, small start-up companies, as well as consumers who might experience longer wait times and higher costs for their online orders due to these changes.

What’s the Problem?

Over the past decade, the rise of online shopping has led to a sevenfold increase in the number of shipments that enter the United States through the de minimis exemption. The US Department of Homeland Security (DHS) has reported that nearly 4 million de minimis shipments enter the United States per day. This volume makes it impossible for the government to properly screen the shipments for import violations. The government is concerned because contraband, including drugs, counterfeit goods, goods violating the Uyghur Forced Labor Prevention Act (UFLPA), and undervalued shipments are allegedly entering the United States through this program. DHS reported that as of July 30, 89% of cargo seizures in fiscal year 2024 originated as de minimis shipments. We have previously reported on proposed legislation and government actions aimed at addressing the alleged misuse of this program to import contraband or improperly declare shipments, particularly those originating from China.

A Focus on China

Most of these shipments are sold on e-commerce platforms and originate in China. As a result, many of these shipments would normally be subject to additional duties under the Section 232, 301, or 201 programs. According to the Administration’s announcement, Section 301 tariffs apply to 40% of US imports, including 70% of textile and apparel goods from China. The Administration’s proposed rule would significantly limit the scope of goods eligible for the Section 321 de minimis program.

Enhancing Transparency in De Minimis Shipments

To assist in targeting problematic shipments and expediting the clearance of lawful shipments, the Administration will also solicit comments on a proposed rule that would require submission of more detailed information in order to use the de minimis exemption. Currently, these shipments can be entered through informal entries by providing the bill of lading or a manifest that outlines the shipment’s origin, the consignee, and details about the merchandise’s quantity, weight, and value. The additional data points required would include the tariff classification number and the identity of the individual claiming the exemption. The Administration asserts that these requirements will protect US business from unfair competition against imported goods that would otherwise be subject to duties and will facilitate US Customs and Border Protection’s (CBP) ability to detect the illicit goods at the border.

Protecting Consumers From De Minimis Shipments

The Administration also announced that the CPSC plans to propose a final rule that would require importers of consumer products to electronically file CoC with CBP and CPSC upon entry, including de minimis shipments. This action is intended to prevent foreign companies from exploiting the de minimis exemption to circumvent consumer protection testing and certification requirements.

Focus on Textiles

The Administration has committed to prioritizing enforcement efforts to prevent importation of illicit shipments of textile and apparel imports through increased targeting of de minimis shipment, more customs audits and verification, as well as the expansion of the UFLPA Entity List.

The Administration’s focus on the textile and apparel industry follows DHS’s enforcement initiative to curb illicit trade to support American textile jobs. Since the DHS announcement in April, we have seen a notable increase in enforcement actions such as CBP requests for information, risk assessment questionnaires, and detentions under the UFLPA.

Potential Legislative Implications

The Administration has also advocated for further legislative action by Congress including:

  • Exclusion of import-sensitive products such as textiles from the de minimis exemption, the exclusion of shipments containing products covered by certain trade enforcement actions, and the passage of previously proposed de minimis reforms.
  • Legislation that would expedite the process of excluding products covered by Sections 301, 201, and 232 from the de minimis exemption.
  • Reforms in the previously introduced Detect and Defeat Counter-Fentanyl Proposal, which would require more data from shippers under the de minimis program and strengthen the CBP’s ability to detect and seize illicit drugs and raw materials.

What This Means for Retailers and How We Can Help

The Administration’s notice of proposed rulemaking suggests that changes to the de minimis program are on the horizon. For e-commerce retailers, these changes could mean a shift in how they manage their imports. Stricter eligibility criteria and enhanced enforcement may require more diligent documentation and compliance efforts. Retailers should stay informed about these proposed changes and prepare to adapt their operations accordingly.

USTR Finalizes New Section 301 Tariffs

The United States Trade Representative (USTR) published a Federal Register notice detailing its final modifications to the Section 301 tariffs on China-origin products. USTR has largely retained the proposed list of products subject to Section 301 tariffs announced in the May 2024 Federal Register notice (see our previous alert here) with a few modifications, including adjusting the rates and implementation dates for a number of tariff categories and expanding or limiting certain machinery and solar manufacturing equipment exclusions. USTR also proposes to impose new Section 301 tariff increases on certain tungsten products, polysilicon, and doped wafers.

The notice, published on September 18, 2024, clarifies that tariff increases will take effect on September 27, 2024, and subsequently on January 1, 2025 and January 1, 2026 (Annex A). The final modifications to Section 301 tariffs will apply across the following strategic sectors:

  • Steel and aluminum products – increase from 0-7.5% to 25%
  • Electric vehicles (EVs) – increase from 25% to 100%
  • Batteries
    • Lithium-ion EV batteries – increase from 7.5% to 25%
    • Battery parts (non-lithium-ion batteries) – increase from 7.5% to 25%
    • Certain critical minerals – increase from 0% to 25%
    • Lithium-ion non-EV batteries – increase from 7.5% to 25% on January 1, 2026
    • Natural graphite – increase from 0% to 25% on January 1, 2026
  • Permanent magnets – increase from 0% to 25% on January 1, 2026,
  • Solar cells (whether or not assembled into modules) – increase from 25% to 50%
  • Ship-to-shore cranes – increase from 0% to 25% (with certain exclusions)
  • Medical products
    • Syringes and needles (excluding enteral syringes) – increase from 0% to 100%
    • Enteral syringes – increase from 0% to 100% on January 1, 2026
    • Surgical and non-surgical respirators and facemasks (other than disposable):
      • increase from 0-7.5% to 25%; increase from 25% to 50% on January 1, 2026
    • Disposable textile facemasks
      • January 1, 2025, increase from 5% to 25%; increase from 25% to 50% on January 1, 2026
    • Rubber medical or surgical gloves:
      • increase from 7.5% to 50% on January 1, 2025; increase from 50% to 100% on January 1, 2026
    • Semiconductors – increase from 25% to 50% on January 1, 2025

USTR adopted 14 exclusions to temporarily exclude solar wafer and cell manufacturing equipment from Section 301 tariffs (Annex B), while rejecting five exclusions for solar module manufacturing equipment proposed in the May 2024 notice. The exclusions are retroactive and applicable to products entered for consumption or withdrawn from warehouse for consumption on or after January 1, 2024, and through May 31, 2025. USTR also granted a temporary exclusion for ship-to-shore gantry cranes imported under contracts executed before May 14, 2024, and delivered prior to May 14, 2026. To use this exclusion, the applicable importers must complete and file the certification (Annex D).

With respect to machinery exclusion, USTR added five additional subheadings to the proposed 312 subheadings to be eligible for consideration of temporary exclusions. USTR did not add subheadings outside of Chapters 84 and 85 or subheadings that include only parts, accessories, consumables, or general equipment that cannot physically change a good. USTR will likely issue additional guidance to seek exclusions of products under these eligible subheadings.

Importers should assess the (i) table of the tariff increases for the specified product groups (Annex A), (ii) temporary exclusions for solar manufacturing equipment (Annex B), (iii) the Harmonized Tariff Schedule of the United States (HTSUS) modifications to impose additional duties, to increase rates of additional duties, and to exclude certain solar manufacturing equipment from additional duties (Annex C), (iv) Importer Certification for ship-to-shore cranes entering under the exclusion (Annex D), and (v) HTSUS subheadings eligible for consideration of temporary exclusion under the machinery exclusion process (Annex E). The descriptions set forth in Annex A are informal summary descriptions, and importers should refer to the HTSUS modifications contained in Annex C for the purposes of assessing Section 301 duties and exclusions.

Importers should also carefully review the final list of products subject to the increased Section 301 tariff, with their supply chains, to identify products subject to increases in tariff rates as a result of the recent of USTR and consider appropriate mitigation strategies.

BIOSECURE Act: Anticipated Movement, Key Provisions, and Likely Impact

Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.

The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology equipment or service produced or provided by a biotechnology company of concern. Subject to some exceptions, it also prohibits federal agencies from contracting with a company that uses equipment or services produced or provided by a biotechnology company of concern. Further, the Act prohibits recipients of a loan or grant from a federal agency from using federal funds to purchase equipment or services from a biotechnology company of concern.

The Senate version of BIOSECURE, sponsored by Sens. Gary Peters (D-MI) and Bill Hagerty (R-TN), was voted out of the Senate Committee on Homeland Security and Governmental affairs with bipartisan support in March 2024. Given its passage in the House last night, the BIOSECURE Act is likely to be signed into law by the end of the year. The House version of BIOSECURE is likely to be the version that becomes law. President Biden is unlikely to veto the Act given its bipartisan support, his previous executive actions to support domestic biotechnology development, and his Administration’s approach towards competition with China.

The Act defines “biotechnology company of concern” as any entity that:

  • is subject to the jurisdiction, direction, control, or operates on behalf of the government of a foreign adversary (defined as China, Cuba, Iran, North Korea, and Russia);
  • is involved in the manufacturing, distribution, provision, or procurement of a biotechnology equipment or service; and
  • poses a risk to U.S. national security based on:
    • engaging in joint research with, being supported by, or being affiliated with a foreign adversary’s military, internal security forces, or intelligence agencies;
    • providing multiomic data obtained via biotechnology equipment or services to the government of a foreign adversary; or
    • obtaining human multiomic data via the biotechnology equipment or services without express and informed consent.

Somewhat unusually, the Act names specific Chinese companies as automatically qualifying as “biotechnology companies of concern”:

  • BGI (formerly known as the Beijing Genomics Institute);
  • MGI;
  • Complete Genomics;
  • WuXi AppTec; and
  • WuXi Biologics.

Both categories include any subsidiary, parent, affiliate, or successor entities of biotechnology companies of concern.

The Act also has very broad definitions of “biotechnology equipment or service.” The definition of equipment encompasses any machine, device, or subcomponent, including software that is “designed for use in the research, development, production, or analysis of biological materials.” The definition of services is similarly broad.

The BIOSECURE Act also requires the Office of Management and Budget (OMB) to publish a list of additional biotechnology companies of concern. The list is prepared by the Secretary of Defense in coordination with the Secretaries of the Departments of Health and Human Services, Justice, Commerce, Homeland Security, and State, as well as the Director of National Intelligence and National Cyber Director. This list of companies must be published by OMB within one year of BIOSECURE’s enactment and reviewed annually by OMB in consultation with the other Departments.

Guidance and Regulatory Authorities

OMB is also tasked with developing guidance and has 120 days from enactment of the statute to do so for the named companies. For the list of biotechnology companies of concern, OMB’s guidance must be established within 180 days after the development of the list.

Beyond OMB, the Act requires the Federal Acquisition Regulatory Council to revise the Federal Acquisition Regulation (FAR) to incorporate its prohibitions. The FAR regulations must be issued within one year of when OMB establishes its guidance.

For named companies the Act’s prohibitions are effective 60 days after the issuance of the FAR regulations. For companies placed on the biotechnology company of concern list, the effective date for the Act’s prohibitions is 80 days after the issuance of FAR regulations.

Impact on Existing Business Relationships

In response to stakeholder concerns about disrupting existing commercial relationships and triggering delays in drug development, the House version of the BIOSECURE Act provides a five-year unwinding period for contracts and agreements entered into before the Act’s effective dates. Contracts entered into after the Act’s effective dates do not qualify for the five year unwinding period.

Process for Designating Companies

BIOSECURE specifies the process for designating a biotechnology company of concern. Critically, the Act does not require OMB to notify a company prior to the Department of Defense making the designation. Rather, a company will receive notice that it is being designated and placed on the biotechnology company of concern list. Moreover, the criteria for listing will only be provided “to the extent consistent with national security and law enforcement interests.” Thus, companies may face a circumstance where they are not provided the evidence supporting their designation.

Once a company receives the notice, it will have 90 days to submit information and arguments opposing the listing. The Act does not require a hearing or any formal administrative process. If practicable, the notice may also include steps the company could take to avoid being listed, but it is not required.

Safe Harbor, Waivers and Exceptions

The Act only has one safe harbor for biotechnology equipment or services that were formerly but no longer provided or produced by a biotechnology company of concern. This safe harbor seems intended to allow a biotechnology company of concern to sell their ownership of a product or service to another company without prohibitions applying to the new owner.

Agency heads may waive the Act’s prohibitions on a case-by-case basis, but only with the approval of OMB acting “in coordination with the Secretary of Defense.” Waivers must be reported to Congress within 30 days of being granted. The waiver may last for up to a year with an additional “one time” extension of 180 days allowed if an agency head determines it is “in the national security interests of the United States.” The 180-day extension must be approved by OMB and the agency head must notify and submit a justification to Congress within 10 days of the waiver being granted.

The Act has only two exceptions. First, its prohibitions do not apply to intelligence activities. Second, the prohibitions do not apply to health care services provided to federal employees, members of the armed services, and government contractors who are stationed in a foreign country or on official foreign travel.

Impact and Considerations for Clients

1. Increased Risk of Partnerships with Chinese Companies and Researchers:

Pharmaceutical and biotechnology companies that receive federal funding or contract with federal agencies should be prepared to wind down business ties to biotechnology companies in China. Impacted companies need to begin evaluating the risk to their supply chains, manufacturing capacity, and R&D pipelines in the event a business partner is listed.

Universities in the United States and other research institutes that receive federal funding will also need to undertake a similar assessment of their research partners and collaborators based in China.

2. Loss of CDMO capacity:

Wuxi App Tec is a large, global provider of contract development and manufacturing (CDMO) services to the life sciences industry. According to the New York Times “[b]y one estimate Wuxi has been involved in developing one-fourth of the drugs used in the United States.” BIOSECURE would effectively ban Wuxi from conducting business in the United States, and if passed, risks causing delays, shortages, and cost increases as companies seek to transition to other CDMOs. It will likely take years for competitors to replace the lost CDMO capacity.

3. Fate of Wuxi U.S. Facilities:

Wuxi has a large presence in the United States. It operates 12 facilities and employs almost 2,000 people. Normally, Wuxi would be expected to sell its U.S.-based facilities. However, based on Tiktok’s experience, it is unclear if the Government of China will permit Wuxi to sell its facilities as opposed to dismantling and/or relocating facilities outside of the United States.

4. OMB’s Management of Biotechnology Companies of Concern List

OMB does not typically manage processes like the one envisioned by BIOSECURE. How OMB interprets the broad criteria for listing companies will be critical. Which Departments, beyond the Department of Defense, will have the greatest influence on OMB’s decision making and how open OMB is to evidence from companies seeking to avoid listing will also need to be watched closely. Until OMB starts preparing its guidance and the FAR regulations are proposed, it is hard to anticipate the rate at which new companies will be added to the list. How the process established by BIOSECURE will interact with or leverage existing entity lists will be another development to closely monitor.

5. Retaliation by China

BIOSECURE’s passage is likely to trigger a response from the Government of China. Responses could range from imposing its own export controls to using the country’s sweeping national security laws to harass United States businesses and their employees. Companies doing business in China, particularly those in the pharmaceutical or biotech industries need to be prepared.

You Are Sponsoring a Foreign National Employee for Permanent Residency, Can You Clawback Some of the Fees?

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.

Listen to this post 

The Administration Creates New Pathways for DACA Recipients to Obtain Legal Status

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:

  1. 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.
  2. 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.
  3. 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.

Top Competition Enforcers in the US, EU, and UK Release Joint Statement on AI Competition – AI: The Washington Report


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.

  1. 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.
  2. 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.
  3. 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.”

  1. 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.
  2. 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.”
  3. 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.