Author: National Law Forum

A group of in-house attorneys developed the National Law Review on-line edition to create an easy to use resource to capture legal trends and news as they first start to emerge. We were looking for a better way to organize, vet and easily retrieve all the updates that were being sent to us on a daily basis.In the process, we’ve become one of the highest volume business law websites in the U.S. Today, the National Law Review’s seasoned editors screen and classify breaking news and analysis authored by recognized legal professionals and our own journalists. There is no log in to access the database and new articles are added hourly. The National Law Review revolutionized legal publication in 1888 and this cutting-edge tradition continues today.

University of Texas at Austin Permanently Blocks TikTok on Network

On Tuesday, January 17, 2023, the University of Texas at Austin announced that it has blocked TikTok access across the university’s networks. According to the announcement to its users, “You are no longer able to access TikTok on any device if you are connected to the university via its wired or WIFI networks.” The measure was in response to Governor Greg Abbott’s December 7, 2022, directive to all state agencies to eliminate TikTok from state networks. Following the directive, the University removed TikTok from university-issued devices, including cell phones, laptops and work stations.

Copyright © 2023 Robinson & Cole LLP. All rights reserved.

For  more Cybersecurity Legal News, click here to visit the National Law Review.

First Major Overhaul of Cosmetics Regulation Since FDR Administration

As part of the Consolidated Appropriations Act, 2023, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). This is the first major reform of cosmetics regulation since the Federal Food, Drug, and Cosmetic Act (“FDCA”) became law in 1938.[1] MoCRA implements new compliance requirements on the cosmetics industry and also significantly expands the U.S. Food and Drug Administration’s (“FDA”) authority to oversee and regulate cosmetics.

New Obligations for Cosmetics Industry

MoCRA imposes the following new requirements on “responsible persons”[2] and “facilities.”[3] We note that certain of these regulatory requirements may differ for entities considered small businesses under MoCRA.

  • Facility Registration and Product Disclosure. All facilitates (domestic or foreign) that manufacture or process cosmetic products for distribution in the United States must register with FDA by December 29, 2023. Registration is biennial. Further, responsible persons must annually submit cosmetic product listings to FDA and disclose key product information, such as ingredients.
  • Adverse Event Recording and Serious Adverse Event Reporting. Generally, responsible persons must keep records of any adverse events related to products used in the United States for six years and submit any “serious adverse events” to FDA within 15 days of the responsible person’s receipt of the report. MoCRA broadly defines what constitutes a serious adverse event, when compared to other FDA regulatory product categories (e.g., dietary supplements).[4]
  • Labeling Requirements. To improve the reporting of adverse events, responsible persons must include contact information on product labels. Additionally, product labels must identify any fragrance allergens in the product. Labels for products intended for use only by licensed professionals must also indicate that only licensed professionals may use the product.
  • Safety Substantiation Requirement. Responsible persons must ensure that a product is “safe” and keep records “adequately substantiating” the product’s safety.[5] Products without adequate safety substantiation may be considered adulterated under the FDCA. MoCRA also contains a provision stating that it is the sense of Congress that animal testing should not be used for safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.

Increased FDA Oversight of Cosmetics

MoCRA significantly expands FDA’s enforcement authority over the cosmetics industry.

  • Issue Mandatory Recalls. FDA now has mandatory recall authority if the agency concludes there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of the cosmetic will cause serious adverse health consequences or death.
  • Access Records. If FDA has a reasonable belief that a cosmetic product (or one of its ingredients) is adulterated and presents a threat of serious adverse health consequences or death, the agency has authority to access records relating to that product.
  • Suspend Facilities. FDA may suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by that facility has a reasonable probability of causing serious adverse health consequences or death and there is a reasonable belief that other products from the same facility may be similarly affected.
  • Federal Preemption. MoCRA explicitly preempts any state or local laws that differ from the federal cosmetics framework regarding facility registration and product listing, good manufacturing practices (“GMPs”), records, recalls, adverse event reporting, or safety substantiation.

Forthcoming FDA Rulemakings and Reports

MoCRA directs FDA to promulgate rules regarding the following three issues. Importantly, the cosmetics industry will have opportunities to provide comment on the proposed rules.

  • GMPs. FDA must establish GMP regulations consistent with national and international standards. Cosmetic products manufactured or processed under conditions that do not meet FDA’s forthcoming GMP regulations may be considered adulterated. The agency must issue a proposed rule by December 29, 2024 and a final rule by December 29, 2025.
  • Fragrance Allergens. FDA must publish regulations to identify fragrance allergens. Cosmetic product labels that do not include fragrance allergen disclosures required by such regulations may be considered misbranded under the FDCA. The agency must issue a proposed rule by June 29, 2024 and a final rule no later than 180 days after the public comment period.
  • Talc. FDA must issue regulations to establish required standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

In addition to the above rulemakings, FDA must issue a report within the next three years on the use of per- and polyfluoroalkyl substances (“PFAS”) in cosmetic products.

Footnotes

  1. MoCRA amends Chapter VI of the FDCA.
  2. A “responsible person” is defined as a manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of that product.
  3. “Facilities” are defined as any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States. MoCRA specifically exempts from registration certain facilities, such as those that (i) only label, relabel, package, hold, or distribute cosmetics products; and (ii) manufacture or process products solely for use in research and evaluation.
  4. “Serious adverse events” are defined as adverse events that result in (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; (v) a congenital anomaly or birth defect; (vi) infection; or (vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance); or that require – based on reasonable medical judgment – a medical or surgical intervention to prevent one of the outcomes described above.
  5. “Safe” is defined as a cosmetic product (and its ingredients) that is not injurious to users under the labeling or customary/usual usage. A cosmetic product (or its ingredients) should not be considered injurious solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. Further, “adequate substantiation” of safety means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support the product’s safety to a reasonable certainty.

Article By Christopher Hanson of Nelson Mullins. Paul Clowes, Law Clerk in the Greenville office, contributed to the drafting of this post.

For more biotech, food, and drug legal news, click here to visit the National Law Review.

Copyright ©2023 Nelson Mullins Riley & Scarborough LLP

Future of Non-Competes Up in the Air

Future of Non-Competes Up in the Air

The FTC recently announced its proposal to ban non-compete clauses in employment agreements. That proposal is currently in a 60-day period of public comment, and employers are (understandably) nervous. While many employers rely on these provisions to manage competition and protect their IP and confidential information, companies across the country may soon find themselves in the shoes of California employers, having to work around restrictions on non-competes to maximize protection within the increasingly narrow confines of the law.

Employers are not without options in responding to the potential changes should they become law–more aggressive retention incentives, intelligent data security, and stricter confidentiality agreements should all be part of the conversation. Even deferred compensation could be on the table, as noted in the article, though beware of the tax implications. Employers should also keep in mind that the FTC proposal, should it become law, will doubtless be subject to legal challenges and could be tied up in the courts for a while before becoming effective.

“Observers on both sides say that limitations on the clauses will compel employers to get more creative about how they retain talent, using everything from compensation to career advancement to keep workers engaged and loyal to the company. Some companies use deferred compensation—such as retention bonuses or rolling stock options that vest after, say, three years—to give people incentives to stay.”

©1994-2023 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Environmental Justice Update: EPA Announces $100 Million in EJ Grants to Local Groups and Issues Guidance Outlining Potential Federal ‘Cumulative Impact’ Claims

“Environmental justice” (EJ) continues as the primary leitmotif of Biden Administration environmental policy in the first weeks of 2023.

Below, we unpack two recently announced EJ efforts: a grant program for groups in environmentally overburdened communities and guidance on legal resources to address “cumulative impacts” issued by the US Environmental Protection Agency’s (EPA) Office of Legal Counsel and outline what these mean for the regulated community taken together in the context of other recent EJ developments.

EPA Announces $100 Million in Grants to Community Groups

This week, EPA announced the availability of approximately $100 million in grants for projects that “advance EJ in underserved and overburdened communities.” The grant programs are part of funding allocated by the Inflation Reduction Act programs discussed here.

Summaries of the two programs:

  • The Environmental Justice Collaborative Problem-Solving Program (EJCPS) Cooperative Agreement Program. The EJCPS program provides $30 million in funding directly to community-based non-profit organizations for projects focused on addressing local environmental or public health issues in their communities. Five million of the funding is reserved for small community-based nonprofit organizations with five or fewer full-time employees. EPA anticipates funding approximately 50 awards of $500,000 and 30 awards of $150,000.

  • Environmental Justice Government-to-Government (EJG2G) Program. EJG2G will provide an estimated $70 million in funding for state, tribal, and local projects completed in conjunction with community-based organizations. In total the agency anticipates funding approximately 70 projects of up to $1 million each for a 3-year project.

Interested applicants must submit proposal packages on or before April 10, 2023, for projects to begin on October 1, 2023.

EPA’s efforts to fund local groups are part of its broader strategic goal of enhancing equitable apportionment of resources and the benefits of environmental policies. EPA’s Equity Action Plan, discussed here, prioritizes building capacity in environmentally underserved communities to lead projects. Projects like these would lead to increased community engagement, which in turn could lead to more equitable outcomes in the environmental space. The strategy of building up local capacity to engage on environmental issues, mirrors private-sector efforts like Bloomberg Philanthropies $85 million “Beyond Petrochemicals” campaign, discussed here.

Federal Cumulative Impact Guidance

EPA’s Office of General Counsel released its Cumulative Impacts Addendum this week. This addendum builds on EPA’s Legal Tools to Advance Environmental Justice, which was released in May 2022. Taken together, these encyclopedia-like documents were created with the purpose of “identifying and making appropriate use of every authority and tool available to EPA under the law to incorporate environmental and climate justice considerations in our work,” in the words of EPA Administrator Michael Regan. The addendum itself indicates that it “is not intended to prescribe when and how [EPA] should undertake specific actions, nor does it provide methodologies for how to conduct a cumulative impacts assessment.” (Note: EPA’s Office of Research and Development has advanced a definition of “cumulative impacts,” summarized here, and is researching methodologies to deploy the concept.)

Structurally, the addendum breaks EPA’s authorities to address cumulative impacts into six subject-matter focused chapters:

  • Clean Air Act Programs

  • Water Programs

  • Waste Management and Emergency Response Programs (i.e. Resource Conservation and Recovery Act; Oil Pollution Act; the Emergency Planning and Community Right-to-Know Act; and the Comprehensive Environmental Response, Compensation, and Liability Act)

  • Pesticides and Toxics Programs (i.e. Federal Insecticide, Fungicide, and Rodenticide Act; the Federal Food, Drug, and Cosmetic Act; and the Toxic Substances Control Act); and

  • Environmental Review Programs (i.e. National Environmental Policy Act and Clean Air Act Section 309 Reviews).

EPA’s intent with the addendum was to outline legal resources for federal, state, and local regulators to consult situationally outlining potential tools that could be used to address cumulative impacts. These legal tools, used in conjunction with EJ-focused screening tools like EJSCREEN (discussed here) and newly developed and (increasingly available) data (see our discussions here and here), are part of EPA’s high prioritization of EJ issues.

Takeaways for the Regulated Community

We offer two takeaways from these developments:

First, EPA’s commitment to a “whole of government” approach to address EJ issues continues unabated. Over time, the Biden Administration has exhibited a willingness to allocate money to address EJ issues; reorient EPA and DOJ to better address them; develop new tools; and indeed, build capacity to engage local communities in an effort to benefit more Americans regardless of their race, language or socioeconomic status.

Second, taken collectively, these efforts will necessitate changes in process for regulated entities because governmental and community engagement in the EJ space is altering the policymaking process at a rapid rate. Relevant here, we expect that a secondary effect of EPA and private parties “building capacity” in local communities will be an increase in community involvement — and potentially opposition — to businesses operating in their communities. These groups are likely to deploy all available resources — including those outlined in the addendum — to address their concerns.

© 2023 ArentFox Schiff LLP
For more Environmental Policy Legal News, click here to visit the National Law Review.

Another Lesson for Higher Education Institutions about the Importance of Cybersecurity Investment

Key Takeaway

A Massachusetts class action claim underscores that institutions of higher education will continue to be targets for cybercriminals – and class action plaintiffs know it.

Background

On January 4, 2023, in Jackson v. Suffolk University, No. 23-cv-10019, Jackson (Plaintiff) filed a proposed class action lawsuit in the U.S. District Court for the District of Massachusetts against her alma matter, Suffolk University (Suffolk), arising from a data breach affecting thousands of current and former Suffolk students.

The complaint alleges that an unauthorized party gained access to Suffolk’s computer network on or about July 9, 2022.  After learning of the unauthorized access, Suffolk engaged cybersecurity experts to assist in an investigation. Suffolk completed the investigation on November 14, 2022.  The investigation concluded that an unauthorized third party gained access to and/or exfiltrated files containing personally identifiable information (PII) for students who enrolled after 2002.

The complaint further alleges that the PII exposed in the data breach included students’ full names, Social Security Numbers, Driver License numbers, state identification numbers, financial account information, and Protected Health Information.  While Suffolk did not release the total number of students affected by the data breach, the complaint alleges that approximately 36,000 Massachusetts residents were affected.  No information was provided about affected out-of-state residents.

Colleges and Universities are Prime Targets for Cybercriminals

Unfortunately, Suffolk’s data breach is not an outlier.  Colleges and universities present a wealth of opportunities for cyber criminals because they house massive amounts of sensitive data, including employee and student personal and financial information, medical records, and confidential and proprietary data.  Given how stolen data can be sold through open and anonymous forums on the Dark Web, colleges and universities will continue to remain prime targets for cybercriminals.

Recognizing this, the FBI issued a warning for higher education institutions in March 2021, informing them that cybercriminals have been targeting institutions of higher education with ransomware attacks.  In May 2022, the FBI issued a second alert, warning that cyber bad actors continue to conduct attacks against colleges and universities.

Suffolk Allegedly Breached Data Protection Duty

In the complaint, Plaintiff alleges that Suffolk did not follow industry and government guidelines to protect student PII.  In particular, Plaintiff alleges that Suffolk’s failure to protect student PII is prohibited by the Federal Trade Commission Act, 15 U.S.C.A. § 45 and that Suffolk failed to comply with the Financial Privacy Rule of the Gramm-Leach-Bliley Act (GLBA),  15 U.S.C.A. § 6801.  Further, the suit alleges that Suffolk violated the Massachusetts Right to Privacy Law, Mass. Gen. Laws Ann. ch. 214, § 1B, as well as its common law duties.

How Much Cybersecurity is Enough?

To mitigate cyber risk, colleges and university must not only follow applicable government guidelines but also  consider following industry best practices to protect student PII.

In particular, GLBA requires a covered organization to designate a qualified individual to oversee its information security program and conduct risk assessments that continually assess internal and external risks to the security, confidentiality and integrity of personal information.  After the risk assessment, the organization must address the identified risks and document the specific safeguards intended to address those risks.  See 16 CFR § 314.4.  

Suffolk, as well as other colleges and universities, may also want to look to Massachusetts law for guidance about how to further invest in its cybersecurity program.  Massachusetts was an early leader among U.S. states when, in 2007, it enacted the “Regulations to safeguard personal information of commonwealth residents” (Mass. Gen. Laws ch. 93H § 2) (Data Security Law).  The Data Security Law – still among the most prescriptive general data security state law – sets forth a list of minimum requirements that, while not specific to colleges and universities, serves as a good cybersecurity checklist for all organizations:

  1. Designation of one or more employees responsible for the WISP.
  2. Assessments of risks to the security, confidentiality and/or integrity of organizational Information and the effectiveness of the current safeguards for limiting those risks, including ongoing employee and independent contractor training, compliance with the WISP and tools for detecting and preventing security system failures.
  3. Employee security policies relating to protection of organizational Information outside of business premises.
  4. Disciplinary measures for violations of the WISP and related policies.
  5. Access control measures that prevent terminated employees from accessing organizational Information.
  6. Management of service providers that access organizational Information as part of providing services directly to the organization, including retaining service providers capable of protecting organizational Information consistent with the Data Security Regulations and other applicable laws and requiring service providers by contract to implement and maintain appropriate measures to protect organizational Information.
  7. Physical access restrictions for records containing organizational Information and storage of those records in locked facilities, storage areas or containers.
  8. Regular monitoring of the WISP to ensure that it is preventing unauthorized access to or use of organizational Information and upgrading the WISP as necessary to limit risks.
  9. Review the WISP at least annually or more often if business practices that relate to the protection of organizational Information materially change.
  10. Documentation of responsive actions taken in connection with any “breach of security” and mandatory post-incident review of those actions to evaluate the need for changes to business practices relating to protection of organizational Information.

An organization not implementing any of these controls should consider documenting the decision-making process as a defensive measure.  In implementing these requirements and recommendations, colleges and universities can best position themselves to thwart cybercriminals and plaintiffs alike.

Article By Ericka A. Johnson and Julia B. Jacobson of Squire Patton Boggs (US) LLP

For more cybersecurity and data privacy legal news, click here to visit the National Law Review.

© Copyright 2023 Squire Patton Boggs (US) LLP

B.S.ing with Bob Major [PODCAST]

When Bob Major founded Major, Lindsey & Africa in 1982, he could not have envisioned what the organization would become and the impact it would have on the legal profession. In this episode of B.S.: Beyond Stereotypes, Bob shares his journey with Merle Vaughn, including his childhood in Texas and Oklahoma, his Stanford education, and how both influenced his outlook on life personally and professionally.

Bob Major, founder and Partner at Major, Lindsey & Africa, grew up in Texas and Oklahoma. He received his undergraduate degree from Stanford University and attended The University of Texas at Austin where he received a J.D. degree. Bob spent five years at the Washington, D.C., firm of Wilmer, Cutler & Pickering (now WilmerHale) practicing in its federal administrative practice. Prior to founding his own legal recruiting firm, he spent a year in-house as securities counsel at Saga Corporation (Menlo Park, California).

Article By Merle Vaughn of Major Lindsey & Africa

For more law office management legal news, click here to visit the National Law Review.

©2023 Major, Lindsey & Africa, an Allegis Group Company. All rights reserved.

EU Foreign Subsidies Regulation Enters Into Force In 2023

On December 23, 2022, Regulation (EU) 2022/2560 of December 14, 2022 on foreign subsidies distorting the internal market (FSR) was published in the Official Journal of the European Union. The FSR introduces a new regulatory hurdle for M&A transactions in the European Union (EU), in addition to merger control and foreign direct investment screening. The FSR’s impact cannot be overstated as it introduces two mandatory pre-closing filing regimes and it gives the Commission wide-reaching ex officio investigative and intervention powers. Soon, the Commission will also launch a public consultation on a draft implementing regulation that should further detail and clarify a number of concepts and requirements of the FSR.

The bulk of the FSR will apply as of July 12, 2023. Importantly, the notification requirements for M&A transactions and public procurement procedures will apply as of October 12, 2023.

We highlight the key principles of the FSR below and provide guidance to start preparing for the application of the FSR. We refer to our On The Subject article ‘EU Foreign Subsidies Regulation to Impact EU and Cross-Border M&A Antitrust Review Starting in 2023’ of August 2, 2022 for a more detailed discussion of the then draft FSR. We also refer to our December 8, 2022 webinar on the FSR. Given the importance of the FSR, we will continue to report any future developments.

IN DEPTH

FSR in a Nutshell

The FSR tackles ‘foreign subsidies’ granted by non-EU governments to companies active in the EU and which ‘distort the internal market’.

  • First, a ‘foreign subsidy’ will be considered to exist where a direct or indirect financial contribution from a non-EU country or an entity whose actions can be attributed to a non-EU country (public entities or private entities) confers a benefit on an undertaking engaging in an economic activity in the EU internal market, and where that benefit is not generally available under normal market conditions but is, instead, limited, in law or in fact, to assisting one or more undertakings or industries. A ‘financial contribution’ covers a broad spectrum and encompasses, amongst others, positive benefits such as the transfer of funds or liabilities, the foregoing of revenue otherwise due (e.g., tax breaks, the grant of exclusive rights below market conditions, or the provision or purchase of goods or services).

  • Second, a ‘distortion in the internal market’ will be considered to exist in case of a foreign subsidy which is liable to improve the competitive position of an undertaking and which actually or potentially negatively affects competition in the EU internal market. The Regulation provides some guidance on when a foreign subsidy typically would not be a cause for concern:
    – A subsidy that does not exceed EUR 200,000 per third country over any consecutive period of three years is considered de minimis and therefore not distortive;
    – A foreign subsidy that does not exceed EUR 4 million per undertaking over any consecutive period of three years is unlikely to cause distortions; and
    – A foreign subsidy aimed at making good/recovering from the damage caused by natural disasters or exceptional occurrences may be considered not to be distortive.

The FSR looks at ‘undertakings’, as is the case for merger control. Therefore, the Commission will not look merely at the legal entity concerned, but at the entire corporate group to which the entity belongs in order to calculate the total amount of foreign financial contributions granted to the undertaking. Even companies headquartered in the EU that have entities outside of the EU that have received foreign financial contributions are covered by the FSR.

The FSR introduces three tools for the European Commission (Commission): (i) a notification requirement for certain M&A transactions, (ii) a notification requirement for certain public procurement procedures (PPP) and (iii) investigations on a case by case basis.

Notification Requirement for Certain M&A Transactions

M&A transactions (or “concentrations”) involving a buyer and/or a target that has received a foreign financial contribution shall be notifiable if they meet the following cumulative conditions:

  • At least one of the merging undertakings, the acquired undertaking (target, not buyer) or the joint venture is established in the EU and has an EU turnover of at least EUR 500 million, AND

  • The combined aggregate financial contributions provided to the undertakings concerned in the three financial years (combined) prior to notification amounts to more than EUR 50 million.

M&A transactions that meet these criteria will need to be notified and approved by the Commission prior to implementation. During its review, the Commission will determine whether the foreign financial contributions received constitute foreign subsidies in the sense of the FSR and whether these foreign subsidies actually or potentially distort or negatively affect competition in the EU internal market. The Commission likely will consider certain indicators including the amount and nature of the foreign subsidy, the purpose and conditions attached to the foreign subsidy as well as its use in the EU internal market. For example, in a case of an acquisition, if a foreign subsidy covers a substantial part of the purchase price of the target, the Commission may consider it likely to be distortive.

Notification Requirement for Certain Public Procurement Procedures

A notifiable foreign financial contribution in the context of PPP shall be deemed to arise where the following cumulative conditions are met:

  • The estimated value of the public procurement or framework agreement net of VAT amounts to at least EUR 250 million, AND

  • The economic operator was granted aggregate foreign financial contributions in the three financial years prior to notification of at least EUR 4 million from a non-EU country.

Where the procurement is divided into lots, the value of the lot or the aggregate value of all lots for which the undertaking bids for must, in addition to the two criteria set out above, also amount to at least EUR 125 million.

Through this procedure, the Commission will ensure that companies that have received non-EU country subsidies do not submit unduly advantageous bids in public procurement procedures.

During the Commission’s review, all procedural steps may continue except for the award of the contract.

Even if the thresholds are not met, the Regulation requires undertakings to provide to the contracting authority in a declaration attached to the tender a list of all foreign financial contributions received in the last three financial years and to confirm that these are not notifiable, which the contracting authority will subsequently send to the Commission.

Investigations on a Case-by-case Basis

The Commission may on its own initiative investigate potentially distortive foreign subsidies (e.g. following a complaint). These investigations are not limited to M&A transactions or PPP. However, on the basis of this power, the Commission may investigate M&A transactions and awarded contracts under PPP which do not fall within the scope of the notification requirements set out above.

If the Commission carries out an ex-officio review, its analysis will be structured in two phases: a preliminary examination and an in-depth investigation. Although these phases have no time limits, the Commission will endeavor to take a decision within 18 months of the start of the in-depth investigation.

HOW TO PREPARE FOR THE APPLICATION OF THE FSR

Application of the FSR – Timetable

As mentioned above, the FSR will apply as of July 12, 2023. The FSR shall apply to foreign subsidies granted in the five years prior to July 12, 2023 where such foreign subsidies create effects at present, i.e., they distort the internal market after July 12, 2023. By way of derogation, the FSR shall apply to foreign financial contributions granted in the 3 years prior to July 12, 2023 where such foreign financial contributions were granted to an undertaking notifying a concentration or notifying a PPP pursuant to the FSR.

The FSR shall not apply to concentrations for which the agreement was signed before July 12, 2023. The FSR shall also not apply to public procurement contracts that have been awarded or procedures initiated before July 12, 2023.

In general, the FSR shall apply from July 12, 2023 while the notification obligations for M&A transactions and PPP shall only apply from October 12, 2023. However, it is advisable to start preparing immediately for the application of the FSR, given the substantial scope of the regulation.

Actions to Take Now

Businesses which conduct activities in the EU, should put in place a system to monitor and quantify foreign financial contributions received since at least July 2020 – to cover the three-year review – and, preferably, July 2018. In particular, attention should be paid to positive benefits and reliefs from certain costs normally due by the company. External counsel can assist in determining whether these foreign financial contributions constitute a ‘foreign subsidy’.

As soon as a company decides to engage in an M&A or PPP in the EU, the company should map all relevant foreign financial contributions for the relevant time period to check whether the relevant notification thresholds are met. Subsequently companies must carefully consider whether any such financial contribution constitutes a foreign subsidy and, if so, whether such foreign subsidy may have a distortive effect. It is also advisable to determine whether there any positive effects relating to the subsidy that could be invoked. Companies should ensure that the preparation above is ably assisted by external counsel.

In particular with regard to M&A transactions, companies should carry out an FSR analysis in addition to merger control and foreign direct investment reviews. Even at the stage of due diligence, it would already be advisable to check whether the target has received any foreign financial contributions. If the transaction might eventually trigger a notification to the Commission, the M&A agreement should provide for Commission approval in the closing conditions. When acting as a bidder for a target that meets the EU turnover threshold, your bid will be much better viewed when accompanied with clear assurances that no FSR filing is required or, alternatively, that a filing may be required but that the foreign subsidies received are not distortive of competition.

© 2023 McDermott Will & Emery
For more Antitrust Legal News, click here to visit the National Law Review.

Artists Are Selling AI-Generated Images of Mickey Mouse to Provoke a Test Case

Several artists, frustrated with Artificially Intelligent (AI) image generators skirting copyright laws, are using similar image generators to produce images of Mickey Mouse and other copyrighted characters to challenge the current legal status of AI art. While an artist’s copyright in a work typically vests at the moment of fixation, including the right to prosecute copyright violation, AI-generated work complicates the issue by removing humans from the creative process. Courts have ruled that AI cannot hold copyright, which by corollary also means that AI-generated art sits in the public domain. This legal loophole has angered many professional artists whose art is used to train the AI. Many AI generators, such as Dall-E 2 and Midjourney, can render pieces in the style of a human artist, effectively automating the artist’s job.

Given Disney’s reputation for vigorously defending its intellectual property, these artists hope that monetizing these public-domain AI Mickeys on mugs and T-shirts will prompt a lawsuit. Ironically, provoking and losing a case in this vein may set a favorable precedent for the independent artist community. As AI becomes more advanced, society will likely need to address how increasingly intelligent and powerful AI can complicate and undermine existing law.

Blair Robinson also contributed to this article.

For more Intellectual Property Legal News, click here to visit the National Law Review.

Venezuela Program Expanded to Cuba, Haiti, and Nicaragua – 30,000 Per Month for All Countries

The Biden administration has announced the expansion of its Venezuela Parole program to three additional countries – Cuba, Haiti, and Nicaragua. On Jan. 5, 2023, the Department of Homeland Security announced an expansion of its new migration process for Venezuelan nationals. The expansion allows those nationals from Cuba, Haiti, and Nicaragua and their immediate family members to request advance authorization for travel and temporary parole for up to two years in the United States, including work authorization. There will be a 30,000 per month cap on the number of parolees from all four countries.

Parolees must have a supporter in the United States who will provide financial and other support, among other requirements. In order to be eligible for advance travel to the United States to request parole at the border, a person must:

  • Be a national of one of the four countries or be an immediate family member (spouse, common-law partner, or unmarried child under the age of 21) of an eligible applicant and traveling with them;
  • Possess a passport valid for international travel;
  • Be outside the United States;
  • Have a U.S.-based supporter who filed a Form I-134 on their behalf that USCIS has vetted and confirmed;
  • Provide for their own commercial travel to a U.S. airport and final U.S. destination;
  • Undergo and clear required screening and vetting;
  • Not be a permanent resident or dual national of any country other than one of these four countries, and not currently hold refugee status in any country;
    • This requirement does not apply to immediate family members (spouse, common-law partner, or unmarried child under the age of 21) of an eligible national of Venezuela with whom are traveling.
  • Not be an unaccompanied child;
    • Children under the age of 18 must be traveling to the United States in the care and custody of their parent or legal guardian.
  • Not have been ordered removed from the United States within the past five years or be subject to a bar based on a prior removal order;
  • Not have crossed irregularly into the United States, between ports of entry, after Oct. 19, 2022;
  • Not have crossed irregularly into the United States, between ports of entry, after Oct. 19, 2022;
  • Not have unlawfully crossed the Mexican or Panamanian borders after Oct. 19, 2022; and
  • Comply with all additional requirements, including vaccination requirements and other public health guidelines.

When the national arrives at the United States port of entry, there will be additional screening and vetting. If granted parole, it will typically be for two years. Once granted parole, nationals may apply for employment authorization and request a social security number.

©2023 Greenberg Traurig, LLP. All rights reserved.
For more Immigration Law news, click here to visit the National Law Review.

Top Legal News of 2022: A Review of the Most Notable and Newsworthy Thought Leadership from the National Law Review’s Contributors

Happy New Year from the National Law Review! We hope that the holiday season has been restful and rejuvenating for you and your family. Here at the NLR, we are wrapping up the second season of our legal news podcast, Legal News Reach. Check out episode seven here: Creating A Diverse, Equitable and Inclusive Work Environment with Stacey Sublett Halliday of Beveridge & Diamond! A few weeks ago, we also announced the winners of our 2022 Go-To Thought Leadership Awards! Each year, around 75 recipients are selected for their timely and high-quality contributions to the National Law Review. This year’s slate of winners was particularly competitive – to see the full list, check out our 2022 National Law Review Thought Leadership Awards page.

As we look forward to a bright and busy 2023 for the legal industry, it is more prudent than ever to review the previous year and all that came with it. 2022 was a chaotic and monumental year for not only the legal profession, but for the world at large. The invasion of Ukraine, global supply chain issues, and the ongoing coronavirus pandemic were only some of the many challenges all industries and sectors faced. In the United States, companies and employers dealt with enormous changes at every level, including but not limited to the reversal of Roe v. Wade, shifting attitudes toward cannabis legalization, and ever-changing standards for COVID-19 vaccinations.

Read on below for some thought leadership highlights from this past year, and for a reminder of all that we’ve passed through in 2022:

January

Most prominently in 2022, the US Supreme Court handed down substantial rulings for coronavirus vaccine mandates, which affected not only healthcare workers but all employers across the country. With a 6-3 majority, SCOTUS stayed the Biden Administration’s OSHA Emergency Temporary Standard that applied to all private employers, but simultaneously ruled in a 5-4 majority that issued a 5–4 unsigned majority that vaccine mandates for medical facilities and medical workers can remain.

January also saw noteworthy changes to labor law in the United States, inviting a handful of significant standard changes for all employers. At the end of 2021 and early in 2022, the NLRB considered cases that altered the standard for determining independent contractor status, as well as the standard that established whether a facially neutral work rule violates Section 8(a)(1) of the National Labor Relations Act. These changes also paved the way for briefings on determining appropriate bargaining units.

Read January 2022’s thought leadership focusing on Labor and Employment law and the related Supreme Court rulings  below for more information:

Supreme Court Stays Private Vaccine Mandate; Upholds Requirement for Certain Healthcare Workers

On Again, Off Again Vaccine Mandates: What Should Employers Do Now?

NLRB Rings in the New Year by Inviting Briefing on Multiple, Far-Reaching Standards Impacting Employers

February

On February 24, 2022, Russia launched a large-scale ground invasion of Ukraine, leading to considerable damage and loss of life and throwing the geopolitical landscape into chaos. Both in February and in the months since, the Russia-Ukraine war has placed an extraordinary  strain on the global supply chain and businesses around the world, as the European Union, the United Kingdom, and the United States have continued to enforce sanctions and trade regulations. Companies must be careful to comply with these orders as the political landscape continues to change and learn how to juggle the dual headaches of the lingering COVID crisis and evolving Ukrainian war

Domestically, President Biden nominated Ketanji Brown Jackson to the US Supreme Court. Succeeding Justice Stephen Breyer, Judge Jackson graduated magna cum laude from Harvard University in 1992 and cum laude from Harvard Law in 1996 and has since served as a judge on the U.S. Court of Appeals for the District of Columbia Circuit. She is the first African American woman to serve on the United States’ highest court of law.

Read select thought leadership articles below for more information:

President Biden Nominates D.C. Circuit Judge Ketanji Brown Jackson to U.S. Supreme Court

Russian Invasion of Ukraine Triggers Global Sanctions: What Businesses Need to Know

Consequences from the Ukrainian Conflict

March

March of 2022 saw the long term  impacts from the military conflict in Ukraine emerge locally and around the world. Sanctions continued to affect businesses, leading to global supply chain slowdowns and difficulties in manufacturing and shipping and new immigration changes and challenges. In the US, the Securities and Exchange Commission “SEC” issued new and noteworthy regulations regarding Environmental, Social & Corporate Governance “ESG” and climate change disclosures for public companies. The Supreme Court also heard oral argument for a large slate of cases, perhaps most notably in ZF Auto. US v. Luxshare, Ltd. and AlixPartners v. The Fund for Prot. of Inv. Rights in Foreign States, which interpreted provisions of Title 28 of the US Code’s (“Section 1782”) reach in seeking US-style discovery from a interested party to a foreign proceeding and whether or not ection 1782 can be used to obtain key information for private international arbitrations.

Read key thought leadership articles published in March for more details:

SEC Issues Long-Awaited Proposed Rule on Climate Disclosures

U.S. Supreme Court Hears Oral Argument on Circuit Split Over Scope of 28 U.S.C. § 1782 for Obtaining Discovery in International Arbitrations

The Effects of the Military Conflict in Ukraine on Supply Contracts

April

In April of 2022, the Biden Administration made notable changes to the National Environmental Policy Act, better known as NEPA, which had been substantially altered under the Trump Administration. A number of key provisions were returned to their pre-Trump state in order to better center the administration’s larger focus on environmental justice. Also of note, a US court for the first time contested the Center for Disease Control’s  “CDC’s” travel mask mandate, on the grounds that it exceeded the CDC’s Statutory Authority under the Administrative Procedure Act “the federal APA”. This ultimately led to a vacating of the COVID travel mask mandate on a nationwide basis.

Elon Musk announced his intention to purchase Twitter in April of 2022, as well. Twitter ultimately adopted a shareholder rights plan, known as a poison pill, in hopes of preventingMusk’s hostile takeover. Poison pills are widely regarded as the an effective but a draconian anti-takeover defense available.

Read select  thought leadership articles below for more information:

Biden Administration Walks Back Key Trump Era NEPA Regulation Changes

Twitter Board of Directors Adopts a Poison Pill

Administrative Law Takeaways from the Federal Travel Mask Mandate Decision

May

On May 17th, the first case of Monkeypox in the United States was reported in Massachusetts. In response, the Environmental Protection Agency “EPA” and the federal government implemented a number of policy changes in hopes of preventing a wider spread, including the speedy authorization of anti-Monkeypox claims for certain registered pesticides and disinfectant products.

The SEC and administrative law at large received a considerable blow after the Fifth Circuit’s ruling in Jarkesy v. SEC. The Fifth Circuit Court held that the SEC in-house courts violated a series of constitutional protections, which may result in far-reaching impacts for how administrative bodies are used to regulate in the future. Additionally in May, the Senate confirmed Commissioner Alvaro Bedoya for the Federal Trade Commission “FTC”, shifting the balance of power back at the Commission in favor of the Democratic Party.

Read the following highlighted thought leadership articles published in May  for more information:

EPA Authorizes Anti-Monkeypox Claims for Pre-Designated Disinfectant Products

Fifth Circuit Holds That SEC Administrative Law Courts Are Unconstitutional

Big News at The FTC: Democrats Finally Get the Majority Back

June

In June of 2022, the Supreme Court released its decision in Dobbs v. Jackson, reversing Roe v. Wade’s 50-year precedent of ensuring abortion as a  protected right. Dobb’s is a  momentous decision and has resulted in a myriad of complex issues for employers, healthcare providers and individuals, including the updating of employee policies, healthcare provisions, ethical and criminal considerations for healthcare providers and the protection of personal data, and ultimately represents a massive shift away from women’s bodily autonomy in the United States. And the partial advance leak of the Dobb’s ruling, added to the myriad of concerns about the stability and public perception of the Supreme Court.

Other notable litigation and legislation in June included the passing of the Uyghur Forced Labor Prevention Act, subjecting the importers of raw materials from China to new enforcement provisions. The Supreme Court also ruled in West Virginia v. EPA, limiting the SEC’s ability to enforce ESG requirements on public companies. The West Virginia v. EPA ruling  presents a considerable obstacle for the Biden Administration’s ongoing climate goals.

Read select legal news  articles below for more information:

Employment Law This Week: SCOTUS Overturns Roe v. Wade – What Employers Should Consider [VIDEO]

Uyghur Forced Labor Prevention Act Enforcement Starts on Imports from China and on Imports with China Origin Inputs

Implications of West Virginia v. EPA on Proposed SEC Climate Rules

July

July of 2022 saw a great deal of changes for the Equal Opportunity Commission’s “EEOC’s” COVID testing guidance for employers. The largest change is determining if testing is needed to prevent workplace transmission and interpreting the business necessity standard under the American with Disabilities Act “ADA”.. The labor law landscape around the country also saw an increased focus on pay transparency laws – most notably, New York state passed a bill requiring employers to post salary or wage ranges on all job listings. Notably, this law is quite similar to one already in effect in New York City and Washington state, Colorado, and Jersey City.

Beginning most prominently in July, the cryptocurrency world also found itself under increased scrutiny by the federal government. Of note this month, the SEC filed a complaint against certain Coinbase employees, alleging insider trading and claiming that these employees had tipped off others regarding Coinbase’s listing announcements. This move was one of the more aggressive moves made by the SEC toward the digital asset industry.

Read select legal thought leadership articles published in July for more information:

EEOC Revises COVID-19 Testing Guidance for Employers

SEC v. Wahi: An Enforcement Action that Could Impact the Broader Crypto / Digital Assets Industry

Pay Transparency Laws Are All The Rage: Looks Like New York State Is Joining the Party

August

On August 12, 2022, the Inflation Reduction Act (“IRA”) was passed by Congress, representing enormous changes for industries across the country. Perhaps most notably, the landmark legislation contained new government incentives for the clean energy sector, creating tax incentives for renewable energy projects that previously did not exist. The Act also included 15% alternative minimum corporate tax and a 1% excise tax on stock buybacks to raise government revenue.

The Inflation Reduction Act also provided significant funding for tribal communities, including but not limited to the reduction of drug prices, the lowering of energy costs, and additional federal infrastructure investments. While the funding is not as significant as COVID relief from previous years and there are still some remaining hurdles, the IRA provides groundbreaking new opportunities for Native communities, including those in Alaska and Hawaii.

Read the select legal articles published in August for more information:

The Inflation Reduction Act: How Do Tribal Communities Benefit?

The Inflation Reduction Act: A Tax Overview

Relief Arrives for Renewable Energy Industry – Inflation Reduction Act of 202

September

In September of 2022, Hurricane Ian made landfall in the United States, caused substaintial property damage and loss of life despite preparations ahead of time. After addressing safety concerns, policyholders began reviewing their insurance policies, collecting documentation and filing claims. In addition to filing claims for property damage, corporate policyholders also filed claims for business interruption and loss of business income.

Lawsuits opposing the remaining COVID-19 vaccine mandates also continued throughout the month of September, exceeding 1,000 complaints nationally. Previously, lawsuits had largely targeted the Biden Administration, but additional focus was also directed toward large employers with vaccine mandates.

Of global significance, Queen Elizabeth II, the UK’s longest reigning monarch, passed away at 96 years old. Her funeral was held September 19, 2022, and was a national holiday in the United Kingdom marking the last day of public mourning.

Read following key thought leadership articles on Hurrican Ian, UK Bank Holiday due to the Sovereign’s passing and Employer’s COVID Mandate headaches  for more information:

Hurricane Ian – Navigating Insurance Coverage

Bank Holiday Announced for Her Majesty Queen Elizabeth II’s State Funeral

Challenges Against Employer COVID-19 Vaccine Mandates Show No Sign of Slowing

October

October saw forward movement in environmental justice, cannabis decriminalization, and Artificial Intelligence  “AI” regulation. The EPA launched their new Office of Environmental Justice and External Civil Rights, to work with state, local, and tribal partners providing financial and technical support to underserved communities disproportionately impacted by the ill effects of climate change. The EPA’s new office has 200 staff members across 10 regions and is expected to provide a unifying focus on civil rights and environmental justice for the EPA and federal government as a whole.

President Biden’s pardon of federal marijuana charges and mandate to review the plant’s Schedule I status signaled a shift in cannabis regulation, with the president urging state officials to follow his example and consider the contrast between wealthy cannabis business owners and those imprisoned for possession in the recent past.

Later in the month, the White House Office of Science and Technology Policy addressed the swell of artificial intelligence technology with their Blueprint for an AI Bill of Rights, which provides guidelines to prevent privacy violations, implicit bias, and other forms of foreseeable harm.

Read selected thought leadership articles below for more information:

EPA Launches Their New Office: What Does the Office of Environmental Justice and External Civil Rights Mean for Companies and ESG in the United States?

“Up in Smoke?” President Biden Announces Pardons and Orders Review of Cannabis Classification

The White House’s AI Bill of Rights: Not for the Robots

November

November was dominated by a nail-biting midterm election season, a cryptocurrency catastrophe, and NDA (Non Disclosure Agreement) reform. While the midterms did not result in a Red Wave as expected, Republicans were able to regain a small majority in the House of Representatives, with the Senate remaining in Democratic control.

The digital finance world was considerably less stable, with the second largest cryptocurrency trading platform, FTX, filing for bankruptcy three days after its lawyers and compliance staff abruptly resigned. The collapse brought into stark relief the importance of solidifying the cryptocurrency custody and insurance landscape.

Also of note, President Biden signed the Speak Out Act, rendering unenforceable nondisclosure and nondisparagement agreements signed prior to incidents of sexual harassment or assault. The law’s passage offers employers the opportunity to review their states’ more robust laws in this area and ensure clauses meant to protect trade secrets and proprietary information don’t inadvertently create issues for sexual misconduct claimants.

Read select  thought leadership articles below fora deeper dive:

2022 Midterm Election Guide

The Spectacular Fall of FTX: Considerations about Crypto Custody and Insurance

Nondisclosure and Nondisparagement Agreements in Sexual Harassment and Assault Cases: Speak Out Act Heads to President’s Desk

December

In December, the Federal Trade Commission (FTC) released their hotly anticipated “Green Guides” amendment proposals, intended to combat greenwashing amidst growing demand for environmentally friendly products. The amended Guides for the Use of Environmental Marketing Claims would impose stricter standards for the use of terms such as “recyclable,” “compostable,” “organic,” and “sustainable” in advertising and on packaging.

Meanwhile, Congress narrowly avoided a railroad worker strike by passing Railway Labor Act legislation affirming all tentative agreements between rail carriers and unions. The contracts included a roughly 24% increase in wages over 4-5 years, along with an extra day of leave. Biden promised to address paid leave further in the near future.

The National Labor Relations Board (NLRB) closed out 2022 with a number of impactful decisions favoring workers. Employees have expanded remedies for National Labor Relations Act violations and protection during Section 7 questioning, while employers have the burden of proof when seeking to expand micro-units or deny union protestors.

Read select legal thought leadership pieces below for more details:

Congress Votes to Impose Bargaining Agreement to Avoid Nationwide Railroad Strike

FTC Starts Long-Awaited Green Guides Review

NLRB Issues Flurry of Blockbuster End-of-Year Decisions (With More to Come?) (US)

Thank you to our dedicated readers and as always to our highly regarded contributing authors and our talented NLR editorial staff for working day in and day out to produce one of the most well read and reputable business law publications in the US.  Have a happy 2023!

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