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New CFIUS Regulations Formally Implemented: What Your Business Needs to Know

CFIUS

New CFIUS Regulations Formally Implemented: What Your Business Needs to Know

The Committee on Foreign Investment in the United States (CFIUS or the Committee) is an interagency government committee authorized to review, modify, and block foreign acquisitions of or investments in U.S. businesses that could adversely affect U.S. national security.

In 2020, new regulations went into effect that broadened the scope of foreign investment transactions subject to review by the Committee. Historically, CFIUS national security reviews were limited to transactions that could result in a foreign investor obtaining “control” of a U.S. business. However, the scope of transactions subject to potential CFIUS review has been expanded, and now includes certain non-controlling foreign investments in U.S. businesses involved in critical technologies, critical infrastructure, or sensitive personal data of U.S. citizens. In addition, CFIUS has instituted new mandatory filing requirements for specific types of foreign investment in U.S. critical technology companies.

It is now more important than ever for non-U.S. companies doing business with or investing in the U.S. to understand how their business can be impacted by the revised CFIUS regulations. If a non-U.S. company is considering buying or investing in a U.S. business, conducting an assessment of potential CFIUS risks and obligations must be included in the due diligence process. To assist with this assessment, below is an overview of CFIUS, as well as a breakdown of the key CFIUS regulatory changes implemented in 2020 that stand to impact your business.

Committee on Foreign Investment in the United States (CFIUS)

CFIUS is chaired by the U.S. Department of Treasury and has the authority to review any transaction by or with a foreign person which could result in control (or in certain non-controlling interests) of a U.S. business by a foreign person. This includes proposed or completed mergers, acquisitions, or takeovers by foreign governments, foreign entities, and those controlled by foreign governments and entities. When CFIUS has jurisdiction over a proposed transaction, parties can voluntarily notify the Committee of the transaction and its terms. CFIUS is authorized to commence reviews unilaterally, but it rarely uses this power.

Foreign investors often seek to file for CFIUS approval voluntarily because once a transaction is cleared by the Committee, it qualifies for a “safe harbor” and is generally considered cleared indefinitely, thereby eliminating CFIUS-related risks. On the other hand, if CFIUS does not clear a particular transaction prior to its closing, there is a chance that the Committee will unilaterally initiate an investigation and ultimately require divestiture of the foreign party, potentially even years after the transaction has closed.

If CFIUS determines that a covered transaction presents a national security risk, it has the authority to impose certain mitigating conditions before allowing the deal to proceed, and may also refer the transaction to the President, who has sole authority to block a proposed transaction or unwind a completed transaction. However, U.S. Presidents have rarely used their power to block transactions because CFIUS generally enters into mitigation agreements with the parties to high-risk transactions in order to alleviate any identified national security concerns.

If CFIUS opposes a foreign investment or acquisition, and mitigating measures cannot be implemented by the transacting parties, it is often the case that the foreign investor withdraws the deal prior to CFIUS escalating its recommendation to the President. While to date only five investments have ever been blocked by a President, numerous proposed transactions have been withdrawn by the parties involved to avoid the risk of having the transaction formally blocked.

CFIUS has become much more active in recent years, particularly under the Trump administration, where the Committee reviewed 697 transactions between 2017 and 2019. Recent high-profile examples include the following:

-In 2017, President Trump blocked the acquisition of Lattice Semiconductor Corp. by the Chinese investment firm Canyon Bridge Capital Partners due to national security and intellectual property concerns.

-In 2018, President Trump blocked the acquisition of U.S. telecommunications equipment company Qualcomm by the Singapore microchip maker Broadcom.

-In 2019, CFIUS raised concerns over Beijing Kunlun Company’s investment in Grindr LLC, an online dating site, over concerns of foreign access to personally identifiable information of U.S. citizens. The Chinese firm subsequently divested itself of Grindr.

-In 2020, President Trump announced plans to ban the popular social media platform TikTok based on its ownership by Chinese technology company ByteDance and its potential access to sensitive personal data of U.S. citizens. CFIUS and ByteDance are still in the process of negotiating the terms of prospective mitigating measures that would allow TikTok to continue its U.S. operations.

Changing Landscape: Foreign Investment Risk Review Modernization Act

In recent years, there has been a push for CFIUS reform by government officials who viewed the process as inadequate to face modern geopolitical threats to U.S. businesses and technologies posed by foreign direct investments into U.S. companies – particularly from Chinese foreign investment. This led to the passing of the broad CFIUS reform legislation known as the Foreign Investment Risk Review Modernization Act (FIRRMA) in August 2018.

FIRRMA was designed to expand the scope of foreign investment reviews conducted by the Committee, and overhauled the CFIUS review process to more effectively address modern U.S. national security concerns. The revised CFIUS regulations provided for in FIRRMA formally took effect in February 2020.

Historically, CFIUS reviews have been based on voluntary notice submissions by parties to a covered transaction. Only transactions that involved foreign control and that raised national security concerns would be filed by the transacting parties with the Committee for approval. Under FIRRMA, the Committee now also has the authority to review non-controlling “covered investments” by a foreign person in a U.S. critical technology, critical infrastructure or sensitive personal data company. These “TID Businesses” (i.e., U.S. Technology, Infrastructure and Data companies) include companies that engage in one of the following activities:

-Produces, designs, tests, manufactures, fabricates or develops one or more critical technologies;

-Owns, operates, manufactures, supplies or services critical infrastructure; or

-Maintains or collects sensitive personal data (e.g., health or financial data) of U.S. citizens that may be exploited in a manner that threatens national security.

A “covered investment” includes circumstances where a foreign investor obtains:

-Access to material non-public technical information;

-Membership or observer rights on the board of directors or an equivalent governing body of the business or the right to nominate an individual to a position on that body; or

-Any involvement, other than through voting of shares, in substantive decision making regarding sensitive personal data of U.S. citizens, critical technologies, or critical infrastructure.

CFIUS has also instituted new mandatory filing requirements involving inbound investment in U.S. companies involved with “critical technology.” When FIRRMA was initially implemented, filings became mandatory for certain transactions involving U.S. critical technology businesses that were included among 27 specified industries identified by their North American Industry Classification System (NAICS) codes.

However, beginning in October 2020, CFIUS implemented a new rule tying the “critical technology” definition to U.S. export control regulations. Now, filing a declaration with CFIUS is mandatory for covered transactions involving a U.S. business that “produces, designs, tests, manufactures, fabricates, or develops one or more critical technologies” where a “U.S. regulatory authorization” would be required for the export, re-export, or transfer of such critical technologies to the foreign investor. Accordingly, having a clear understanding of U.S. export control classification regimes and licensing requirements, including those promulgated under the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR), is now a significant component of any CFIUS analysis.

In addition, FIRRMA added mandatory filings requirements for certain types of foreign government investment. If a foreign government holds a “substantial interest” in a foreign investor that in turn obtains a “substantial interest” in a TID Business, a CFIUS filing is now mandatory. This filing requirement is triggered when a foreign government holds at least a 49% (direct or indirect) interest in the foreign investor, whereas a foreign person will obtain a “substantial interest” in a TID Business if it seeks to obtain at least a 25% (direct or indirect) interest. In such scenarios, the parties must file a mandatory declaration with CFIUS at least 30 days prior to the transaction’s closing.

Global Impact

In terms of global impact, U.S. businesses and foreign investors previously unfamiliar with the CFIUS filing process, or that were previously outside the jurisdiction for a covered transaction, will now have to analyze the potential implications of a mandatory or voluntary CFIUS filing when considering even passive forms of foreign investment. This includes businesses ranging from health care companies, telecommunications companies, technology start-ups, related infrastructure industries, venture capital funds, emerging technology companies and manufacturers, and any company that maintains or can access sensitive U.S. consumer personal or health data.

Robust due diligence on proposed foreign investments will be more important than ever to ensure compliance with any mandatory CFIUS requirements. This will result in cross-border deals becoming much more time-consuming processes that will require significant scrutiny and attention to detail when drafting contractual rights afforded to foreign investors. Importantly, this will also require increased “up-stream” due diligence on any proposed non-U.S. investor’s corporate structure and ultimate ownership.

The business decision that a potential non-U.S. investor will need to make regarding which type of filing (if any) should be made with CFIUS is based on factors such as the complexity of the transaction, the working relationship between the parties, the national security implications and risk-level of the U.S. business, the likelihood of a successful resolution with CFIUS, the economy of legal resources, the evolving definition of what constitutes a “national security concern,” and current CFIUS enforcement priorities.

_______________________________________________________________

Alan Enslen and Julius Bodie are attorneys at law firm Baker Donelson, they can be reached at aenslen@bakerdonelson.com and jbodie@bakerdonelson.com. Jiri Mestecky, Takanori Nakajima and Yunosuke Hirano are are attorneys at Kitahama Partners. They can be reached at JMestecky@kitahama.or.jp, TNakajima@kitahama.or.jp and YHirano@kitahama.or.jp.

PPE

COVID-19 Trade Update: FEMA Implements Export Controls and Exclusion Guidance for Personal Protective Equipment

On April 3, 2020, President Trump issued a Presidential Memorandum directing the Department of Homeland Security, through the Federal Emergency Management Agency (“FEMA”), to utilize the Defense Production Act to restrict the export of scarce domestic materials being used to respond to the spread of COVID-19, including certain personal protective equipment (“PPE”).

Effective Tuesday, April 7, FEMA implemented this Order through a Temporary Final Rule (the “TFR”) that restricts U.S. exports of 5 specific categories of PPE products that were previously designated by the Department of Health and Human Services (“HHS”) as “scarce or threatened materials.” Both U.S. Customs and Border Protection (“CBP”) and FEMA have since issued additional guidance on the TFR that provides further detail on the scope of the restrictions as well as key exclusions for certain U.S. exporters.

The TFR differs from traditional U.S. export control regulations, such as those administered by the U.S. Departments of Commerce and State, in that there is no licensing system in place and FEMA’s determination is not based on the proposed end-use or end-user of the product – rather, FEMA will assess all U.S. exports of designated PPE materials and reallocate those products domestically as required. Because FEMA is not an agency that traditionally administers U.S. export control regulations, it is critical for manufacturers, suppliers, and distributors of PPE products and related medical materials to be aware of the specific articles impacted by the TFR, the scope of the restrictions, the timeline for implementation, consequences for non-compliance, and the potential for expanded product coverage.

PPE Export Restrictions Overview

The TFR providing for PPE export restrictions is effective as of April 7, 2020 for a period of 120 days. The TFR designates 5 of 15 categories of materials previously identified as “scarce or threatened materials” by HHS. In particular, the subject restricted PPE “covered materials” are the following:

-N-95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;

-Other Filtering Facepiece Respirators (e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100), including single-use, disposable half-mask respiratory protective devices that cover the user’s airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181;

-Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;

-PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials; and

-PPE gloves or surgical gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes.

Before any shipments of the above-listed PPE materials can be exported from the U.S., CBP will temporarily detain the shipment so that FEMA can determine whether to (i) prohibit the export and return the shipment for domestic use; (ii) utilize the Defense Product Act (“DPA”) to issue a “rated order” for the materials (a priority contract or order placed in support of a national defense program under the DPA), or (iii) allow the export of part or all of the shipment.

In making its determination, FEMA may consider the following factors: (1) the need to ensure that scarce or threatened items are appropriately allocated for domestic use; (2) minimization of disruption to the supply chain, both domestically and abroad; (3) the circumstances surrounding the distribution of the materials and potential hoarding or price-gouging concerns; (4) the quantity and quality of the materials; (5) humanitarian considerations; and (6) international relations and diplomatic considerations.

Scope and Exemptions

On April 9, 2020, CBP issued an updated internal guidance memorandum (the “CBP Internal Guidance”) to its field operators to clarify key definitions and general exceptions to the PPE export restrictions provided for in the TFR. CBP highlighted that the focus of the TFR is on “commercial quantities” of PPE exports, currently defined as shipments valued at $2,500 or more and containing more than 10,000 units.

The CBP Internal Guidance then lists the following export circumstances that are excluded from the FEMA restrictions:

-Exports to Canada or Mexico;

-Exports to U.S. government entities such as U.S. military bases overseas;

-Exports by U.S. Government agencies;

-Exports by U.S. charities;

-Exports by critical infrastructure industries for the protection of their workers;

-Exports by the 3M Company;

-Express or Mail Parcels that do not meet the “commercial quantity” definition above;

-In-transit shipments.

On April 21, 2020, FEMA published additional guidance in the Federal Register on the full scope of the initial list of 10 exemptions, which are described as follows:

-Shipments to U.S. Commonwealths and Territories, including Guam, American Samoa, Puerto Rico, U.S. Virgin Islands, and the Commonwealth of the Northern Mariana Islands (including minor outlying islands).

-Exports of “covered materials” by non-profit or non-governmental organizations that are solely for donation to foreign charities or governments for free distribution (not sale) at their destination.

-Intracompany transfers of “covered materials” by U.S. companies from domestic facilities to company-owned or affiliated foreign facilities.

-Shipments of “covered materials” that are exported solely for assembly in medical kits and diagnostic testing kits destined for U.S. sale and delivery.

-Sealed, sterile medical kits and diagnostic testing kits when only a portion of the kit is made up of one or more “covered materials” that cannot be easily removed without damaging the kits.

-Declared diplomatic shipments from foreign embassies and consulates to their home countries.

-Shipments to overseas U.S. military addresses, foreign service posts (e.g. diplomatic post offices), and embassies.

-In-transit merchandise: Shipments in transit through the U.S. with a foreign shipper and consignee, including shipments temporarily entered into a warehouse or temporarily admitted to a foreign trade zone.

-Shipments for which the final destination is Canada or Mexico.

-Shipments by or on behalf of the U.S. federal government, including its military.

Certain exclusions will require the submission of a letter of attestation certifying to FEMA the purpose of the shipment of covered materials that will also be placed on file with CBP.

Practical Advice and Next Steps

All U.S. manufacturers, suppliers, and distributors of PPE materials or other products designated by HHS as “scarce or threatened” (the relevant HHS guidance can be found here) that are considering exporting their products for sale need to have a comprehensive understanding of the FEMA TFR and applicable export restrictions. It may be the case that additional FEMA guidance will be issued regarding products identified by HHS as “scarce or threatened” in connection with the fight against the spread of COVID-19, and those additional items could be added to the list of restricted products for exports, including portable ventilators and certain drug treatment products that contain chloroquine phosphate or hydroxychloroquine HCl. Additional export, exporter or product-based exclusions may be issued in the finalized published FEMA/CBP guidance as well.

In the meantime, U.S. exporters of PPE products can expect delays at CBP ports around the country as FEMA and CBP develop and implement the TFR and related policy guidance. If you have any questions about the TFR, the impact of the TFR on exports of PPE products, or whether a particular product or proposed export is covered by a CBP exclusion, please contact a member of Baker Donelson’s Global Business Team.

_________________________________________________________

Alan Enslen is a shareholder with Baker Donelson and leads the International Trade and National Security Practice and is a member of the Global Business Team. He can be reached at aenslen@bakerdonelson.com.

 Julius Bodie is an associate with Baker Donelson who assists U.S. and foreign companies across multiple industries with international trade regulatory issues. He can be reached at jbodie@bakerdonelson.com.

PPE

COVID-19 Trade Update: FEMA Implements Export Controls for PPE as CBP Issues Guidance Restrictions

On April 3, 2020, President Trump issued a Presidential Memorandum directing the Department of Homeland Security, through the Federal Emergency Management Agency (FEMA), to utilize the Defense Production Act to restrict the export of scarce domestic materials being used to respond to the spread of COVID-19, including certain personal protective equipment (PPE).

Effective Tuesday, April 7, FEMA implemented this Order through a Temporary Final Rule (the TFR) that restricts U.S. exports of five specific categories of PPE products that were previously designated by the Department of Health and Human Services (HHS) as “scarce or threatened materials.”

U.S. Customs and Border Protection (CBP) has since issued its own internal guidance on the TFR that provides further detail on the scope of the restrictions as well as key exclusions for certain U.S. exporters.

The TFR differs from traditional U.S. export control regulations, such as those administered by the U.S. Departments of Commerce and State, in that there is no licensing system in place and FEMA’s determination is not based on the proposed end-use or end-user of the product – rather, FEMA will assess all U.S. exports of designated PPE materials and reallocate those products domestically as required. Because FEMA is not an agency that traditionally administers U.S. export control regulations, it is critical for manufacturers, suppliers, and distributors of PPE products and related medical materials to be aware of the specific articles impacted by the TFR, the scope of the restrictions, the timeline for implementation, consequences for non-compliance, and the potential for expanded product coverage.

PPE Export Restrictions Overview

The TFR providing for PPE export restrictions is effective as of April 7, 2020 for a period of 120 days. The TFR designates five of fifteen categories of materials previously identified as “scarce or threatened materials” by HHS. In particular, the subject restricted PPE materials are the following:

-N-95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;

-Other Filtering Facepiece Respirators (e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100), including single-use, disposable half-mask respiratory protective devices that cover the user’s airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181;

-Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;

-PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials; and

-PPE gloves or surgical gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes.

Before any shipments of the above-listed PPE materials can be exported from the U.S., CBP will temporarily detain the shipment so that FEMA can determine whether to:

-Prohibit the export and return the shipment for domestic use;

-Utilize the Defense Product Act (DPA) to issue a “rated order” for the materials (a priority contract or order placed in support of a national defense program under the DPA); or

-Allow the export of part or all of the shipment.

In making its determination, FEMA may consider the following factors:

-The need to ensure that scarce or threatened items are appropriately allocated for domestic use;

-Minimization of disruption to the supply chain, both domestically and abroad;

-The circumstances surrounding the distribution of the materials and potential hoarding or price-gouging concerns;

-The quantity and quality of the materials;

-Humanitarian considerations; and

-International relations and diplomatic considerations.

Scope and Exemptions

On April 9, 2020, CBP issued an updated internal guidance memorandum (CBP Internal Guidance) to its field operators to clarify key definitions and general exceptions to the PPE export restrictions provided for in the TFR.

First, CBP highlights that the focus of the TFR is on “commercial quantities” of PPE exports, currently defined as shipments valued at $2,500 or more and containing more than 10,000 units.

The CBP Internal Guidance then lists the following export circumstances that are excluded from the FEMA restrictions:

-Exports to Canada or Mexico;

-Exports to U.S. government entities such as U.S. military bases overseas;

-Exports by U.S. Government agencies;

-Exports by U.S. charities;

-Exports by critical infrastructure industries for the protection of their workers;

-Exports by the 3M Company;

-Express or Mail Parcels that do not meet the “commercial quantity” definition above;

-In-transit shipments.

However, it is important to note that as of April 16, the Internal CBP Guidance on exclusions for the TFR has not been formally published in the Federal Register or elsewhere by CBP, and may be subject to additional revisions in its final form.

Practical Advice and Next Steps

All U.S. manufacturers, suppliers, and distributors of PPE materials or other products designated by HHS as “scarce or threatened” (the relevant HHS guidance can be found here) that are considering exporting their products for sale need to have a comprehensive understanding of the FEMA TFR and applicable export restrictions. Expect additional CBP and/or FEMA guidance in the near future with refined definitions, clarifications as to how the exclusions will be administered, and further details on how product definitions will be determined. It may be the case that additional products identified by HHS as “scarce or threatened” in connection with the fight against the spread of COVID-19 will be added to the list of restricted products for exports, including portable ventilators and certain drug treatment products that contain chloroquine phosphate or hydroxychloroquine HCl. Additional export, exporter, or product-based exclusions may be issued in the finalized published FEMA/CBP guidance as well.

In the meantime, U.S. exporters of PPE products can expect delays at CBP ports around the country as FEMA and CBP develop and implement the TFR and related policy guidance. If you have any questions about the TFR, the impact of the TFR on exports of PPE products, or whether a particular product or proposed export is covered by a CBP exclusion, please contact a member of Baker Donelson’s Global Business Team.

_________________________________________________________________

Alan Enslen is a shareholder with Baker Donelson and leads the International Trade and National Security Practice and is a member of the Global Business Team. He can be reached at aenslen@bakerdonelson.com.

Julius Bodie is an associate with Baker Donelson who assists U.S. and foreign companies across multiple industries with international trade regulatory issues. He can be reached at jbodie@bakerdonelson.com.