FDA Announces Plans for Post-Market Review of Chemicals in Food
On May 15, 2025, FDA announced a three-part agenda “to increase transparency and ensure the safety of chemicals in our food.” This step follows from the Agency’s post-market activities last fall, where FDA published a discussion paper and held a public meeting to outline its plan for developing a robust post-market review process for chemicals in food and to seek input from stakeholders. It is unclear from the announcement to what extent the comments submitted to FDA in January 2025 have been considered, following FDA’s public meeting on the development of a post-market assessment program.
Regarding its current proposal, FDA’s initiative will include the following elements: (1) a modernized, evidence-based prioritization scheme for reviewing existing chemicals; (2) a final, systematic post-market review process shaped by stakeholder input; and (3) an updated list of chemicals under review. FDA will continue to share information about the status of this work on its public website as part the Agency’s push for greater transparency.
FDA’s updated list of substances in the food supply undergoing review includes butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), and azodicarbonamide (ADA). All three of these substances have been targeted by Vani Hari, aka the Food Babe, indicating what appears to be an increase in her influence of the Make America Healthy Again (MAHA) agenda. The Agency also stated it will take steps to expedite substances currently under review, including titanium dioxide, for which FDA had determined in 2024 does not present a safety concern when used as a color additive for foods, phthalates, and propylparaben.
FDA’s announcement was concurrent with a presentation by Mark Hartman, Director of FDA’s Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI) at the Food and Drug Law Institute’s (FDLI’s) Annual Meeting in Washington, DC, where Hartman reassured the audience that, although a substance may undergo post-market review, this does not mean it is destined to be deemed unsafe. The OFCSDSI Director also relayed during his presentation that FDA is actively working on a rulemaking regarding self-GRAS determinations, a directive from HHS Secretary Kennedy on March 10, 2025. In this regard, Hartman shared that FDA is considering whether new chemicals should be allowed to continue to operate under a voluntary system or require mandatory GRAS Notice submissions, and which regulatory approaches should be used to address the lack of visibility on past self-GRAS positions.
FDA and HHS Solicit Comments on Deregulation
FDA and the Department of Health and Human Services (HHS) have launched a public Request for Information (RFI) to “identify and eliminate outdated or unnecessary regulations” in alignment with President Donald Trump’s Executive Order 14192.
Under the RFI, HHS Secretary Robert F. Kennedy, Jr. has committed to rescinding at least ten existing regulatory actions for every new regulation proposed. The effort is intended to “lower the cost of living, remove bureaucratic barriers, and allow health care providers to devote more time and resources to patient care.”
HHS intends to implement the following measures under the Executive Order:
The 10-to-1 rule: Eliminate at least ten existing regulations for every new regulation introduced.
Regulatory cost cap: The total cost of all new regulations in fiscal year 2025 must be significantly less than zero.
Expanded scope: The order applies to guidance documents, memoranda, policy statements, and similar directives, in addition to formal regulations.
Radical transparency: HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset.
According to FDA Commissioner Marty Makary, “[t]his initiative is about restoring common sense to health care regulation. . . .We welcome public input to help identify reforms that truly make a difference.”
During an FDA Update session at the Food and Drug Law Institute’s (FDLIs) Annual Meeting in Washington, D.C., FDA officials reiterated the Agency’s commitment to transparency and complying with the Executive Order while also working toward FDA’s priorities. For example, the Agency has moved forward with approving new uses for three non-certified color additives as part of the Agency’s strategy to phase out certified color additives, as we previously blogged.
The RFI’s 60-day public comment period opened May 13, 2025. Comments may be submitted through regulations.gov under docket AHRQ-2025-0001 or at regulations.gov/deregulation.
If “Will” Means “Shall”, Does “Shall” Mean “Will”, “May” or “Must”?
In reviewing a recent agreement, I came across the following interpretive provision:
The word “will” shall be construed to have the same meaning and effect as the word “shall.”
As someone who has commented about the ambiguity of “shall” in corporate documents, I find this rule of interpretation to be decidedly unhelpful:
Although “shall” is a perfectly fine word, I’m trying to eschew using it in legal documents. In my view, it has the potential for ambiguity. As a test, take a set of bylaws and then try to substitute “will”, “may” or “must” for “shall”. For example, a bylaw might provide that board meetings shall be called by the Chairman of the Board, the President or any Vice President. This doesn’t mean that these individuals must call special meetings – only that these are the persons that may do so. Another bylaw may provide that expenses incurred in defending a proceedings shall be advanced. Here, the intent is likely to be that the corporation must do so.
Over the weekend, I had the pleasure of again attending the Nevada Old Time Fiddle Contest in Eureka, Nevada. The town justifiably calls itself the “friendliest town on the loneliest road in America”. I could not agree more.
The contest is held in the historic and beautiful opera house, which is featured in this song by Richard Elloyan.
Eureka County also appears to have a correspondingly low incidence of criminal activities. According to the local paper in Eureka County, “For the dates of May 2, 2025 – May 8, 2025, there were no arrests reported and no Court cases.”
Beltway Buzz, May 16, 2025
The Beltway Buzz™ is a weekly update summarizing labor and employment news from inside the Beltway and clarifying how what’s happening in Washington, D.C., could impact your business.
Republican Legislators Push Ahead With Agenda. This week, the U.S. House of Representatives’ Committee on Ways and Means advanced—on a party-line 26–19 vote—a tax reform package that included Republicans’ top fiscal priorities. The bill makes permanent many provisions of the 2017 Tax Cuts and Jobs Act and includes other measures, such as an expansion of the child tax credit. Of particular interest to the Buzz, the bill also provides temporary (2025 through 2028 tax years) above-the-line deductions for qualified tips and overtime premium pay. There is still quite a long way to go for this bill, and changes are expected, especially considering that some Republicans in the U.S. Senate have already expressed some reservations about the proposal.
OMB Approves EEO-1 Changes. On May 12, 2025, the Office of Management and Budget (OMB) approved changes to the EEO-1 form that removes employers’ option to disclose non-binary employee data. The U.S. Equal Employment Opportunity Commission (EEOC) requested the changes pursuant to President Trump’s Executive Order 14168, “Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” The proposed instruction booklet filed with OMB indicates that the 2024 EEO-1 filing period would begin on May 20, 2025. There has been no word yet from the EEOC in light of OMB’s approval of the change. Kiosha H. Dickey and James A. Patton, Jr. have the details.
PBGC Nominee on the Move. On May 15, 2025, the U.S. Senate Committee on Health, Education, Labor and Pensions voted to advance the nomination of Janet Dhillon to serve as the director of the Pension Benefit Guaranty Corporation (PBGC). Created by the Employee Retirement Income Security Act of 1974, PBGC protects workers’ retirement benefits through its single-employer and multiemployer insurance programs. Dhillon previously served as chair of the EEOC. Her nomination now awaits a vote on the Senate floor.
House Committee Examines OSHA. On May 15, 2025, the House Committee on Education and the Workforce’s Subcommittee on Workforce Protections held a hearing entitled “Reclaiming OSHA’s Mission: Ensuring Safety Without Overreach.” The hearing focused on the Occupational Safety and Health Administration’s (OSHA) regulatory and enforcement agenda during the Biden administration and “explore[d] common-sense solutions that can return OSHA to fulfilling its purpose of advancing workplace safety.” Legislators and witnesses discussed OSHA’s proposed heat standard, the final “walkaround rule,” and the Severe Violator Enforcement Program. With regard to OSHA’s heat proposal, Republicans and their witnesses criticized its one-size-fits-all proscriptions—arguments that are likely to be made at OSHA’s public hearing on the proposal in June.
Disparate Impact Follow-Up. President Trump’s recent executive order directing federal agencies to limit the use of disparate-impact theories of liability is having a ripple effect at implementing agencies and among stakeholders. Here is the latest fallout:
Department of Energy Rescinds Regulations. The U.S. Department of Energy—not an agency that we normally deal with at the Buzz—took steps this week to rescind forty-seven regulations. Included is a direct-to-final rule, entitled, “Rescinding Regulations Related to Nondiscrimination in Federally Assisted Programs or Activities (General Provisions).” With regard to a regulatory provision concerning nondiscrimination in federally assisted programs or activities, the direct-to-final rule states the following:
Furthermore, absent a specific, identified, instance of intentional discrimination, statistical information indicating that certain protected groups are underrepresented in some occupations or professions does not obligate any FFA [federal financial assistance] recipient to take remedial or affirmative action under this part. To the contrary, any affirmative action for which “measures of success” depend on “whether some proportional goal has been reached” amounts to “outright racial balancing” which is “patently unconstitutional.” For these reasons, DOE is rescinding 10 CFR 1040.8 in its entirety.
Former EEO Officials Respond. While federal agencies begin implementing the executive order (EO), former EEOC and Office of Federal Contract Compliance Programs (OFCCP) officials issued a statement challenging the legal rationale underlying the EO, noting that President Trump’s executive order “may not change a clear statutory mandate and decades of legal precedent.” The statement further notes that contrary to the EO’s claim that the disparate impact theory eliminates meritocracy in the workplace, “disparate impact liability is a means to ensure that merit prevails and that unnecessary and unjustified criteria do not disqualify meritorious candidates on grounds linked to their race, sex, or other protected personal characteristic.” To be sure, the statement will have no impact on the administration’s current views, but it does serve as a reminder to employers and workers that while disparate impact may be deprioritized by the administration, it is still codified in federal law, has been affirmed by the Supreme Court of the United States, and is a viable legal theory for plaintiffs’ counsel.
Immigration: TPS Update.
In a notice published in the Federal Register on May 13, 2025, the U.S. Department of Homeland Security announced that it would not extend the designation of Afghanistan for Temporary Protected Status (TPS), which is set to terminate on May 20, 2025. Pursuant to the required sixty-day notice period, TPS for Afghanistan will now expire on July 14, 2025. According to the notice, “there are notable improvements in the security and economic situation such that requiring the return of Afghan nationals to Afghanistan does not pose a threat to their personal safety due to armed conflict or extraordinary and temporary conditions.”
Venezuela TPS. A bipartisan group of representatives has introduced the Venezuela TPS Act of 2025. The bill would automatically designate Venezuela for TPS for eighteen months—with an option for renewal—from the time the bill is enacted. Of course, enactment will be a significant challenge in the Republican-controlled U.S. Congress. Pursuant to a federal court ruling, Venezuela’s TPS designation has been extended through October 2, 2026, and work authorization remains valid through April 2, 2026.
RIP, Justice Souter. Supreme Court Justice David Souter died last week at the age of eighty-five. Appointed by President George H. W. Bush, Souter served on the Supreme Court from 1990 to 2009. The Buzz remembers Souter for his role in authoring two significant Supreme Court decisions on employment law. Souter authored the majority opinion in Faragher v. City of Boca Raton (1998), which held that “an employer is vicariously liable for actionable discrimination caused by a supervisor, but subject to an affirmative defense looking to the reasonableness of the employer’s conduct as well as that of a plaintiff victim.” Additionally, in Meacham v. Knolls Atomic Power Laboratory (2008)—a disparate-impact case under the Age Discrimination in Employment Act (ADEA) involving a reduction in force—the Court held that the employer, not the employee, has the burden of proving that its employment decision was based on reasonable factors other than age. Souter, writing for the 7–1 majority, stated that while “there is no denying that putting employers to the work of persuading factfinders that their choices are reasonable makes it harder and costlier to defend[,]” the Court must read the ADEA “the way Congress wrote it.”
Rising Temperatures Bring New Obligations for Maryland Employers
Maryland employers are facing the first summer under a heat-related illness prevention standard issued by Maryland Occupational Safety and Health (MOSH). MOSH joins several other Democratic-led Occupational Safety and Health Administration (OSHA) state-plan states, such as California, Nevada, Oregon, and Washington, that have promulgated similar standards in recent years.
Quick Hits
Maryland employers must comply with Maryland Occupational Safety and Health’s (MOSH) new heat-related illness prevention standard.
The MOSH standard has been criticized for its vagueness and the burden it places on employers, leading to potential confusion and inconsistent enforcement.
The Supreme Court’s decision in Loper Bright Enterprises v. Raimondo may limit MOSH’s ability to enforce its interpretation of the new standard, potentially leading to legal challenges.
The MOSH standard applies to all employers whose employees are exposed to an indoor or outdoor heat index of 80°F for more than fifteen minutes in an hour. At a heat index of 90°F or more, high-heat procedures apply. Maryland employers must:
monitor the heat index throughout the work shift;
develop and maintain a written heat-related illness prevention and management plan, made available to their employees and MOSH, that includes an extensive list of required elements, including the importance and availability of rest and drinking water, alternative cooling and control measures, symptoms of heat-related illness and how to respond, acclimatization, high-heat procedures, emergency response, and training;
acclimatize newly hired employees and those returning to the workplace after an absence of seven or more days;
provide adequate and accessible shade, or alternative cooling and control measures;
provide cool and potable drinking water throughout the workday (at least thirty-two ounces per hour per employee); and
provide training regarding heat-related illness prevention at least annually and “[i]mmediately following any incident at the worksite involving a suspected or confirmed case of heat-related illness.” The training must cover a list of specific topics, including environmental and personal factors affecting heat-related illness, acclimatization, the importance of water and rest breaks, signs and symptoms of heat-related illness, responding to heat-related illness, and how the employer will comply. Employers must retain training records for one year following the training date.
The MOSH standard is among the most onerous for employers and has been criticized for the vagueness of its acclimatization, monitoring, and training requirements. While MOSH claims the standard is intended to provide the flexibility to implement a program that considers the unique conditions present at each worksite, the standard’s breadth and ambiguity have caused confusion among employers and set the stage for inconsistent enforcement and litigation.
MOSH promised to provide guidance. It initially issued “Key Requirements” and a “Summary of Key Maryland Requirements fact sheet,” both of which simply reiterate the vague language in the standard. More recently, however, MOSH published an optional model program, itemizing specific and detailed actions that the agency stated employers should consider in developing their plan. Additionally, MOSH conducted a webinar to discuss compliance with the standard, and has now made the recording available on its website. In the webinar, MOSH offered some practical tips beyond the written guidance, including:
Employers may use the wet bulb globe temperature (WBGT) method to monitor the heat index, even though it is not specifically listed as an option in the standard.
The acclimatization schedule is specific to the individual employee—it can be less or more than the general timelines set forth in the standard.
Employers that use their own health care professional (HCP) for pre-employment physicals can direct the HCP to ask the new employee about chronic conditions or medications that pose additional risks for heat-related illness. Although the HCP should not share that specific information with the employer, the HCP can alert the employer that the employee may be more prone to heat-related illness.
Employers may not ask employees directly about their medical conditions or medications in advance of heat-related illness incidents. Employees should be trained that if they have such conditions, they must be more mindful of heat stress.
The definition of “alternative cooling and control measures” includes a variety of protective measures, such as misting equipment and cooling devices, that can alter the employer’s obligation to develop acclimatization procedures and mandatory breaks in accordance with the language in the standard.
The mandatory break periods do not necessarily require cessation of all work but instead can include light duty, paperwork, and similar activities.
Nonworking rest periods of under twenty minutes must be paid in compliance with the Fair Labor Standards Act. Longer nonworking breaks can be unpaid.
Employers must assume that day laborers and temporary employees are not acclimatized.
While the information MOSH provided in the webinar is helpful, additional written compliance guidance would be more helpful to employers developing plans. Given the ambiguous provisions in the MOSH standard, “Monday-morning quarterbacking” may be inevitable, with MOSH taking the position that the employer must be out of compliance if an employee suffers a significant heat-related illness. That position ignores the fact that heat-related illnesses often involve conditions outside of the employer’s control, such as illness, physical fitness, personal medical conditions, and age.
From a legal standpoint, MOSH’s ability to enforce its ad hoc interpretation of the standard’s provisions may be limited. In Loper Bright Enterprises v. Raimondo, the Supreme Court of the United States eliminated deference to an agency’s interpretation of its own statute. The holding will limit the ability of federal agencies to argue successfully that a court must defer to their interpretation of a standard or regulation. The effect of the Loper Bright holding on state regulatory provisions remains to be seen, but it could limit MOSH’s ability to impose its own interpretation of vague provisions on employers, particularly in the absence of written compliance guidance.
Antitrust Compliance for North Carolina Construction Companies: Avoiding Legal Pitfalls
The construction industry has long been a target for antitrust enforcement.
For construction company owners and managers, understanding antitrust laws and implementing effective compliance measures isn’t just good business practice, it’s essential protection against potentially devastating legal consequences.
Why Antitrust Matters in Construction
Antitrust laws are designed to protect consumers and the competitive marketplace from behaviors that restrict competition or trade. They apply to businesses of all sizes, including construction companies, and carry serious penalties for violations.
The construction industry faces particular scrutiny for several reasons. The project-based nature of the business creates numerous opportunities for competitors to interact on bids and contracts. The prevalence of subcontractor relationships often blurs the lines between competitors and partners. Local trade associations often bring competitors together, creating environments where improper discussions may occur. Additionally, the substantial dollar values involved in many construction projects naturally increase regulatory interest in ensuring fair and competitive practices.
Understanding the Legal Landscape
Antitrust laws operate at both federal and state levels and can create both civil and criminal liability. The core federal antitrust statutes include three primary laws that construction company managers should understand.
The Sherman Act serves as the foundational antitrust law, outlawing conduct that unreasonably restricts trade and criminalizing monopolization. It creates both civil and criminal liability for anti-competitive behaviors, making it particularly powerful in enforcement actions.
The Clayton Act, prohibits specific anti-competitive practices. These include price discrimination between customers when harmful to competition, “refusal to deal” arrangements, “tying” arrangements that stifle competition, and selling goods at unreasonably low prices specifically to destroy competition.
The Federal Trade Commission Act broadly bans “unfair methods of competition” and “unfair and deceptive acts or practices,” providing a flexible tool for regulators to address emerging anti-competitive behaviors that might not fit clearly into other statutory frameworks.
While these laws might seem abstract, courts have translated them into very specific prohibitions that affect day-to-day decisions in construction management.
“Per Se” Violations: The Highest Risk Activities
Certain behaviors are considered so inherently anti-competitive that they are deemed “per se” violations—meaning they’re automatically illegal regardless of their actual effect on competition. For construction companies, the most common per se violations fall into three categories: price fixing, market division, and bid rigging.
Price Fixing
Price fixing occurs when competitors agree to raise, fix, or maintain prices rather than allowing market forces to determine them. This doesn’t require an explicit agreement to charge exactly the same price—almost any coordination on pricing elements can violate the law.
Common examples in construction include agreements among competitors to establish or adhere to certain price discounts, hold prices firm, adopt standard formulas for computing prices, or adhere to minimum fee schedules. Each of these practices undermines the competitive pricing that antitrust laws are designed to protect.
Several warning signs might indicate potential price fixing. These include identical prices among competitors, especially when they previously varied; simultaneous price increases not supported by increased costs; or elimination of discounts that were historically offered. Any of these patterns should prompt careful review of competitive practices.
Market Division
Market division schemes involve competitors agreeing to divide markets among themselves, whether by geographic area, customer type, or project category. For example, if two contractors whose footprints previously overlapped agree that one will only pursue projects in eastern North Carolina while the other focuses on the Piedmont region, that may be an illegal market division.
These agreements also can manifest in more subtle ways. Even bidding behaviors like consistently declining to bid in certain areas or for certain customers, or submitting intentionally high bids outside your “territory,” can suggest market division. Both refusing to sell in certain markets and quoting intentionally high prices in those markets can raise suspicions of market allocation agreements.
Bid Rigging
Bid rigging is particularly relevant to construction companies and takes many forms. In bid suppression schemes, competitors agree that some will refrain from bidding or withdraw bids so that another can win. The winning bidder often rewards the others with subcontracts as compensation for not competing. With complementary bidding, competitors submit “cover bids” that are intentionally too high or contain special terms ensuring they won’t be accepted, creating the illusion of competition while guaranteeing a predetermined winner. In bid rotation schemes, all competitors submit bids but take turns being the lowest bidder according to a predetermined pattern.
Each of these practices artificially inflates prices and undermines the competitive bidding process that public and private owners rely on to obtain fair market prices. Government enforcement agencies are particularly vigilant about bid rigging in public construction projects, where taxpayer funds are at stake.
High-Risk Situations: When to Be Especially Vigilant
Certain business situations potentially create higher antitrust risk and deserve special attention from construction company managers and owners.
Interactions with Competitors
Direct communication with competitors presents the highest risk of antitrust violations. When interaction becomes necessary, construction managers should keep communications concise and strictly business-related. Any discussion of pricing, costs, or bidding strategies should be scrupulously avoided. It’s important to remember that all written communications, including emails and text messages, are potentially discoverable in litigation. Never fall into the trap of justifying questionable practices because “everyone else is doing it”—this provides no legal protection and may actually make the violation appear more deliberate.
Trade Association Meetings
Trade associations are typically the first place government investigators look when suspecting antitrust violations. While these organizations provide valuable industry benefits, they also create regular opportunities for competitors to interact. When participating in trade association activities, construction managers should avoid any discussions of prices, terms or conditions of sale, costs, future production, or marketing plans—even in informal settings like dinners or social events. Reviewing meeting agendas in advance can help identify potentially problematic discussion topics. If conversations venture into sensitive competitive areas, consider leaving the meeting to avoid even the appearance of participating in improper discussions. Having legal counsel review any information-sharing programs before participation can provide additional protection.
Joint Ventures and Partnerships
Joint ventures between competitors can serve legitimate business purposes but require careful structuring to avoid antitrust issues. If you’re considering a joint venture with a potential competitor, consulting legal counsel at the earliest possible stage can help ensure the arrangement is properly structured to achieve business objectives without creating antitrust exposure.
Communications About Pricing and Bidding
Any exchange of price information between competitors is dangerous under antitrust laws—even if the information is publicly available. This extends to all discussions about competitive bids, which are legally equivalent to discussions about prices and other sales terms. Even seemingly innocent sharing of pricing strategies or bidding approaches between competitors can create significant legal risk.
While you cannot discuss pricing with competitors, antitrust laws don’t prohibit gathering market intelligence from non-competitor sources. Customers, vendors, and publications can provide legitimate market insights without creating legal exposure. These channels allow construction companies to understand market conditions without engaging in direct communications with competitors.
Practical Compliance Strategies for Construction Managers
To protect your company and yourself from antitrust liability, several practical strategies can be implemented:
Developing a clear compliance policy is essential—this written document should clearly identify prohibited behaviors and provide guidance for high-risk situations. Regular review and updates ensure this policy remains current with changing enforcement priorities.
Implementing regular training for all employees involved in pricing, bidding, or competitive decision-making ensures everyone understands not just what’s prohibited but why these rules matter. These educational efforts should be documented and refreshed annually.
Establishing standardized protocols for bid development emphasizes independent decision-making and creates documentation showing the legitimate business basis for bidding decisions. These procedures help demonstrate that pricing decisions reflect individual business judgment rather than collusion.
Creating confidential channels for employees to report potential violations without fear of retaliation supports early internal detection of problems, allowing for corrective action before government involvement. This reporting system should include protections for whistleblowers and clear procedures for investigating concerns.
Maintaining clear records that show the legitimate business justifications for pricing decisions, market strategies, and joint ventures with competitors provides valuable evidence if questions ever arise. These records should document the business rationale, market factors, and cost considerations that drove important competitive decisions.
Implementing thorough due diligence procedures for activities like joint ventures and trade association participation helps identify and mitigate antitrust risks before they become problems. This assessment process should involve legal counsel when appropriate.
If You’re Contacted by Investigators
If government investigators contact you about a potential antitrust matter, your initial response is critical. Always treat investigators professionally and courteously, but avoid answering substantive questions until speaking with legal counsel. Limit your responses to basic identification information regarding your employment, and politely explain that any document requests must be directed to company legal counsel.
Resources
For additional guidance, valuable resources include the Department of Justice’s primer on “Price Fixing, Bid Rigging, and Market Allocation Schemes” and the FTC’s Competition Guidance Documents, both available online.
Cal/OSHA Announces Discussion Drafts for Revised Wildfire Smoke Protection and Heat Illness Prevention Standards
On Friday, May 9, 2025, the California Division of Occupational Safety and Health (Cal/OSHA) announced discussion drafts for the wildfire smoke regulation, as well as the indoor heat and outdoor heat regulations. The drafts were posted online and provide for substantial changes to both regulations. Future advisory committees will be announced, however, and Cal/OSHA requests written comments by July 7, 2025.
Quick Hits
The revisions to Section 3395, the outdoor heat illness prevention regulation, provide greater details and requirements for acclimatization. The same changes are intended for Section 3396, the indoor heat illness prevention regulation.
Both the indoor and outdoor heat draft revisions would require that the plan be distributed to new employees upon hire, during heat illness prevention training, and at least once a year.
The draft wildfire smoke regulation would adjust the AQI table to indicate that AQI Category for PM2.5 at 301 or above (as opposed to 301 to 500) as “hazardous.” Additionally, the proposed regulation clarifies that a written respiratory protection program and fit testing are not required unless the AQI for PM2.5 exceeds 500.
Despite the fact that the federal Occupational Safety and Health Administration’s (OSHA) heat proposal draft has not been adopted (on June 16, 2025, OSHA will host a virtual public hearing on its proposed rule), Cal/OSHA appears to be moving ahead, attempting to codify aspects of the federal proposal prior to that rule’s adoption.
Next Steps
Employers interested in Cal/OSHA’s draft proposals to revise the wildfire smoke protection and heat illness prevention standards can submit written comments by July 7, 2025, to [email protected] and [email protected]. An advisory meeting will be scheduled at a later date.
The Regulatory Horizon: Legal Framework for Commercial Fusion Power
Key Takeaways
The fusion power industry has evolved from primarily government-led initiatives to include over 45 private companies with combined funding exceeding $7 billion
The NRC is developing fusion-specific regulations with proposed rules anticipated in May 2025
In 39 “Agreement States,” state authorities may regulate fusion under delegated NRC authority
Beyond nuclear regulations, fusion facilities will face state and local permitting related to land use, environmental impact, and public safety
Early engagement with both federal and state regulators is advisable for fusion companies to navigate this evolving regulatory landscape
Strategic Considerations for Stakeholders
For Fusion Developers: Submit comments during the NRC’s rulemaking period to shape regulations favorable to your technology approach
For Investors: Evaluate potential fusion investments based partly on regulatory preparedness and engagement with authorities
For Utilities: Begin exploring power purchase agreement structures that account for fusion’s unique regulatory status
For Communities: Prepare to participate in upcoming state and local permitting processes by developing informed positions on fusion facility siting
For Policy Advocates: Identify gaps in current regulatory frameworks that could be addressed through state legislation or federal guidance
For International Entities: Monitor the U.S. regulatory approach as a potential model for other jurisdictions developing fusion regulations
The energy source that powers the stars was first demonstrated in an experiment in 1934.
Ever since then the promise of clean, virtually limitless energy has been greatly anticipated with commercial fusion power perennially predicted to come “within the next ten years.” Recent advances in physics, materials science, and other fields may finally prove those predictions true. This article provides a brief overview of the current state of the fusion power industry and discusses the developing regulatory framework as we await the reality of commercial fusion power.
The Emerging Fusion Industry
Fusion R&D was historically dominated by national governments collaborating on major projects like Euratom’s Joint European Torus (1973) and the International Thermonuclear Experimental Reactor (1985), which began with Euratom, Japan, the US, and Soviet Union and now includes 27 nations. While national projects in China, Japan, South Korea, France and elsewhere continue advancing fusion technology, they’ve been joined by private sector companies bringing new energy (pun intended) to commercial fusion development.
Today, over 45 companies worldwide are pursuing commercial fusion with funding exceeding $7 billion from venture capital, governments, and energy-intensive industries seeking to become fusion power customers. Unlike government efforts focused on limited technologies, private enterprises explore diverse innovative approaches. All stakeholders face challenges in high-temperature materials, plasma stability, commercial scalability, and system costs. This competition and collaboration between entrepreneurial companies and governmental projects fuels growing optimism that commercial fusion power may soon become a reality.
As technical development progresses, parallel efforts are creating regulatory frameworks that recognize fusion’s unique characteristics, ensuring safe deployment without inhibiting industry growth.
…Congress and the U.S. Nuclear Regulatory Commission (USNRC) have taken a number of steps to develop a regulatory framework for fusion power.
Evolution of the U.S. Fusion Power Regulatory Framework
As discussed in previous articles in this series, there is an extensive statutory and regulatory framework applicable to fission-based nuclear power in the United States. This framework is predicated broadly on issues related to public safety and control of the fissile material that fuels commercial reactors which could present weapons proliferation concerns if not regulated appropriately. Recognizing that fusion facilities do not present these same risks, Congress and the U.S. Nuclear Regulatory Commission (USNRC) have taken a number of steps to develop a regulatory framework for fusion power.
The Nuclear Energy Innovation and Modernization Act of 2018 (NEIMA) included “fusion reactors” in the definition of “advanced reactors” and directed USNRC to develop a regulatory framework for the licensing of advanced reactors by December 31, 2027. Following USNRC Staff’s consideration of various licensing approaches, in 2023 USNRC directed its staff to develop rules for the licensing and regulation of fusion energy facilities that treat these facilities under the “byproduct material” regulations rather than the regulations applicable to commercial fission power facilities. Congress essentially codified this decision in Section 205 of the Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy (ADVANCE) Act of 2024 which amended the Atomic Energy Act (42 U.S.C. § 2014) and NEIMA to define “fusion machines” and classify the radioactive materials used in and produced by them as byproduct material.
This regulatory approach makes sense since fusion machines use certain byproduct materials as fuel and may produce additional byproduct materials through the fusion reaction. It offers the benefits of a streamlined process as compared to the 10 CFR Part 50 processes applicable to fission reactors and technology-neutral, risk-informed, performance-based regulations that could be relevant to multiple fusion technologies.
Since 2023, USNRC Staff has engaged with public stakeholders to develop proposed rules that will provide regulatory clarity and predictability for the US fusion power industry. USNRC has described this as a limited-scope rulemaking that considers known fusion systems and those that can be reasonably anticipated in the immediate future, builds on existing regulations as much as possible, and focuses on license application requirements and processes and other issues specific to fusion systems. USNRC’s proposed fusion power regulations will be located primarily in 10 CFR Part 30 – Rules of General Applicability to Domestic Licensing of Byproduct Material, with additional guidance in a new fusion-specific Volume 22 of NUREG-1566, Consolidated Guidance About Materials Licenses. A draft of NUREG-1566, Volume 22 was released in March 2024 and provides additional information for fusion system possession license applications and implementing guidance. Publication of the proposed rules is presently anticipated in May 2025 which will initiate the formal rulemaking proceeding.
Currently, 39 states have entered into such agreements and USNRC has indicated it intends to work with Agreement States to develop a comprehensive fusion regulatory framework.
The Agreement States Program and Other State Regulations
The Agreement States Program is based in Section 274b of the Atomic Energy Act and enables USNRC to authorize individual states to license and regulate nuclear materials – including source materials, special nuclear materials, and byproduct materials – in order to protect the public from radiation hazards associated with such materials. These agreements effectively delegate to the state USNRC’s authority to regulate the specified nuclear materials for the duration of the agreement. USNRC may also grant exemptions from certain licensing requirements of the Atomic Energy Act and from its regulations applicable to certain licensees as needed to carry-out the agreements. Such exemptions may include requirements and regulations related to byproduct materials. This is particularly relevant given that USNRC intends to regulate fusion power under the byproduct materials framework.
Currently, 39 states have entered into such agreements and USNRC has indicated it intends to work with Agreement States to develop a comprehensive fusion regulatory framework. In Agreement States, entities seeking regulatory approval to use byproduct materials for fusion applications will be required to apply to the relevant state authority; in non-Agreement States, the application will be filed with USNRC.
…it is also important to keep in mind that fusion facilities will also be regulated by state and local governments under their existing land use, environmental, public health and safety, and other relevant authority.
While states’ specific role in regulating not only byproduct materials used in fusion systems but also the systems themselves may evolve following completion of the USNRC rulemaking, states such as Massachusetts, Washington, and others are already regulating fusion systems being used for R&D purposes under their existing nuclear materials authority. Given the current state of fusion regulations and the unique technical and radiological issues associated with fusion, which state radiation control offices may be unfamiliar with, it is advisable for fusion companies to engage early with their relevant state regulators. Such engagement will allow time for states to gather relevant information and seek technical support from USNRC under the Agreement States program thereby increasing the likelihood of a timely state licensing decision that meets the company’s schedule.
While substantial attention is being paid to the federal regulations for fusion systems and, by extension, regulation by Agreement States, it is also important to keep in mind that fusion facilities will also be regulated by state and local governments under their existing land use, environmental, public health and safety, and other relevant authority. State and local permitting and siting authorities are likely to have many questions concerning how First-of-A-Kind fusion systems can be located appropriately and developed and operated consistent with public interests. Therefore, it is equally prudent for fusion companies to engage with these authorities at the appropriate stage in project development.
Conclusion
As we witness the convergence of technological breakthroughs, substantial private investment, and regulatory development, the long-promised potential of fusion energy appears increasingly within reach. USNRC’s proposed regulatory framework acknowledges fusion’s unique characteristics while providing necessary oversight. For industry stakeholders across the spectrum—from developers and investors to utilities and communities—the next three years present a window of opportunity to shape this emerging framework. By engaging proactively with federal and state regulators, participating in upcoming rulemaking processes, and preparing for implementation of the final regulations, stakeholders can help ensure that the regulatory environment supports rather than hinders fusion’s commercial development. As fusion technology moves from laboratory to commercial deployment, this collaborative approach to regulation may well become a model for how emerging clean energy technologies can be safely and effectively integrated into our energy infrastructure, potentially unlocking one of humanity’s most promising solutions to climate change and energy security challenges.
Find the previous articles from this series here:
Powering the Digital Future: Navigating the Nuclear Option for Data Centers
Cybersecurity in the Nuclear Industry: US and UK Regulation and the Sellafield Case
New Life for Nuclear Power: License Extensions and Recommissioning
Powering The Future: The UK’s Nuclear Revolution
Washington Governor Signs State’s ‘Mini-WARN Act’: Notice Required for Site Closings and Mass Reductions in Force
On May 13, 2025, Washington Governor Bob Ferguson signed a bill into law that will require employers with fifty or more full-time employees to notify the state, any union, and affected employers of a business site closing or mass reduction in force (RIF).
Quick Hits
Washington Governor Ferguson has signed the state’s new “Mini-WARN Act” law, requiring notice before closing certain business sites or conducting a mass RIF.
The Washington law requires more notice than what is required under federal law and has specific protections for employees taking state mandated paid family or medical leave.
The law, Senate Bill (SB) 5525 or the “Securing Timely Notification and Benefits for Laid-Off Employees Act,” provides employees with similar protections regarding business site closings or a “mass layoff” as the federal Worker Adjustment and Retraining Notification (WARN) Act. The Washington law is one of many state laws, known as “Mini-WARN Acts,” that provide similar notice protections regarding mass RIFs.
However, SB 5525, which was passed by state lawmakers in April 2025, requires most covered employers to provide more notice than what is required under the WARN Act, and will also protect employees from being included in a reduction while they are taking Washington’s paid family or medical leave. Further, the law grants the Washington State Employment Security Department (ESD), aggrieved employees, or the employees’ union bargaining representative a private right of action to enforce.
Next Steps
The law will now go into effect on July 27, 2025. A more comprehensive breakdown of the SB 5525 can be found in our prior article here.
Throwing Away the Toaster: Where AI Controls Are Now and May be Heading
Years ago, when I was a baby lawyer living in a group house in DC, we had a toaster—my toaster. I had owned the toaster since college and it was showing its age. Eventually, you had to hold down the thing[1] to keep the bread lowered in the slots and toasting. But the appliance still heated bread and produced toast. One morning, I became so frustrated with that toaster and the thing-holding-down effort that I threw the toaster out, fully intending to get a new toaster.
The following day, my housemate, we’ll call him Mike,[2] raised an important series of questions:
Mike: Did you throw away the toaster?
Me: Yes. I was frustrated that it did not work right.
Mike: Did you get a new toaster?
Me: No, but I will soon.
Mike: Did our old toaster make toast?
Me: [pause] Ah . . . well, I mean, umm, yes. I see your point.
Anyhow, on a possibly related note, on May 14, 2025, BIS announced that it will rescind the AI Diffusion Rule and that, until the time of the official recission, would not enforce the Biden-era regulation.
Stop-Gap Stopped
Reading the BIS announcements, it appears that, once the AI Diffusion Rule is officially rescinded, there will not be any U.S. export control that restricts the provision of cloud computing through Infrastructure as a Service (IaaS). While the export of the certain ICs will still be controlled, ICs already owned or lawfully obtained could be put to any purpose, such as providing IaaS services for the development of AI in China.
If we return to October 2023, we see a comment made regarding the 2022 semiconductor regulations, highlighting that those rules, as then written, “may give China computational access to their equivalent ‘supercomputers’ via an IaaS arrangement.” (88 Fed. Reg. 73467). BIS acknowledged that the semiconductor regulations did not then cover IaaS, when it recognized that it was “concerned regarding the potential for China to use IaaS solutions to undermine the effectiveness of the October 7 IFR controls and [BIS] continues to evaluate how it may approach this through a regulatory response.” A plain reading of that statement indicates that the semiconductor regulations were not meant to (or could not be read to) cover IaaS.
However, the 2025 AI Diffusion Rule attempted to cover to that regulatory loophole and prohibit IaaS access for Chinese AI development. The Rule created ECCN 4E091 to cover certain AI models and then created a presumption that certain IaaS services would result in an unauthorized export of those 4E091 AI models. Effectively, that presumption created a restriction on cloud service providers to be able to provide certain IaaS services to entities in the PRC. With the recission of the AI Diffusion Rule, it appears that the loophole has been reopened.
Guidance Through and Inter-Rule Interim
In tandem with the rescission of the AI Diffusion Rule, BIS also issued three guidance documents that (1) put companies on notice that the Huawei Ascend 910 series chips are presumptively subject to General Prohibition 10[3], (2) provides guidance on due diligence that companies can conduct to prevent diversion of controlled ICs, and (3) reiterates existing controls that put restrictions on certain end-users and end-uses.
Those three guidance documents give the impression of a certain tension in the rulemaking process and they provide some hints as to be in store for the replacement AI rule:
On one hand, the new administration rescinded the AI Diffusion Rule in line with, if not in response to, calls from U.S. AI-related industry. The administration also recognized that there may have been flaws with the AI Diffusion Rule. For instance, the tiered approach to limiting and restricting exports of controlled ICs exclude many countries that are friendly to the U.S.—such as Iceland, Israel, and much of the EU and Eastern Europe. The AI Diffusion Rule did not put those U.S.-aligned countries on a tier in which they could freely acquire U.S. AI-supporting chips and, additionally, did not present a clear path for how those countries could move into the more favored tier.
As an alternative to the tiered approach researchers have suggested the idea of a country-by-country approach. That approach appears to be consistent with the administration’s recent trip to the Middle East, where it is reported that agreements with Saudi Arabia and the UAE have been negotiated to purchase U.S. producers’ GPUs (notwithstanding the fact that, under current regulations, those countries face restrictions on the purchase of certain advance semiconductors because of diversion risk).
While major semiconductor manufacturers have been the face of the recission effort, other major AI infrastructure players have been lobbying the administration to have the rule rescinded. Those companies had established or were working on data center projects in countries like Malaysia, Brazil, or India that were affected by the AI Diffusion Rule, particularly in how it limited compute capacity in those countries and restricted the use of the data centers.
On the other hand, with the AI Diffusion Rule scrapped, and no replacement ready, we suspect that officials at Commerce could be concerned about the re-opening of the IaaS loophole. The guidance documents appear to attempt to try to cover the gap left by the recission of the AI Diffusion Rule. In those guidance documents, BIS explains a policy whereby sellers of controlled ICs would need to conduct additional due diligence of IaaS providers when red flags are present. That approach stands in contrast to the AI Diffusion Rule, which put some diligence requirement on the service providers. In that we see a significant clue that a new replacement rule will likely find some way to restrict IaaS providers, but balance the interests of U.S. chip manufacturers and AI hyperscalers.
The guidance also announced the Huawei Ascend 910-series chips were presumptively a foreign direct product and subject to the EAR, presumptively violative of the EAR, and ultimately subject to General Prohibit 10. Ostensibly, that guidance could have a chilling effect on the purchase of Huawei chips, particularly in countries that wish to align with U.S. policy, and would help U.S. semiconductor manufacturers regain any ground lost to Huawei in those markets.
Striking a Balance in the New AI Rule
Looking to the future, the yet-to-be-seen replacement rule is going to have to balance the competing interests of a U.S. semiconductor and AI industry that want to expand freely and globally, and the national security concerns of those in government who would want restrict access to advanced semiconductors and AI technology by countries of concern.
For example, U.S. chipmakers will want to continue selling their leading edge GPUs to data centers in Malaysia and India. At the same time, U.S. export policy hawks would want to mitigate the risk of putting immense compute power proximate to, and potentially at the disposal of, PRC AI developers. Additionally, cloud service providers in Southeast Asia will want to be able to sell their services to the largest customer in the region, and would consider using Huawei chips over U.S. alternatives if it meant they could do so. That may mean that BIS cannot put too many restrictions on the region before the chipmakers and hyperscalers begin to voice objections and press to reduce the regulation.
Now that we have thrown away the toaster, selecting a new one—writing a new AI diffusion regulation—will require regulators to walk a narrow line to satisfy the interests of both industry and national security. Those interests are not necessarily opposed to one another, but their interests may be divergent, and it will be up to drafters to find a potentially very narrow common ground.
FOOTNOTES
[1] You know. The thing. It’s a technical term in the appliance repair world.
[2] Because that was his name. In fact, it still is.
[3] General Prohibit 10—or GP10 as it is affectionately known around the Sheppard Mullin offices—is a comprehensive prohibition on essentially doing anything with an item, including destroying or moving the item, if has caused a violation or will cause a violation of the EAR.
Federal Court Nullifies EEOC Guidance on LGBTQ+ Protections
On May 15, 2025, a federal court vacated portions of the U.S. Equal Employment Opportunity Commission’s (EEOC) workplace harassment guidance, specifically, guidance on harassment based on sexual orientation and gender identity. The court vacated portions of the EEOC’s enforcement guidance because the EEOC allegedly “exceeded its statutory authority by issuing” it and by “requiring bathroom, dress, and pronoun accommodations inconsistent with the text, history, and tradition of Title VII and recent Supreme Court precedent.”
Quick Hits
A federal district court recently vacated parts of the EEOC’s guidance related to workplace harassment of LGBTQ+ employees.
Despite the Supreme Court’s holding in Bostock that discrimination based on sex in hiring or firing decisions violates Title VII’s prohibition on sex discrimination, the district court vacated the guidance based on the guidance’s “expanded” definition of sex discrimination to include sexual orientation and gender identity.
The court ruled that the EEOC exceeded its statutory authority by requiring accommodations related to bathrooms, dress, and pronouns, which it found inconsistent with Title VII of the Civil Rights Act of 1964 and recent Supreme Court precedent.
This decision follows President Trump’s executive order recognizing sex as binary and immutable, which has created uncertainty for employers regarding compliance with federal, state, and local antidiscrimination laws.
Background
In vacating the EEOC’s guidance related to LGBTQ+ workplace harassment, the U.S. District Court for the Northern District of Texas held that the EEOC’s April 2024 “Enforcement Guidance on Harassment in the Workplace” overstepped by stating Title VII’s prohibition on sex discrimination also prohibits discrimination based on sexual orientation or gender identity. The EEOC guidance flowed from the Supreme Court of the United States’ 2020 decision in Bostock v. Clayton County, Georgia, where the Court ruled Title VII prohibits employers from firing workers for being “homosexual” or transgender. The Court specifically held: “An employer who fires an individual for being homosexual or transgender fires that person for traits or actions it would not have questioned in members of a different sex. Sex plays a necessary and undisguisable role in the decision, exactly what Title VII forbids.” The Court’s key holding in Bostock went on to clearly state that “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex.”
Following the Bostock decision, the EEOC published guidance in 2021 stating employers may not deny employees access to bathrooms, locker rooms, or showers aligning with gender identity. The 2021 guidance also stated an employer intentionally and repeatedly using an incorrect name or pronoun to refer to a transgender worker constituted unlawful harassment under Title VII. As noted in the district court’s memorandum opinion and order, the 2021 guidance was enjoined, but the EEOC issued new guidance in 2024, which the parties challenged.
On January 20, 2025, President Donald Trump released Executive Order 14168 (“Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government”), which established that the federal government recognizes only two genders, male and female. This executive order instructed the EEOC to rescind portions of its harassment guidance that were inconsistent with the order.
On January 28, 2025, EEOC Acting Chair Andrea R. Lucas rolled back much of the Biden-era technical assistance related to discrimination and harassment against LGBTQ+ individuals. However, the April 2024 enforcement guidance has not been officially rescinded because the EEOC currently lacks a quorum.
The Court Order
The U.S. District Court for the Northern District of Texas granted summary judgment to the State of Texas and the Heritage Foundation, which had sued to block the EEOC’s 2024 guidance. The court concluded the EEOC may not legally:
define “sex” to include sexual orientation and gender identity; and
define “sexual orientation” and “gender identity” as a protected class under federal law; and
prohibit employers from repeatedly and intentionally using the wrong pronouns for transgender employees.
The court’s reasoning was based on its conclusion that the EEOC’s guidance is “final agency action” and that it “produces legal consequences and determines rights and obligations of covered employers.” According to the order, “the Guidance determines the legal obligations of employers in navigating accommodation requests from transgender employees.”
According to the court, the EEOC’s “Enforcement Guidance contravenes Title VII’s plain text by expanding the scope of ‘sex’ beyond the biological binary. Second, the Enforcement Guidance contravenes Title VII by defining discriminatory harassment to include failure to accommodate a transgender employee’s bathroom, pronoun, and dress preferences.”
Next Steps
Employers will want to note that it is still unclear whether the court’s order—which states the guidance is “vacated”—has nationwide impact, making next steps unclear at this time. Moreover, the vacating of this guidance does not necessarily mean that employers are not required to abide by the EEOC’s enforcement guidance.
Despite the court’s order, employers should note that Bostock continues to be good law. Nevertheless, courts across the country have differed on whether the Bostock decision extends to bathrooms, locker rooms, showers, or similar facilities for employees to use, as well as pronoun and name usage. Various state and local laws and guidance both protect single-sex facility usage based on gender identity, and, alternatively (in government buildings), require usage of single-sex facilities based on birth sex. Indeed, many states and localities protect both gender identity as well as sexual orientation under relevant state and local antidiscrimination laws. Employers should carefully assess how to create and maintain workplaces free of harassment, discrimination, and retaliation under all applicable laws, including with regard to using employees’ names and pronouns.
Acting Chair Lucas and the Trump administration have indicated their opposition to the EEOC guidance at issue, so it is unlikely that they would appeal this case to a federal circuit court. Employers in all states may wish to review their policies and practices to ensure compliance with state and federal laws banning discrimination based on sex.
Workplace Strategies Watercooler 2025: The AI-Powered Workplace of Today and Tomorrow [Podcast]
In this installment of our Workplace Strategies Watercooler 2025 podcast series, Jenn Betts (shareholder, Pittsburgh), Simon McMenemy (partner, London), and Danielle Ochs (shareholder, San Francisco) discuss the evolving landscape of artificial intelligence (AI) in the workplace and provide an update on the global regulatory frameworks governing AI use. Simon, who is co-chair of Ogletree’s Cybersecurity and Privacy Practice Group, breaks down the four levels of risk and their associated regulations specified in the EU AI Act, which will take effect in August 2026, and the need for employers to prepare now for the Act’s stringent regulations and steep penalties for noncompliance. Jenn and Danielle, who are co-chairs of the Technology Practice Group, discuss the Trump administration’s focus on innovation with limited regulation, as well as the likelihood of state-level regulation.