Category: Administrative & Regulatory

EEOC Announces Enforcement Priorities for 2023-2027

On Tuesday January 10, 2023, the Equal Employment Opportunity Commission (“EEOC”) publicly released its Draft Strategic Enforcement Plan (“SEP”) for fiscal years 2023-2027. The SEP describes the EEOC’s top enforcement priorities, making it critical information for employers around the country.

The Draft SEP sets out the EEOC’s six subject matter priorities for fiscal years 2023-2027:

  1. Eliminating Barriers in Recruitment and Hiring;

  2. Protecting Vulnerable Workers and Persons From Underserved Communities From Employment Discrimination;

  3. Addressing Emerging and Developing Issues;

  4. Enforcing Equal Pay Laws;

  5. Preserving Access to the Legal System; and

  6. Preventing Harassment Through Systemic Enforcement and Targeted Outreach.

With respect to the first category, “Eliminating Barriers in Recruitment and Hiring,” the Draft SEP states the EEOC will focus on “the use of automatic systems, including artificial intelligence or machine learning, to target advertisements, recruit applicants, or make or assist in hiring decisions where such systems intentionally exclude or adversely impact protected groups.” The Draft SEP also expressly emphasizes the “lack of diversity” in both the construction and tech industries, noting the EEOC’s priority will typically involve systemic cases, though claims by an individual or small group may qualify for enforcement focus if it raises a policy, practice, or pattern of discrimination. Employers should note the EEOC’s decision to focus on AI and the tech industry demonstrates a heightened priority on remedying and preventing discrimination from automated and electronic screening tools used in hiring practices and employment decisions.

On January 31, 2023, the EEOC held a public hearing titled “Navigating Employment Discrimination in AI and Automated Systems: A New Civil Rights Frontier” where higher education professors, nonprofit organization representatives, attorneys, and workforce consultants prepared statements regarding the EEOC’s new focus.

The Draft SEP includes specific details regarding the types of hiring practices and policies that the agency seeks to scrutinize. For example, the EEOC aims to prevent employers from isolating and separating workers in certain jobs or job duties based on membership in a protected class. The EEOC plans to achieve this goal by identifying vulnerable workers for more focused attention. In addition, the EEOC will scrutinize practices which limit access to work opportunities, such as (1) job postings which either exclude or discourage some protected groups from applying, and (2) denying training, internships, or apprenticeships based on protected status. The Draft SEP also prioritizes preventing employers from denying opportunities to move from temporary to permanent roles.

As for the second category, “Protecting Vulnerable Workers and Persons From Underserved Communities From Employment Discrimination,” the Draft SEP expands the ”vulnerable worker priority” to include categories of workers who, according to the EEOC, “may be unaware of their rights . . . or reluctant or unable to exercise their legally protected rights.” These categories include workers with intellectual and developmental disabilities, individuals with arrest or conviction records, LGBTQI+ individuals, pregnant workers, individuals with pregnancy-related medical conditions, temporary workers, older workers, individuals employed in low-wage jobs, and persons with limited literacy or English proficiency. The Draft SEP proposes that district EEOC offices and the agency’s federal sector program will identify vulnerable workers and underserved communities in their districts or within the federal sector for focused attention. Employers should be aware that the “vulnerable workers” focused on under this category may vary based on location.

The Draft SEP’s third category, “Addressing Emerging and Developing Issues,” includes a focus on (1) qualification standards and inflexible policies or practices that discriminate against individuals with disabilities, (2) protecting individuals affected by pregnancy, childbirth, and related medical conditions under the Pregnancy Discrimination Act, the Americans with Disabilities Act, and the newly enacted Pregnant Workers Fairness Act, (3) employment issues relating to backlash in response to local, national, or global events, and (4) “employment discrimination associated with the COVID-19 pandemic.” The priorities for the EEOC’s COVID-19-related enforcement in this category include:

  • pandemic related harassment, particularly against individuals of Asian descent;

  • unlawful denials of accommodations to individuals with disabilities;

  • unlawful medical inquiries, improper direct threat determinations, or other discrimination related to disabilities that arose during or were exacerbated by the pandemic; and

  • discrimination against persons who have an actual disability or are regarded as having a disability related to COVID–19, including individuals with long COVID, and pandemic-related caregiver discrimination based on a protected characteristic

With respect to the fourth category, “Enforcing Equal Pay Laws,” the Draft SEP sets out a focus on pay discrimination based on any protected category. The Draft SEP also states the EEOC may use “Commissioner Charges and directed investigations” to enforce equal pay. Notably, the EEOC has been hesitant to use Commissioner Charges in the past, as they comprise of less than 1% of annual charge volume since 2015. However, Commissioner Charges may become necessary to identify and remedy discrimination based on artificial intelligence or machine learning, as outlined in the first category.

The fifth and sixth categories remain largely unchanged from prior EEOC SEPs. The focus for the fifth category, preserving access to the legal system, will continue to identify and target (1) overly broad waivers, releases, non-disclosure and non-disparagement agreements; (2) improper mandatory arbitration provisions; (3) employers failure to keep proper records; and (4) improper retaliatory practices. As for the final category, the EEOC will continue to focus on promoting comprehensive anti-harassment programs and practices.

The EEOC will vote on a final version of the SEP following the public notice and comment period, which concludes on February 9, 2023.

Article By Dan Syed of Sheppard, Mullin, Richter & Hampton LLP

For more labor and employment legal news, click here to visit the National Law Review.

Copyright © 2023, Sheppard Mullin Richter & Hampton LLP.

DHS Guidelines Give Protection from Deportation to Undocumented Workers Who Report Labor Violations

If an employer hires undocumented workers, are they covered under the U.S. employment laws? Initially, employers must complete Form I-9s for all new employees and cannot hire workers who are unable to establish that they’re authorized to work. But once hired, the script flips and undocumented workers generally enjoy the same legal protections as the rest of the workforce (e.g., Title VII, FLSA, etc.). Undocumented workers, however, are often reluctant to make complaints to or cooperate in investigations with the EEOC, the Department of Labor, or other labor agencies, even when they have a legitimate beef with their employer. Why? It may be at least in part because they fear that they’ll be hauled into immigration court and deported. But now, the Biden administration has given those workers a possible safety valve.

Last month, the Department of Homeland Security released guidelines providing a process for undocumented workers to seek deferred action from removal (deportation) when they report a violation to a labor agency or cooperate in an agency investigation. In some circumstances, the individuals who utilize this process may also be eligible for temporary work authorization. Although each request for deferred action will be decided on a case-by-case basis, it’s clear that the purpose of this new process is to encourage undocumented workers to report labor violations and assist with agency investigations.

How Does the Process Work?

The U.S. Citizenship and Immigration Services (USCIS) will manage the process using a centralized intake system. If an undocumented worker makes a complaint to the EEOC, the DOL, or other labor agency, or assists the agency with an investigation, that worker can request deferred action from removal by submitting certain required documents. Among other things, the worker must submit his or her own statement setting forth the basis for the request, as well as a supporting “statement of interest” from the involved labor agency. According to the guidelines, the agency’s “statement of interest” should provide details about the nature of its investigation, how the worker may be helpful to that investigation, and how granting the worker’s request for deferred action would support the agency’s enforcement interests.

If the worker is already in removal proceedings or subject to an order of removal, the request for deferred action will be forwarded to ICE for determination. Otherwise, USCIS will adjudicate the request. Either way, USCIS or ICE will exercise its discretion on a case-by-case basis. In certain cases, the interested agency may also ask that the worker’s request be adjudicated on an expedited basis.

If an undocumented worker’s request is approved, the grant of deferred action will normally be good for two years, although it is subject to termination at any time. When submitting the request, the worker may also apply for temporary employment authorization on USCIS Form I-765. Approved applications for employment authorization, while not guaranteed, will typically allow the individual to work for the entire period of deferred action. Subsequent requests to extend the worker’s deferred action can be made if the labor agency continues to have an investigative or enforcement interest in the worker’s matter.

What’s the Practical Impact?

This is less clear. Will undocumented workers take advantage of this new process in significant numbers? The guidelines offer some potential protection, but the approval of an individual worker’s request is not automatic and, even if approved, the grant of deferred action is temporary.  Notably, the guidelines do not provide any long-term path to lawful status. And, because the guidelines have been issued without Congressional or regulatory action, they are subject both to being challenged in the courts and to being revoked in two years if there’s a change in the White House. Will undocumented workers feel comfortable using this process in the face of all this uncertainty? Stay tuned.

Article By Keith Covington and Anne R. Yuengert of Bradley Arant Boult Cummings LLP

For more immigration legal news, click here to visit the National Law Review.
© 2023 Bradley Arant Boult Cummings LLP

10 Tips When Hiring a Federal Appeals Lawyer

When hiring a federal appeals attorney, it is important not to take your decision lightly. There is a good chance that the outcome of your appeal will have a major impact on your life or business—whether positive or negative—and your choice of counsel will have a major impact on your chances of success.

For many people, their first instinct is to engage their trial counsel for their appeal. On its face, this makes sense. Trial counsel is already intimately familiar with the facts of your case, and trial counsel is—or should be—well aware of the grounds that are available for seeking relief at the appellate level.

But, while trial counsel can be a good option in some cases, defendants should not engage their trial counsel by default. There are many circumstances in which hiring trial counsel to continue forward with an appeal will not be the right choice. There are several factors to consider, and considering all of these factors is essential for making an informed decision.

“Some lawyers are better equipped to handle federal criminal appeals than others. This is not a slight toward lawyers who don’t handle federal appeals, but rather simply an acknowledgment that federal appeals are a unique practice area just like white collar criminal defense, healthcare fraud defense, or defending against allegations of serious violent crimes. If you need to appeal the outcome of your federal criminal case, it is imperative that you choose a lawyer who has been there many times before.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

Due to the unique challenges involved in successfully pursuing a federal criminal appeal, the considerations involved in choosing a federal appeals attorney are not the same as those involved in choosing trial counsel for a federal criminal case. This is important to keep in mind, and understanding the unique nature of the federal appeals process will help you make an informed choice about your appellate representation.

How To Choose Appellate Counsel for a Federal Criminal Appeal

So, how should you choose appellate counsel for your federal criminal appeal? Here are 10 tips to keep in mind when hiring a federal appeals lawyer:

1. Understand that an Appeal is Not a Re-Trial

The first thing to understand that will help you make an informed decision about your choice of appellate counsel is that an appeal is not a re-trial. As a result, being an effective trial lawyer does not necessarily translate to having the skills needed to provide effective representation at the appellate level. The federal trial and appellate processes are very different, and many of the arguments and strategies that work at trial are completely irrelevant to the process of seeking relief from an unjust conviction or sentence on appeal.

For example, while providing effective trial representation requires the ability to effectively question witnesses and argue the facts to the jury, providing effective appellate representation requires persuasive writing abilities and the ability to effectively argue the law to a panel of judges who aren’t necessarily focused on the defendant’s guilt or innocence. On appeal, the focus is instead on determining whether errors at the trial level entitle the defendant to the opportunity to pursue a different outcome.

2. Focus on Hiring a Lawyer with Significant Federal Appellate Experience

Given the unique nature of the federal appeals process, relevant experience is undoubtedly the most important factor to consider when choosing a lawyer to represent you. This means experience handling federal criminal appeals in cases similar to yours—and ideally experience handling federal criminal appeals in the U.S. Circuit Court of Appeals that will hear your case. Although, this latter consideration is definitely the less important of the two. While each U.S. Circuit Court of Appeals has its own rules of practice, it is far easier to adapt to a new set of procedural rules than it is to get up to speed on the substantive issues involved in a complex federal case.

3. Carefully Consider Whether Your Trial Counsel is Your Best Option

As we touched on above, continuing to work with your trial counsel for your federal criminal appeal may or may not be your best option. As a baseline, you should only consider engaging your trial counsel for your appeal if he or she has extensive experience in federal appellate practice. While some lawyers handle trials and appeals, many devote their careers to handling one type of case or the other.

Even if your trial counsel also has significant experience, you will still want to weigh other factors as well. How effective was your trial representation? Do you have any concerns about whether your trial counsel was able to effectively preserve your grounds for appeal? Does your attorney have other major trials in the pipeline? These are all important questions to consider when making your decision.

4. Expand Your Search

When choosing a federal appeals attorney, you don’t necessarily have to stay local—and, in fact, staying local might not be your best option either. There are federal appeals lawyers who handle cases throughout the country; and, depending on where you live or your business is located, your local options may be fairly limited. You can (and should) expand your search to law firms with a nationwide presence, and you can (and should) choose a lawyer based on relevant experience rather than geographic proximity.

5. Schedule a Consultation to Discuss Your Appeal

Whether you are considering your trial counsel or you are looking elsewhere for your appellate representation, you should schedule a consultation to discuss your appeal. Before you invest in an appeal, you need to make sure it makes sense to move forward. Scheduling a consultation also gives you the opportunity to speak with a lawyer one-on-one and decide whether he or she seems like the right choice to handle your case on appeal.

6. Do Some Legwork Yourself

In addition to scheduling a consultation, you can also do some legwork to help you make an informed decision—and to help yourself and your lawyer begin preparing for your appeal. When it comes to choosing a federal appeals lawyer, this includes taking steps such as:

  • Visiting the lawyer’s website and reading about his or her experience

  • Reading client reviews and testimonials online

  • Preparing a list of questions to ask during your initial consultation

When it comes to preparing for your appeal, some of the steps you can take to prepare in advance of your initial appellate consultation include:

  • Taking notes about any potential grounds for appeal that you have discussed with your trial counsel

  • Taking notes about any other specific issues during your trial that you think may have led to an unjust result

  • Familiarizing yourself with the unique aspects of federal appellate practice

7. Do Not Fall for a Sales Pitch

While a lawyer should only be willing to take your case if he or she is capable of representing you effectively, you still need to be careful to avoid falling for a sales pitch. Unfortunately, if you schedule a consultation with a lawyer who isn’t the right choice to handle your case, there is a possibility that he or she may still try to convince you otherwise. While these instances are relatively rare, they do happen. If you feel like a lawyer is pressuring you to move forward with an engagement, this is most likely a sign that you should choose someone else for your federal criminal appeal.

8. Schedule Another Consultation if Necessary

This brings us to another important point: If you schedule a consultation with a lawyer and you are not confident in the lawyer’s ability to handle your appeal effectively for any reason, you should not hesitate to schedule another consultation at another firm.

9. Make Your Decision Carefully

If it is not already abundantly clear, when hiring a federal appeals attorney, you need to make your decision carefully. You should not rush, and you should not make your decision out of convenience or the desire to avoid putting in effort. Your effort to find the right lawyer for your appeal will be well worth it. Whether you are facing a conviction as an individual or your business has been convicted of corporate fraud or any other crime, you need to have unwavering confidence in your counsel’s ability to provide strategic and efficient appellate representation. The more effort you put into choosing the right lawyer, the more confidence you will have in your decision.

10. Make Your Decision Promptly

Finally, while it is important not to rush your decision, you still need to make your decision promptly. Under the Federal Rules of Appellate Procedure, you only have 14 days to file a Notice of Appeal. While a Notice of Appeal is a simple form filing, you cannot afford to risk any mistakes or delays. So, whether it has been hours or days since the trial court’s decision, finding the right federal appeals lawyer to represent you (or your business) needs to be your top priority.

Article By Dr. Nick Oberheiden of Oberheiden P.C.

For more litigation legal news, click here to visit the National Law Review.

Oberheiden P.C. © 2023

Employment-Based Immigration Updates for 2023

As we move deeper into the new year, the U.S. government continues to try to resolve the challenges facing the immigration system due to the disruptions of the COVID-19 pandemic and the resulting processing backlogs. These challenges may still continue, but new changes and updates have already taken effect—and more will likely come in 2023, impacting employers and the decisions they make with regard to their foreign national employees. Below are several updates the U.S. government has already released that impact employment-based immigration processes.

USCIS Proposed Fee Increases

On January 4, 2023, U.S. Citizenship and Immigration Services (USCIS) proposed changes to its fees for certain types of cases. The changes to the fees are dramatic increases to some employment-based visa types and are in an effort to make up for funding shortages that have impacted USCIS. Proposed filing fee increases for the following employment-based visa types include:

  • H-1B: $460 to $780
  • H-1B registration fee: $10 to $215
  • L-1: $460 to $1,385
  • O-1: $460 to $1,055
  • Adjustment of Status Application (I-485): $1,225 to $2,820

As we previously reported, the proposed rule—which is in the public comment phase—also includes a change to the existing premium processing timeline. The timeline would increase from fifteen calendar days to fifteen business days.

Continued Expansion of Premium Processing

On May 24, 2022, USCIS implemented a phased approach to expanded premium processing service. In 2022, premium processing was expanded to I-140 petitions, and on January 30, 2023, premium processing will be available to all EB-1C multinational executive and manager and EB-2 National Interest Waiver petitions. The January 30 expansion will include new filings as well as upgrades on pending petitions.

USCIS’s next phase of premium processing expansion will apply to the following applications:

  • Form I-539, Application to Extend/Change Nonimmigrant Status
  • Form I-765, Application for Employment Authorization

Foreign National Employees and RIFs

With changes in the U.S. economy and world markets, employers may start conducting reductions in force (RIF) to adjust to new budget goals. RIFs have the potential to impact foreign national employees. As we discussed in a recent podcast, employers may want to consider the potential impact of restructurings on workers who are in nonimmigrant status, those who are in the permanent residency process, and students working in F-1 status.

Equal Pay Transparency Laws

An increasing number of states and local jurisdictions—such as California, Colorado, Connecticut, New York State, New York City, Rhode Island, and Washington—have implemented equal pay transparency (EPT) laws that now require employers to make additional disclosures regarding offered salaries and/or benefits on job requisitions and postings. This will have a significant impact on the PERM process for green card applications in these jurisdictions by mandating employers list a salary or salary range on PERM and non-PERM recruitment materials. EPT laws vary across jurisdictions as to which types of postings or recruitment efforts will require additional information.

Nonimmigrant Visa Interview Waivers Extended Until December 31, 2023

In an effort to reduce visa wait times and processing backlogs at U.S. consulates, the U.S. Department of State has extended the authority of consular officers to waive in-person interviews for certain nonimmigrant categories through December 31, 2023.

Fiscal Year 2024 H-1B Cap Preparation

With the annual H-1B lottery just two months away, employers may want to consider the foreign national employees they plan to sponsor and enter into this year’s upcoming H-1B cap or quota process. The process will start with the initial registration period, which typically opens at the beginning of March and lasts for a minimum of fourteen calendar days each fiscal year (FY). USCIS will soon announce details about the FY 2024 H-1B registration period. If enough registrations are submitted, USCIS will conduct a random selection of the registration entries to determine who will be eligible to file H-1B petitions. If selected, the employers will have ninety days to file the H-1B petitions, starting April 1. So far, there have not been any changes in this process for this upcoming cycle.

Article By Awanti A. Damle of Ogletree, Deakins, Nash, Smoak & Stewart, P.C.

For more immigration legal news, click here to visit the National Law Review.

© 2023, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.

Washington’s Focus on the Electric Vehicle Supply Chain in 2023

If a picture is worth a thousand words, the “photo-op” of the president test driving Ford’s new electric F-150 in May of 2021 was the burning image that foretold the US policy direction for the electric mobility industry.

In 2022, the president and US Congress solidified their support of the industry by passing sweeping legislation aimed at funding and incentivizing US electric mobility manufacturing for the next decade and beyond.

Looking ahead to 2023, the Administration will be writing the rules to implement that support. This will take the form of rulemaking for key statutes such as the Infrastructure Investment and Jobs Act (IIJA), the CHIPS Act, and the more recent Inflation Reduction Act of 2022 (IRA). On the non-tariff front, Congress passed, and the president signed, the 2021 Uyghur Forced Labor Prevention Act.

Background

  • The IIJA authorized $18.6 billion to fund new and existing electric vehicle (EV)-related programs, including a nationwide network of 500,000 EV charging stations and monies for publicly accessible alternative fuel infrastructure. Also, the law injected $10.9 billion in funding for transitioning school buses, transit buses, and passenger ferries to low- and/or zero-emissions alternatives.
  • The CHIPS Act allocated $11 billion in support of advanced semiconductor manufacturing research and set up a $2 billion fund to support technology transfers from laboratory to applications.
  • The IRA, perhaps the most significant development from Washington, DC, injected billions of dollars in tax credits and other incentives to spur US domestic manufacturing of electric vehicles.
  • In December 2022, news came that a United States-Mexico-Canada Agreement (USMCA) Dispute Settlement Panel had completed its findings on a complaint by Mexico and supported by Canada that the United States has been misinterpreting the product origin calculations for “core parts” for USMCA vehicle qualification. In January of 2023, that ruling was made public. See Long Awaited USMCA Panel Decision on Automotive “Core Parts” – What Happened and What’s Next.
  • In June 2022, the Administration published its “Strategy to Prevent the Importation of Goods Mined, Produced, or Manufacture with Forced Labor.” Customs and Border Protection (CBP) has launched a vigorous and highly intrusive enforcement strategy for a number of key sectors, including the automotive industry.

What to Know

Based on the legislative developments from the last year, the EV industry should expect:

  • Import Enforcement. If 2022 was the year of federal infusion of funding and policy development, 2023 will be the year of import enforcement and accountability. Supply chains will be scrutinized, and compliance will have to be demonstrated. In addition, claims of tariff preferences under US trade agreements will be closely monitored to guard against fraudulent product descriptions or county of origin. In terms of US forced labor legislation, a January 2023 article in a well-read trade media reported on a meeting with US Trade Representative Katherine Tai at which the Ambassador “suggested that auto or auto parts imported from China could be in CBP crosshairs.” (International Trade Today, January 6, 2023 Vol 39, No 4).
  • Accountability. With the massive funding from Congress and the White House, federal agencies will be scrutinizing how monies have been spent, particularly whether they have been spent to meet the goals to incentive US domestic production. Global supply chains will come under the microscope. A December 2022 Treasury Department publication can be read here.
  • Corporate Readiness. Companies that engage in the global marketplace dread the unknown. There is no crystal ball. But what corporate executives can do to mitigate the risk of potentially bad news on the trade front is to monitor developments, conduct self-assessments, and, where possible, build in flexibilities.
  • Know Your Customer. Know Your Suppliers. Know Your Suppliers’ Suppliers. A common thread weaving throughout these developments on the trade front is Washington’s not so subtle objective of determining the essential source of imported products. That effort will shift the onus onto the private sector, with companies having to provide far more transparency into their product’s life span.

For product development and marketing executives in the electric mobility sector, 2023 is potentially a very good news story. But for general counsels and corporate compliance and procurement officers, the uncertainties of regulatory change will require extra attention. In the interim, company officials are taking a fresh look at the current legal and regulatory exposures of their supply chains to be best prepared for the trade policy changes ahead. The adage “when in uncertain times, start with what you know” is particularly relevant today.

To that end, the USMCA can play a critical “bridge” for many companies with strategic business interests in the US market.

Article By Birgit Matthiesen, David R. Hamill, Antonio J. Rivera, and James Kim of ArentFox Schiff LLP

For more utilities and transportation legal news, click here to visit the National Law Review.

© 2023 ArentFox Schiff LLP

USDA Finalizes the Strengthening Organic Enforcement Rule

  • USDA’s Agricultural Marketing Service (AMS) administers the National Organic Program (NOP) as authorized by the Organic Foods Production Act of 1990 (OFPA).  The USDA organic regulations, which were published on December 21, 2000, and became effective on October 21, 2002, govern the production, handling, labeling, and sale of organically produced agricultural products.  On August 5, 2020, in response to mandates in the Agriculture Improvement Act of 2018, as well as pressure from the industry and recommendations from the National Organic Standards Board (NOSB), USDA published a proposed rule called Strengthening Organic Enforcement (SOE) that is aimed at preventing loss of organic integrity—through unintentional mishandling of organic products and intentional fraud meant to deceive—and strengthening trust in the USDA organic label.
  • On January 19, 2023, USDA published the SOE final rule.  The final rule includes clarifications and additional examples in response to comments received on the SOE proposed rule.  Key updates include:
    • Requiring certification of more businesses, like brokers and traders, at critical links in organic supply chains;
    • Requiring NOP Import Certificates for all organic imports;
    • Requiring organic identification on nonretail containers;
    • Increasing authority for more rigorous on-site inspections of certified operations;
    • Requiring uniform qualification and training standards for organic inspectors and certifying agent personnel;
    • Requiring standardized certificates of organic operation;
    • Requiring additional and more frequent reporting of data on certified operations;
    • Creating authority for more robust recordkeeping, traceability practices, and fraud prevention procedures; and
    • Specifying certification requirements for producer groups.
  • The compliance date for the SOE final rule is March 19, 2024, or 12 months after the effective date of March 19, 2023.

Article By Food and Drug Law Practice Group at Keller and Heckman

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

© 2023 Keller and Heckman LLP

Beltway Buzz, January 20, 2023

Union Membership Decreases. The percentage of workers who are union members dropped to 10.1 percent in 2022 from 10.3 percent in 2021, according to data released this week by the U.S. Bureau of Labor Statistics (BLS). In the private sector, the unionization rate fell to 6 percent last year from 6.1 percent in 2021. According to BLS:

The 2022 unionization rate (10.1 percent) is the lowest on record. In 1983, the first year where comparable union data are available, the union membership rate was 20.1 percent and there were 17.7 million union workers.

Thus, despite some splashy headlines and a few high-profile examples, the great majority of employees continue to reject unionization. Expect labor unions and their allies in Washington, D.C., to spin these numbers as a reason to double down on efforts to tilt the labor policy field in favor of labor unions.

D.C. Circuit Issues Ruling on NLRB 2019 Election Regs. This week, the U.S. Court of Appeals for the District of Columbia Circuit issued a decision relating to five specific provisions of the National Labor Relations Board’s (NLRB) 2019 changes to its regulations governing union elections. In a May 2020 decision, the U.S. District Court for the District of Columbia (in an opinion by then-judge Ketanji Brown Jackson) invalidated the five provisions as contrary to the Administrative Procedure Act because the NLRB did not seek public comment on the changes. (The Board argued that the changes were procedural, not substantive, in nature and that public comment was not necessary.) In this week’s decision, the D.C. Circuit agreed that the district court was correct in invalidating three provisions: “the rules regarding the eligible employee-voters list, the timeline for certification of election results, and election-observer eligibility.” However, the D.C. Circuit ruled that the two remaining provisions—regarding pre-election litigation of voter eligibility and the timing of the date of an election—are “‘internal house-keeping’ rules” that are exempt from notice and comment requirements.

House Republicans Seek Information From Federal Agencies. Representative Virginia Foxx (R-NC) is wasting no time exercising her authority as chair of the House Committee on Education and the Workforce. Late last week, Foxx resent to federal labor agencies a series of previous information requests that were answered while Republicans were in the House minority in 2021 and 2022. The requests include the following:

  • Letters to Secretary of Labor Martin Walsh regarding, among other issues, his involvement in various high-profile labor disputes; documents and communications relating to the development and implementation of the Occupational Safety and Health Administration’s (OSHA) 2021 vaccine-or-test emergency temporary standard; and information surrounding the February 2022 report offered by the Task Force on Worker Organizing and Empowerment, such as attendance lists, meeting minutes, rejected policy proposals, involvement of outside organizations.
  • A letter to National Labor Relations Board (NLRB) General Counsel Jennifer Abruzzo regarding her April 2022 memorandum relating to employer speech. Specifically, the letter asks for information about the possible involvement of outside organizations, other agencies, and the White House, in the drafting of the memo.
  • A letter to NLRB Chair Lauren McFerran inquiring about potential conflicts of interest that Member Gwynne Wilcox and Member David Prouty may have regarding the Board’s joint employer policy.

The Buzz suspects that these letters are just the first examples of what will be at least two years of aggressive agency oversight by the committee.

DHS Announces Deferred Action for Workers Involved in Labor Investigations. Late last week, the U.S. Department of Homeland Security (DHS) announced a new streamlined and expedited process for undocumented workers seeking deferred action as a result of their cooperation in investigations into potential violations of labor laws. The new policy further implements provisions of DHS’s October 2021 memorandum, “Worksite Enforcement: The Strategy to Protect the American Labor Market, the Conditions of the American Worksite, and the Dignity of the Individual.” According to the announcement, DHS will “provid[e] new guidance to labor agencies regarding processes to seek deferred action for certain workers” and will create a “single intake point for deferred action requests from noncitizen workers.” As such, “[t]he centralized intake process will allow DHS to efficiently review these time-sensitive requests, provide additional security to eligible workers on a case-by-case basis, and more robustly support the mission of labor agencies.”

OFCCP Proposes Changes to Complaint Intake Process. This week, the Office of Federal Contract Compliance Programs (OFCCP) proposed changes to its complaint intake process. OFCCP is proposing to add a preliminary step to evaluate the timeliness of allegations, whether it has jurisdiction over a matter, and how the matter should proceed. If OFCCP determines that an investigation is warranted, it will direct the complainant to fill out a more detailed form. According to the proposal, this two-step procedure “will improve the efficiency of [OFCCP’s] complaint intake process.” Comments are due by March 20, 2023.

Days of Hayes. President Rutherford Birchard Hayes passed away this week (January 17) in 1893. Hayes, the nineteenth president, was a former congressman and three-time governor of Ohio before he ran for president in 1876. His election against Democrat Samuel Tilden, the governor of New York, was mired in controversy and allegations of voter intimidation, resulting in disputed Electoral College votes. This led to the creation of an electoral commission, which eventually swung the Electoral College votes to Hayes by a margin of 185–184. The process earned Hayes the nickname “Rutherfraud” from Democrats. While Hayes hasn’t been the subject of popular movies or Broadway shows, he was a very interesting president:

  • Although twelve presidents who served before him were lawyers, Hayes was the first president to graduate from law school.
  • At almost forty years old, with no previous military experience, Hayes volunteered to fight for the Union during the Civil War. He was wounded several times, and served in the same infantry unit as fellow future president, William McKinley.
  • In 1879, Hayes signed the “Lockwood Bill,” which permitted women to practice law in federal court.
  • Hayes was the first president to make a trip to the West Coast and the first president to have both a telephone and a typewriter in the White House.

Hayes is responsible for the first Easter Egg Roll on the White House lawn, a tradition that will celebrate its 145th anniversary in just a few weeks.

Article By James J. Plunkett of Ogletree, Deakins, Nash, Smoak & Stewart, P.C.

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© 2023, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.

Humanitarian Parole Program for Cubans, Haitians, Nicaraguans, Venezuelans with Sponsorship

As of January 6, 2023, Cubans, Haitians, Nicaraguans, and Venezuelans and their immediate family members may be eligible for safe passage into the United States for up to two years as parolees if they have a financial supporter. This program is like the Uniting for Ukraine program. Organizations, including companies, can provide the financial support and, upon admission, the parolees may apply for Employment Authorization Documents (EADs).

Proposed beneficiaries cannot apply directly. Supporters must start the process.

The first step is for the supporter to submit a Form I-134A, Online Request to be Supporter and Declaration of Financial Support, including documentation proving they are able to financially support the beneficiaries they are agreeing to support. Only after that application is reviewed and adjudicated will USCIS notify the proposed beneficiary and provide instructions about how to proceed. The beneficiary will be told how to submit biographic information online and, if approved, will eventually receive travel instructions. They will be told to arrange to fly directly to their destination in the United States. Upon arrival at a U.S. port of entry, the beneficiary will be vetted again before being paroled into the country. Beneficiaries should not attempt to enter through a land port of entry as that will likely lead to a denial.

Financial supporters must be U.S. citizens or nationals, legal permanent residents (“green card holders”), conditional permanent residents, non-immigrants in lawful status, asylees, refugees, parolees, and beneficiaries of TPS, DACA or Deferred Enforced Departure (DED). While an individual must submit the Form I-134A, they can do so in association with or on behalf of an organization, business, or other entity that will provide some or all the support. Individuals who file the form on behalf of an organization must submit a letter of commitment or other documentation from an officer or other credible representative of the organization or business describing the monetary or other types of support they will provide. Beyond monetary support, other forms of support can include housing, basic necessities, and transportation. When an individual is submitting the form on behalf of an organization that will be providing the necessary level of support, the individual need not submit their own financial information.

Applications will be considered on a case-by-case basis. The grant of parole is discretionary, based on urgent humanitarian reasons or if the applicants would provide a significant public benefit to the United States.

To be eligible, proposed beneficiaries must:

  • Have a financial supporter in the United States;
  • Undergo robust security screening;
  • Have a passport valid for international travel;
  • Meet vaccination requirements;
  • Provide their own transportation to the United States, if approved for travel;
  • Meet other general requirements; and
  • Warrant an exercise of discretion.

Article By Forrest G. Read IV of Jackson Lewis P.C.

For more immigration legal news, click here to visit the National Law Review.

Jackson Lewis P.C. © 2023

EPA and Army Corps Issue New “WOTUS” Rule While Supreme Court Considers Jurisdiction Over Adjacent Wetlands

Yesterday, the US Environmental Protection Agency (EPA) and the US Army Corps of Engineers (Corps) (together, the Agencies) published a final rule revising the definition of “waters of the United States” (WOTUS) subject to federal regulation and permitting requirements under the Clean Water Act (CWA).  This rule is the latest attempt by the Agencies to craft a durable rule defining WOTUS.  The new rule, which largely mirrors the 2021 proposal, asserts a broader geographic scope of federal jurisdiction than the 2020 Navigable Waters Protection Rule (NWPR).  In particular, the Agencies adopt the broadest possible interpretation of the Supreme Court’s decision in Rapanos (through incorporation of both the plurality’s “relatively permanent” test and Justice Kennedy’s “significant nexus” test).  The final rule would, for the first time, codify aspects of the Agencies’ 2008 Rapanos Guidance and would rely on the significant nexus test’s case-by-case approach for evaluating jurisdiction for tributaries, wetlands, and other waters.  The Agencies released the final rule while the Supreme Court considers the scope of CWA authority over a major category of WOTUS, “adjacent wetlands,” in Sackett v. EPA, and the Supreme Court could hand down a decision in the coming months that could require changes to the rule.

For project proponents, the new rule would likely mean more features would be subject to regulation under the CWA, and projects that might have previously qualified for nationwide permits may no longer meet the acreage limits and would instead require an individual permit.  Also, case-by-case significant nexus determinations could result in lengthy reviews with uncertain and inconsistent results.

The final rule will go into effect on March 20.  While the Agencies previously characterized this rule as Phase 1 of a two-step process to enact a new WOTUS definition, EPA recently indicated that it is not currently planning a major second phase.

Summary of Final Rule

The rule defines WOTUS to include:

  1. Traditional navigable waters (TNWs), the territorial seas, and interstate waters.  TNWs include large rivers and lakes and tidally influenced waterbodies used in interstate or foreign commerce.  Interstate waters are rivers, lakes, and other waters that flow across, or form part of, State boundaries.  The TNW definition (i.e., all waters currently used, or were used in the past, or may be susceptible to use in interstate or foreign commerce, including all waters which are subject to the ebb and flow of the tide) is consistent with the text of the 1986 regulations and the NWPR.  However, the preamble indicates that the Agencies plan to include “waters currently being used for … commercial waterborne recreation (for example, boat rentals, guided fishing trips, or water ski tournaments),” which appears to broaden the scope of TNW waters.
  2. Impoundments of WOTUS.  The final rule retains the provision in the 1986 regulations that defines WOTUS to include impoundments of WOTUS.  The preamble defines impoundments as “created by discrete structures (often human-built) like dams or levees that typically have the effect of raising the water surface elevation, creating or expanding the area of open water, or both.”  88 Fed. Reg. at 3,066.
  3. Tributaries.  The final rule extends jurisdiction to tributaries of categories 1 and 2 waters if the tributary meets either the Agencies’ new formulation of the relatively permanent or the significant nexus standards from Rapanos (discussed in more detail below).  Ephemeral streams that meet the significant nexus test would be jurisdictional tributaries.  In this respect, the rule is much broader than the NWPR, which categorically excluded ephemeral tributaries from jurisdiction.
  4. Adjacent wetlands.  The rule retains the definition of “adjacent” from the 1986 regulations meaning “bordering, contiguous, or neighboring” and adds language that adjacent wetlands are considered WOTUSifthey meet the relatively permanent or significant nexus standards.  The NWPR had narrowed the definition of adjacent wetlands to include only those wetlands that abutted or otherwise had a direct surface connection to other jurisdictional waters in a typical year.  The final rule creates a broader category of adjacent wetlands, leading to additional regulatory requirements for activities that cross or impact such features.
  5. Other waters.  The rule asserts jurisdiction over “other waters” under the relatively permanent and significant nexus standards from Rapanos.  Under this provision, which essentially serves as a “catch-all” category, “intrastate lakes and ponds, streams, or wetlands” not identified in categories 1-4 can be assessed for jurisdiction under the relatively permanent standard or significant nexus standard.  This list is intended to be exclusive, 88 Fed. Reg. at 3,100, but broad enough to include a large variety of water types (e.g., prairie potholes, sloughs, playa lakes, etc.).  This category is a clear departure from the 2008 Rapanos Guidance, which did not assert jurisdiction over “other waters” based on the relatively permanent waters or significant nexus standards.

Exclusions.  The final rule provides a list of features that are excluded even where they would otherwise qualify as jurisdictional impoundments, tributaries, adjacent wetlands, or other waters.  Importantly, features that qualify as category 1 waters (TNWs, territorial seas, and interstate waters) cannot be excluded even if they meet the criteria of the exclusions provided.  Key non-jurisdictional waters or exclusions include waste treatment systems, ditches, prior converted cropland, artificially irrigated areas, artificial lakes or ponds, and swales and erosional features.  The list of exclusions is similar to the list provided in the 2015 WOTUS Rule and 2020 NWPR, although it does not provide the clear definitions that were included in the NWPR and in some instances changes the exemption based on preamble interpretations.

Key Definitions. The rule also includes a number of important definitions.

  • The “relatively permanent standard” asserts jurisdiction over relatively permanent, standing or continuously flowing waters connected to category 1 waters, and waters with a continuous surface connection to such relatively permanent waters or to category 1 waters.  88 Fed. Reg. at 3,006.  The final rule does not define or quantify what constitutes “relatively permanent” flow.  The preamble states that the relatively permanent standard encompasses surface waters that have flowing or standing water year-round or continuously during certain times of the year.  88 Fed. Reg. at 3,084.
  • The significant nexus standard asserts jurisdiction over waters that, either alone or in combination with similarly situated waters in the region, significantly affectthe chemical, physical, or biological integrity of category 1 waters.  In a change from the proposal, the final rule defines “significantly affect” to mean “a material influence on the chemical, physical, or biological integrity of [category 1] waters.”  To determine whether waters, either alone or in combination with similarly situated waters in the region, have a material influence on the chemical, physical, or biological integrity of category 1 waters, the Agencies will assess the  list of functions and factors, including, for example contribution of flow, distance from a category 1 water, and hydrologic connections.  The preamble states distance from a category 1 water and hydrology—will generally be given the greatest weight in the assessment.  88 Fed. Reg. at 3,120.  The new significant nexus standard will likely allow for broader assertions of jurisdiction because it allows the Agencies to aggregate all tributaries and adjacent wetlands within a particular geographic area and evaluate whether they have a “material influence” on category 1 waters based on a case-by-case application of the enumerated factors and functions.  This type of case-by-case significant nexus analysis has resulted in lengthy review times as well as unpredictable and inconsistent results.

Existing Jurisdictional Determinations

Landowners may obtain a jurisdictional determination in the form of either: (1) an approved jurisdictional determination (AJD), which is a Corps document identifying the limits of WOTUS on a parcel; or (2) a preliminary jurisdictional determination (PJD), which is a non-binding document in which an applicant can assume all waters will be treated as jurisdictional without making a formal determination.

The Agencies take the position that AJDs issued pursuant to the NWPR may not be relied upon in making new permit decisions.  According to the preamble, because the NWPR was vacated by two district courts, NWPR AJDs “may not reliably state the presence, absence, or limits of [WOTUS] on a parcel and will not be relied upon by the Corps in making new permit decisions.”  88 Fed. Reg. at 3,136.  The Agencies take the position that AJDs issued under earlier WOTUS definitions—except those AJDs issued under the NWPR—remain valid until the AJD’s expiration date.  Also, the new rule will govern any pending requests for AJDs, if the AJD is issued on or after the effective date of the rule (March 20, 2023).

In contrast to AJDs, PJDs are advisory in nature and have no expiration date.  The preamble clarifies that the new WOTUS rule has no impact on existing PJDs.

Potential Litigation and the Sackett Case

Multiple challenges to the new rule are likely to be filed in district courts across the country.  The state of Texas and an industry coalition immediately filed suits in the U.S. District Court for the Southern District of Texas, and other suits are likely.  At the same time, the Supreme Court’s pending decision in Sackett may have implications for the durability of provisions of the rule.

Many commenters recommended that the Agencies defer issuing a final rule until the Supreme Court issues a decision in Sackett—a case in which the issue before the Court is “the proper test for determining whether wetlands are [WOTUS] under the [CWA].”  A decision in the Sackett case is expected in the next few months.  Perhaps trying to insulate the rule from a potentially unfavorable Supreme Court decision, the Agencies assert in the preamble the severability of the individual provisions of the rule.  The preamble states, “if a court were to determine that a wetland cannot be treated as adjacent if it is separated from a jurisdictional water by road or other barrier, the agencies intend that other categories of wetlands within the rule’s definition of ‘adjacent’ would remain subject to jurisdiction.”  88 Fed. Reg. at 3,135.  Although it is not clear how the Supreme Court will rule in Sackett, it is possible that the decision could require the Agencies to make changes to the new WOTUS definition or face legal challenges.

Article By Kerry L. McGrath, Brian R. Levey, Andrew J. Turner, Karma B. Brown, Deidre G. Duncan, and Matthew Z. Leopold of Hunton Andrews Kurth

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Copyright © 2023, Hunton Andrews Kurth LLP. All Rights Reserved.

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.

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