EPA Designates Two PFAS as Hazardous Substances

On April 19, 2024, the U.S. Environmental Protection Agency (EPA) announced that it was designating two common per- and polyfluoroalkyl substances (PFAS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), commonly known as Superfund. As expected, EPA is issuing a final rule to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances. The pre-publication version of the rule is available here.

Once the rule is effective, entities will be required to report releases of PFOA and PFOS into the environment that meet or exceed the reportable quantity. Reporting past releases is not required if the releases have ceased as of the effective date of the rule. EPA will have the authority to order potentially responsible parties to test, remediate, or pay for the cleanup of sites contaminated with PFOA or PFOS under CERCLA.

Massachusetts established reportable concentrations for six PFAS, including PFOA and PFOS, in 2019. The Massachusetts regulations also contain cleanup standards for PFAS contamination in soil and groundwater.

Under Maine law, these substances also are automatically deemed a Maine hazardous substance regulated under the Maine Uncontrolled Hazardous Substance Sites Law. Maine’s PFAS screening levels are available here.

Solid waste facility operators had expressed serious concerns about the prospect of PFOA and PFOS being listed as hazardous substances under CERCLA and have advocated for a narrow exemption. Landfills can be recipients of PFAS-containing waste without knowing it. Similarly, wastewater treatment plant operators feared liability and increased costs if the rule designating PFOA and PFOS as hazardous substances became final.

EPA’s announcement of the final rule came with a CERCLA enforcement discretion policy [PFAS Enforcement Discretion and Settlement Policy Under CERCLA] that makes clear that EPA will focus enforcement on parties that significantly contributed to the release of PFAS into the environment.

The policy states that the EPA does not intend to pursue certain publicly‑owned facilities such as solid waste landfills, wastewater treatment plants, airports, and local fire departments, as well as farms where biosolids are applied to the land. Firefighting foam (aqueous film-forming foam, or AFFF) is known to contain PFAS, and runoff from the use of AFFF has been known to migrate into soil and groundwater.

FTC Issues Report to Congress Highlighting Collaboration with State Attorneys General

On April 10, 2024, the Federal Trade Commission issued a report to Congress on the agency’s collaboration with state attorneys general highlighting current cooperative law enforcement efforts, best practices to ensure continued collaboration and legislative recommendations to enhance such efforts.

The report, directed by the FTC Collaboration Act of 2021, “Working Together to Protect Consumers: A Study and Recommendations on FTC Collaboration with the State Attorneys General” makes legislative recommendations that would enhance these efforts, including reinstating the Commission’s authority to seek money for defrauded consumers and providing it with the independent authority to seek civil penalties.

“Today’s consumer protection challenges require an all-hands-on-deck response, and our report details how the FTC is working closely with state enforcers to share information, stop fraud, and ensure fairness in the marketplace,” said FTC attorney Samuel Levine, Director of the Bureau of Consumer Protection. “We look forward to seeking new opportunities to strengthen these ties and confront the challenges of the future.”

In June 2023, the Commission announced a request for public information (RFI) seeking public comments and suggestions on ways it can work more effectively with state AGs to help educate consumers about, and protect them from, potential fraud. After reviewing and analyzing the comments received, the agency developed the report to Congress issued today. The report is divided into three sections: 1) The FTC’s Existing Collaborative Efforts with State
Attorneys General to Prevent, Publicize, and Penalize Frauds and Scams; 2) Recommended Best Practices to Enhance Collaboration; and 3) Legislative Recommendations to Enhance Collaboration Efforts.

The first section lays out the roles and responsibilities of the FTC and state AGs in protecting consumers from frauds and scams, provides an overview of their respective law enforcement authority, and discusses how federal and state enforcers share their information and expertise to facilitate effective communication and cooperation. It also provides a breakdown of the FTC’s
structure and a description of the Consumer Sentinel consumer complaint database, the largest such information-sharing network in the United States.

The second section details best practices used to enhance strong information-sharing between the FTC and its state law enforcement partners, discusses how the Commission coordinates joint and parallel enforcement actions with state AGs and other state consumer protection agencies, and presents ideas on expanding the sharing of expertise and technical resources between agencies.

Finally, the third section stresses the legislative need to restore the FTC’s Section 13(b) authority to seek equitable monetary refunds for injured consumers, presents ways to enhance collaboration and conserve resources by providing the FTC with the independent authority to seek civil penalties, and describes the agency’s need for clear authority to pursue legal actions against those who assist and facilitate unfair or deceptive acts or practices.

The Commission vote approving the report to Congress was 3-0-2, with Commissioners Melissa Holyoak and Andrew N. Ferguson not participating. Chair Lina M. Khan issued a separate statement, in which she was joined by Commissioners Rebecca Kelly Slaughter and Alvaro M. Bedoya. Commissioner Slaughter also issued a separate statement.

U.S. Supreme Court: Forced Transfers of Employees Without Loss of Pay or Rank Violate Title VII

Federal law prohibits employers from relying on certain protected statuses (race, color, religion, sex, or national origin) when making employment decisions. Lower courts have required employees suing employers to point to a materially adverse harm caused by the alleged employer discrimination. But is a forced transfer of an employee to another department—with no loss of pay or rank—an “adverse employment” decision? On April 17, 2024, the U.S. Supreme Court ruled 9-0 in the affirmative.

In Muldrow v. City of St. Louis, a female police sergeant alleged she was transferred from one job to another because she is a woman, in violation of Title VII. While her rank and pay remained the same in the new position, her responsibilities (moving from being a plainclothes intelligence officer to a more administrative role), perks (e.g., no longer having a take-home car), and schedule (fewer weekends off) did not. The District Court reiterated Title VII’s prohibition against basing employment decisions on a person’s gender, but further opined that because the female police sergeant did not demonstrate there was a “significant” change in working conditions producing “material employment disadvantage,” her discrimination claim failed as a matter of law. The District Court reached this conclusion because she suffered no “change in salary or rank,” and therefore, there was no harm and no foul. The U.S. Court of Appeals for the Eighth Circuit agreed, concluding that the plaintiff did not have a viable employment discrimination claim because her job transfer “did not result in a diminution to her title, salary, or benefits.”

Writing for a unanimous court, Justice Elena Kagan reversed the Eighth Circuit, ruling that an employee need not show “significant, serious” or “material” change in employment conditions to maintain a discrimination claim “because the text of Title VII imposes no such requirement.” More specifically, the Supreme Court reasoned that there is nothing in Title VII that distinguishes “between transfers causing significant disadvantages and transfers causing not-so-significant ones.” All a plaintiff need show in a forced discriminatory transfer case is that the transfer left the employee “worse off,” but not “significantly worse” as numerous federal appellate decisions have previously held.

For All Patent/Trademark Practitioners: USPTO Provides Guidance for Use of AI in Preparing USPTO Submissions

The USPTO expounds a clear message for patent and trademark attorneys, patent agents, and inventors: use of artificial intelligence (AI), including generative AI, in patent and trademark activities and filings before the USPTO entails risks to be mitigated, and you must disclose use of AI in creation of an invention or practice before the USPTO if the use of AI is material to patentability.

The USPTO’s new guidance issued on April 11, 2024 is a counterpart to its guidance issued on February 13, 2024, which addresses AI-assisted invention creation process. In the new guidance issued on April 11, 2024, USPTO officials communicate the risks of using AI in preparing USPTO submissions, including patent applications, affidavits, petitions, office action responses, information disclosure statements, Patent Trial and Appeal Board (PTAB) submissions, and trademark / Trademark Trial and Appeal Board (TTAB) submissions. The common theme between the February 13 and April 11 guidance is the duty to disclose to the USPTO all information known to be material to patentability.

Building on the USPTO’s existing rules and policies, the USPTO’s April 11 guidance discusses the following:

(A) The duty of candor and good faith – each individual associated with a proceeding at the USPTO owes the duty to disclose the USPTO all information known to be material to patentability, including on the use of AI by inventors, parties, and practitioners.

(B) Signature requirement and corresponding certifications – using AI to draft documents without verifying information risks “critical misstatements and omissions”. Any submission for the USPTO in which AI helped prepare must be carefully reviewed by practitioners, who are ultimately responsible, to ensure that they are true and submitted for a proper purpose.

(C) Confidentiality of information – sensitive and confidential client information risks being compromised if shared to third-party AI systems, some of which may be located outside of the United States.

(D) Foreign filing licenses and export regulations – a foreign filing license from the USPTO does not authorize the exporting of subject matter abroad for the preparation of patent applications to be filed in the United States. Practitioners must ensure data is not improperly exported when using AI.

(E) USPTO electronic systems’ policies – Practitioners using AI must be mindful of the terms and conditions for the USPTO’s electronic system, which prohibit the unauthorized access, actions, use, modifications, or disclosure of the data contained in the USPTO system in transit to/from the system.

(F) The USPTO Rules of Professional Conduct – when using the AI tools, practitioners must ensure that they are not violating the duties owed to clients. For example, practitioners must have the requisite legal, scientific, and technical knowledge to reasonably represent the client, without inappropriate reliance on AI. Practitioners also have duty to reasonably consult with the client, including about the use of AI in accomplishing the client’s objectives.

The USPTO’s April 11 guidance overall shares principles with the ethics guidelines that multiple state bars have issued related to generative AI use in practice of law, and addresses them in the patent- and trademark-specific context. Importantly, in addition to ethics considerations, the USPTO guidance reminds us that knowing or willful withholding of information about AI use under (A), overlooking AI’s misstatements leading to false certification under (B), or AI-mediated improper or unauthorized exporting of data or unauthorized access to data under (D) and (E) may lead to criminal or civil liability under federal law or penalties or sanctions by the USPTO.

On the positive side, the USPTO guidance describes the possible favorable aspects of AI “to expand access to our innovation ecosystem and lower costs for parties and practitioners…. The USPTO continues to be actively involved in the development of domestic and international measures to address AI considerations at the intersection of innovation, creativity, and intellectual property.” We expect more USPTO AI guidance to be forthcoming, so please do watch for continued updates in this area.

USCIS Announces Information on EB-5 Regional Center Audits

U.S. Citizenship and Immigration Services (USCIS) has announced new provisions regarding EB-5 regional center audits in accordance with the EB-5 Reform and Integrity Act of 2022. Each designated regional center will be audited at least once every five years, and audits will review documentation required to be maintained by the regional center and the flow of immigrant investor capital into capital investment projects. Audits aim to enhance the integrity of the EB-5 program by verifying information in regional center applications, annual certifications, and associated investor petitions.

During site visits for audits, if a regional center representative refuses to participate, the visit will be canceled and the audit report will be completed using available data, noting the cancellation at the request of the regional center. Regional centers that refuse consent or obstruct audits may have their designation terminated.

However, there are generally no immediate adverse consequences for EB-5 associated entities or petitioners solely based on a negative audit result, except in cases of deliberate noncompliance or obstruction. The findings may be used to evaluate a regional center’s eligibility to remain designated and compliance with applicable requirements.

Starting April 23, 2024, audits will adhere to Generally Accepted Government Auditing Standards to ensure uniformity. USCIS launched a new EB-5 Regional Center Audits webpage to provide information on the auditing process.

Pregnant Workers Fairness Act Final Regulations Released

The Equal Employment Opportunity Commission (EEOC) released the text of the final regulations and interpretative guidance implementing the Pregnant Workers Fairness Act (PWFA) on April 15, 2024. The final regulations are expected to be formally published in the April 19, 2024, Federal Register and will be effective 60 days later.

The EEOC received more than 100,000 public comments, including comments from Jackson Lewis, in response to the Commission’s notice of the proposed regulations issued on Aug. 11, 2023. Although largely unchanged from the proposed regulations, the final regulations provide important clarifications and insights into how the EEOC will enforce the law. Discussed below are some key points employers need to know about the final regulations.

Key PWFA Requirements

The PWFA, which went into effect on June 27, 2023, requires employers with at least 15 employees and other covered entities to provide reasonable accommodations to a qualified employee’s or applicant’s known limitations related to, affected by, or arising out of pregnancy, childbirth, or related medical conditions, unless the accommodation will cause undue hardship on the operation of the employer’s business.

Qualified Employee

Under the PWFA, an employee has two ways to establish they are a “qualified employee”:

  1. Like under the Americans With Disabilities Act (ADA), “an employee or applicant who, with or without reasonable accommodation, can perform the essential functions of the employment position” is qualified.
  2. If an employee (or applicant) cannot perform all essential job functions even with reasonable accommodation, the employee can be qualified for accommodations under the PWFA if: (a) the inability to perform an essential job function is for a temporary period; (b) the essential job function(s) could be performed in the near future; and (c) the inability to perform the essential function(s) can be reasonably accommodated. The Act, however, does not define “temporary” or “in the near future.” Several commentors raised concerns about the EEOC’s definition of these terms in the proposed regulations.

Like the proposed regulations, the final regulations state that “temporary” means “lasting for a limited time, not permanent, and may extend beyond ‘in the near future.’” Unlike the proposed regulations, however, the final regulations state that assessing whether all essential job functions can be performed in the near future depends on the circumstances:

  • For a current pregnancy, “in the near future” is generally defined as 40 weeks from the start of the temporary suspension of an essential function.
  • For conditions other than a current pregnancy, “in the near future” is not defined as any particular length of time. However, the preamble to the final regulations explains that an employee who needs indefinite leave cannot perform essential job functions “in the near future.”

The final regulations explain that employers should consider whether an employee will be able to perform the essential functions “in the near future” each time an employee asks for an accommodation that requires suspension of an essential job function.

Ultimately, whether an employee is “qualified” involves a fact-sensitive evaluation whether the temporary suspension of essential job functions can be reasonably accommodated by the employer. This is significantly different from the ADA reasonable accommodation obligation and may involve, as the final regulations state, removing essential job functions and other arrangements including, but not limited to, requiring the employee perform the remaining job functions and other functions assigned by the employer, temporarily transferring the employee to another job or assigning the employee to light or modified duty, or allowing the employee to participate in an employer’s light or modified duty program.

Accommodations Only Required for Individual With Limitation

The EEOC explains that the regulations do not require employers to provide accommodations to an employee when an employee’s partner, spouse, or family member — not the employee themselves — has a physical or mental condition related to, affected by, or arising out of pregnancy, childbirth, or related medical conditions. For clarity, the EEOC revised the final regulations’ definition of “limited” to state the limitation must be the specific employee.

Known Limitations

Employers are only obligated under the PWFA to accommodate an individual’s “known limitation.”

A “limitation” is defined as a “physical or mental condition related to, affected by, or arising out of pregnancy, childbirth, or related medical conditions, of the specific employee in question.” The condition may be “modest, minor, and/or episodic, and does not need to meet the definition of “disability” under the ADA.

It becomes “known” to the employer when the employee or the employee’s representative has communicated the limitation to the employer. An employee’s representative may include a family member, friend, healthcare provider, union representative, or other representative.

The limitation may be communicated to a supervisor, a manager, someone who has supervisory authority for the employee or who regularly directs the employee’s tasks (or the equivalent in the case of an applicant), human resources personnel, or other appropriate official or by following the steps in the employer’s policy to request an accommodation.

This communication need not be in any specific format and may also be oral.

Pregnancy, Childbirth, Related Medical Conditions

Although the EEOC acknowledged receiving many comments on the scope of the proposed definition of “pregnancy, childbirth or related medical conditions,” it made no substantive changes to the definition in the final regulations.

“Pregnancy” and “childbirth” are still defined as including current pregnancy, past pregnancy, potential or intended pregnancy (which can include infertility, fertility treatments and the use of contraception), labor, and childbirth (including vaginal and cesarean delivery).

The term “related medical conditions” continues to be defined as conditions that are “related to, are affected by, or arise out of pregnancy or childbirth.” The regulations provide the following non-exhaustive list of examples: termination of pregnancy, including by miscarriage, stillbirth, or abortion; lactation and conditions related to lactation; menstruation; postpartum depression, anxiety or psychosis; vaginal bleeding; preeclampsia; pelvic prolapse; preterm labor; ectopic pregnancy; gestational diabetes; cesarean or perineal wound infection; maternal cardiometabolic disease; endometriosis; changes in hormone levels; and many other conditions.

The final regulations also reference related medical conditions that are not unique to pregnancy or childbirth, such as chronic migraine headaches, nausea or vomiting, high blood pressure, incontinence, carpal tunnel syndrome, and many other medical conditions. These conditions are covered by the PWFA only if the condition relates to pregnancy or childbirth or are exacerbated by pregnancy or childbirth, although the ADA or other civil rights statutes may apply.

Documentation

The final PWFA regulations continue to provide for a “reasonableness” standard in evaluating the circumstances under which an employer may request documentation from an employee. The final regulations, however, modify the definition of “reasonable documentation.” An employer may only request the “minimum documentation” necessary to confirm the employee has a physical or mental condition related to, affected by, or arising out of pregnancy, childbirth, or related medical conditions (a limitation) and describe the adjustment or change at work due to the limitation.

In addition to stating when an employer can ask for documentation, the PWFA regulations add a paragraph regarding an employee’s self-confirmation of their pregnancy status. It provides that an employer must accept as sufficient an employee’s self-confirmation when: (1) the pregnancy is obvious; or (2) an employee seeks one of the “predictable assessment” accommodation requests set forth in the regulations (discussed below).

The final PWFA regulations make clear the circumstances where it is not reasonable to seek supporting documentation. These circumstances include when: (1) the limitation and adjustment or change needed is obvious and the employee provides self-confirmation; (2) the employer has sufficient information to determine whether the employee has a qualifying limitation and needs an adjustment or change due to the limitation; (3) when the employee is pregnant a “predictable assessment”; (4) the reasonable accommodation relates to a time and/or place to pump or to nurse during work hours, and the employee provides self-confirmation; or (5) the requested accommodation is available to employees without known limitations under the PWFA pursuant to a policy or practice without submitting supporting documentation.

Importantly, the same prohibitions on disability-related inquiries and medical examinations as well as the protection of medical information enforced under the ADA apply with equal force to documentation collected under the PWFA. Employers should ensure they continue to limit inquiries to only those that are job-related and consistent with business necessity. Employers should also treat all documentation relating to a PWFA accommodation request like they treat ADA documentation — maintain it confidentially and separate from an employee’s personnel file.

Reasonable Accommodations

The PFWA requires employers to provide reasonable accommodations, which the final regulations define to be generally consistently with the ADA except for temporarily excusing or eliminating the performance of an essential job function. Otherwise, the rule provides that a reasonable accommodation is a modification or adjustment that is “reasonable on its face, i.e., ordinarily or in the run of cases” if it appears to be “feasible” or “plausible.” An accommodation also must be effective in meeting the qualified employee’s needs to remove a work-related barrier and provide an employee with equal employment opportunity to benefit from all privileges of employment.

The final regulations include examples of requests that may be reasonable. These include schedule changes due to morning sickness or to treat medical issues following delivery, adjustments to accommodate restrictions for lifting or requests for light duty, time and/or space to pump or nurse during work hours, or time off to recover from childbirth.

Lactation Accommodations

The EEOC’s final regulations require reasonable accommodation for lactation beyond what may be required under the Providing Urgent Maternal Protection for Nursing Mothers Act (PUMP Act). The PUMP Act generally requires reasonable break time and space shielded from view and free from intrusion for a nursing mother to express breast milk. The final PWFA regulations provide a non-exhaustive list of examples of accommodations relating to lactation, including space for pumping that is in reasonable proximity to a sink, running water, and refrigeration for storing milk.

The final regulations add nursing during working hours (as distinct from pumping) to the list of potentially reasonable accommodations. In the comments explaining this addition, the EEOC cautioned that accommodations for nursing mothers during work hours address situations where the employee and child are in close proximity in the normal course of business, such as where the employee works from home or where the employer offers on-site daycare. The EEOC stated this is not intended to create a right to proximity to nurse because of an employee’s preference.

Predictable Assessments

Like the proposed regulations, the final regulations recognize four “predictable assessments” that will not impose an undue hardship in “virtually all cases”:

  1. Allowing an employee to carry or keep water near to enable them to drink;
  2. Permitting an employee to take additional restroom breaks as needed;
  3. Allowing an employee whose work requires standing to sit and whose work requires sitting to stand as needed; and
  4. Allowing an employee to take breaks to eat and drink as needed.

Despite stating the predictable assessments above will not “in virtually all cases” impose an undue hardship, the EEOC clarified this does not mean such requests are reasonable per se. The EEOC recognized that in certain industries, these predictable assessments may cause an undue hardship. Accordingly, employers may still conduct an individualized assessment of a predictable assessment accommodation request. However, the final regulations make clear that any such individualized assessment should be particularly simple and straightforward.

Many individuals and organizations that submitted comments on the proposed regulations suggested the addition of other types of predictable assessment accommodations, including dress code modifications, minor workstation modifications, proximity to a restroom, permitting eating and drinking at a workstation, rest breaks, and personal protective equipment. Although noting agreement with the commenters and stating that employers should be able to provide such requests with “little difficulty,” the EEOC declined to expand the list of predictable assessments beyond the four originally listed that in “virtually all cases” will be considered reasonable and will not pose an undue hardship. In response to comments objecting to predictable assessments based on different challenges by industry, the EEOC guidance recognizes that an employer in certain industries may assert an accommodation request otherwise deemed to be a predictable assessment causes the employer an undue hardship and may deny the request.

Undue Hardship

The EEOC adopted the same standard for undue hardship in the final regulations as was in the proposed regulations. When an employee can perform all their essential job functions, the EEOC stated that undue hardship has the same meaning as under the ADA and generally means significant difficulty or expense for the employer’s operation. If an employee cannot perform all essential functions and the accommodation is temporary suspension of an essential job function, the employer needs to consider the ADA definition of undue hardship and the following relevant factors: (1) the length of time the employee or applicant will be unable to perform the essential function(s); (2) whether there is work for the employee to accomplish by allowing the employee to perform all the other functions of the job, transferring the employee to a different position, or otherwise; (3) the nature of the essential function, including its frequency; (4) whether the covered entity has temporarily suspended the performance of essential job functions for other employees in similar positions; (5) whether there are other employees, temporary employees, or third parties who can perform or be temporarily hired to perform the essential function(s); and (6) whether the essential function(s) can be postponed or remain unperformed for any length of time and for how long.

EEOC Interpretative Guidance

The EEOC’s final regulations include an appendix entitled “Appendix A to Part 1636—Interpretative Guidance on the Pregnant Workers Fairness Act” (Interpretative Guidance). The Interpretative Guidance, which becomes part of the final regulations, has the same force and effect as the final regulations.

The Interpretative Guidance addresses the major provisions of the PWFA and its regulations and explains the main concepts pertaining to an employer’s legal requirements under the PWFA to make reasonable accommodations for known limitations (physical or mental conditions related to, affected by, or arising out of pregnancy, childbirth, or related medical conditions). It represents the EEOC’s interpretation of the PWFA and, as stated in comments to the final regulations, the EEOC will be guided by the Interpretive Guidance when enforcing the PWFA. The Interpretative Guidance includes many examples and other practical guidance illustrating common workplace scenarios and how the PWFA applies.

Remedies, Enforcement

The final regulations’ remedies and enforcement are the same as proposed. Remedies under the PWFA mirror those under Title VII of the Civil Rights Act and include injunctive and other equitable relief, compensatory and punitive damages, and attorney’s fees. Employers that demonstrate good faith efforts to work with employees to identify and make reasonable accommodations have an affirmative defense to money damages.

PWFA’s Relationship to Other Federal, State, Local Laws

The final regulations provide that the PWFA does not invalidate or limit the powers, remedies, or procedures available under any federal, state, or local law that provides greater or equal protection for individuals affected by pregnancy, childbirth, or related medical conditions. About 40 states and cities have laws protecting employees and applicants from discrimination due to pregnancy, childbirth, and related medical conditions. Accordingly, employers should evaluate whether state and/or local law may provide greater rights and obligations than the PWFA. To the extent such laws provide greater obligations, the PWFA final regulations require employers to comply with both the PWFA and analogous state and local law.

SEC Stays Climate Disclosure Regulations in Response to Consolidated Eighth Circuit Challenges

On April 4, the SEC issued an order staying the implementation of the recently finalized climate disclosure rules (Final Rules) in response to the consolidated legal challenges in the US Court of Appeals for the Eighth Circuit. The SEC has discretion to stay its rules pending judicial review and the SEC stated that a stay would “allow the court of appeals to focus on deciding the merits [of the cases].” However, this voluntary stay should not be taken as a sign that the SEC intends to abandon the Final Rules, as the SEC said it will “continue vigorously defending the Final Rules’ validity in court and looks forward to expeditious resolution of the litigation.”

The Final Rules have faced a slew of legal challenges since adoption and the SEC also noted that the stay avoids potential uncertainty if registrants were to become subject to the Final Rules during the pendency of the legal challenges.

FCC Puts Another Carrier On Notice with Cease and Desist Letter

If you haven’t already figured it out, the FCC is serious about carriers and providers not carrying robocalls.

The FCC sent a cease and desist letter to DigitalIPvoice informing them of the need to investigate suspected traffic. The FCC reminded them that failure to comply with the letter “may result in downstream voice service providers permanently blocking all of DigitalIPvoice’s traffic”.

For background, DigitalIPvoice is a gateway provider meaning they accept calls directly from foreign originating or intermediate providers. The Industry Traceback Group (ITG) investigated some questionable traffic back in December and identified DigitalIPvoice as the gateway provider for some of the calls. ITG informed DigitalIPvoice and “DigitialIPVoice did not dispute that the calls were illegal.”

This is problematic because as the FCC states “gateway providers that transmit illegal robocall traffic face serious consequences, including blocking by downstream providers of all of the provider’s traffic.”

Emphasis in original. Yes. The FCC sent that in BOLD to DigitalIPvoice. I love aggressive formatting choices.

The FCC then gave DigitalIPvoice steps to take to mitigate the calls in response to this notice. They have to investigate the traffic and then block identified traffic and report back to the FCC and the ITG on the outcome of the investigation.

The whole letter is worth reading but a few points for voice service providers and gateway providers:

  1. You have to know who your customers are and what they are doing on your network. The FCC is requiring voice service providers and gateway providers to include KYC in their robocall mitigation plans.
  2. You have to work with the ITG. You have to have a traceback policy and procedures. All traceback requests have to be treated as a P0 priority.
  3. You have to be able to trace the traffic you are handling. From beginning to end.

The FCC is going after robocalls hard. Protect yourself by understanding what is going to be required of your network.

Keeping you in the loop.

For more news on FCC Regulations, visit the NLR Communications, Media & Internet section.

Global Regulatory Update for April 2024

WEBINAR – Registration Is Open For “Harmonizing TSCA Consent Orders with OSHA HCS 2012”: Register now to join The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®) for “Harmonizing TSCA Consent Orders with OSHA HCS 2012,” a complimentary webinar covering case studies and practical applications of merging the requirements for consent order language on the Safety Data Sheet (SDS). In this webinar, Karin F. Baron, MSPH, Director of Hazard Communication and International Registration Strategy, Acta, will explore two hypothetical examples and provide guidance on practical approaches to compliance. An industry perspective will be presented by Sara Glazier Frojen, Senior Product Steward, Hexion Inc., who will discuss the realities of managing this process day-to-day.

SAVE THE DATE – “TSCA Reform — 8 Years Later” On June 26, 2024: Save the date to join Acta affiliate B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health for a day-long conference reflecting on the challenges and accomplishments since the implementation of the 2016 Lautenberg Amendments and where the Toxic Substances Control Act (TSCA) stands today. This year, the conference will be held in person at the George Washington University Milken Institute School of Public Health (and will be livestreamed via YouTube). Continuing legal education (CLE) credit will be offered in select states for in-person attendees only. Please check ELI’s event page in the coming weeks for more information, including an agenda, CLE information, registration, and more. If you have questions in the meantime, please contact Madison Calhoun (calhoun@eli.org).

AUSTRALIA

Changes To Categorization, Reporting, And Recordkeeping Requirements For Industrial Chemicals Will Take Effect April 24, 2024: The Australian Industrial Chemicals Introduction Scheme (AICIS) announced regulatory changes to categorization, reporting, and recordkeeping requirements will start April 24, 2024. For the changes to take effect, the Industrial Chemicals (General) Rules 2019 (Rules) and Industrial Chemicals Categorisation Guidelines will be amended. According to AICIS, key changes to the Rules include:

  • Written undertakings replaced with records that will make compliance easier;
  • Greater acceptance of International Nomenclature of Cosmetic Ingredients (INCI) names for reporting and recordkeeping;
  • Changes to the categorization criteria to benefit:
    • Local soap makers;
    • Introducers of chemicals in flavor and fragrance blends; and
    • Introducers of hazardous chemicals where introduction and use are controlled; and
  • Strengthening criteria and/or reporting requirements for health and environmental protection.

AICIS announced final changes to the Industrial Chemicals Categorisation Guidelines that will take effect April 24, 2024. According to AICIS, the changes include:

  • Refinement of the requirement to check for hazardous esters and salts of chemicals on the “List of chemicals with high hazards for categorisation” (the List);
  • Provision to include highly hazardous chemicals to the List based on an AICIS assessment or evaluation;
  • Expanded options for introducers to demonstrate the absence of skin irritation and skin sensitization; and
  • More models for in silico predictions and an added test guideline for ready biodegradability.

AICIS states that it will publish a second update to the Guidelines in September 2024 due to industry stakeholders’ feedback that they need more time to prepare for some of the changes. It will include:

  • For the List: add chemicals based on current sources and add the European Commission (EC) Endocrine Disruptor List (List I) as a source; and
  • Refined requirements for introducers to show the absence of specific target organ toxicity after repeated exposure and bioaccumulation potential.

CANADA

Canada Provides Updates On Its Implementation Of The Modernized CEPA: As reported in our June 23, 2023, memorandum, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, received Royal Assent on June 13, 2023. Canada is working to implement the bill through initiatives that include the development of various instruments, policies, strategies, regulations, and processes. In April 2024, Canada updated its list of public consultation opportunities:

  • Discussion document on the implementation framework for a right to a healthy environment under the Canadian Environmental Protection Act, 1999 (CEPA) (winter 2024);
  • Proposed Watch List approach (spring/summer 2024);
  • Proposed plan of chemicals management priorities (summer 2024);
  • Draft strategy to replace, reduce or refine vertebrate animal testing (summer/fall 2024);
  • Draft implementation framework for a right to a healthy environment under CEPA (summer/fall 2024);
  • Discussion document for toxic substances of highest risk regulations (winter 2025); and
  • Discussion document on the restriction and authorization of certain toxic substances regulations (winter/spring 2025).

EUROPEAN UNION (EU)

ECHA Checks More Than 20 Percent Of REACH Registration Dossiers For Compliance: The European Chemicals Agency (ECHA) announced on February 27, 2024, that between 2009 and 2023, it performed compliance checks of approximately 15,000 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations, representing 21 percent of full registrations. ECHA states that it met its legal target for dossier evaluation, which increased from five percent to 20 percent in 2019. ECHA notes that for substances registered at quantities of 100 metric tons or more per year, it has checked compliance for around 30 percent of the dossiers.

According to ECHA, in 2023, it conducted 301 compliance checks, covering more than 1,750 registrations and addressing 274 individual substances. ECHA “focused on registration dossiers that may have data gaps and aim to enhance the safety data of these substances.” ECHA sent 251 adopted decisions to companies, “requesting additional data to clarify long-term effects of chemicals on human health or the environment.” ECHA states that during the follow-up evaluation process, it will assess the incoming information for compliance. ECHA will share the outcome of the incoming data with the EU member states and the EC to enable prioritization of substances. ECHA will work closely with the member states for enforcement of non-compliant dossiers. Compliance of registration dossiers will remain a priority for ECHA. In 2024, ECHA will review the impact of the Joint Evaluation Action Plan, aimed at improving REACH registration compliance, and, together with stakeholders, develop new priority areas on which to focus. More information is available in our March 29, 2024, blog item.

Council Of The EU And EP Reach Provisional Agreement On Proposed Regulation On Packaging And Packaging Waste: The Council of the EU announced on March 4, 2024, that its presidency and the European Parliament’s (EP) representatives reached a provisional political agreement on a proposal for a regulation on packaging and packaging waste. The press release states that the proposal considers the full life-cycle of packaging and establishes requirements to ensure that packaging is safe and sustainable by requiring that all packaging is recyclable and that the presence of substances of concern is minimized. It also includes labeling harmonization requirements to improve consumer information. In line with the waste hierarchy, the proposal aims to reduce significantly the generation of packaging waste by setting binding re-use targets, restricting certain types of single-use packaging, and requiring economic operators to minimize the packaging used. The proposal would introduce a restriction on the placing on the market of food contact packaging containing per- and polyfluoroalkyl substances (PFAS) above certain thresholds. The press release notes that to avoid any overlap with other pieces of legislation, the co-legislators tasked the EC to assess the need to amend that restriction within four years of the date of application of the regulation.

EP Adopts Position On Establishing System To Verify And Pre-Approve Environmental Marketing Claims: The EP announced on March 12, 2024, that it adopted its first reading position on establishing a verification and pre-approval system for environmental marketing claims to protect citizens from misleading ads. According to the EP’s press release, the green claims directive would require companies to submit evidence about their environmental marketing claims before advertising products as “biodegradable,” “less polluting,” “water saving,” or having “biobased content.” Micro enterprises would be exempt from the new rules, and small and medium-sized enterprises (SME) would have an extra year to comply compared to larger businesses. The press release notes that the EP also decided that green claims about products containing hazardous substances should remain possible for now, but that the EC “should assess in the near future whether they should be banned entirely.” The new EP will follow up on the file after the European elections that will take place in June 2024.

On April 3, 2024, a coalition of industry associations issued a “Joint statement in reference to ‘the ban of green claims for products containing hazardous substances’ in the Green Claims Substantiation Directive (GCD).” The associations “fully support the principle that consumers should not be misled by false or unsubstantiated environmental claims and share the EU’s objective to establish a clear, robust and credible framework to enable consumers to make an informed choice.” The associations express concern that the proposed prohibition of environmental claims for products containing certain hazardous substances “will run contrary to the objective of the Directive to enable consumers to make sustainable purchase decisions and ensure proper substantiation of claims.” According to the associations, for a number of consumer products, “the reference to ‘products containing’ would encompass substances that would have intrinsic hazardous properties,” implying that there would be a ban of making any environmental claim(s), “even if such trace amounts of unavoidable and unintentional impurities and contaminants are present in these products.” The signatories include the International Association for Soaps, Detergents and Maintenance Products; the European Brands Association; APPLiA; the Association of Manufacturers and Formulators of Enzyme Products; CosmeticsEurope; the European Power Tool Association; the Federation of the European Sporting Goods Industry; the International Fragrance Association; LightingEurope; the International Natural and Organic Cosmetics Association; Toy Industries of Europe; Verband der Elektro- und Digitalindustrie; and the World Federation of Advertisers.

ECHA Clarifies Next Steps For PFAS Restriction Proposal: ECHA issued a press release on March 13, 2024, to outline how the Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will progress in evaluating the proposal to restrict PFAS in Europe. As reported in our February 13, 2023, memorandum, the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted a proposal to restrict more than 10,000 PFAS under REACH. The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks. Following the screening of thousands of comments received during the consultation, ECHA states that it is clarifying the next steps for the proposal. According to ECHA, RAC and SEAC will evaluate the proposed restriction together with the comments from the consultation in batches, focusing on the different sectors that may be affected.

In tandem, the five national authorities who prepared the proposal are updating their initial report to address the consultation comments. This updated report will be assessed by the committees and will serve as the foundation for their opinions. The sectors and elements that will be discussed in the next three committee meetings are:

March 2024 Meetings

  • Consumer mixtures, cosmetics, and ski wax;
  • Hazards of PFAS (only by RAC); and
  • General approach (only by SEAC).

June 2024 Meetings

  • Metal plating and manufacture of metal products; and
  • Additional discussion on hazards (only by RAC).

September 2024 Meetings

  • Textiles, upholstery, leather, apparel, carpets (TULAC);
  • Food contact materials and packaging; and
  • Petroleum and mining.

More information is available in our March 18, 2024, blog item.

ECHA Adopts And Publishes CoRAP For 2024-2026: On March 19, 2024, ECHA adopted and published the Community rolling action plan (CoRAP) for 2024-2026. The CoRAP lists 28 substances suspected of posing a risk to human health or the environment for evaluation by 11 Member State Competent Authorities. The CoRAP includes 11 newly allocated substances and 17 substances already included in the previous CoRAP 2023-2025 update, published on March 21, 2023. For 11 out of these 17 substances, ECHA notes that the evaluation year has been postponed, mainly to await submission of new information requested under dossier evaluation. Of the 28 substances to be evaluated, ten are to be evaluated in 2024, 13 in 2025, and five in 2026. The remaining substance of the 24 substances listed in the previous CoRAP was withdrawn as its evaluation is currently considered to be a low priority. According to ECHA, for this substance, a compliance check is needed first. ECHA states that the substance can be placed in the CoRAP list again, if after the conclusion of the dossier evaluation process, concerns remain beyond what can be clarified through dossier evaluation. ECHA has posted a guide for registrants that need to update their dossiers with new relevant information such as hazard, tonnages, use, and exposure.

Comments On Proposals To Identify New SVHCs Due April 15, 2025: A public consultation on proposals to identify two new substances of very high concern (SVHC) will close on April 15, 2024. The substances and examples of their uses are:

  • Bis(α,α-dimethylbenzyl) peroxide: This substance is used in products such as pH-regulators, flocculants, precipitants, and neutralization agents; and
  • Triphenyl phosphate: This substance is used as a flame retardant and plasticizer in polymer formulations, adhesives, and sealants.

UNITED KINGDOM (UK)

HSE Publishes UK REACH Work Programme For 2023/24: In February 2024, the Health and Safety Executive (HSE) published its UK REACH Work Programme 2023/24. The Work Programme sets out how HSE, with the support of the Environment Agency, will deliver its regulatory activities to meet the objectives and timescales set out in UK REACH. Alongside these activities, HSE and the Environment Agency will engage with stakeholders. The Work Programme includes the following deliverables and target deadlines:

Topic Deliverable Target
Substance evaluation Evaluate substances in the Rolling Action Plan (RAP) Evaluate one
Authorization Complete the processing of received applications within the statutory deadline (this includes comments from public consultation and REACH Independent Scientific Expert Pool (RISEP) input) 100 percent
SVHC identification Undertake an initial assessment of substances submitted for SVHC identification under EU REACH during 2022/23 and consider if they are appropriate for SVHC identification under UK REACH Assess up to five
Regulatory management options analysis (RMOA) Complete RMOAs initiated in 22/23 

Initiate RMOAs for substances identified as priorities

Up to ten 

Up to five

Restriction Complete ongoing restriction opinions 

Begin Annex 15 restriction dossiers

Initiate scoping work for restrictions

Two

One 

Two

HSE Opens Call For Evidence On PFAS In FFFs: HSE is working with the Environment Agency to prepare a restriction dossier that will assess the risks of PFAS in firefighting foams (FFF). HSE will propose restrictions, if necessary, to manage any significant risks identified. To help compile the dossier, HSE opened a call for evidence. HSE states that it would like stakeholders to identify themselves as willing to engage in further dialogue throughout the restrictions process. In particular, it would like to hear from stakeholders with relevant information on PFAS (or alternatives) in FFFs, especially information specific to Great Britain (GB). Regarding relevant information, HSE is interested in all aspects of FFFs, including:

  • Manufacture of FFFs: Substances used, process, quantities;
  • Import of FFF products of all types: Quantities, suppliers;
  • Use: Quantities, sector of use, frequency, storage on site, products used;
  • Alternatives to PFAS in FFF: Availability, cost, performance in comparison to PFAS-containing foams, barriers to switching;
  • Hazardous properties: SDSs, new studies on intrinsic properties and exposure, recommended risk management measures;
  • Environmental fate: What happens to the FFF after it is used, where does it go;
  • Waste: Disposal requirements, recycling opportunities, remediation; and
  • Standards: Including product-specific legislation, performance, certification.

HSE states that the call for evidence targets companies (manufacturers, importers, distributors, and retailers) and professional users of FFFs, trade associations, environmental organizations, consumer organizations, and any other organizations and members of the public holding relevant information. HSE intends to publish the final dossier, including any restriction proposals, on its website in March 2025. Interested parties will also then be able to submit comments on any proposed restriction.

New GB BPR Data Requirements Will Apply To Applications Submitted In October 2025: The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024, which update the data requirements in Annexes II and III of the GB Biocidal Products Regulation (BPR), were laid in Parliament on March 13, 2024, and came into force on April 6, 2024. The legislation updates some of the data requirements to reflect developments in science and technology. These include the use of alternative testing approaches to determine some hazardous properties that previously relied on animal testing. HSE held a public consultation on the proposed changes in 2023 and has posted a report on the outcome of the consultation. The new data requirements will apply to applications received 18 months after the legislation came into force (October 6, 2025) and do not apply to existing applications. HSE will provide further guidance on the changes in the future.

Using an LLC to Protect the Family Vacation Home

Vacation homes offer a retreat from daily life, providing a sanctuary to relax and create cherished family memories. Many owners envision passing down their vacation home for future generations to enjoy, but the lack of proper planning can often lead to intra-family disputes. Leaving a vacation home outright to children or other family members may be the easiest option, but the potential for discord over the control and usage of the property only increases as ownership is passed from one generation to the next. A limited liability company (LLC) can mitigate the risk of conflict and provide a tailored solution to the meet the specific needs of a family.

When a vacation home is owned by an LLC, the membership interests in the LLC are passed down to younger generations, which allows for the continued use and enjoyment of the property by the family. The structure also provides a framework for management through an operating agreement, which governs the LLC. An operating agreement allows the original owner to create a plan for how the property will be used and managed as additional owners are added. The agreement can determine who is responsible for property management, how expenses should be proportioned and paid, how decisions should be made and provide guidelines for scheduling family usage. By establishing clear rules and procedures, an LLC can reduce the likelihood of disputes and encourage fairness among different generations.

Another benefit of an LLC is the ability to prevent unwanted transfers of ownership thus ensuring that the property stays in the family. A well-drafted operating agreement can prohibit membership interests from being transferred to third parties, protecting the family as a whole from an individual’s divorce or creditor problems. The LLC can also hold additional assets, including rental income and deposits of other funds earmarked for property expenditures, which facilitates the proper management and use of resources to cover expenses.

An LLC offers an efficient structure to avoid intra-family turmoil and preserves the spirit of the family vacation home for generations to come.

For more news on Protecting Real Estate Ownership, visit the NLR Real Estate section.