Re: Petition to OSHA to Implement Work-Hour Regulations for All Resident Physicians
XX XX XX, 2025
The Honorable Amanda Wood Laihow,
Acting Assistant Secretary of Labor for Occupational Safety and Health
U.S. Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue, NW
Washington, D.C. 20210
Re: Petition to OSHA to Implement Work-Hour Regulations for All Resident Physicians
Dear Acting Assistant Secretary Laihow,
Public Citizen, a consumer advocacy organization with more than 500,000 members and supporters nationwide and the American Medical Student Association (AMSA), an international organization representing over 30,000 physicians-in-training, hereby petition the Occupational Safety and Health Administration (OSHA) to implement the following key regulations for the work hours of resident physicians in all residency and subspecialty fellowship programs, which are similar but not identical to the recommendations put forth in the 2009 report Resident Duty Hours: Enhancing Sleep, Supervision, and Safety by the Institute of Medicine (IOM, which in 2015 was renamed National Academy of Medicine; for additional details, see Table 1):[1]
(1) A limit of 80 hours of work in each and every workweek, without averaging;
(2) A limit of 16 consecutive hours worked in one shift for all resident physicians and subspecialty resident physicians, with no exceptions;
(3) At least one 24-hour period of time off work per week (no averaging) and one 48-hour period of time off work per month, no averaging;
(4) In-hospital on-call frequency no more than once every three nights, no averaging;
(5) A minimum of at least 10 hours off work after a day shift and a minimum of 12 hours off work after a night shift; and
(6) A maximum of four consecutive night shifts with a minimum of 48 hours off after a sequence of three or four night shifts.
Work hours include any time asleep at the work site. Time off work is time away from the hospital or other work site while not on call. As stated by the Accreditation Council for Graduate Medical Education (ACGME), any time resident physicians spend on “at-home call must count toward the 80-hour maximum weekly limit.”[2]
Table 1: Comparison of Petitioners’ Request and the IOM Recommendations
IOM Recommendations [3] Petitioner’s Request
Maximum hours of work per week 80 per week, averaged over four weeks. 80 hours per week, no averaging
Maximum shift length 30 hours, including a five-hour protected sleep period between 10 pm and 8 am.
Without a protected, uninterrupted, continuous sleep period, 16 hours.
16 hours, no exceptions
Mandatory time off duty One 24-hour period off per week, no averaging; one 48-hour period off per month At least one 24-hour period off per week (no averaging), one 48-hour period off per month (no averaging)
Maximum in-hospital on-call frequency Every third night, no
averaging
No more than once every three nights, no averaging
Minimum time off between shifts A minimum of 10 hours after a day shift that is not part of an extended period; a minimum of 12 hours after a night shift that is not part of an extended duty period; a minimum of 14 hours after an extended duty period At least 10 hours off work after a day shift and a minimum of 12 hours off work after a night shift.
No extended work shifts.
Maximum frequency of in-hospital night shifts Four night shifts; 48 hours off after three or four nights of consecutive duty Four consecutive night shifts with a minimum of 48 hours off after a sequence of three-four night shifts.
We are not asking OSHA to assume oversight of resident physician education and supervision; these are the continuing responsibilities of the ACGME.
In this petition we define resident physicians as physicians “who have graduated from medical school and are pursuing specialization.”[4] As will be discussed in detail below, evidence convincingly demonstrates that these recommendations are necessary to protect the safety of resident physicians. These work-hour regulations should also help to reduce medical errors and contribute to a safer, better standard of care for patients nationwide.
Contents
Part 1: Resident Physicians Work Excessive Hours.
1.1. The history of work-hour regulations in the United States.
1.2 OSHA has jurisdiction over limiting resident physician work hours.
Part 2: Arguments for Reducing Work Hours, Evidence of Harm to Resident Physicians.
2.1. Evidence of sleep deprivation in resident physicians.
2.2. Increased risk of motor vehicle crashes.
2.3. Increased risk of percutaneous injuries.
2.4. Increased risk of obstetric complications.
2.5. Increased risk of mental health conditions.
Part 3: Arguments for Reducing Work Hours, Evidence of Harm to Patients.
3.1. Negative effects of long work hours on patient safety outcomes.
3.2. The effects of work-hour regulations on patient safety.
3.3. The FIRST and iCOMPARE trials.
Limitations of the FIRST and iCOMPARE trials.
Part 4: Evaluation of Existing Work-Hour Regulations.
4.1. Effects and limitations of work-hour regulations in the United States.
4.2. Work-hour compliance and violations.
4.3. Other countries’ responses to resident physician work hours.
4.4. U.S. work-hour regulations in other industries.
Part 5: Responses to Concerns About Reducing Work Hours.
5.1. Lack of effect of work-hour regulations on medical education.
5.2. Lack of effect of work-hour regulations on the continuity of patient care.
5.3. Perspectives of program directors and resident physicians.
5.4. The perspective of the public.
Part 1: Resident Physicians Work Excessive Hours
Long work hours for resident physicians have long been depicted by some not only as a way to prepare junior doctors for “an occupation that requires hard work and dedication,”[5] but also as a “rite of passage” that needs to be endured.[6] In fact, the term “resident physician” itself refers to the fact that medical trainees were once required to stay at the hospital for their entire postgraduate training.[7] The origin of this practice may in part be responsible for the belief held by some that long hours are still an integral and necessary part of medical training, despite substantial evidence to the contrary.
To this day, resident physicians regularly work at least 80 hours a week, and often much longer. They also frequently work shifts of 28 consecutive hours or more, during which they get no or only very little sleep.[8],[9] Such long shifts are called “extended shifts,” and although OSHA states that any work shift that is longer than “eight consecutive hours during the day, five days a week with at least an eight-hour rest” should be considered “extended or unusual,”[10] in the context of medical residency programs, extended shifts usually refer to shifts that are 24 hours or longer. In this petition we use the term “extended shift” to refer to the latter.
A U.S. nationwide prospective cohort study published in 2023 found that 9.7% of resident physicians regularly worked more than 80 hours a week.[11] Moreover, each month, resident physicians tended to work an average of 1.6 extended-duration shifts of more than 24 hours where they obtained only about 2.5 hours of sleep on average, and during about 14% of these extended duration shifts, resident physicians did not obtain any sleep.
There is a substantial and growing body of evidence demonstrating that such long work hours and extended shifts are associated with sleep deprivation and fatigue. Moreover, acute and chronic sleep deprivation has been shown to have a detrimental impact on the health and safety of resident physicians and the patients under their care.[12] For example, sleep deprivation places resident physicians at an increased risk of being involved in fatigue-related motor vehicle crashes and near misses,[13] negatively affects their mental health,[14] increases the risk of percutaneous (needlestick) injuries,[15] and increases the risk of obstetric complications in pregnant resident physicians.[16] At the same time, impaired sleep associated with long work hours has been linked to increased medical errors and preventable adverse events, leading to worse patient safety outcomes.[17]
Despite these findings, the necessity for long, grueling work hours during medical residency and whether and to what degree work hours should be reduced have continued to be hotly debated topics for decades. Moreover, unlike for employees in other occupations, no federal agency ensures the right of resident physicians to a safe and healthful workplace.
Based on the lack of federal regulations and the serious safety concerns for resident physicians and patients associated with the work-hour standards for resident physicians in the United States, Public Citizen’s Health Research Group and co-petitioners filed petitions to OSHA in 2001[18] and again in 2010,[19] each time requesting work-hour limitations that are largely in line with the recommendations outlined in the influential 2009 IOM report (although in 2001, the maximum shift length requested by the petitioners was 24 hours, not 16 hours as requested in the 2010 and current petition).[20]
Unfortunately, OSHA denied both petitions, although the agency shared the petitioners’ concerns over resident physicians’ health and safety.[21] The 2001 petition was denied about one-and-a-half years after we filed it, in part because OSHA stated that the agency was already fully committed to addressing other important workplace and health issues. Moreover, OSHA argued that because a report that the ACGME had just endorsed and that addressed the key concerns highlighted in the petition, “the ACGME and other entities are well suited to address work-duty restrictions of medical residents and fellows.”
Although the ACGME implemented its first work-hour regulation in 2003, it fell short of the limitations the petitioners argue to be necessary to protect the health and safety of resident physicians and patients.[22] They were also not adequately enforced by the ACGME.[23] For this reason, Public Citizen and co-petitioners again filed a petition to OSHA in 2010. OSHA again denied the petition, a year after it was submitted, in part because the ACGME had just implemented updated work-hour regulations in 2011 (which also fell short of the petitioners’ request).[24] The agency again stated that the petition was filed “at a time when the Agency faces significant challenges.”
In 2017 the ACGME again implemented new work-hour regulations that rolled back some of the protections the ACGME had put in place for first-year resident physicians in 2011. For this reason, the work-hour standard has in fact deteriorated since the last Public Citizen petition was filed. At the same time, as detailed below, more evidence has demonstrated that the current ACGME work-hour regulations do not ensure a safe and healthful workplace for resident physicians and a safe standard of care for patients.
Public Citizen and the American Medical Student Association therefore petition OSHA to implement an evidence-based federal work-hour standard that will 1) ensure a humane and safe work environment for resident physicians and 2) ensure that patients are not harmed by excessive work hours of resident physicians.
1.1. The history of work-hour regulations in the United States
Since the beginning of the 20th century, various organizations have accredited medical residency programs. However, none of these organizations regulated work hours for resident physicians.[25] In fact, although the negative effect of extended work hours on patient outcomes had long been demonstrated,[26], [27] it was only after Libby Zion, a college student, died while hospitalized in a New York City teaching hospital in 1984 that the issue gained wider attention.[28]
At the time, a grand jury investigation found that the 36-hour shifts worked by the resident physicians who cared for Libby Zion had contributed to her death and called for a reform of work hours.[29] This in turn led to the formation of the Bell Commission, which in 1987 recommended limiting resident physician work hours to no more than 24 consecutive work hours and no more than 80 hours a week. In 1989 these recommendations were implemented in New York, which became the first state in the United States to regulate work hours for resident physicians. The recommendations were not implemented in other states.
At present, the ACGME, which became an independent corporation in 2002, is solely responsible for accrediting residency programs in the United States and for monitoring residency programs’ compliance with its work-hour standards. However, as discussed in more detail below, the ACGME does not adequately enforce its work-hour standards, and violations are not always reported.[30]
In 2003 the ACGME first limited work hours for all resident physicians to a maximum of 80 to 88 hours a week (averaged over four weeks) and limited extended shifts to 24 continuous hours that could be extended to 30 hours “for continuity of care and education” (see Table 2 for additional details).[31] In 2009, however, the IOM concluded in an influential report that working more than 16 hours consecutively without sleep is unsafe.[32] In fact, the report stated that if no protected sleep period is provided, shifts “must not exceed 16 hours.”
In part based on the results of the IOM report,[33] the ACGME put new work-hour regulations into effect in 2011.[34] The new standard kept the weekly limit at 80 to 88 hours for all resident physicians (averaged over four weeks, as per their 2003 work-hour policy) and required that extended shifts be capped at 16 hours for first-year resident physicians (interns) only (see Table 2).[35] The ACGME argued that limiting shifts to 16 hours for interns is warranted because “PGY-1 [postgraduate year one] residents make more errors when working longer consecutive hours.” However, against the recommendations of the IOM report, many resident physicians (roughly 80% of resident physicians are in the second or later years of residency training) were permitted to continue working continuously in shifts that could still be extended from 24 up to 28 hours (instead of 30 hours as per the 2003 standard).[36]
ACGME’s reasoning for only limiting shifts to 16 hours for interns was in part that resident physicians in their second or later year of training had already gained more experience that could help them counterbalance the risks associated with extended shifts. However, there are no data suggesting that more experience makes people less vulnerable to the negative effects of sleep deprivation or that more training will help overcome the safety concerns associated with fatigue.[37],[38] The ACGME further argued that work-hour regulations could lead to a shift-worker mentality that stands in opposition to the professional responsibilities physicians have towards their patients.[39] Moreover, the ACGME argued that reduced work hours would leave resident physicians unprepared for their duties after their residencies when they need to “function when fatigued.”[40] Of note here is, however, that resident physicians usually work more hours a week and longer shifts than attending physicians, other health care workers, or workers in other professions.[41],[42] As will be discussed in more detail below, evidence also shows that reducing work hours does not negatively affect the continuity of care for patients or learning opportunities for resident physicians.
The 2011 work-hour policies were in place until 2017, when the ACGME reversed its decision to limit shift length to 16 hours for interns and again permitted all resident physicians to work extended shifts of 24 hours with an additional four hours “for transitioning care and formal didactics,” for a total of 80-88 hours per week (averaged over four weeks; see Table 2 for additional details).[43] This decision was in part based on the publication of the 2016 Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial,[44] which found that the surgical patient safety outcomes in residency programs with flexible, extended-duration shifts were non-inferior (meaning no worse) than in those with limited work hours. The ACGME also claimed that the results of the Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, published in 2019,[45] constituted additional support for the ACGME’s reversal of the 2011 work-hour standards.[46] This trial again found that for several patient outcomes, including 30-day mortality, extended-duration shifts were non-interior to limited shifts. However, as discussed in more detail below, both trials were funded by the ACGME, poorly designed, and raised ethical concerns.[47]
Importantly, however, evidence from the two trials showed that extended shifts led to decreased well-being, morale, and health in resident physicians and that interns who were working longer shifts had to change their sleep patterns to compensate for extended shifts. At the same time, both trials showed that working long hours was non-inferior to working shorter hours not only for patient safety but also for educational outcomes.[48]
At present, the 2017 ACGME work-hour policies are still in place.[49] Not only do these standards fall short of the recommendations of several expert panels, but they are also not supported by the growing body of research that clearly demonstrates the detrimental effect of sleep deprivation associated with long work hours and extended shifts on the health and safety of resident physicians and the patients in their care. An overview of the key literature is provided below, which updates the evidence presented in the 2001[50] and 2010[51] petitions.
Moreover, the 2017 work standards provide even less protection for resident physicians than the ACGME’s 2011 work-hour regulations did.[52] This rollback of ACGME’s 2011 cap on shifts of more than 16 continuous hours for interns was based on trials that not only were poorly designed but also failed to demonstrate the necessity of extended shifts for patient safety or optimal educational outcomes.
Table 2: Summary of Several Key ACGME Work-Hour Requirements in 2003, 2011, and 2017
2003 ACGME Work-Hour Requirements[53] | 2011 ACGME Work-Hour Requirements[54] | 2017 ACGME Work-Hour Requirements[55] | |
---|---|---|---|
Maximum hours of work per week | 80 hours, up to 88 hours for some specialties (averaged over four weeks) | 80 hours, up to 88 hours for some specialties (averaged over four weeks) | 80 hours, up to 88 hours for some specialties (averaged over four weeks) |
Maximum shift length | 30 hours (24 hours plus 6 hours for “continuity of care and education”) | 16 hours for interns only 28 hours for all other resident physicians (24 hours plus 4 hours for “transitions in care”) | Elimination of 16-hour cap for interns[56] 28 hours (24 hours plus 4 hours for “activities related to patient safety… and/or resident education”) |
Maximum in-hospital on-call frequency | Once every three nights (averaged over four weeks) | no more than every third night (averaged over four weeks) for second-year resident physicians and above | no more than every third night (averaged over four weeks) |
Minimum time off between scheduled shifts | 10 hours between duty periods | 8-10 hours between duty periods 14 hours free of duty after 24 hours of in-house duty | Eight hours between scheduled clinical work and education periods 14 hours off clinical work and education after 24 hours of in-house call |
Minimum time off duty | One day free per seven days (averaged over four weeks) | One day free every week (averaged over four weeks) | One day free of clinical work and required education per seven days (averaged over four weeks) |
1.2 OSHA has jurisdiction over limiting resident physician work hours
At present, the federal government does not regulate resident physician work hours. This is particularly striking because there are federal work-hour regulations for employees in many other occupations, such as pilots and truck drivers.[57] The ACGME, an “independent, 501(c)(3), not-for-profit organization,”[58] accredits residency programs and is also responsible for regulating and enforcing work hours. As will be demonstrated in this petition, the ACGME has not adequately limited work hours to protect resident physicians and their patients. Moreover, as will be discussed in detail below, the ACGME has not robustly enforced its current work-hour standards and penalized work-hour violations when they occur. The dual role of the ACGME creates additional problems. For instance, resident physicians who report work-hour violations may in fact be penalized by their program or risk that their program will lose its ACGME accreditation if their concerns are fully addressed.
Establishing and enforcing federal evidence-based work-hour standards for resident physicians is essential to 1) ensure a humane and safe work environment for resident physicians and 2) decrease the risk that patients will be harmed by resident physicians with excessive work hours. The petitioners maintain that OSHA has jurisdiction over establishing and enforcing a federal work-hour standard. Petitioners are not requesting that OSHA assumes oversight of resident physician education and residency programs, which should be the continuing responsibility of the ACGME.
Since the Occupational Safety and Health Act was enacted in 1970, every employee in the United States has had a right to “safe and healthful working conditions.”[59] However, for a period of time, some resident physicians were considered to be students, not employees.[60] Because resident physicians are still completing their medical training, the National Labor Relations Board (NLRB) ruled in 1976 that resident physicians at private hospitals are students. This decision was only overturned in 1999 because, according to the New York Times, the NLRB argued that resident physicians “worked long hours, made many medical decisions and received salaries and fringe benefits, including vacations and workers’ compensation,” which made them employees.[61],[62] Yet this debate over resident physicians’ employment status may have contributed to work hours continuing to be regulated by the ACGME, not a federal agency. For example, in response to Public Citizen’s 2010 petition,[63] OSHA stated that the agency recognizes the ACGME as the body regulating work hours for resident physicians because work-hour limitations “are best addressed within the context of resident training and education.”[64] Importantly, however, resident physicians are employees and as such have a right to be protected by federal labor law. In fact, in 2011 OSHA explicitly acknowledged that resident physicians as employees are covered by the Occupational Safety and Health Act of 1970 but argued that they “are also students since they receive training critical to their professional education.”
As discussed in detail below, under the current work-hour standards, conditions for resident physicians are not “safe and healthful” as required by federal law.[65] The petitioners maintain that it is OSHA’s responsibility to protect resident physicians from unsafe labor practices in the same ways that the agency protects workers in other industries. Moreover, OSHA has acknowledged that work shifts longer than “eight consecutive hours during the day, five days a week with at least an eight-hour rest” are “stressful physically, mentally, and emotionally” and can “disrupt the body’s regular schedule, leading to increased fatigue, stress, and lack of concentration” and “an increased risk of operator error, injuries and/or accidents.”[66]
The petitioners therefore request the acting assistant secretary for Occupational Safety and Health to exercise authority under section 6 of the Occupational Safety and Health Act[67] to promulgate an occupational safety and health standard on the grounds that work hours in excess of the requested limits are physically and mentally harmful to resident physicians. The acting assistant secretary should ensure that a federal work-hour standard is put in place to provide resident physicians with safe employment.
Part 2: Arguments for Reducing Work Hours, Evidence of Harm to Resident Physicians
There is extensive evidence that sleep loss due to long work hours and extended shifts has a profound influence on resident physician health, safety, and well-being.[68] For instance, sleep deprivation has been linked to unwanted weight changes, increased use of medication, and increased alcohol consumption.[69] Impaired sleep is also associated with reduced cognitive performance, which can affect resident physicians’ ability to retain knowledge and their ability to learn.[70],[71]
Moreover, numerous studies have demonstrated that sleep deprivation among resident physicians is associated with decreased alertness and vigilance. For instance, one study found that when resident physicians worked more than 48 hours a week, they were significantly more likely to report motor vehicle crashes and near-miss crashes, needlestick injuries, and other occupational exposures to potentially contaminated body fluids.[72] When resident physicians worked more than one extended-duration shift a month, these risks increased substantially. The long work hours associated with residency have also been linked to obstetric complications in pregnant resident physicians.[73] Lack of sleep has been shown to affect mental health (such as depression and burnout), with consequences for resident physicians’ well-being and the patients in their care.[74]
Reducing work hours for resident physicians can be an effective tool to mitigate these risks. For instance, a 2020 prospective analysis found that the work-hour limits mandated by the ACGME in 2011 helped to reduce the risk of motor vehicle crashes by 24% and reduced the number of near crashes by 44%.[75] Among interns, the risk of needlestick injuries decreased by 46%. Moreover, a 2006 survey across different specialties in one university found that 77% of interns were burnt out before the 2003 ACGME work-hour standard, whereas significantly fewer interns (43%) reported burnout after their implementation.[76]
2.1. Evidence of sleep deprivation in resident physicians
Research has repeatedly shown that for employees in safety-sensitive professions (such as firefighters, police officers, pilots, first responders, and health care providers), shift work (night shifts, extended-duration shifts, and rotating shifts [referring to shifts that are scheduled to change regularly]) can lead to acute or chronic sleep deprivation and circadian desynchronization.[77] This can in turn increase the risk of short- and long-term health problems, such as gastric and duodenal ulcers, cardiovascular disease, obesity, and cancer. In 2024 a Government Accountability Office report recognized “very long work hours,” defined as 55 work hours or more per week, as a risk factor for stroke and heart disease.[78]
It is also well documented that sleep deprivation can take a toll on stress-management abilities and negatively affects interpersonal skills and mood. For instance, sleep-deprived individuals tend to have lower empathy towards others and a decreased ability to accurately recognize human emotions.[79],[80] Inadequate sleep has also been associated with decreased alertness, deteriorating performance, and a decreased ability to concentrate, which has important implications for safety.[81] Sleep deprivation in safety-sensitive occupations can thus profoundly affect public safety.
Resident physicians are at a particularly high risk of sleep deprivation because they frequently are required to work long hours, often with little opportunity to sleep during extended shifts. There is extensive evidence that for resident physicians across specialties, sleep loss associated with shifts of more than 16 consecutive hours has numerous detrimental effects, both for their own well-being and for the safety of the patients in their care (as discussed in Part 3 below).[82],[83] Moreover, because the loss of sleep is cumulative over the course of residency, resident physicians frequently suffer both from acute sleep loss and chronic sleep deprivation.
A national survey on self-reported sleep hours among approximately 3,600 interns and second-year resident physicians across several specialties in the 1998-1999 training year, published in 2004, showed that those who had slept for an average of five or fewer hours per night were more likely to report negative outcomes of sleep deprivation.[84] Similarly, an anonymous internet-based survey among 178 otolaryngology resident physicians published in 2016 found that those who slept less than six hours a night or worked more than 60 hours a week were significantly sleepier and more fatigued than those who slept more than six hours a night.[85] In fact, many resident physicians stated that they were excessively (32%) or severely (12%) sleepy, and the majority (78%) reported that their sleep had an effect on their daily functioning.
Another study, published in 2017, assessed the alertness of first-year resident physicians during their internal medicine and oncology rotations.[86] Interns who worked extended overnight shifts (often sleeping only about two hours or less) were compared with those who rarely or never worked long overnight shifts. Interns who were on call during nights slept on average 2.2 hours and during 18% of nights did not sleep at all. Not only did the interns report that they were “profoundly impaired,” but compared with those on regular shifts, they were significantly less alert in the morning after a night on call.
“Strategic napping” during extended shifts has sometimes been suggested to help mitigate some of the detrimental effects of sleep loss. However, research does not support a role for strategic napping in mitigating sleep loss, possibly due to the underlying levels of acute and chronic sleep loss.[87],[88] For example, a study including 34 first-year resident physicians published in 2019 found that on 92% of nights in which resident physicians worked extended shifts, they had less than four hours of sleep.[89] Importantly, with less than four hours of sleep, they had more attentional failures than when they were scheduled to work without extended shifts. The researchers found that significant reductions in attentional failures occurred only if resident physicians slept more than four hours during their extended shift, but they still had nearly three times the levels of attentional failures during post-call compared with post-call during work schedules without extended work hours.
Resident physicians tend to not be able to objectively rate their own sleepiness or may think that they can acclimate to sleep deprivation. They may continue to feel that they are able to function, learn, or care for patients despite being severely fatigued.[90], [91]
2.2. Increased risk of motor vehicle crashes
According to the Bureau of Transportation Statistics there were 5,250,837 motor vehicle crashes in the United States in 2020, leading to 2,282,015 injured persons and 38,824 fatalities.[92] One contributing factor is drowsy driving. One analysis, for example, identified operator fatigue (which is associated with a decreased ability to concentrate, and can affect reaction times, alertness, and cognitive function) as a probable cause or finding in 40% of highway-crash investigations.[93]
Between 2000 and 2014 motor vehicle accidents were one of the leading causes of mortality among U.S. resident physicians.[94] Surveys, studies, and driving simulations among resident physicians from numerous specialties demonstrate that driving while sleep deprived, fatigued, or driving after a night shift or a shift of more than 16 consecutive hours puts resident physicians at significant risk of traffic safety events (such as falling asleep while driving, stopping in traffic, near-miss crashes, and motor vehicle crashes).[95],[96],[97]
A survey published in 1996 compared 70 pediatric resident physicians who were on call every fourth night with 85 faculty members, who were rarely disturbed at night.[98] 44% of pediatric resident physicians who slept little while on call (average 2.7 hours) fell asleep at the wheel while stopping at a red light (mainly while driving post-call) compared with 12.5% of faculty who had slept for an average of 6.5 hours.
A national survey published in 2004 on self-reported sleep hours among 3,604 interns and second-year resident physicians across several specialties reported similar outcomes.[99] Resident physicians who had slept five or fewer hours per night were more likely to report negative outcomes of sleep deprivation, including being 1.8 times more likely to be involved in a serious accident or injury, than those who had slept longer. They were also 1.7 times more likely to report making a significant medical error.
A 2005 web-based prospective survey based on 17,003 monthly reports of 2,737 first-year resident physicians found that in the months in which interns worked five or more extended shifts (24 hours or more), their risk of falling asleep while driving or while stopped in traffic was significantly increased.[100] In addition, the monthly risk of a motor vehicle crash during the commute from work increased by 16.2 % for every scheduled extended work shift. Moreover, resident physicians were more than twice as likely to have a documented motor vehicle crash on their commute after an extended shift. Near-miss incidents were also more than five times as likely after an extended shift than a standard one.
Another study, also published in 2005, demonstrated that long work hours and limited sleep impaired the psychomotor performance of resident physicians to a similar degree as having about three to four standard drinks (0.04 to 0.05 g% blood alcohol concentration) during a light call rotation.[101] This finding is of particular concern because alcohol ingestion is an accepted standard for functional impairment and is well known to decrease inhibitions and diminish attention and judgment, which can thus lead to hazardous driving. In this study, the post-call performance on several tests (including for sustained attention and simulated driving) of 34 pediatric resident physicians in the final week of a four-week rotation with heavy call duty (working on average between 80 to 90 hours a week and working consecutive shifts of 34-36 hours every fourth or fifth night) was equivalent to or worse than that of resident physicians with light call rotations (working with some exceptions only daytime shifts for an average of 44 hours per week) who had a 0.04 to 0.05 g% blood alcohol concentration. Resident physicians on heavy call duty also had slower reaction times, were less alert, and made more commission and omission errors. They were also significantly less likely to stay in their lane and maintain speed during simulated driving tests.
In a 2016 study, 29 anesthesiology resident physicians had a driving simulator test after six consecutive overnight work shifts.[102] The study found that the resident physicians had significantly impaired driving performance compared with when they took the test at the beginning of a day shift (that was not after a shift on call), including slower reaction times, an increase in the number of lapses in attention, and difficulties with lane position, steering, and controlling speed. For example, after six night shifts, resident physicians had an increased number of collisions compared with after a day shift. After six overnight work shifts, resident physicians also reported feeling less safe to drive and felt significantly sleepier and less alert than after a day shift.
A 2018 study used specialized glasses and a drowsiness measurement system to assess the drowsiness levels of 16 resident physicians from different specialties on their work commutes.[103] The study found that after a shift of 24 hours or more, resident physicians were sleepier on their commute from work (75%) than their commute to work (12%). Extended work hours were also associated with an increase of about 40% in self-reported sleepiness on the commute home and were positively correlated with objective measurements of drowsiness. Unsurprisingly, on the commute home after extended shifts, resident physicians had three to five times greater odds of reporting sleep-related inattentive or hazardous driving than when commuting to work.
A 2021 retrospective survey among 58 general surgery resident physicians found that 96.6% of resident physicians who commuted for work reported work-related fatigue that diminished their ability to drive safely and 82.8% reported that they had fallen asleep or almost fell asleep while driving on their commute to or from work.[104] Close to two-thirds of resident physicians reported that fatigue was an issue for their driving safety on a daily or weekly basis. Most resident physicians (75.9%) reported feeling the greatest fatigue after a scheduled 24-hour shift.
A national survey among over 7,300 general surgery resident physicians published in 2021 found that self-reported hazardous traffic-safety events were more common among those who worked more hours than the ACGME work-hour standard than those with fewer work-hour violations.[105] For instance, those who had frequently violated the 80-hours-per-week limit over the past six months reported nodding off (59.8%), having near-miss motor vehicle crashes (53.6%), and motor vehicle crashes (14.0%) more often than those without such violations (27.2%, 19.2%, and 3.5%, respectively). Similarly, 50.8% of those who reported that they had eight or fewer hours off work between shifts three or more times in the most recent month reported nodding off and 11.7% reported motor vehicle crashes, in contrast with 32.8% and 4.2%, respectively, of resident physicians who reported having eight or fewer hours off work between shifts two or fewer times.
In 2023 a nationwide, prospective cohort study found that resident physicians in their second or higher year of training had more than double the risk of near-miss motor vehicle crashes when they worked more than 70 hours a week than did resident physicians who had worked no more than 48 hours a week.[106] Those who worked longer hours also had a significantly higher risk of near-miss crashes when they worked one or more extended shifts (while averaging no more than 80 hours per week in a month). The resident physicians who worked extended shifts and worked more than 80 hours a week had the highest risk.
2.3. Increased risk of percutaneous injuries
According to the Centers for Disease Control and Prevention, percutaneous injuries (also called needlestick injuries) are sharps injuries involving “a penetrating stab wound from a needle, scalpel, or other sharp object that may result in exposure to blood or other body fluids.”[107] Although needlestick injuries are often not reported, they are a serious health concern and are among the most common occupational hazards for health care workers.[108] For example, each year there are about 385,000 percutaneous injuries among hospital-based health care workers[109] and, by some estimates, these injuries happen in about 15% of all operations.[110]
Although the risk of contracting an infectious disease through a needlestick injury is low,[111] these injuries can put health care personnel at risk of contracting hepatitis B, hepatitis C, human immunodeficiency virus (HIV), and several other blood-borne pathogens. Moreover, many blood-borne pathogens are not detected in patients prior to surgery. In fact, one study in an urban, university-based general surgical practice found that when blood was tested prior to surgeries, in 38% of cases, positive results for hepatitis B, hepatitis C, or HIV were found.[112] Needlestick injuries also put affected health care workers at risk of adverse effects from postexposure treatments to prevent or treat infections, can have implications for future employment, and are associated with substantial financial and psychosocial burdens.[113],[114]
Needlestick injuries are also common among resident physicians,[115],[116] who often have a higher risk of injuries than other health care professionals, including surgeons, medical students, or nurses. Evidence suggests that key contributors to the higher rates of these injuries among resident physicians are the long work hours, fatigue, and sleep deprivation associated with residency training.[117] For instance, a nationwide, prospective cohort study published in 2023 found a significant increase in self-reported needlestick injuries when work hours increased beyond 48 hours a week, such as when resident physicians worked one or more extended-duration shifts in a month.[118] By the end of their surgery residency training, most resident physicians had experienced at least one needlestick injury, many involving patients at high risk of harboring blood-borne pathogens.
Some studies indicate that more needlestick injuries are reported in the first years of residency training, particularly in the first six months[119] (arguably due to lack of experience).[120],[121] Other studies indicate that the risk increases with the years in medical training.[122],[123],[124],[125] In the later years of their training, resident physicians may spend more time in operating rooms and have more exposure to sharp instruments, despite being more familiar with medical and surgical procedures. For all resident physicians regardless of their level of experience, high workload, long work hours, fatigue, and stress have consistently been shown to contribute to their risk of sustaining a needlestick injury.
For example, a 2006 web-based prospective cohort study found that needlestick injuries were twice as frequent at night and that resident physicians had a 61% increase in the odds of such injuries when they worked 24 hours or more continuously.[126] For injuries that occurred at night or after extended shifts, resident physicians were significantly more likely to identify fatigue as a contributing factor. Another study published in 2007 found that fatigue associated with sleep deprivation and long work hours was associated with a threefold increase in the risk of needlestick injuries among resident physicians.[127] Resident physicians slept less than usual in the week before the injury, and reports of these injuries were also more likely if they were fatigued. Study participants were eight times as likely to report being fatigued at the time of the injury if they had been working for more than 12 hours and four times as likely if they had worked more than 40 hours or more than five days in the week prior to the injury.
A survey including all general surgery resident programs, published in 2019, found that surgical resident physicians who reported frequently working more than 80 hours per week had 42% higher odds of needlestick injuries.[128] Although the authors stated that “[t]he easiest explanation for this association is resident fatigue,” the resident physicians themselves did not cite fatigue (21.4%) as the most common contributing factor but instead blamed their own carelessness (48.8%) or feeling rushed (31.3%). In another study, published in 2020, that included resident physicians from anesthesiology and several surgical specialties, fatigue was similarly not identified by most as a contributing factor leading to needlestick injuries except by those in the only program that had received prior training on fatigue.[129] These findings may indicate that resident physicians who have not received prior training may not be able to accurately self-assess their levels of fatigue.
2.4. Increased risk of obstetric complications
Most women in medicine, including resident physicians, delay childbearing due to medical training or their career.[130] Delayed childbearing can have long-term health and financial consequences; in fact, fertility in women overall decreases by about 50% between their early twenties and late thirties.[131] Of more concern, however, is that if resident physicians are pregnant during their training, the long work hours associated with residency may increase their risk of poor obstetric outcomes.
Research has repeatedly demonstrated that in the general population, long work hours and night or rotating shifts can increase the risk of adverse pregnancy outcomes.[132] For example, standing or working for more than 30 hours a week has been linked to increased risks of preterm delivery,[133] miscarriage, or having an infant with low birth weight.[134] Similarly, rotating shifts have been weakly associated with increased odds for preeclampsia and gestational hypertension. Some research also indicates that sleep disturbances (including short or long sleep duration and poor sleep quality) may increase the risk of preeclampsia, gestational hypertension, and preterm birth.[135]
Given these increased risks of long work hours during pregnancy, it is not surprising that pregnant resident physicians are also at risk of adverse pregnancy outcomes, especially if they are working long hours, extended shifts, and experience sleep disturbances during residency training. For example, one survey of plastic-surgery resident physicians concluded that pregnant physicians had higher rates of several pregnancy complications than the general population, including miscarriages and hyperemesis gravidarum.[136] A systematic review of 27 studies published in 2020 found that pregnant surgical resident physicians had rates of pregnancy complications ranging from 25% to 82%, especially when they were working long hours or night shifts.[137] These complication rates are much higher than for the general population (range of 5% to 15%).
In 2015 a retrospective cohort study of medical and surgical residency programs found that when pregnant resident physicians were on call during their pregnancy, they had a higher rate of complications than women of similar age in the general population.[138] Pregnant resident physicians had higher rates of miscarriage (11.8% vs. 4.2%), intrauterine growth restriction (9.2% vs. 3.9%), pregnancy-related hypertension (10.5% vs. 6.3%), and placental abruption (1.3% vs. 0%). For pregnant resident physicians who were on call for more than six nights per month, the overall rate of any of these risks was even higher (49.3%) compared with pregnant resident physicians who were on call for six or fewer nights per month (26.4%).
Several studies have found that pregnant resident physicians have higher rates of obstetric complications than the pregnant partners of male resident physicians. For example, a study published in 2003 showed that resident physicians who were pregnant during residency had a higher incidence of preeclampsia, fetal growth restrictions, and premature labor than the pregnant partners of male resident physicians.[139] A 2024 cross-sectional survey of 5,692 resident physicians in general surgery residency programs reported similar findings.[140] A significantly higher proportion of pregnant resident physicians experienced obstetric complications (41.8%) and postpartum depression (19.4%), than the pregnant partners of male resident physicians (33.7% and 12.5%, respectively). Postpartum depression can negatively affect the health of the child and is also associated with burnout and suicidal ideation.
Maternity leave and other current protections for pregnant resident physicians are not enough to address the increased risk of obstetric complications. For instance, the 2003 study found that pregnant resident physicians were more likely to work more than 80 hours a week than male resident physicians with pregnant partners, and they also seemed to increase their work hours, particularly during the first two trimesters of pregnancy.[141] More than three-quarters also took no days off work before delivery. Moreover, the 2020 systematic review that included studies published between the years 2003 and 2018 found that less than 12% of pregnant surgical resident physicians were working reduced hours and that 95% continued working night call shifts during their pregnancies.[142]
2.5. Increased risk of mental health conditions
Mental health conditions such as depression and burnout are common among all health workers and occur at a higher rate than would be expected in the general population.[143],[144] In 2022 Dr. Vivek Murthy, then U.S. surgeon general, described burnout among health workers as a crisis and national priority that required change in “training institutions, where the seeds of wellbeing can be planted early.”[145] Although burnout is not considered to be a medical condition, it “is a syndrome conceptualized as resulting from chronic workplace stress that has not been successfully managed” and is characterized by feeling exhausted, feeling negative or cynical about one’s job, and being less effective.[146] Burnout is also associated with an increased risk of developing other mental health conditions and is a risk factor for substance abuse and depression.[147],[148] Burnout is also associated with suicidal ideation, which is of particular concern because suicide is the second-leading cause of death among all resident physicians and the leading cause of death among male resident physicians.[149] Poor mental health during residency training can also have long-lasting consequences for resident physicians, including unintended weight changes[150] and an increased risk of future depressive episodes.[151] Resident physicians with poor mental health are also more likely to experience needlestick injuries.[152]
Research suggests that the rates of burnout and depression are especially high among resident physicians across all specialties[153],[154] and that the risk of these conditions may be even higher for those in surgical residencies.[155] For example, a prospective cohort study among 123 pediatric resident physicians published in 2008 found that 20% of the resident physicians were at high risk of depression and 75% met the criteria for burnout.[156] In this study, almost all resident physicians who met the criteria for depression also met the criteria for burnout. Similarly, a survey study published in 2013 found that 22% of 1,508 resident physicians in anesthesiology programs were depressed and 41% were at a high risk of burnout.[157] In this study only 17% of respondents were both depressed and had a high risk of burnout. Likewise, in a survey of 108 resident physicians in cardiothoracic surgery programs, published in 2021, more than 40% of those who responded screened positively for depression and more than half met the criteria for burnout.[158] In a survey of plastic-surgery resident physicians, published in 2020, about two-thirds of the 113 resident physicians who responded met at least one definition of burnout.[159]
In addition to the high levels of burnout and depression across different residency programs, evidence shows that resident physicians have higher rates of mental health conditions after they start their residencies than before they start their training. For instance, a prospective longitudinal cohort study across 13 hospitals in the United States published in 2010, which included 740 interns from pediatric, obstetrics/gynecology, internal medicine, general surgery, and psychiatry residency programs showed that significantly more interns met the criteria for depression during their residency than before their internship.[160] The interns in the study also had higher depressive-symptom scores after residency started than before. Similarly, a 2022 study on new-onset depression, which included 2,793 surgical interns found that 32% of interns who had not previously screened positive for depression developed new-onset depression during their training.[161]
Burnout and depression have repeatedly been linked to extended work hours and sleep deprivation.[162] A prospective study of the employees in an IT company published in 2012 identified less than six hours of sleep as a main risk factor for burnout.[163] Similarly, research among resident physicians indicates that the risk of burnout and depression is higher with insufficient time to sleep and long work hours, including night shifts.[164],[165],[166] A cohort study that analyzed data from repeating cohorts starting in 2009 through 2020 found that when interns worked more than 90 hours a week they had an almost threefold increased risk of developing depressive symptoms as compared with interns who were working 40-45 hours a week.[167]
Evidence also shows that burnout and other mental health concerns can leave resident physicians feeling exhausted and detached from their work or personal relationships.[168],[169] Mental health conditions can lead to impaired cognitive function and decrease resident physicians’ effectiveness. Impaired function at work has important implications for patient safety. The prospective cohort study published in 2010, discussed above, found that depressed resident physicians were at a significantly higher risk of reporting medical errors compared with resident physicians who did not have depressive symptoms.[170] Similarly, the previously discussed 2008 prospective cohort study found that resident physicians who met the criteria for depression made 6.2 times as many medication errors per month than those not meeting the criteria.[171] The rate of medical errors, however, was similar between resident physicians meeting the criteria for burnout and those not meeting the criteria. Because burnout has also been linked to emotional fatigue and cynicism among resident physicians, it can contribute to decreased professionalism.[172]
Part 3: Arguments for Reducing Work Hours, Evidence of Harm to Patients
The detrimental effects of long work hours and extended shifts on patient safety are well documented.[173],[174] Sleep deprivation associated with long work hours has been linked to decreased cognitive and clinical performance, trouble with concentration, and reduced motor skills.[175],[176],[177] Sleep-deprived resident physicians also report becoming inefficient, falling asleep at inappropriate times on the job, and “cutting corners.”[178] For these reasons, they are also more likely to report making serious medical errors, have attentional failures, and have higher complication rates than resident physicians with adequate rest. Sleep-deprived resident physicians tend to be more irritable, less composed, and more likely to report conflicts with colleagues.[179],[180] Sleep-deprived resident physicians may have reduced empathy for patients and less patience and attention with patients and their families. As previously discussed, fatigued resident physicians often cannot objectively rate their own sleepiness and feel that they can function well despite being sleep deprived.[181] Decades of research supports the beneficial effects of reduced work hours on patient safety.[182],[183] In contrast, data suggesting that reduced work hours have no effect or negative effects on patient safety are quite limited.[184],[185]
3.1. Negative effects of long work hours on patient safety outcomes
In 2004 a national survey about self-reported sleep hours among more than 3,600 interns and second-year resident physicians across several specialties found that resident physicians who had slept five or fewer hours per night were 1.7 times more likely to report making a significant medical error than resident physicians who slept more than five hours per night.[186] More recent data confirm these findings. A multicenter clinical trial published in 2021 compared 294 resident physicians in pediatric intensive care rotations who worked either shifts with extended work hours of 24 hours or more every third or fourth shift, or shifts that were limited to 16 consecutive hours.[187] The trial found that resident physicians working the extended-shift rotations were sleepier, had slower reaction times, were less alert, and had significantly more attentional failures that were associated with serious medical errors.
The negative effects of long work hours are also evident when data for first-year resident physicians and resident physicians in their second or later year are analyzed separately. A prospective randomized trial published in 2004 found that interns in intensive care units who worked extended shifts of 24 hours or more and were on call every third night made 5.6 times as many serious diagnostic errors than when they were working according to an intervention schedule of 63 work hours per week and no extended shifts.[188] Similarly, another intervention study, also published in 2004, compared 20 intensive care interns on different rotations.[189] When the interns were in a rotation in which they worked an average of 84.9 hours per week including extended shifts, they had more than double the rate of attentional failures during nighttime shifts and 1.5 times the rate of attentional failures during daytime shifts than they did if they were in a rotation where they worked less than 80 hours a week and shifts of no more than 16 hours.
For more experienced resident physicians (who were at least in their second year of their residency program), a nationwide, prospective cohort study showed that patient and resident physician safety were put at risk when resident physicians worked more than 48 hours a week or worked extended-duration shifts.[190] This study, published in 2023, was based on monthly web-based reports of over 4,800 resident physicians from different specialties in the United States. The researchers found that resident physicians who worked more than 80 hours per week had almost four times higher odds of reporting a medical error than when they worked fewer hours. Moreover, the risk of self-reported medical errors increased significantly after 48 hours of work in a week and doubled when resident physicians worked between 60 and 70 hours a week. When resident physicians worked one or more extended-duration shifts a month, despite averaging no more than 80 work hours per week, the risk of medical errors also increased.
3.2. The effects of work-hour regulations on patient safety
Substantial evidence suggests that reducing work hours is beneficial for patient outcomes. For example, a systematic review of the effects of the 2003 work-hour regulations, which was funded by the ACGME, found that these work-hour regulations were associated with significant improvements in patient mortality (including inpatient, 30-day, and overall mortality) and resident well-being.[191]
A 2023 systematic review of 68 studies comparing mortality outcomes before and after ACGME work-hour regulations found that the reduction of work hours overall had a positive effect on patient safety.[192] Specifically, when the researchers compared patient outcomes before and after the 2003 ACGME work-hour policy (which first regulated work hours for all resident physicians), they found that the policy change was associated with a “highly significant” reduction in patient mortality of 11%. Moreover, only one of the 33 studies included in this analysis found that the implementation of the 2003 work-hour restrictions was associated with worse patient safety.
The effect of the 2011 ACGME regulations discussed in this review was less clear, however. Only two of 15 studies demonstrated reduced patient morbidity after this regulation was implemented, while the other studies found no difference in patient outcomes.[193] Similarly, a 2014 observational study including admissions from almost 2.8 million Medicare patients to over 3,000 short-term, acute-care hospitals found no significant changes in mortality rates or readmissions before or after the 2011 work-hour regulation.[194] The authors of both articles speculated that the 2011 policy change might not have had as significant effects on patient outcomes as the 2003 reform, because the 2011 regulations only limited the lengths of continuous shifts for interns, a change that affected only about a quarter of resident physicians. Moreover, little is known about the extent to which residency programs implemented the 2011 regulations and complied with the work-hour reduction policies.
When researchers analyzed the effect of the 2011 work-hour regulations on interns only, the beneficial effects of the changes were evident. An analysis of several prospective cohort studies, published in 2022, evaluated the effect of ACGME’s 2011 work-hour standard on medical errors.[195] The researchers compared pooled reports of medical errors of 14,796 first-year resident physicians in five academic years before the implementation of the 2011 ACGME work-hour regulations with those reported in the three academic years after the policy change. The study found that when interns worked fewer hours, the risk of at least one significant medical error reported in a month decreased by 32% and the risk of medical errors that led to patient deaths was reduced by 63%. In another study that included 13% of all interns in the United States and that was published in 2020, the same group of researchers found that the 2011 work-hour regulations were associated with a 18% reduction in attentional failures.[196]
Despite the extensive evidence that long work hours and extended-duration shifts are detrimental to patient and resident physician safety, other factors during the same timeframe may also have affected safety outcomes. Such factors include changes in medical education, practice patterns, and technologies.[197] However, studies conducted outside of the United States have also found that reduced work hours improved patient safety outcomes. For example, a study published in 2009 found that in the United Kingdom, resident physicians who were working 48 hours per week (in accordance with the European Working Time Directive that limits workweeks to 48 hours for all employees, including resident physicians) made 32.7% fewer medical errors than resident physicians who were working 56 hours per week.[198]
3.3. The FIRST and iCOMPARE trials
The findings of the FIRST and iCOMPARE trials[199],[200] led the ACGME to reverse the cap on extended shifts of more than 16 hours for first-year resident physicians. Both trials compared resident physicians enrolled in “standard” residency programs that adhered to the 2011 ACGME work-hour policies with those enrolled in residency programs that followed a “flexible policy.” The flexible policy allowed program directors to disregard maximum shift lengths and time off between work shifts as long as the work hours adhered to the ACGME 80-hours-per-week, frequency of on-call duty, and days-off requirements. Before and during the trials, Public Citizen and the American Medical Student Association repeatedly urged ACGME and the Office for Human Research Protections to suspend the iCOMPARE trial and investigate ethical concerns about both the iCOMPARE and FIRST trials.[201],[202],[203],[204]
Both trials allowed first-year resident physicians to work shifts of 28 consecutive hours or more — nearly twice the maximum number of hours permitted by the ACGME at that time for interns. Resident physicians could not avoid participating in either trial except by leaving their residency programs entirely.[205] Moreover, no informed consent was obtained from “participating” interns (in fact, the FIRST trial investigators claimed that the trial did not involve human subject research).[206] The ACGME extended work-hour waivers and contributed funding for these trials.
Patients seeking care in hospitals with participating residency programs were not informed either about the ongoing trials or that they were being treated by interns who were required to work extended shifts that were not in accordance with the ACGME regulations at the time. In 2011, ACGME’s reasoning for limiting shifts to 16 hours was, in part, that “PGY-1 residents make more errors when working longer consecutive hours.”[207] Yet the trials were designed to test whether patients treated by resident physicians working longer hours were more likely to die than those cared for by interns working according to the 2011 ACGME work-hour limits. Importantly, the trials did not have a protocol to monitor or mitigate resident physician or patient safety concerns in real time.
The FIRST trial
The FIRST trial, conducted in the academic year 2014-2015, was a national cluster-randomized trial among 117 surgery residency programs to assess several patient safety outcomes, including 30-day rate of postoperative death or serious complications, as well as resident physicians’ satisfaction and perception regarding the quality of their education, patient care, and resident physician well-being.[208]
The study’s main finding was that there were no significant differences in patient outcomes between patients who were treated by interns working standard hours and those working flexible hours. For example, the rate of death or serious complications in the flexible programs (9.1%) was non-inferior to (not worse than) that in the standard residency programs (9.0%). Although resident physicians assigned to the flexible groups were significantly less likely to leave work during an operation or “hand off” to another resident physician during active patient issues, effects on the outcomes for patients were non-inferior to those in standard programs.
Resident physicians in programs assigned to standard work hours were similarly dissatisfied with the quality of their education (10.7%) compared with resident physicians in programs assigned to flexible work hours (11.0%). There was also no difference in mean scores on the American Board of Surgery In-Training Examination or in the pass rates of the Qualifying Examination or Certifying Examination between the two groups.[209]
Importantly, resident physicians working longer, flexible hours were less satisfied with the effect their work hours had on their well-being.[210] For example, compared with those assigned to standard work hours, those who worked flexible hours were almost four times as likely to report that their work hours had a negative impact on their ability to spend time with family and friends and their ability to rest. They were also almost three times as likely to report negative health effects.[211]
The iCOMPARE trial
The iCOMPARE trial was a randomized trial conducted in 63 internal medicine residency programs during the 2015-2016 academic year.[212] The trial evaluated whether safety outcomes for patients cared for by resident physicians in programs with flexible work hours were non-inferior to those who received care from resident physicians in programs following the 2011 ACGME work-hour standard. The trial also assessed the effect of work hours on sleep outcomes (including alertness, sleep duration, and morning sleepiness)[213] and educational experiences.[214]
For 30-day mortality, the outcomes for patients cared for by resident physicians in programs with longer work hours were non-inferior to the outcomes for patients cared for by resident physicians in programs following the 2011 ACGME work-hour standard.[215] Although the overall sleep duration (per 24 hours) as well as sleepiness among first-year resident physicians working flexible hours were non-inferior to those of resident physicians in the programs following the ACGME work-hour standard, interns in the flexible programs with longer work hours were sleeping less on average, especially during extended overnight shifts.[216] The study also found that interns in the flexible work-hour programs compensated for the loss of sleep during their longer shifts by changing their sleep patterns, for example by sleeping longer on their days off. There were also no significant differences between the groups in terms of how much time interns spent on direct patient care or on education.[217] Although program directors were more satisfied with the flexible work-hour programs, interns in these programs reported less satisfaction with their educational opportunities than those in the programs following the ACGME work-hour standard.
Limitations of the FIRST and iCOMPARE trials
In addition to the ethical concerns discussed above, the FIRST and iCOMPARE trials appear to have been poorly designed and biased to provide evidence that the ACGME’s 2011 shift limit of 16 hours for interns was not needed to protect resident physicians and patients.[218] For example, although resident physicians may work beyond the work-hour standard or underreport work hours (which is a concern for all studies trying to assess the effects of work-hour limitations),[219] in the FIRST and iCOMPARE trials flexible work hours were not clearly defined.[220],[221],[222] Program directors could assign longer shifts but were not required to. As a result, there were large variations in work hours across residency programs. The differences between the work schedules of the two groups and the actual numbers of hours worked were poorly characterized. Moreover, the FIRST trial only evaluated the effect of work hours on patient safety in surgical interns. In the first year of training, surgical resident physicians typically have a lesser role in surgical procedures than in subsequent years.[223] In the iCOMPARE trial, the chosen non-inferiority margin of one percentage point for inferiority has been criticized as “unreasonable.”[224] For example, according to a 2023 systematic review, a difference of one percentage point in 30-day mortality used in this trial would translate into an increase of mortality due to medical errors of more than 30%, corresponding to at least 39,000 additional deaths.[225],[226]
Part 4: Evaluation of Existing Work-Hour Regulations
As discussed above, extensive research indicates that sleep deprivation and fatigue associated with long work hours and extended shifts have a detrimental effect on the health and safety of both resident physicians and patients. At the same time, reducing work hours and especially limiting extended work shifts to no more than 16 hours have been shown to improve resident physician wellness and to decrease their risk of motor vehicle crashes, percutaneous injuries, obstetric complications, and worsening of mental health. As discussed, reduced work hours and limits on extended work shifts also have overall positive effects on patient safety outcomes.
4.1. Effects and limitations of work-hour regulations in the United States
When the ACGME established its 2011 work-hour standards, the council’s task force argued that the 2003 reforms had failed to increase the amount of sleep resident physicians got and failed to decrease fatigue.[227] Moreover, as there is also evidence that limiting work hours and shift lengths can increase workload and stress for resident physicians (resident physicians have to complete the same amount of work in less time),[228],[229],[230] there is concern that reducing work hours might not be the best approach to addressing sleep deprivation with the goal of improving patient outcomes.[231]
A multicenter trial, published in 2020, compared the effects of different work schedules on patient safety.[232] The study found that the same group of pediatric resident physicians in an intensive care unit appeared to make fewer serious errors when they were working longer hours than when they were working shifts of 16 hours or less (79.0 vs. 97.1 serious errors per 1,000 patient-days, respectively). However, after the researchers adjusted the number of serious errors by the number of patients a resident physician cared for (8.8 patients when they worked reduced hours and 6.7 patients when they worked extended hours), there was no longer an increase in errors associated with reduced work hours. The authors concluded that finding worse patient outcomes was not related to shorter shifts but instead due to an increase in workload and number of patients cared for. Thus, the implementation of work-hour standards also requires additional regulations regarding workload and staffing.
Numerous studies have demonstrated that the ACGME’s limitations of weekly work hours and especially reducing shift lengths to no more than 16 hours help to reduce the hours resident physicians work and to increase the hours they sleep. For example, a 2004 study compared the same 20 interns when they were working in an intensive care rotation with extended work shifts (of 24 hours or more) or in a rotation with shifts of 16 hours or less.[233] The researchers found that 85% of the interns who worked extended shifts had worked more than 80 hours a week, whereas during the limited shift rotation, interns worked on average 19.5 hours less and slept 5.8 hours more per week. During the rotation with shorter shifts, the rate of attentional failures during on-call night shifts was also reduced by more than half.
Similarly, a national prospective cohort study published in 2006 found that after the 2003 ACGME regulations were put in place, work hours among interns decreased from an average of 70.7 hours a week to an average of 66.6 hours, extended work shifts decreased from an average of 32.1 hours to an average of 29.9 hours, and sleep duration increased from an average of 5.9 hours to an average of 6.3 hours per night.[234] However, 29% of interns’ workweeks still exceeded 80 hours. Importantly, 12.1% of interns’ workweeks exceeded 90 hours and 3.9% exceeded 100 hours.
A cluster-randomized crossover trial (ROSTERS) published in 2019 compared 302 resident physicians taking part in 370 one-month pediatric intensive care unit rotations.[235] The resident physicians worked in rotations with extended-duration shifts of 24 hours or more as well as rotations with work schedules where shifts were limited to a maximum of 16 consecutive hours. When resident physicians worked limited shifts, they were working significantly fewer hours (62 hours) and slept longer (53 hours) than when they worked extended shifts (worked 68 hours a week and only slept 49 hours). Resident physicians in rotations with extended shifts were also significantly more likely to exceed the ACGME’s 2017 28-hour work limit in 9% of these shifts, compared with when they were on the restricted schedule (0.1%). The ROSTERS trial also demonstrated that neurobehavioral performance improved in resident physicians on shorter shifts compared to those working extended shifts.
Another prospective study, published in 2020, included 13% of all interns in the United States and compared resident physicians’ monthly work hours and several safety outcomes before and after the 2011 ACGME work-hours policy was put in place.[236] The study found that the implementation of the 16-hour shift cap decreased mean work hours from 71 to 62 hours a week and reduced the mean number of shifts that lasted 24 hours or longer from 3.9 times to 0.2 times a month. Importantly, the researchers also found that even one extended work shift a month had a detrimental effect on resident safety (including motor vehicle crashes and percutaneous injuries).
Based on this evidence, limiting work hours through the ACGME work-hour standard, and especially the introduction of a 16-hour cap on shifts, has been successful in increasing sleep time and decreasing shift length and frequency. This evidence underscores the importance of establishing a federal work-hour standard that requires a 16-hour shift cap for all resident physicians.
4.2. Work-hour compliance and violations
The ACGME generally does not specify how resident work hours should be tracked and has not routinely made robust compliance data publicly available.[237],[238] However, even when the ACGME makes compliance data public, these data might not accurately reflect the extent of compliance with work-hour regulations, particularly if the information is based on resident self-reports.
Because the ACGME can withdraw the accreditation of residency programs that do not comply with its work-hour regulations, resident physicians have an incentive to underreport violations of their work hours.[239] They may fear punitive actions from their program or the loss of their residency position if their program were to lose its ACGME accreditation. Resident physicians may work more hours than are permitted for various reasons, including because they feel long hours are expected or because they feel pressure to meet patient needs or educational objectives.[240] Studies by researchers who are not affiliated with the ACGME repeatedly found high levels of underreporting and frequent noncompliance with work-hour limits after the 2003, 2011, and 2017 work-hour regulations.
A national prospective cohort study published in 2006 analyzed the compliance of 4,015 interns with work-hour restrictions across specialties.[241] The researchers found that in the year after the implementation of the 2003 ACGME work-hour standard, 83.6% of interns reported that they worked more than the work-hour limits in one or more months. For example, 67.4% reported working shifts of more than 30 consecutive hours, 43.7% reported not having one in seven days off, and 43.0% reported working more than 80 hours a week averaged over four weeks.
Similarly, in a large representative survey of U.S. resident physicians, which included 6,202 resident physicians across multiple specialties published in 2013, only about half of the respondents stated that they were always compliant with the ACGME’s 2011 work-hour limits.[242] Also, 42.9% admitted that they falsified their reports at some point, and 18.6% stated that they falsely reported their work hours at least once or twice per month. Program directors who also took part in this survey confirmed that resident physicians were variably compliant with work-hour limits.
A 2017 survey about the 2011 ACGME work-hour standard among 495 resident physicians across 24 specialties found that although most respondents believed that work-hour regulations were reflected in work schedules and enforced in almost all institutions, many resident physicians still violated the work-hour standard.[243] For instance, 11% reported working more than 80 hours per week and 8% worked shifts of more than 28 hours. Of the respondents, 80% felt that in some situations working more than the permitted number of hours was justified.
A national survey of motor vehicle crashes among surgery resident physicians, published in 2021, found frequent violations of ACGME work-hour limits.[244] For instance, 86.2% of resident physicians had worked up to two shifts of more than 28 continuous hours in the prior month, and 13.8% worked three or more such shifts in the most recent month. Of the respondents, 25% stated that they had exceeded the 80-hour-per-week limit in one or two of the previous six months, 8.4% exceeded the limit in three or four months, and 4.8% had exceeded it almost every month.
The 2013 survey discussed above also found that resident physicians with a negative opinion of work-hour limitations were more likely to be noncompliant with the regulations.[245] For example, resident physicians who felt that the 2011 work-hour limitations negatively affected patient safety were 1.5 times more likely to report noncompliance than those who felt the regulations had no or a positive effect on patient safety. The authors concluded that a zero-tolerance policy about falsifying work-hour records is necessary. In sum, the inadequate implementation and enforcement of work-hour limitations may have substantially limited their effectiveness.[246]
4.3. Other countries’ responses to resident physician work hours
Resident physicians in the United States typically work much longer hours than resident physicians in many other countries. A qualitative, comparative analysis published in 2023 compared the work hours of resident physicians in 14 high-income countries.[247] The analysis found that although all countries included in the analysis limited the maximum number of weekly work hours, there were different regulations in place, including limiting duration of consecutive work hours and number and duration of extended or overnight shifts. Overall, with the current weekly work-hour limit of 80 to 88 hours, resident physicians in the United States not only had amongst the highest number of weekly work hours, but they also were permitted to work more night shifts per month than resident physicians in other countries.
In contrast to the United States, the European Commission stated in a European Working Time Directive (EWTD) that became effective in 2004 that “[e]very worker has the right to working conditions which respect his or her health, safety and dignity.”[248] The EWTD’s limits were implemented gradually in different ways (such as maximum hours per shift or number of night shifts per month) across different countries.[249] Since 2009 the weekly working hours for all employees in the European Union, including resident physicians, have been limited to 48 hours a week.
Outside the European Union, resident physicians in many other high-income regions also work fewer hours per shift and fewer hours per week than resident physicians in the United States. For example, in 1990, Quebec (a province in Canada) lowered the limit on consecutive work hours from 36 hours to 24 (in response to Libby Zion’s death in the United States, discussed above).[250] In 2011, Quebec further reduced consecutive work hours to an in-house 16-hour call limit, a first in North America. This decision was strongly supported by public opinion.
Moreover, in New Zealand a shift limit of 16 hours has been in place since 1985[251] and in England shifts for resident physicians are limited to 13 hours.[252] Although Australia does not have formal work-hour limitations, resident physicians are cautioned that working for longer than 50 hours a week puts them at higher risks associated with extended work hours as discussed above, such as worse mental health, increased involvement in motor vehicle crashes, disruptions of one’s social life, and compromised ability to learn, as well as higher risks of cognitive and physical impairment, cardiovascular disease, and negative obstetric outcomes.[253]
Importantly, as will be discussed in more detail below, these more restrictive work-hour limits outside the United States have not negatively affected patient outcomes or educational opportunities for resident physicians.[254],[255]
4.4. U.S. work-hour regulations in other industries
The 2017 ACGME work-hour standard requires work hours for resident physicians that are much longer than for employees in most other industries in the United States. In fact, in many other industries’ work hours have long been restricted because of safety concerns for employees and the public.
In transportation industries (such as highway, marine, railway, or aviation), fatigue has long been recognized as a key contributing factor for crashes.[256] Moreover, a 2000 consensus statement of an international group of sleep researchers identified long work hours and inadequate sleep as major contributors to fatigue in transport operations and thus the “largest identifiable and preventable cause of accidents in transport operations.”[257] An analysis of investigations by the National Transportation Safety Board (NTSB) from 2001 to 2012 found that in about 20% of cases, fatigue was a contibuting factor, probable cause, or a finding of a crash.[258] The analysis also suggests that fatigue-related crashes in transportation industries can be addressed through interventions such as improved work-hour schedules.
The federal government has long recognized the importance of regulating work hours in transportation and other industries. In 1907 in the Hours of Service Act, the United States limited the work hours of railway engineers because of safety concerns.[259] In 1935 the Motor Carrier Act first limited work hours for certrain commercial drivers.[260] Since 1972 the NTSB has issued over 200 fatigue-related safety recommendations, including work-hour limitations, to federal agencies and transportation operators.[261]
Under the jurisdiction of the Department of Transportation, several work-hour limits and rest-period requirements for the highway, aviation, railroad, and maritime industries have been established. For example, the Federal Motor Carrier Safety Administration limits property-carrying drivers in commercial industries to driving no more than 11 hours after 10 consecutive hours off duty and passenger-carrying drivers to drive no more than 10 hours after eight consecutive hours off duty.[262] Moreover, property- and passenger-carrying drivers may not drive after having been on duty for 60 hours in seven consecutive days (or 70 hours in eight consecutive days, referred to as 60/70-hour limit). Similarly, the Code of Federal Regulations limits the duty period of a flight crew with one pilot to no more than eight hours of flight time per duty with a minimum rest of 10 to 12 hours after duty and a maximum duty period of 14 hours.[263] According to the Federal Railroad Administration, a train employee may generally not work longer than 12 consecutive hours until that employee has had at least 10 consecutive hours off before duty.[264]
Long-standing federal regulations from the Department of Transportation and other agencies are essential in addressing fatigue-related crashes and have been instrumental in maximizing worker and public safety.[265] The rationale for these regulations has many parallels to the arguments for federal regulation of resident physician work hours.[266]
Part 5: Responses to Concerns About Reducing Work Hours
Some argue that long work hours during medical residency are necessary and have been an integral part of medical training for decades.[267],[268],[269] One argument is that long work hours are necessary for resident physicians to develop their professional identity and sense of responsibility for the many aspects of patient care and to fully participate in educational and clinical opportunities. Another argument is that reducing work hours would lead to disruptions in the continuity of care and an increased frequency of “handoffs” of care between physicians, thereby introducing more opportunities for medical errors.
Often, these concerns are voiced by residency program directors.[270],[271],[272] Although program directors have a unique point of view, it is also important to note that they, their staff, and faculty members frequently report that their workload increases when resident physician work hours are reduced.[273],[274] Because faculty and other medical staff may have to perform work that had previously been performed by resident physicians,[275] this may influence their views.
Another concern about reductions in work hours for resident physicians is the additional expenditures, such as for hospitals and other health care organizations.[276],[277],[278] This is mainly due to the costs of hiring additional medical personnel, who often are paid more than resident physicians.[279],[280]
The concerns about reducing work hours for resident physicians are discussed in more detail in the following sections. The most important response to these arguments, however, is that resident physicians would continue to work long hours once our petition is granted but would be required to have work schedules that are consistent with protecting the health and safety of resident physicians and the patients they care for. Working 80 hours (without averaging) of the 168 hours in a week are long work hours by any standard. Additional costs to hospitals and health care organizations should be seen in the context of needed expenses to restore or maintain the proper work balance for resident physician education, well-being, and patient care.
5.1. Lack of effect of work-hour regulations on medical education
As stated above, one of the arguments against reducing work hours is that resident physicians will have fewer educational opportunities and a decreased quality of training.[281] Although a few studies support this view, there is far more evidence to the contrary. In fact, many studies have demonstrated that improvements in resident physician quality of life and patient safety did not come at the price of significantly reducing educational and clinical experiences.[282]
For example, a systematic review of 72 studies published in 2011 suggested that the reduction of working hours to less than 80 hours per week in the United States did not have a negative effect on training opportunities overall.[283] Similarly, a national survey-based study published in 2014 compared the educational and clinical experiences of 316 pediatric interns during their neonatal rotations who worked shifts of 16 hours or more in 2011 with 509 interns who worked shifts of 16 hours or less in 2012.[284] The researchers found that the 2011 ACGME work-hour regulation did not lead to significantly different experiences. Although interns attended fewer grand rounds, lectures, and mock resuscitations, after the 16-hour cap there was no difference between the cohorts in the proportion of correct responses on a knowledge-based multiple-choice test. Importantly, there was also no difference in the number of patients they saw or how many deliveries and procedures they attended.
The FIRST trial (despite the fact it was poorly designed and raised ethical concerns, as discussed above) also confirmed that resident physicians who worked shorter shifts did not have different mean scores or pass rates in several tests (including the American Board of Surgery In-Training Examination, the Qualifying Examination, and Certifying Examination) than those working flexible, longer shifts.[285] Additionally, a 2015 study conducted in the Netherlands found that even after the implementation of the 48-hour workweek as part of the European Working Time Directive, the number of surgical procedures performed by resident physicians stayed largely the same.[286]
There is additional evidence that work-hour limitations have had either no effect or even a positive effect on medical education. A systematic review published in 2010 found that, overall, reduced work hours did not have a significant effect on medical education outcomes (nine of 14 studies).[287] Four studies, however, found significant improvements (such as increased test scores or higher number of operative or surgical cases). Only one study found worse educational outcomes.
A 2013 study compared the educational opportunities of 47 internal medicine interns in one medical center before the ACGME 16-hour shift limitation in 2011 with those of 50 interns after the implementation of this shift limitation.[288] The researchers concluded that because the median number of selected procedures performed remained the same before and after the 2011 policy change, the 16-hour cap did not reduce the clinical experiences of interns. Moreover, interns cared for significantly more patients (on average 140 per intern over 24 weeks) after the implementation than before the work-hour limit (on average 118 patients per intern). After the 16-hour cap was implemented, interns also wrote significantly longer and more detailed notes and were more likely to attend the weekly chief resident conference.
Another study, published in 2015, retrospectively reviewed resident performance on the American Board of Surgery In-Training Examination and their surgical-case volume in one institution over five years of such training.[289] The researchers compared certain outcome measures of surgical training among 169 general surgery resident physicians before the 2011 ACGME work-hour standard (July 2008-June 2011) with those of 115 resident physicians in the years after implementation (July 2011-June 2013). Not only did study examination scores not significantly differ before and after the 2011 policy reform, case volumes also significantly increased after the work-hour limitations. For example, chief resident physicians finished their programs with 1,062 major cases after the work-hour limitations, compared with 945 cases for their counterparts before the work-hour limitations. The positive effect of the work-hour limitation on educational opportunities may have been facilitated by an organizational restructuring of the institute, which included hiring additional staff (such as nurse practitioners and physician assistants who, under the supervision of senior resident physicians, could provide coverage in place of interns during night shifts).
5.2. Lack of effect of work-hour regulations on the continuity of patient care
As stated above, there is a false concern that work-hour regulations may have negative effects on patient care, including the continuity of care. Several studies indicate, however, that limiting work hours for resident physicians did not lead to decreased time spent in direct patient care.[290]
For example, as part of the iCOMPARE trial the researchers assumed that flexible, longer work hours would allow interns to spend more time in direct patient care than working according to the 2011 ACGME work-hour standard.[291] The study (despite the serious concerns about its biased study design discussed above) found, however, that internal medicine interns in the standard program spent a comparable amount of time in direct patient care (11.8%) to those in the flexible work-hour model (13.0%). Importantly, interns who worked flexible hours were more likely to be dissatisfied with several aspects of their training, such as the quality of their education, their overall well-being, and the effect the residency schedule had on their personal lives. Notably, unlike interns, the directors of flexible residency programs were more satisfied with the educational opportunities for their resident physicians than directors of standard programs.
Similarly, although surgical resident physicians working standard hours in the FIRST trial were more likely to report leaving during an operation or handing off active patient issues than those who were working flexible hours, the researchers did not demonstrate that this had a significant impact on patient outcomes.[292]
Moreover, a 2010 study conducted in one region in England (NHS North West) that had implemented the 48-hour EWTD work-hour restrictions one year ahead of schedule found that limiting work hours had not negatively affected quality of care and patient safety.[293] When the researchers compared several outcome measures (such as increases in length of hospitalization, rates of readmission, or mortality) in this region with national data for that year, they found no significant differences. In fact, an analysis of the average length of stay found that the region with shorter work hours performed better than the national average, where longer work hours were still standard.
As discussed above, shorter shifts for resident physicians can often lead to an increased number of handoffs of patient care between physicians. Especially if handoffs are poorly executed, the concern is that critical information may not be communicated, contributing to medical errors and patient harm.[294],[295] An assumption underlying this concern is that handoffs between physicians are inherently more detrimental to patient safety than resident physician fatigue.[296] Handoffs, however, occur regardless of shift length. In fact, the likelihood of failing to communicate critical information may be higher if resident physicians have worked continuously for 24 hours or more rather than working a 16-hour shift.
A retrospective analysis published in 2013 found that although the number of handoffs increased after the 2011 ACGME policy change, there was not a significant effect on quality of care or efficiency among medical inpatients not requiring intensive care.[297] A retrospective cohort study published in 2017 compared the types of medical errors that occurred while surgical resident physicians at one institution were working either standard hours or flexible hours.[298] The researchers found that there were no differences in the types of errors between the periods and no differences in mortality or complication rates. Importantly, flexible hours were not associated with fewer errors due to handoffs.
A prospective intervention study published in 2014 found that errors associated with handoffs can be significantly reduced with a program designed to optimize handoffs through improved quality of oral and written communication during handoffs between shifts.[299] Specifically, the researchers compared 5,516 patient admissions before the program with 5,224 patient admissions after the intervention and found that handoff optimization was associated with a decrease of 23% in medical errors and a decrease of 30% in preventable adverse events. Implementation of the program did not affect the workflow, because resident physicians spent a similar percentage of time with patients and their families. Further, the intervention did not change the duration of the handoffs.
5.3. Perspectives of program directors and resident physicians
Residency programs are heterogeneous, varying by size and specialty. A national survey of residency program directors published in 2010 found that most directors approved of some work-hour regulations (such as an 80-hour workweek or one day per week off).[300] However, other regulations, especially the capping of work shifts at 16 hours, were viewed more critically. The survey also found that attitudes towards work hours differed across specialties, with program directors of pediatrics or internal medicine programs viewing limiting work hours more positively than directors of surgery programs.
A survey of 549 pediatrics, internal medicine, or general surgery residency program directors, published in 2013, found that most program directors did not view the 2011 ACGME regulations as changing any of several important aspects of residency programs, such as exam scores and the balance of education and service.[301] Instead, approximately half of the program directors viewed the reductions in works hours as leading to improvements in the quality of life of resident physicians. Surveys of resident physicians have found that most are satisfied with work-hour reductions because they increased their quality of life[302] and had a positive effect on their training.[303]
As discussed above, the views of resident physicians and program directors often differ on key issues, such as satisfaction with flexible (and longer) or standard work hours.[304] One explanation for this mismatch is that some program directors may be unaware of, or insufficiently responsive to, their resident physicians’ needs.[305] They may therefore make “well-intentioned but ultimately ill-informed decisions about the design and delivery of the residency programs”, especially given the evidence of the positive effects of reduced work hours on the health and safety of resident physicians and their patients.
The opinions of program directors can also affect the views of resident physicians about work-hour regulations. A national survey study, published in 2011, including responses from 1,314 orthopedic resident physicians and 185 residency program directors, found that although 70% of resident physicians and 79% of program directors believed reducing work hours increased the number of handoffs that would be detrimental to patient care, 71% of resident physicians felt that a 80-hour workweek was still appropriate, whereas only 38% of program directors agreed.[306] Moreover, 70% of program directors, but only 24% of resident physicians, thought that the ACGME’s 2003 work-hour regulation had not improved patient care. Although 60% of resident physicians reported improvements in their ability to function after the work-hour regulation was implemented, only 17% of the program directors agreed.
A survey, published in 2020, with responses from 123 resident physicians and 136 faculty of general surgery residency programs found a similar mismatch of perceptions.[307] For example, although 92.6% of resident physicians routinely checked on their patients while off duty, faculty thought that only about 36.8% did. Only about a quarter of faculty thought that resident physicians had a similar or higher degree of “patient ownership” as they had themselves.
In aggregate, the available studies indicate that the concerns about work-hour restrictions for resident physicians are not based on facts but on beliefs that extended, less-restricted work hours are required because it has always been this way, and that they are a necessary price that resident physicians need to pay to demonstrate their “professional commitment” to patients and their medical training.[308]
5.4. The perspective of the public
Public-opinion surveys have consistently found that the public does not want to be cared for by resident physicians who have worked extended shifts and are sleep deprived. Moreover, the public does not approve of the long work hours and extended shifts permitted in residency programs.
Over the last decade, public opinion on this issue has changed little. Nationally representative surveys repeatedly find that adults in the United States disapprove of the current work hours of resident physicians.[309],[310] The public also believes that further limits on work hours would be an effective way to reduce medical errors and that the hours worked by resident physicians are longer than what most believe to be safe.
This finding is of particular interest because most of the public tends to seriously underestimate the hours resident physicians typically are permitted to work. For instance, a representative survey published in 2010 found that the public estimated that shifts last about 13 hours and that resident physicians worked about 58 hours a week.[311] In fact, in 2010, under the ACGME’s 2003 work-hour standard, resident physicians were allowed to work extended shifts of up to 30 hours once or twice a week and a total of up to 88 hours a week, although, as discussed above, many resident physicians violated these standards and frequently worked even longer hours.
Importantly, the public feels that they should be told if their treating resident physician had worked an extended shift without sleep. In fact, most respondents reported that they would not want to be treated by a sleep-deprived resident physician.[312] In 2016 a representative national poll of likely U.S. voters commissioned by Public Citizen found that about 80% of the respondents were in support of lowering shift limits from 28 hours to a maximum of 16 hours for all resident physicians in their second year or above. The same poll also found that 86% of the public opposed the proposal to eliminate the 16-hour cap on shifts for interns (the 16-hour cap that the ACGME rolled back in 2017).
Similarly, a nationally representative poll conducted in 2022 and published in 2024 found that 97% of respondents believed that resident physicians should not work shifts longer than 24 hours and 96% believed that the current resident workweek of 80 hours was too long.[313] Two-thirds of the respondents thought that resident physicians should work no more than 12 consecutive hours per shift and their workweeks should be no more than 59 hours. Across these two polls, less than 6% of the public supported work shifts that are scheduled for 24 hours or longer and 80 or more work hours per week.
Although often ignored, public opinion is a very relevant consideration for resident physician work-hour regulations. The public pays indirectly for medical education through taxes and Medicare premiums that fund residency programs and directly by paying for health care services.[314] At the same time, long work hours for resident physicians can contribute to patient harms, as discussed above.
Part 6: Petitioners’ Request
Public Citizen and the American Medical Student Association request that OSHA applies the following work-hour regulations to resident physicians in all residency and subspecialty fellowship programs:
- A limit of 80 hours of work in each and every workweek, without averaging;
- A limit of 16 consecutive hours worked in one shift for all resident physicians and subspecialty resident physicians, with no exceptions;
- At least one 24-hour period of time off work per week (no averaging) and one 48-hour period of time off work per month, no averaging;
- In-hospital on-call frequency no more than once every three nights, no averaging;
- A minimum of at least 10 hours off work after a day shift and a minimum of 12 hours off work after a night shift; and
- A maximum of four consecutive night shifts with a minimum of 48 hours off after a sequence of three or four night shifts.
Work hours include any time asleep at the work site. Time off work is time away from the hospital or other work site while not on call. As stated by the ACGME, any time resident physicians spend on “at-home call must count toward the 80-hour maximum weekly limit.”[315]
Petitioners’ requests shall not be construed to require or permit a resident physician to abandon a patient in need of emergency or critical care. In a patient care emergency and when there are no available alternatives, the resident physician’s or subspecialty resident physician’s work may exceed the maximum 16-consecutive-hour shift or 80-hour-per-week limit for this reason only. Regardless, resident physicians should not be scheduled to be at a worksite more than the 16-hour-per-day or 80-hour-per-week limit.
Petitioners’ requests differ from the current ACGME work-hour standards, effective as of 2022, in several ways: First, whereas the most recent ACGME work-standard policy calls for an 80-hour workweek averaged over a four-week period, petitioners’ requests are for an 80-hour workweek that is not averaged. Allowing resident physicians to work “beyond their scheduled work periods to care for a patient or participate in an educational activity,” as argued by the ACGME, is not consistent with minimizing harm to physicians and patients, and exceptions to an 80-hour week should not be granted to any residency program. At present, the ACGME may grant “rotation-specific exceptions for up to 10 percent or a maximum of 88 clinical and educational work hours to individual programs based on a sound educational rationale.”[316] As stated previously, the petitioners request that the same standard apply to all rotations and specialties because exceptions other than for emergency or critical care as discussed above undermine the purpose of the 80-hour workweek limit. Thus, the petitioners request an 80-hour limit of work per week be applied to all residency and subspecialty fellowship programs, with no exceptions, across specialties.
Second, the ACGME rules allow resident physicians to work up to 28 consecutive hours. The petitioners request a maximum continuous shift time of 16 hours (as was implemented by the ACGME between 2011 and 2017 for interns only) for all resident physicians, without exceptions.
Third, the current ACGME work-hour standard provides for a minimum of one day off per week when averaged over four weeks. Petitioners request that resident physicians have at least one day (24-hour period) off work per week without averaging as well as at least one two-day (48-hour) period of time off work per month without averaging.
Fourth, the petitioners request that in-hospital on-call frequency should be no more than every third night without averaging for all resident physicians, not averaged over a four-week period as the ACGME currently permits.
Fifth, as recommended by the IOM,[317] resident physicians should have a minimum of 10 hours off work after a daytime work shift (that is not part of an extended shift) and 12 hours off work after a night shift (that is not part of an extended shift). At present, the ACGME work-hour standard requires only eight hours off between work and education periods,[318] which contributes to inadequate sleep on a regular basis once commuting time and personal responsibilities are accounted for.
Finally, although the ACGME in the past allowed resident physicians to work up to six night shifts in a row,[319] at present the ACGME does not specify a maximum number of consecutive night shifts. ACGME’s rules state that the “maximum number of consecutive weeks of night float… may be further specified by the Review Committee.”[320] The petitioners maintain that resident physicians should not be permitted to work more than four consecutive night shifts, as the IOM recommended.[321] Moreover, after three to four consecutive nights of work, petitioners request that a 48-hour period without work be required to allow for recovery sleep and prevent the buildup of sleep debt.
Enforcement
Petitioners request that strict enforcement accompany the regulations. Previous efforts to limit resident physician work hours have been undermined by inadequate enforcement. Resident physician work schedules and work hours should be accurately recorded and maintained as records by the residency programs and the hospitals and other health care facilities where resident physicians work. These records should be fully available for inspection by OSHA:
- OSHA should establish an official, confidential, and easy-to-use procedure for reporting work-hour violations for resident physicians and widely publicize this reporting procedure.
- OSHA should conduct unannounced and frequent inspections of residency programs for compliance with work-hour regulations.
- OSHA should establish enforcement mechanisms of work-hour regulations, including provisions for fines of sufficient amounts to deter violations; financial penalties to teaching hospitals that do not adequately monitor, enforce, and otherwise comply with the regulations; and public reporting of violations.
Conclusion
As outlined in this petition, as well as Public Citizen’s previous petitions in 2001[322] and 2010,[323] there is a substantial body of evidence that convincingly demonstrates that long work hours and extended shifts for resident physicians are associated with sleep deprivation and fatigue. Moreover, these excessive work schedules have been shown to increase numerous risks for resident physicians’ lives and health — including an increased risk of being involved in motor vehicle crashes, higher risks of negative mental health outcomes, higher risks of obstetric complications among pregnant resident physicians, and higher risk of percutaneous injuries. Sleep-impaired resident physicians also pose a risk for the patients in their care because sleep deprivation associated with long work hours has been linked to increased medical errors and preventable adverse events, leading to worse patient safety outcomes.
In 2003, 2011, and again in 2017 the ACGME failed to demonstrate that it can establish and enforce work-hour standards that would ensure “safe and healthful working conditions”[324] for resident physicians as guaranteed under the Occupational Safety and Health Act of 1970 for every employee — including resident physicians — in the United States. Because resident physicians have a right to be protected by federal labor law, federal work-hour regulations are overdue.
We respectfully request that OSHA adopts the evidence-based work-hour standards requested in this petition, which are based on those suggested by the IOM report and represent an expansion of those put forth by the ACGME.
Nina Zeldes, Ph.D.
Health Researcher
Public Citizen’s Health Research Group
Robert Steinbrook, M.D.
Director
Public Citizen’s Health Research Group
Annelise M. Silva-Chong, MD EdM
AMSA National President
for the
American Medical Student Association (AMSA)
—
[1] Institute of Medicine. Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedule to Improve Patient Safety, National Research Council. Resident Duty Hours: Enhancing Sleep, Supervision, and Safety. Ulmer C, Miller Wolman D, Johns MME, editors. Washington (DC): The National Academies Press; 2009.
[2] Accreditation Council for Graduate Medical Education. ACGME common program requirements (residency). September 17, 2022. https://www.acgme.org/globalassets/pfassets/programrequirements/cprresidency_2023.pdf. Accessed April 25, 2025.
[3] Institute of Medicine. Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedule to Improve Patient Safety, National Research Council. Resident Duty Hours: Enhancing Sleep, Supervision, and Safety. Ulmer C, Miller Wolman D, Johns MME, editors. Washington (DC): The National Academies Press; 2009.
[4] Accreditation Council for Graduate Medical Education. Physician education. https://www.acgme.org/about/physician-education/. Accessed April 25, 2025.
[5] Philibert I, Taradejna C. A brief history of duty hours and resident education. In: Philibert I, Amis Jr S, Vasilou E. ACGME task force on quality care and professionalism: The ACGME 2011 duty hour standard. Enhancing Quality of Care, Supervision, and Resident Professional Development. Chicago, IL; 2011: 5-11.
[6] Papp KK, Stoller EP, Sage P, et al. The effects of sleep loss and fatigue on resident-physicians: a multi-institutional, mixed-method study. Acad Med. 2004;79(5):394-406.
[7] Czeisler CA, Weaver MD, Landrigan CP, et al. Extended work hours increase risk of harm, regardless of resident physicians’ experience levels. BMJ. 2023;381(April 13):838.
[8] Landrigan CP, Barger LK, Cade BE, et al. Interns’ compliance with accreditation council for graduate medical education work-hour limits. JAMA. 2006;296(9):1063-1070.
[9] Schlick CJ, Hewitt DB, Quinn CM, et al. A national survey of motor vehicle crashes among general surgery residents. Ann Surg. 2021;274(6):1001-1008.
[10] Occupational Safety and Health Administration. Extended/unusual work shifts guide. https://www.osha.gov/emergency-preparedness/guides/extended-unusual-work-shifts. Accessed April 25, 2025.
[11] Barger LK, Weaver MD, Sullivan JP, et al. Impact of work schedules of senior resident physicians on patient and resident physician safety: nationwide, prospective cohort study. BMJ Med. 2023;2(1):e000320.
[12] Ibid.
[13] Freedman-Weiss MR, Heller DR, White EM, et al. Driving safety among surgical residents in the era of duty hour restrictions. J Surg Educ. 2021;78(3):770-776.
[14] Martini S, Arfken CL, Balon R. Comparison of burnout among medical residents before and after the implementation of work hours limits. Acad Psychiatry. 2006;30(4):352-355.
[15] Sethi N, Evans D, Murray A. Needlestick occurrences and reporting among residents in the operative setting. J Surg Educ. 2020;77(6):1542-1551.
[16] Behbehani S, Tulandi T. Obstetrical complications in pregnant medical and surgical residents. J Obstet Gynaecol Can. 2015;37(1):25-31.
[17] Weaver MD, Landrigan CP, Sullivan JP, et al. National improvements in resident physician-reported patient safety after limiting first-year resident physicians’ extended duration work shifts: a pooled analysis of prospective cohort studies. BMJ Qual Saf. 2022;32(2):81-89.
[18] Public Citizen. Petition requesting medical residents work hour limits. April 30, 2001. https://www.citizen.org/article/petition-requesting-medical-residents-work-hour-limits/. Accessed April 25, 2025.
[19] Public Citizen. Petition to reduce medical resident work hours. September 2, 2010. https://www.citizen.org/article/petition-to-reduce-medical-resident-work-hours-2/. Accessed April 25, 2025.
[20] Institute of Medicine. Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedule to Improve Patient Safety, National Research Council. Resident Duty Hours: Enhancing Sleep, Supervision, and Safety. Ulmer C, Miller Wolman D, Johns MME, editors. Washington (DC): The National Academies Press; 2009.
[21] Public Citizen. Letter responding to OSHA’s denial of resident work hours petition. November 3, 2011. https://www.citizen.org/article/letter-responding-to-oshas-denial-of-resident-work-hours-petition/. Accessed April 25, 2025.
[22] Accreditation Council for Graduate Medical Education (ACGME). The ACGME’s approach to limit resident duty hours 12 months after implementation: a summary of achievements. https://www.acgme.org/globalassets/pfassets/publicationspapers/dh_dutyhoursummary2003-04.pdf. Accessed April 25, 2025.
[23] Landrigan CP, Barger LK, Cade BE, et al. Interns’ compliance with accreditation council for graduate medical education work-hour limits. JAMA. 2006;296(9):1063-1070.
[24] Public Citizen. Letter responding to OSHA’s denial of resident work hours petition. November 3, 2011. https://www.citizen.org/article/letter-responding-to-oshas-denial-of-resident-work-hours-petition/. Accessed April 25, 2025.
[25] Philibert I, Taradejna C. A brief history of duty hours and resident education. In: Philibert I, Amis Jr S, Vasilou E. ACGME task force on quality care and professionalism: The ACGME 2011 duty hour standard. Enhancing Quality of Care, Supervision, and Resident Professional Development. Chicago, IL; 2011: 5-11.
[26] Friedman RC, Bigger JT, Kornfeld DS. The intern and sleep loss. N Engl J Med. 1971;285(4):201-203.
[27] Weaver MD, Sullivan JP, Landrigan CP, et al. Systematic review of the impact of physician work schedules on patient safety with meta-analyses of mortality risk. Jt Comm J Qual Patient Saf. 2023;49(11):634-647.
[28] Miulli DE, Valcore JC. Methods and implications of limiting resident duty hours. J Am Osteopath Assoc. 2010;110(7):385-395.
[29] Philibert I, Taradejna C. A brief history of duty hours and resident education. In: Philibert I, Amis Jr S, Vasilou E. ACGME task force on quality care and professionalism: The ACGME 2011 duty hour standard. Enhancing Quality of Care, Supervision, and Resident Professional Development. Chicago, IL; 2011: 5-11.
[30] Landrigan CP, Barger LK, Cade BE, et al. Interns’ compliance with accreditation council for graduate medical education work-hour limits. JAMA. 2006;296(9):1063-1070.
[31] Accreditation Council for Graduate Medical Education (ACGME). The ACGME’s approach to limit resident duty hours 12 months after implementation: a summary of achievements. https://www.acgme.org/globalassets/pfassets/publicationspapers/dh_dutyhoursummary2003-04.pdf. Accessed April 25, 2025.
[32] Institute of Medicine. Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedule to Improve Patient Safety. Resident Duty Hours: Enhancing Sleep, Supervision, and Safety, National Research Council. Ulmer C, Miller Wolman D, Johns MME, editors. Washington (DC): The National Academies Press; 2009.
[33] Fletcher KE, Reed DA, Arora VM. Patient safety, resident education and resident well-being following implementation of the 2003 ACGME duty hour rules. J Gen Intern Med. 2011;26(8):907-919.
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[185] Silber JH, Bellini LM, Shea JA, et al. Patient safety outcomes under flexible and standard resident duty-hour rules. N Engl J Med. 2019;380(10):905-914.
[186] Baldwin DC Jr, Daugherty SR. Sleep deprivation and fatigue in residency training: results of a national survey of first- and second-year residents. Sleep. 2004;27(2):217-223.
[187] Rahman SA, Sullivan JP, Barger LK, et al. Extended work shifts and neurobehavioral performance in resident-physicians. Pediatrics. 2021;147(3):e2020009936.
[188] Landrigan CP, Rothschild JM, Cronin JW, et al. Effect of reducing interns’ work hours on serious medical errors in intensive care units. N Engl J Med. 2004;351(18):1838-1848.
[189] Lockley SW, Cronin JW, Evans EE, et al. Effect of reducing interns’ weekly work hours on sleep and attentional failures. N Engl J Med. 2004;351(18):1829-1837.
[190] Barger LK, Weaver MD, Sullivan JP, et al. Impact of work schedules of senior resident physicians on patient and resident physician safety: nationwide, prospective cohort study. BMJ Med. 2023;2(1):e000320.
[191] Fletcher KE, Reed DA, Arora VM. Patient safety, resident education and resident well-being following implementation of the 2003 ACGME duty hour rules. J Gen Intern Med. 2011;26(8):907-919.
[192] Weaver MD, Sullivan JP, Landrigan CP, et al. Systematic review of the impact of physician work schedules on patient safety with meta-analyses of mortality risk. Jt Comm J Qual Patient Saf. 2023;49(11):634-647.
[193] Ibid.
[194] Patel MS, Volpp KG, Small DS, et al. Association of the 2011 ACGME resident duty hour reforms with mortality and readmissions among hospitalized Medicare patients. JAMA. 2014;312(22):2364-2373.
[195] Weaver MD, Landrigan CP, Sullivan JP, et al. National improvements in resident physician-reported patient safety after limiting first-year resident physicians’ extended duration work shifts: a pooled analysis of prospective cohort studies. BMJ Qual Saf. 2022;32(2):81-89.
[196] Weaver MD, Landrigan CP, Sullivan JP, et al. The association between resident physician work-hour regulations and physician safety and health. Am J Med. 2020;133(7):e343-e354.
[197] Hwang J, Kelz R. Impact of medical education on patient safety: finding the signal through the noise. BMJ Qual Saf. 2023;32(2):61-64.
[198] Cappuccio FP, Bakewell A, Taggart FM, et al. Implementing a 48 h EWTD-compliant rota for junior doctors in the UK does not compromise patients’ safety: assessor-blind pilot comparison. QJM. 2009;102(4):271-282.
[199] Bilimoria KY, Chung JW, Hedges LV, et al. National cluster-randomized trial of duty-hour flexibility in surgical training. N Engl J Med. 2016;374(8):713-727.
[200] Silber JH, Bellini LM, Shea JA, et al. Patient safety outcomes under flexible and standard resident duty-hour rules. N Engl J Med. 2019;380(10):905-914.
[201] Public Citizen. Letter to the ACGME regarding Public Citizen’s report, bipartisan consensus: the public wants well-rested medical residents to help ensure safe patient care. September 13, 2016. https://www.citizen.org/article/letter-to-the-acgme-regarding-public-citizens-report-bipartisan-consensus-the-public-wants-well-rested-medical-residents-to-help-ensure-safe-patient-care/. Accessed April 25, 2025.
[202] Public Citizen. iCOMPARE and FIRST trials comparing standard and long work schedules for medical residents. November 19, 2015. https://www.citizen.org/article/icompare-and-first-trials-comparing-standard-and-long-work-schedules-for-medical-residents/. Accessed April 25, 2025.
[203] Public Citizen. Effort to weaken rules on resident physician work hours threatens safety of residents and their patients. March 15, 2016. https://www.citizen.org/news/effort-to-weaken-rules-on-resident-physician-work-hours-threatens-safety-of-residents-and-their-patients/. Accessed April 25, 2025.
[204] Public Citizen. Unethical trials force hundreds of resident doctors nationwide to work dangerously long shifts, placing them and their patients at risk of serious harm. November 19, 2015. https://www.citizen.org/news/unethical-trials-force-hundreds-of-resident-doctors-nationwide-to-work-dangerously-long-shifts-placing-them-and-their-patients-at-risk-of-serious-harm/. Accessed April 25, 2025.
[205] Public Citizen. The Unethical iCOMPARE and FIRST trials. May 2016. https://www.citizen.org/wp-content/uploads/publiccitizenfactsheet-icomparefirst.pdf. Accessed April 25, 2025.
[206] Ibid.
[207] Accreditation Council for Graduate Medical Education. The ACGME 2011 Duty Hour Standards: Enhancing Quality of Care, Supervision, and Resident Professional Development. 2011. https://www.acgme.org/globalassets/pdfs/jgme-monograph1.pdf. Accessed April 25, 2025.
[208] Bilimoria KY, Chung JW, Hedges LV, et al. National cluster-randomized trial of duty-hour flexibility in surgical training. N Engl J Med. 2016;374(8):713-727.
[209] Blay E Jr, Hewitt BD, Chung JW, et al. Association between flexible duty hour policies and general surgery resident examination performance: A flexibility in duty hour requirements for surgical trainees (FIRST) trial analysis. J Am Coll Surg. 2017;224(2):137-142.
[210] Dahlke AR, Quinn CM, Chung JW, et al. Surgical residents’ work hours and well-being in year 2 of the FIRST trial. N Engl J Med. 2017;377(2):192-194.
[211] Bilimoria KY, Chung JW, Hedges LV, et al. National cluster-randomized trial of duty-hour flexibility in surgical training. N Engl J Med. 2016;374(8):713-727.
[212] Silber JH, Bellini LM, Shea JA, et al. Patient safety outcomes under flexible and standard resident duty-hour rules. N Engl J Med. 2019;380(10):905-914.
[213] Basner M, Asch DA, Shea JA, et al. Sleep and alertness in a duty-hour flexibility trial in internal medicine. N Engl J Med. 2019;380(10):915-923.
[214] Desai SV, Asch DA, Bellini LM, et al. Education outcomes in a duty-hour flexibility trial in internal medicine. N Engl J Med. 2018;378(16):1494-1508.
[215] Silber JH, Bellini LM, Shea JA, et al. Patient safety outcomes under flexible and standard resident duty-hour rules. N Engl J Med. 2019;380(10):905-914.
[216] Basner M, Asch DA, Shea JA, et al. Sleep and alertness in a duty-hour flexibility trial in internal medicine. N Engl J Med. 2019;380(10):915-923.
[217] Desai SV, Asch DA, Bellini LM, et al. Education outcomes in a duty-hour flexibility trial in internal medicine. N Engl J Med. 2018;378(16):1494-1508.
[218] Public Citizen. Effort to weaken rules on resident physician work hours threatens safety of residents and their patients. March 15, 2016. https://www.citizen.org/news/effort-to-weaken-rules-on-resident-physician-work-hours-threatens-safety-of-residents-and-their-patients/. Accessed April 25, 2025.
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[221] Weaver MD, Landrigan CP, Sullivan JP, et al. National improvements in resident physician-reported patient safety after limiting first-year resident physicians’ extended duration work shifts: a pooled analysis of prospective cohort studies. BMJ Qual Saf. 2022;32(2):81-89.
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[225] Weaver MD, Sullivan JP, Landrigan CP, et al. Systematic review of the impact of physician work schedules on patient safety with meta-analyses of mortality risk. Jt Comm J Qual Patient Saf. 2023;49(11):634-647.
[226] Landrigan CP, Czeisler CA. Patient safety under flexible and standard duty-hour rules. N Engl J Med. 2019;380(24):2379-2380.
[227] Nasca TJ, Day SH, Amis ES Jr; ACGME Duty Hour Task Force. The new recommendations on duty hours from the ACGME Task Force. N Engl J Med. 2010;363(2):e3.
[228] Rahman SA, Sullivan JP, Barger LK, et al. Extended work shifts and neurobehavioral performance in resident-physicians. Pediatrics. 2021;147(3):e2020009936.
[229] Barger LK, Sullivan JP, Blackwell T, et al. Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS). Sleep. 2019;42(8):zsz110.
[230] Hanna J, Gutteridge D, Kudithipudi V. Finding the elusive balance between reducing fatigue and enhancing education: perspectives from American residents. BMC Med Educ. 2014;14(Suppl 1):S11.
[231] Bandiera G, Hynes MK, Spadafora SM. Duty hour restrictions: organizational dynamics, systems issues, and the impact on faculty. BMC Med Educ. 2014;14(Suppl 1):S5.
[232] Landrigan CP, Rahman SA, Sullivan JP, et al. Effect on patient safety of a resident physician schedule without 24-hour shifts. N Engl J Med. 2020;382(26):2514-2523.
[233] Lockley SW, Cronin JW, Evans EE, et al. Effect of reducing interns’ weekly work hours on sleep and attentional failures. N Engl J Med. 2004;351(18):1829-1837.
[234] Landrigan CP, Barger LK, Cade BE, et al. Interns’ compliance with accreditation council for graduate medical education work-hour limits. JAMA. 2006;296(9):1063-1070.
[235] Barger LK, Sullivan JP, Blackwell T, et al. Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS). Sleep. 2019;42(8):zsz110.
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[254] Cappuccio FP, Bakewell A, Taggart FM, et al. Implementing a 48 h EWTD-compliant rota for junior doctors in the UK does not compromise patients’ safety: assessor-blind pilot comparison. QJM. 2009;102(4):271-282.
[255] Collum J, Harrop J, Stokes M. Patient safety and quality of care continue to improve in NHS North West following early implementation of the European Working Time Directive. QJM. 2010;103(12):929-940.
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[258] Marcus JH, Rosekind MR. Fatigue in transportation: NTSB investigations and safety recommendations. Inj Prev. 2017;23(4):232-238.
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[260] Federal Register. Hours of service of drivers; driver rest and sleep for safe operations. May 2, 2000. https://www.federalregister.gov/documents/2000/05/02/00-10703/hours-of-service-of-drivers-driver-rest-and-sleep-for-safe-operations#h-15. Accessed April 25, 2025.
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[263] C.F.R. § 91.1059.
[264] U.S.C. 49 USC § 21103.
[265] Marcus JH, Rosekind MR. Fatigue in transportation: NTSB investigations and safety recommendations. Inj Prev. 2017;23(4):232-238.
[266] Public Citizen. Petition to reduce medical resident work hours. September 2, 2010. https://www.citizen.org/article/petition-to-reduce-medical-resident-work-hours-2/. Accessed April 25, 2025.
[267] Accreditation Council for Graduate Medical Education. The ACGME 2011 duty hour standards: enhancing quality of care, supervision, and resident professional development. 2011. https://www.acgme.org/globalassets/pdfs/jgme-monograph1.pdf. Accessed April 25, 2025.
[268] Randle RW, Ahle SL, Elfenbein DM, et al. Surgical trainees’ sense of responsibility for patient outcomes: a multi-institutional appraisal. J Surg Res. 2020;255(November):58-65.
[269] Miulli DE, Valcore JC. Methods and implications of limiting resident duty hours. J Am Osteopath Assoc. 2010;110(7):385-395.
[270] Theobald CN, Stover DG, Choma NN, et al. The effect of reducing maximum shift lengths to 16 hours on internal medicine interns’ educational opportunities. Acad Med. 2013;88(4):512-518.
[271] Mir HR, Cannada LK, Murray JN, et al. Orthopaedic resident and program director opinions of resident duty hours: a national survey. J Bone Joint Surg Am. 2011;93(23):e1421-e1429.
[272] Coverdill JE, Alseidi A, Borgstrom DC, et al. Assessing the 16 hour intern shift limit: Results of a multi-center, mixed-methods study of residents and faculty in general surgery. Am J Surg. 2018;215(2):326-330.
[273] Drolet BC, Khokhar MT, Fischer SA. The 2011 duty-hour requirements—a survey of residency program directors. N Engl J Med. 2013;368(8):694-697.
[274] Bandiera G, Hynes MK, Spadafora SM. Duty hour restrictions: organizational dynamics, systems issues, and the impact on faculty. BMC Med Educ. 2014;14(Suppl 1):S5.
[275] Miulli DE, Valcore JC. Methods and implications of limiting resident duty hours. J Am Osteopath Assoc. 2010;110(7):385-395.
[276] Blum AB, Raiszadeh F, Shea S, et al. US public opinion regarding proposed limits on resident physician work hours. BMC Med. 2010;8(June 1):33.
[277] Mansukhani MP, Kolla BP, Surani S, et al. Sleep deprivation in resident physicians, work hour limitations, and related outcomes: a systematic review of the literature. Postgrad Med. 2012;124(4):241-249.
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[279] Romano M. Lightening their load. Mod Healthc. 2003;33(17):32-35,47.
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[281] Bolster L, Rourke L. The effect of restricting residents’ duty hours on patient safety, resident well-being, and resident education: An updated systematic review. J Grad Med Educ. 2015;7(3):349-363.
[282] Levine AC, Adusumilli J, Landrigan CP. Effects of reducing or eliminating resident work shifts over 16 hours: A systematic review. Sleep. 2010;33(8):1043-1053.
[283] Moonesinghe SR, Lowery J, Shahi N, et al. Impact of reduction in working hours for doctors in training on postgraduate medical education and patients’ outcomes: systematic review. BMJ. 2011;342(March 22):d1580.
[284] DeLaroche A, Riggs T, Maisels MJ. Impact of the new 16-hour duty period on pediatric interns’ neonatal education. Clin Pediatr. 2014;53(1):51-59.
[285] Blay E Jr, Hewitt BD, Chung JW, et al. Association between flexible duty hour policies and general surgery resident examination performance: A flexibility in duty hour requirements for surgical trainees (FIRST) trial analysis. J Am Coll Surg. 2017;224(2):137-142.
[286] Hopmans CJ, den Hoed PT, van der Laan L, et al. Impact of the European Working Time Directive (EWTD) on the operative experience of surgery residents. Surgery. 2015;157(4):634-641.
[287] Levine AC, Adusumilli J, Landrigan CP. Effects of reducing or eliminating resident work shifts over 16 hours: A systematic review. Sleep. 2010;33(8):1043-1053.
[288] Theobald CN, Stover DG, Choma NN, et al. The effect of reducing maximum shift lengths to 16 hours on internal medicine interns’ educational opportunities. Acad Med. 2013;88(4):512-518.
[289] Condren AB, Divino CM. Effect of 2011 Accreditation Council for Graduate Medical Education duty-hour regulations on objective measures of surgical training. J Surg Educ. 2015;72(5):855-861.
[290] Weaver MD, Landrigan CP, Sullivan JP, et al. National improvements in resident physician-reported patient safety after limiting first-year resident physicians’ extended duration work shifts: a pooled analysis of prospective cohort studies. BMJ Qual Saf. 2022;32(2):81-89.
[291] Desai SV, Asch DA, Bellini LM, et al. Education outcomes in a duty-hour flexibility trial in internal medicine. N Engl J Med. 2018;378(16):1494-1508.
[292] Bilimoria KY, Chung JW, Hedges LV, et al. National cluster-randomized trial of duty-hour flexibility in surgical training. N Engl J Med. 2016;374(8):713-727.
[293] Collum J, Harrop J, Stokes M. Patient safety and quality of care continue to improve in NHS North West following early implementation of the European Working Time Directive. QJM. 2010;103(12):929-940.
[294] Choma NN, Vasilevskis EE, Sponsler KC, et al. Effect of the ACGME 16-hour rule on efficiency and quality of care: duty hours 2.0. JAMA Intern Med. 2013;173(9):819-821.
[295] Starmer AJ, Spector ND, Srivastava R, et al. Changes in medical errors after implementation of a handoff program. N Engl J Med. 2014;371(19):1803-1812.
[296] Sandefur BJ, Shewmaker DM, Lohse CM, et al. Perceptions of the 2011 ACGME duty hour requirements among residents in all core programs at a large academic medical center. BMC Med Educ. 2017;17(1):199.
[297] Choma NN, Vasilevskis EE, Sponsler KC, et al. Effect of the ACGME 16-hour rule on efficiency and quality of care: duty hours 2.0. JAMA Intern Med. 2013;173(9):819-821.
[298] Anderson JE, Goodman LF, Jensen GW, et al. Restrictions on surgical resident shift length does not impact type of medical errors. J Surg Res. 2017;212(May 15):8-14.
[299] Starmer AJ, Spector ND, Srivastava R, et al. Changes in medical errors after implementation of a handoff program. N Engl J Med. 2014;371(19):1803-1812.
[300] Antiel RM, Thompson SM, Reed DA, et al. ACGME duty-hour recommendations—a national survey of residency program directors. N Engl J Med. 2010;363(8):e12.
[301] Drolet BC, Khokhar MT, Fischer SA. The 2011 duty-hour requirements—a survey of residency program directors. N Engl J Med. 2013;368(8):694-697.
[302] Miulli DE, Valcore JC. Methods and implications of limiting resident duty hours. J Am Osteopath Assoc. 2010;110(7):385-395.
[303] Sandefur BJ, Shewmaker DM, Lohse CM, et al. Perceptions of the 2011 ACGME duty hour requirements among residents in all core programs at a large academic medical center. BMC Med Educ. 2017;17(1):199.
[304] Desai SV, Asch DA, Bellini LM, et al. Education outcomes in a duty-hour flexibility trial in internal medicine. N Engl J Med. 2018;378(16):1494-1508.
[305] McMahon GT. Managing the most precious resource in medicine. N Engl J Med. 2018;378(16):1552-1554.
[306] Mir HR, Cannada LK, Murray JN, et al. Orthopaedic resident and program director opinions of resident duty hours: a national survey. J Bone Joint Surg Am. 2011;93(23):e1421-e1429.
[307] Randle RW, Ahle SL, Elfenbein DM, et al. Surgical trainees’ sense of responsibility for patient outcomes: a multi-institutional appraisal. J Surg Res. 2020;255(November):58-65.
[308] Veazey Brooks J, Bosk CL. Remaking surgical socialization: work hour restrictions, rites of passage, and occupational identity. Soc Sci Med. 2012;75(9):1625-1632.
[309] Weaver MD, Barger LK, Sullivan JP, et al. Public opinion of resident physician work hours in 2022. Sleep Health. 2024;10(1S):S194-S200.
[310] Public Citizen. Bipartisan consensus: The public wants well-rested medical residents to help ensure safe patient care. September 13, 2016. https://www.citizen.org/wp-content/uploads/hrg2335a.pdf. Accessed April 25, 2025.
[311] Blum AB, Raiszadeh F, Shea S, et al. US public opinion regarding proposed limits on resident physician work hours. BMC Med. 2010;8(June 1):33.
[312] Ibid.
[313] Weaver MD, Barger LK, Sullivan JP, et al. Public opinion of resident physician work hours in 2022. Sleep Health. 2024;10(1S):S194-S200.
[314] Weaver MD, Barger LK, Sullivan JP, et al. Public opinion of resident physician work hours in 2022. Sleep Health. 2024;10(1S):S194-S200.
[315] Accreditation Council for Graduate Medical Education. ACGME common program requirements (residency). September 17, 2022. https://www.acgme.org/globalassets/pfassets/programrequirements/cprresidency_2023.pdf. Accessed April 25, 2025.
[316] Ibid.
[317] Institute of Medicine. Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedule to Improve Patient Safety. Resident Duty Hours: Enhancing Sleep, Supervision, and Safety, National Research Council. Ulmer C, Miller Wolman D, Johns MME, editors. Washington (DC): The National Academies Press; 2009.
[318] Accreditation Council for Graduate Medical Education. ACGME common program requirements (residency). September 17, 2022. https://www.acgme.org/globalassets/pfassets/programrequirements/cprresidency_2023.pdf. Accessed April 25, 2025.
[319] Riebschleger, M, Nasca TJ. New duty hour limits: discussion and justification. https://www.acgme.org/globalassets/pdfs/jgme-11-00-29-37.pdf. Accessed April 25, 2025.
[320] Accreditation Council for Graduate Medical Education. ACGME common program requirements (residency). September 17, 2022. https://www.acgme.org/globalassets/pfassets/programrequirements/cprresidency_2023.pdf. Accessed April 25, 2025.
[321] Institute of Medicine. Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedule to Improve Patient Safety. Resident Duty Hours: Enhancing Sleep, Supervision, and Safety, National Research Council. Ulmer C, Miller Wolman D, Johns MME, editors. Washington (DC): The National Academies Press; 2009.
[322] Public Citizen. Petition requesting medical residents work hour limits. April 30, 2001. https://www.citizen.org/article/petition-requesting-medical-residents-work-hour-limits/. Accessed April 25, 2025.
[323] Public Citizen. Petition to reduce medical resident work hours. September 2, 2010. https://www.citizen.org/article/petition-to-reduce-medical-resident-work-hours-2/. Accessed April 25, 2025.
[324] 29 U.S.C. § 651-78.
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Public Citizen Opposition to Ways & Means Tax Bill
U.S. House of Representatives
Committee on Ways & Means
1139 Longworth House Office Building
Washington, DC 20515
Dear Chairman Smith, Ranking Member Neal, and Honorable Committee Members,
On behalf of Public Citizen’s more than 500,000 members and supporters across the country, we write in opposition to the Amendment in the Nature of a Substitute to fulfill the Ways & Means Committee section of the reconciliation package, H. Con. Res. 14.
This legislation will take America in absolutely the wrong direction, and it represents one side of a cruel tradeoff that has put the wants of the few over the needs of the many. Among other problems, the bill would provide unconscionable giveaways for the wealthy that will further entrench income inequality in our nation, misguided corporate handouts that double down on disproven trickle-down theories and that will exacerbate offshoring of jobs and investments, and dangerous rollbacks of climate-focused incentives that were speeding the transition to clean energy sources. This bill also presents a dire threat to nonprofit organizations in the shape of provisions that would allow the Trump Administration to weaponize the Treasury Department and provide the Executive Branch with unbridled power to punish political opponents through revocation of nonprofit status without due process protections. Moreover, this version of the tax portion of the reconciliation package would end the popular free IRS e-file software, Direct File, ensuring private companies continue their stranglehold over online filing in the absence of a true public option like Direct File. It also cannot be ignored that these astronomically expensive tax giveaways are being partially funded by inhumanely cutting people’s healthcare, nutrition and educational assistance, and other much-needed government programs that give a hand up to people who are struggling.
Public Citizen has joined with our allies from several different coalitions to oppose extension of the 2017 Trump tax law[1] given how skewed it was toward the rich and how it relied on disproven claims of trickle-down economics that unsurprisingly failed to deliver on its promises to working Americans. Instead of rejecting these backward priorities encapsulated in the 2017 law, this bill would worsen the issues caused by the 2017 law by deepening and broadening the wealth gap between ordinary Americans, some of whom are living paycheck to paycheck, and wealthy billionaires. The 2017 tax law was a blanket giveaway to the underserving richest individuals in the nation, multimillionaire estates, and closely held companies like hedge funds.[2]
This legislation also represents a lost opportunity to shift gears and finally embrace tax policies that would address economic inequality. Lawmakers could instead be proposing progressive tax policies that would grow generous enough revenues to actually support American families through policies like universal pre-K programs, expanded higher education support, paid medical and family leave, lower energy bills, cleaner air and water, and other critical investments targeted at improving the lives of low-income and vulnerable communities. Instead of policies to make Wall Street pay more of its fair share, such as through a financial transaction tax or closing the carried interest loophole; or raising the top individual tax rate; or requiring profitable corporations to pay more in taxes, as they have done historically; the drafters of this bill instead chose to permanently heap additional benefits on the wealthy few while expanding giveaways for price gouging companies. These choices will haunt our country for years to come.
This legislation is a clear handout to the richest Americans. For example, at a time when many American families are struggling to make ends meet due to rising costs, this legislation’s permanent lowering of the top income tax rate is an affront to everyday Americans that will further entrench economic inequality. Moreover, though the estate tax was put in place to disincentivize dynastic transfers of generational wealth in this country, instead of allowing the doubled exemption threshold to expire, the expanded exemption was made permanent (now $30 million per couple) and is tied to inflation.
This bill is a handout to large, profitable companies that already are not paying their fair share. Take the 2017 Trump tax law’s 199A “pass-through” provision, which was shown to overwhelmingly benefit big businesses and millionaires[3] and allowed billionaires to receive massive tax cuts. This legislation intensifies this giveaway (moving it from 20 percent to 23 percent) ensuring it will continue to benefit companies like hedge funds, given it lacks needed guardrails to keep it from benefitting the richest Americans. The international provisions of this bill also represent a commitment to “America Last” policies that incentivize offshoring of investment by, for example, not allowing the Base Erosion and Anti-Abuse Tax (BEAT) rate to increase or for the deduction for Foreign Derived Intangible Income (FDII) to become less generous, as was scheduled to happen. Additionally, already expired tax cuts for corporations like bonus depreciation, research and experimentation expensing, and weakened rules around interest deductions have now been included in this tax giveaway package as well, albeit with sunset dates, though these corporate handouts have been shown to be ineffective in spurring the economic benefits they are purported to incentivize.
This legislation further adds insult to injury by doing away with a program that put an average of $160 per year into the hands of tax filers, the IRS’s Direct File e-file software. Expanded to 25 states this filing season after a very successful pilot year in 2024, this move cuts off this very popular program before it even had a chance to take off. Since 98 percent of Direct File taxpayers in 2025 were “satisfied” or “very satisfied” with their experience, it is totally wrongheaded to dismantle this program simply to ensure Big Tax Prep is able to annually milk filers of hundreds of dollars simply to use their paid software programs.
These giveaways to the rich and corporations are paid for– in addition to cruelly slashing healthcare, food assistance, and other needed programs—by rolling back climate-focused solutions through the gutting or outright repeal of green energy credits[4] passed as part of the Inflation Reduction Act. These green tax credits have already shown important benefits of reducing the cost of clean energy and Americans’ energy bills while also reducing pollution across the country. Credits for electric vehicles, solar, and energy efficient homes are on the chopping block and other credits will now be made functionally unworkable. The clawback of vital climate solutions while climate disruption and extreme weather continue to decimate communities is yet another example of how this bill chooses the wishes of the few over the needs of the many.
Nonprofit organizations should also all be wary of providing the Trump Administration with unchecked power to remove the tax exempt status of charitable organizations without necessary due process that exist to ensure these decisions will not be politically motivated and used as retribution for political opponents.
This letter has only touched on a few of the most egregious elements of this destructive tax package that will lock in inequality, shower campaign donors with giveaways, and provide unnecessary tax benefits to large, profitable companies that are already not pulling their weight when it comes to supporting this country’s revenue needs. And, at the same time, other committees plan to effectuate their portion of this misguided reconciliation plan by stripping away important protections like healthcare, nutrition, and education support.
It’s not too late to right these wrongs and shift direction toward a path that will actually lift the living situations of all Americans, not just those who need it the least. Public Citizen strongly urges you to oppose this Amendment in the Nature of a Substitute for the Ways & Means Committee section of the reconciliation package, H. Con. Res. 14.
Sincerely,
Susan E. Harley, J.D.
Managing Director- Congress Watch
[1] See, for example, Coalition Letter Opposing Extension of Trump Tax Scam, Americans for Tax Fairness (Feb. 12, 2025) https://americansfortaxfairness.org/atf-coalition-letter-opposing-extension-trump-tax-scam/.
[2] Ways & Means Mark-Up Trump Tax Law 2.0 Analysis, Americans for Tax Fairness (May 12, 2025) Ways & Means Mark-Up Trump Tax Law 2.0 Analysis – Americans For Tax Fairness.
[3] The Pass-Through Deduction Is Skewed to the Rich, Costly, and Failed to Deliver on Its Promises, Center on Budget and Policy Priorities (June 6, 2024) The Pass-Through Deduction Is Skewed to the Rich, Costly, and Failed to Deliver on Its Promises | Center on Budget and Policy Priorities.
[4] Rapid Analysis: House GOP’s Clean Energy Repeal and What it Means for the Affordability Crisis, Evergreen Action (May 12, 2025) The GOP’s proposed budget reconciliation bill kills jobs and raises household energy costs.
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Comments in Response to Chevron/Hess and Sheffield (Pioneer) Petitions to Overturn FTC Orders
FTC must reject oil executives' petitions following findings of collusion with OPEC
Federal Trade Commission
Office of the Secretary
600 Pennsylvania Avenue NW
Washington, DC 20580
Re: Chevron/Hess Petition to Reopen; Docket No. C-4814
Dear Commissioners,
On behalf of Public Citizen, we appreciate the opportunity to respond to the Federal Trade Commission’s (FTC) request for comment on the petition to reopen and set aside the Commission’s January 17, 2025 Decision and Order in Docket No. C-4814, Decision and Order in the Matter of Chevron Corporation & Hess Corporation (the Order). Public Citizen opposes the petition by Chevron and Hess to overturn this Order. The FTC documented John Hess’s participation in efforts to coordinate oil supply in order to fix domestic energy prices with the Organization of the Petroleum Exporting Countries (OPEC). The FTC correctly found the merger between Chevron and Hess, as proposed, to be in violation of Section 5 of the FTC Act and Section 7 of the Clayton Act due to Mr. Hess’s anticompetitive activities. It was more than prudent and reasonable for the Commission to condition approval of the Chevron-Hess merger by barring Mr. Hess from Chevron’s board of directors. The Order should stand, and the FTC should reject the petition.
During the period when the FTC alleges Mr. Hess coordinated with OPEC to manipulate oil supply, inflation peaked at over nine percent, with energy prices responsible for one-third of price acceleration. The actions taken by Mr. Hess and other U.S. oil executives accused of colluding with OPEC harmed American consumers at a time of significant economic stress. When oil prices reached their peak in 2022, U.S. companies kept supply low, driving up gas prices and electric bills, while rewarding shareholders. Serving on Chevron’s Board of Directors would provide Mr. Hess a larger platform to engage in activities that constrain oil supply and drive energy prices up at the expense of the American people.
Reopening a final settlement, as the petition seeks, is a highly unusual practice that should be strongly disfavored by the agency. FTC functioning will be diminished if settlements are up for ongoing negotiation or if parties and the public cannot rely on settlements—agreed on by both sides—to be permanent. Moreover, reopening this case appears to be part of the Trump Administration’s broader campaign of corporate clemency—ending enforcement actions against many of the largest and most powerful companies being investigated or accused of wrongdoing by federal agencies.
Reopening and setting aside the Commission’s Decision and Order in Docket No. C-4814 is inappropriate in light of Mr. Hess’s well-documented anticompetitive behavior.
The Order bars Chevron from nominating, designating, or appointing Hess CEO John B. Hess from joining Chevron’s Board of Directors or allowing Mr. Hess to serve in an advisory or consulting capacity to, or as a representative of, Chevron or the Chevron Board. It was issued to remedy Mr. Hess’s harm to competition as described in the FTC’s corresponding complaint. The complaint alleges that the proposed acquisition of Hess by Chevron, which includes in the agreement increasing the size of the Chevron’s Board from twelve to thirteen members and appointing Mr. Hess as a Chevron director “heighten[s] the risk of harm to competition, including meaningfully increasing the risk of industry coordination.”
The complaint documents Mr. Hess’s coordination with OPEC representatives during his tenure as CEO of Hess. While OPEC member nations have free reign to operate as an explicit cartel, coordinating production and price targets, U.S. oil companies are barred by U.S antitrust law from participating in this coordination. Nevertheless, the FTC found that “[Mr. Hess] communicated publicly and privately with OPEC representatives and oil ministers of OPEC member states about global output and other dimensions of crude oil market competition.” The complaint alleges that “these interactions presented OPEC representatives with opportunities for discussion, meetings, and communications with their rival U.S. oil producers relating to maintaining market stability that ultimately is likely to increase prices.” Instead of acting as a market competitor to OPEC, Mr. Hess collaborated with the oil cartel to advance mutually beneficial constraints on oil production.
The complaint documents numerous examples of public and private communication between Mr. Hess and former OPEC Secretary General Mohammad Barkindo, current OPEC Secretary General Haitham Al Ghais, and other OPEC-affiliated industry and political leaders. Mr. Hess and Mr. Barkindo shared numerous public appearances, including at annual CERAWeek conferences, at Davos, and other policy forums. At these events, Mr. Hess spoke supportively of OPEC policies, including comments that OPEC played a positive role in stabilizing oil prices, and about the opportunity for a collaborative relationship between OPEC and U.S. oil producers. In 2023, Mr. Hess spoke at the OPEC International Seminar and Hess Corporation served as a sponsor for the event. Excerpts of private communications between Mr. Hess and OPEC representatives are largely redacted in the complaint, but the FTC alleges that themes from private communications, including market stability and other business topics, were echoed on earnings calls, investor conferences, and in other public forums.
Mr. Hess’s actions to coordinate oil output reductions may have contributed to high prices and harmed American consumers.
Coordinating oil production and price targets with OPEC comes at the direct expense of American consumers who depend on competitive markets to keep energy prices down. U.S. shale producers such as Hess have historically acted as swing producers—increasing production when prices rise and decreasing production as prices fall. During periods of high prices, U.S. producers benefit from moving quickly to bring supply to market—racing one another to gain market share before the increased supply brings prices down. A lawsuit brought by Andrew Caplen Installations LLC against Hess and seven other U.S. shale producers, alleges this predictable behavior began breaking down in early 2021. Instead of racing one another to increase oil supply during periods of high prices, the lawsuit alleges U.S. producers began coordinating output with OPEC to keep supply down during these periods.
Following Russia’s invasion of Ukraine in February 2022, the price of West Texas Intermediate crude oil surged to about $120 a barrel. Despite the high price, U.S. firms didn’t increase production, citing the tight labor market and challenges in procuring needed equipment. But U.S. oil producers also expressed their collective intention to keep production stable for the purpose of keeping prices and profitability high. In February 2022, Pioneer Natural Resources CEO Scott Sheffield said, “the public[ly listed] [I]ndependents are staying in line” and “I’m confident they will continue to stay in line.” On an August 2022 EOG Resources earnings call, a representative said the company was “committed to remaining disciplined.” An April 2023 Bloomberg article cited an industry expert explaining, “OPEC and shale are much more on the same team now, with supply discipline on both sides” which “really puts a floor under the price of oil long term.”
American families and businesses have paid the price for these coordinated efforts to keep supply constrained and prices high. Four months following Russia’s invasion of Ukraine, U.S. inflation reached a peak of over 9 percent, with energy prices responsible for a third of overall inflation. Average gasoline prices rose from their pandemic lows of $2.50 per gallon in January 2021 to $5.00 per gallon at their peak in June, 2022, amid a strong economic recovery from the COVID-19 pandemic and Russia’s invasion of Ukraine. Price shocks in the fossil fuel sector not only translated to higher gas prices and utility bills, they pushed prices up across the economy as a ubiquitous input across sectors. High energy prices further squeezed consumers already experiencing high prices following supply chain disruptions and other sources of inflation in the wake of the pandemic, further eroding Americans’ purchasing power and financially straining low- and moderate-income Americans most acutely.
The impact of high energy prices not only impacted American families and businesses, it also impacted the federal government and in turn all taxpayers. In an attempt to bring energy prices down from their peak, the Biden Administration released 180 million barrels of oil from the strategic petroleum reserve (SPR) in 2022, bringing year end reserves to their lowest level in 40 years. To replenish the SPR, the Department of Energy directly purchased 59 million barrels of oil at an average price of $76 per barrel and secured an additional 140 million barrels by canceling mandated sales between FY24 and FY26, at a price of $74 a barrel. In total, the cost of replenishing the SPR exceeded $14.8 billion.
Conclusion
If the FTC’s Order is set aside and Mr. Hess is permitted to join Chevron’s Board of Directors, he would be in position to continue the activities of which he was accused in the FTC’s original complaint. According to the complaint, as a Chevron director, he could “direct, approve, or influence Chevron’s investments and policies to align more closely with OPEC’s mission and operations.” Permitting Mr. Hess to serve on Chevron’s board would further threaten competitive energy markets in the U.S., enriching shareholders while leaving American families and businesses to pay the price. The Commission should deny the petition.
Thank you for your attention to this important issue. With questions, please contact Elyse Schupak at eschupak@citizen.org.
Sincerely,
Public Citizen
Federal Trade Commission
Office of the Secretary
600 Pennsylvania Avenue NW
Washington, DC 20580
Re: Sheffield Petition to Reopen; Docket No. C-4815
Dear Commissioners,
On behalf of Public Citizen, we appreciate the opportunity to respond to the Federal Trade Commission’s (FTC) request for comment on the petition to set aside and vacate the Commission’s May 2, 2024 Decision and Order in Docket No. C-4815, Decision and Order in the Matter of Exxon Mobil Corporation (the Order). Public Citizen opposes the petition by Scott Sheffield to overturn this Order. The FTC documented Scott Sheffield’s participation in efforts to coordinate oil supply in order to fix domestic energy prices with the Organization of the Petroleum Exporting Countries (OPEC). The FTC correctly found the merger between Exxon Mobil Corporation (“Exxon”) and Pioneer Natural Resources Company (“Pioneer”), as proposed, to be in violation of Section 5 of the FTC Act and Section 7 of the Clayton Act due to Mr. Sheffield’s anticompetitive activities. It was more than prudent and reasonable for the Commission to condition approval of Exxon’s acquisition of Pioneer on barring Mr. Sheffield from Exxon’s board of directors. The Order should stand, and the FTC should reject the petition.
During the period when the FTC alleges Mr. Sheffield coordinated with OPEC to stabilize oil supply, inflation peaked at over nine percent, with energy prices responsible for one-third of price acceleration. The actions taken by Mr. Sheffield and other U.S. oil executives accused of colluding with OPEC harmed American consumers at a time of significant economic stress. When oil prices reached their peak in 2022, U.S. companies kept supply low, driving up gas prices and electric bills, while rewarding shareholders. Serving on Exxon’s Board of Directors would provide Mr. Sheffield a larger platform to engage in activities that constrain oil supply and drive energy prices up at the expense of the American people.
Reopening a final settlement, as the petition seeks, is a highly unusual practice that should be strongly disfavored by the agency. FTC functioning will be diminished if settlements are up for ongoing negotiation or if parties and the public cannot rely on settlements—agreed on by both sides—to be permanent. Moreover, reopening this case appears to be part of the Trump Administration’s broader campaign of corporate clemency—ending enforcement actions against many of the largest and most powerful companies being investigated or accused of wrongdoing by federal agencies.
Setting aside and vacating the Commission’s Decision and Order in Docket No. C-4815 is inappropriate in light of Mr. Sheffield’s well-documented anticompetitive behavior.
The Order in the Matter of Exxon Mobil Corporation bars Exxon from nominating, designating, or appointing Scott Sheffield, or any other Pioneer representative, to the Exxon Board or to an advisory role to Exxon’s board or management. It was issued to remedy Mr. Sheffield’s harm to competition as described in the FTC’s corresponding complaint. The complaint alleges that the proposed acquisition of Pioneer by Exxon, in which Exxon agreed to “take all necessary actions to cause Scott D. Sheffield … to be appointed to the board of directors,” would “meaningfully increase the likelihood of coordination, and thereby harm competition, in the market for development, production, and sale of crude oil.”
The complaint documents Mr. Sheffield’s coordination with OPEC and OPEC+ representatives, U.S. oil producers, and others during his tenure as CEO of Pioneer. While OPEC member nations have free reign to operate as an explicit cartel, coordinating production and price targets, U.S. oil companies are barred by U.S antitrust law from participating in this coordination. Nevertheless, the FTC found that Mr. Sheffield participated in a sustained and longrunning strategy to coordinate output reductions with OPEC. The complaint alleges that “[Mr. Sheffield] is in close contact with top OPEC member state oil ministers and other high-ranking officials representing the cartel, and uses these relationships to encourage OPEC production controls and to discuss U.S. producers’ efforts to maintain capital discipline in order to increase Pioneer’s profits”
The complaint documents numerous examples of public and private communication between Mr. Sheffield and OPEC representatives as well as public statements made by Mr. Sheffield expressing alignment with and support for OPEC production targets. Mr. Sheffield also attempted to keep other U.S. oil producers in line with Pioneer production targets. In 2021, Mr. Sheffield said “everybody’s going to be disciplined, regardless of whether it’s $75 Brent, $80 Brent, or $100 Brent.” In 2024, Mr. Sheffield said, “even if oil gets to $200/bl, the independent producers are going to be disciplined.” Excerpts of private communications between Mr. Sheffield and OPEC representatives are largely redacted in the complaint, but the FTC documents several examples of Mr. Sheffield communicating privately with OPEC representatives on the topic of oil pricing and output as well as facilitating communication between OPEC representatives and other U.S. oil producers.
Mr. Sheffield’s actions to coordinate oil output reductions may have contributed to high prices and harmed American consumers.
Coordinating oil production and price targets with OPEC comes at the direct expense of American consumers who depend on competitive markets to keep energy prices down. U.S. shale producers such as Pioneer have historically acted as swing producers—increasing production when prices rise and decreasing production as prices fall. During periods of high prices, U.S. producers benefit from moving quickly to bring supply to market—racing one another to gain market share before the increased supply brings prices down. A lawsuit brought by Andrew Caplen Installations LLC against Pioneer and seven other U.S. shale producers, alleges this predictable behavior began breaking down in early 2021. Instead of racing one another to increase oil supply during periods of high prices, the lawsuit alleges U.S. producers began coordinating output with OPEC to keep supply down during these periods.
Following Russia’s invasion of Ukraine in February 2022, the price of West Texas Intermediate crude oil surged to about $120 a barrel. Despite the high price, U.S. firms didn’t increase production, citing the tight labor market and challenges procuring needed equipment. But U.S. oil producers also expressed their collective intention to keep production stable for the purpose of keeping prices and profitability high. In February 2022, Mr. Sheffield said, “the public[ly listed] [I]ndependents are staying in line” and “I’m confident they will continue to stay in line.” On an August 2022 EOG Resources earnings call, a representative said the company was “committed to remaining disciplined.” An April 2023 Bloomberg article cited an industry expert explaining, “OPEC and shale are much more on the same team now, with supply discipline on both sides” which “really puts a floor under the price of oil long term.”
American families and businesses have paid the price for these coordinated efforts to keep supply constrained and prices high. Four months following Russia’s invasion of Ukraine, U.S. inflation reached a peak of over 9 percent, with energy prices responsible for a third of overall inflation. Average gasoline prices rose from their pandemic lows of $2.50 per gallon in January 2021 to $5.00 per gallon at their peak in June 2022, amid a strong economic recovery from the COVID-19 pandemic and Russia’s invasion of Ukraine. Price shocks in the fossil fuel sector not only translated to higher gas prices and utility bills, they pushed prices up across the economy as a ubiquitous input across sectors. High energy prices further squeezed consumers already experiencing high prices following supply chain disruptions and other sources of inflation in the wake of the pandemic, further eroding Americans’ purchasing power and financially straining low- and moderate-income Americans most acutely.
The impact of high energy prices not only impacted American families and businesses, it also impacted the federal government and in turn all taxpayers. In an attempt to bring energy prices down from their peak, the Biden Administration released 180 million barrels of oil from the strategic petroleum reserve (SPR) in 2022, bringing year end reserves to their lowest level in 40 years. To replenish the SPR, the Department of Energy directly purchased 59 million barrels of oil at an average price of $76 per barrel and secured an additional 140 million barrels by canceling mandated sales between FY24 and FY26, at a price of $74 a barrel. In total, the cost of replenishing the SPR exceeded $14.8 billion.
Conclusion
If the FTC’s Order is set aside and Mr. Sheffield is permitted to join Exxon’s Board of Directors, he would be in position to continue the activities of which he was accused in the FTC’s original complaint. According to the complaint, this role would provide a “larger platform from which to advocate for greater industry-wide coordination.” Permitting Mr. Sheffield to serve on Exxon’s board would further threaten competitive energy markets in the U.S., enriching shareholders while leaving American families and businesses to pay the price. The Commission should deny the petition.
Thank you for your attention to this important issue. With questions, please contact Elyse Schupak at eschupak@citizen.org.
Sincerely,
Public Citizen
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Don’t be Fooled by Trump’s “Most-Favored Nation” Executive Order
Trump’s Order Is an Attempt to Distract from Republican Efforts to Raise Drug Prices and Take Away Health Care from Millions of People
Key Takeaways
- Bringing U.S. drug prices down to levels obtained in other countries has broad bipartisan support, but Trump’s Executive Order (EO) is unlikely ever to achieve that goal.
- Trump’s EO is a naked attempt to distract from Republican efforts to exclude more drugs and delay negotiations years longer in the Medicare drug price negotiation program.
- Attacking other countries that more effectively combat drug corporation price gouging will do nothing to lower prices in the United States.
- If Trump and congressional Republicans were serious about lowering U.S. drug prices to those paid in other countries, they would achieve it through strengthening and expanding the Medicare drug price negotiation law, not ill-conceived executive dictates.
- Instead, Trump and congressional Republicans are seeking legislation to take away health care from millions of people in order to give tax cuts to billionaires and corporations, including prescription drug corporations.
Background
- The Trump administration first proposed a confused international reference pricing-themed model in an Advanced Notice of Proposed Rulemaking (ANPRM) for Medicare Part B in 2018. The model languished without action until after Trump lost the 2020 presidential election.
- The proposal faced immense congressional resistance; 13 Senate Finance Committee Republicans voted in favor of blocking the “International Price Index” model in 2019.
- After losing the 2020 election, the Trump administration released an updated Interim Final Rule of its proposal, rebranded as the Most Favored Nation Model. The CMS Office of the Actuary estimated dramatic decreases in patient access to prescription drugs impacted by the model because Trump’s proposal failed to ensure physician offices were able to obtain drugs at prices that are not higher than the levels at which Medicare reimburses. (This problem could be avoided if instead prices were lowered by incorporating an international reference price-based ceiling in the Medicare Drug Price Negotiation Program through legislation.)
- Because the administration rushed out the Interim Final Rule at the last minute without following administrative procedures, the proposal faced legal jeopardy and was ultimately withdrawn by the Biden administration.
- Now, congressional Republicans are pursuing through budget reconciliation legislation to lengthen the delay before Medicare is permitted to negotiate drug prices from 7 to 11 years after a drug receives FDA approval and to widen the orphan drug loophole, excluding many more costly medicines from ever facing Medicare price negotiations.
- In an executive order last month, President Trump pressured congressional Republicans to include the negotiation delay proposal in its budget reconciliation megabill.
The “Most-Favored Nation” Executive Order
- The EO directs the HHS Secretary to communicate “most-favored nation price targets” to drug corporations to get “the best deal”. However, the U.S. government does not currently have the authority to negotiate prices across the U.S. market or compel drug corporations to offer the prices it dictates.
- The EO directs the HHS Secretary to facilitate a new direct-to-consumer purchasing program for drug companies that sell products to American patients at the most-favored nation price, but it is not clear through what legal authority this would be accomplished, or what power the administration possesses to compel drug corporations to lower prices for such a program. The overwhelming majority of patients obtain prescription drugs through public insurance programs or private insurance plans.
- The EO references unspecified HHS rulemaking, on an unspecified timeline, to force drug corporations to lower prices if the HHS Secretary’s negotiations are not successful. As noted above, previous Trump rulemaking efforts on international reference pricing were deeply flawed and never advanced.
- The EO directs the Attorney General and Chairman of the FTC to undertake enforcement actions against anticompetitive practices. Enforcing current laws against anticompetitive practices can have some positive results but is unlikely to have a substantial impact on the overall prescription drug market or pricing.
- The EO instructs the HHS Secretary to consider certifying that drug importation pose no risk to public health and safety, but a previous attempt by the Trump administration to support drug importation in his first term still has not resulted in any drugs being imported.
- The EO directs the U.S. Trade Representative and Department of Commerce to pressure other countries to raise prices, but higher prices internationally will do nothing to lower prices for American patients and taxpayers. When people in the United States say they want the same prices as other countries, they do not mean that we should bully other countries into permitting more drug corporation price gouging like policymakers allow here.
Conclusion
Trump’s EO is poorly conceived and very unlikely to result in lower prices for U.S. patients and taxpayers.
It is an attempt by the Trump administration to “flood the zone” and obfuscate efforts to take away health care from millions of people to pay for tax cuts to billionaires and corporations, all while delivering drug corporations their top lobbying priority in reconciliation: undermining the Medicare Drug Price Negotiation Program.
Policymakers should instead support strengthening and improving the Medicare Drug Price Negotiation Program. An overwhelming majority of Americans support Medicare negotiating prices for more drugs, not exempting more drugs from negotiation.
Please reach out to Public Citizen Access to Medicines Advocate, Steven Knievel (sknievel@citizen.org), with any questions. For more information, also see Public Citizen’s Fact Sheet: Delaying Drug Price Negotiations = More Big Pharma Price Gouging and Issue Brief: Protecting Medicare Drug Price Negotiations.
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Sen. Warren and Rep. DeLauro Press for Transparency on Trade Talks
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Duplicitous Oligarch Grifting Endlessly
It remains unclear exactly what, precisely, the so-called “Department of Government Efficiency” (DOGE) is. The Trump administration first described this Elon Musk-led project as a non-governmental advisory entity, then presented it via Executive Order as a technology-focused office inside the White House (a repurposing of the U.S. Digital Service) and simultaneously a new governmental Temporary Organization.[1] Since then, Musk’s amorphous DOGE has sent detailees (some very young and inexperienced)[2] into various departments to seize reams of data or to embed themselves inside the agencies, worked to unilaterally dissolve key agencies, and facilitated the reckless slashing of staff throughout the government.[3] DOGE is carrying out its destructive rampage under the guise of targeting “inefficiencies,” but in reality Musk and DOGE have gutted essential government services that everyday people rely on, ignoring actual inefficiencies.[4]
The makeup and mandate of DOGE may be murky, but one thing is abundantly clear: Elon Musk has leveraged the project to ascend to power within the federal government.[5] President Trump and the administration have hemmed and hawed about Musk’s exact role while serving as a “special government employee,” but he quite plainly has been driving the DOGE agenda.[6]
Yet even while functioning as the most powerful actor in the federal government outside of the president, Musk has continued to lead multiple large companies that contract with and are regulated by federal agencies.
Reportedly, Musk is slated to soon take a step back from DOGE.[7] As he is potentially on his way out of the Trump administration, it is useful to mark the departments and agencies that his DOGE project has targeted during his tenure, and which overlap with his personal business interests.
The chart below maps the departments and agencies DOGE has targeted and identifies which ones carry a known conflict of interest for Elon Musk’s business entanglements. This report finds that Elon Musk has had a conflict of interest at more than 70% of the cabinet and large independent agencies that DOGE has targeted. Highlights of these findings are discussed in greater detail below and in Table 1 in the Appendix.
Methodology
This report analyzes the departments and agencies that Elon Musk’s DOGE has targeted and that also pose a potential conflict of interest for Musk due to his business endeavors.
This report considers an agency to have been targeted by DOGE if Musk or DOGE personnel have done some combination of the following: publicly stating they are focusing on an agency or intend to; physically showing up at the office seeking access or control; embedding staff inside the agency; soliciting or receiving access to the agency’s data; or forcing a reduction in staffing, spending, and/or office space. It should be noted that DOGE-affiliated individuals have taken up authority roles at the Office of Personnel Management (OPM), which subsequently offered deferred resignations to and ordered layoffs of probationary employees across the entire federal workplace and so, in that sense, every government department and agency has been targeted by DOGE.[8] However, this report focuses on instances in which such actions resulted in significant reductions that are specifically attributed to DOGE in public reporting. Additionally, this report does not consider an agency targeted by DOGE because it has been affected by other Trump administration actions, such as firings or executive actions, that do not appear to be led by DOGE.
Public Citizen used the Office of Personnel Management (OPM) website to build a list of all cabinet level agencies as well as large independent agencies – which includes independent agencies with 1,000 or more employees, according to OPM.[9] In total, we found 32 cabinet and large independent agencies that met our criteria for DOGE involvement in the agencies’ operations. We found conflicts of interest between Elon Musk and his businesses at 23 of them.[10]
This report considers Elon Musk to have a conflict of interest with one of the DOGE-targeted agencies if at least one of his companies meet one or more of these factors according to publicly available reporting: it has received contracts or grants from the agency; it has an interest in its proprietary data; it is subject to the agency’s regulations; or has been subjected to enforcement action by that agency.
Some of the most egregious Musk conflicts are described in the narrative below.
Consumer Financial Protection Bureau
The CFPB works to counter bad banking and financial practices and rectify harms by scams, predatory lenders, debanking and other corporate malfeasance. The agency estimates that it has returned more than $20 billion to everyday people, and helped more than 200 million individuals and businesses rectify harms caused by illegal business practices.[11]
Yet the CFPB has become a target of corporate billionaire Musk’s ire and a pet project for DOGE under the guide of making government more “efficient.” Despite the agency’s laudable track record delivering for taxpayers, Musk has tweeted “Delete CFPB” and “CFPB RIP.”[12]
The DOGE attacks on the CFPB moved from Musk social media posts to reality, as DOGE detailees arrived at CFPB offices demanding sensitive data. Building upon DOGE’s targeting of the agency, the Trump administration has ordered a halt to agency operations (including “ceas[ing] any pending investigations”), canceled the headquarters lease, and attempted to fire its employees.[13] Challenges to these actions are making their way through the courts (including in a case in which Public Citizen serves as co-counsel) but in the meantime, real people who depend on the CFPB suffer the consequences.[14]
Musk has a direct business interest in shuttering the CFPB. Musk infamously purchased Twitter, renamed it “X,” and vowed to turn it into an “everything app.”[15] This appears to include plans to add payment processing services, including a partnership with Visa already in the works to establish this service.[16] If X is to be a payment processor, it will be regulated by the CFPB – or, at least it will be, assuming the agency continues to exist.
The CFPB has aggressively policed digital payment processors similar to the one Musk envisions creating through X, including issuing a rule regulating them and demanding information from PayPal, Square (now renamed Block), Amazon, Google, Apple, and other corporations engaged in digital payment processing.[17] If the CFPB doesn’t exist, or doesn’t have the capacity or interest in conducting aggressive oversight of these businesses, Musk will likely be able to pursue his vision of an X-run payment processor with fewer guardrails that serve to protect consumers. Additionally, by securing access to the CFPB’s databases as previously described, it is possible that Musk may be able to come into possession of proprietary information about rival companies that would directly benefit X.
The CFPB also oversees the auto lending industry.[18] This is significant because Musk remains the head of Tesla, a car company that provides auto loans through its financing arm.[19] Reporting shows that the CFPB has fielded hundreds of complaints about Tesla related to debt collection and loan problems.[20]
If CFPB indeed were to permanently “RIP,” it would be very bad for the country but potentially very good for some of Elon Musk’s companies.
Department of Defense
Among the many business interests that Elon Musk brings with him as an influential “special government employee” in the Trump administration is his role as founder of SpaceX, a company that provides space launch services. SpaceX is a major defense contractor, with about $22 billion in government contracts.[21] These contracts include the provision of launch services to the military for classified satellites and broadband connectivity through its internet service provider subsidiary, Starlink. Musk and SpaceX also ally closely with Silicon Valley artificial intelligence weapons producers such as Palantir and Anduril.[22]
Secretary of Defense Pete Hegseth has explicitly invited DOGE to visit DOD.[23] Already, in keeping with the government-slashing DOGE project, DOD has frozen civilian credit card purchases and travel.[24] And a Pentagon spokesperson announced that DOGE had identified about $80 million in cuts to the DOD budget – notably, nearly all costs identified were in diversity, equity and inclusion programming.[25]
In addition to Musk’s profiting from DOD contracts, he also has a potential interest in proprietary data collected by the department. The Pentagon houses a massive database – USXports – that contains information about foreign weapons sales.[26] If DOGE affiliates achieve access to USXports, they will uncover a treasure trove of information about Musk’s defense contractor competitors. If Musk were able to access this information, it could provide him with a major competitive advantage in seeking DOD contracts.
More generally, at an agency which can’t pass an audit and regularly pays for weapons systems that don’t work or have dubious purpose, Elon Musk stands to personally benefit from the choices that DOGE makes about which kinds of government spending are “waste.”[27] Indeed, reporting indicates SpaceX is being looked at as a possible arbiter of increased military cargo transportation around the world.[28] Further, Hegseth has ordered programs across the Pentagon to identify opportunities for budget reallocations, but has explicitly exempted several categories of Pentagon spending that should not be touched, including procurement of weapons systems like drone technology favored by Musk and his Silicon Valley friends.[29]
National Labor Relations Board
The NLRB is tasked with protecting American workers against unfair labor practices. According to an agency whistleblower, DOGE detailees arrived at NLRB headquarters in early March, seeking and securing access to the agency’s trove of sensitive information that includes workers’ personal information and proprietary corporate documents.[30] NLRB workers were reportedly alarmed after this encounter, when they noticed a large amount of data being transferred out of the agency despite the DOGE staffers taking steps to avoid monitoring and tracking their activities.
Such information could be of particular interest to Elon Musk, as it could include damaging information about his business competitors. Further, the New York Times reported that the NLRB has 24 pending investigations into Musk’s various companies.[31] Many of these are related to the mass firings and surveillance of sensitive information Musk implemented shortly after taking the helm at Twitter, in a move foreshadowing the current sweeping DOGE activities.
The NLRB has long been a target of Musk companies’ ire. In particular, the NLRB’s very existence had previously been challenged by Musk-led SpaceX, in a lawsuit alleging the agency is unconstitutional.[32] The charge followed NLRB investigations into complaints from SpaceX workers.
Department of Justice
The nation’s highest law enforcement entity has also been permeated by DOGE. After DOGE detailees visited DOJ headquarters in person, Attorney General Pam Bondi has directed the formation of an internal team called “JUST DOGE” made up of senior DOJ officials with a mandate to work with DOGE on identifying and implementing spending cuts.[33] Additionally, DOGE-affiliated staffers have been embedded within the department’s immigration enforcement division and the Federal Bureau of Investigation.[34]
Several of Musk’s various business endeavors are under scrutiny from the Justice Department, as Public Citizen has documented.[35]
The DOJ’s investigation of Tesla and potentially Musk himself as head of the company includes an examination of the company’s characterization of the cars’ “Autopilot” and “Full Self-Driving” modes, including whether claims about these features have been criminally fraudulent.[36]
The department had also brought a case against Musk’s SpaceX in 2023, alleging discrimination against refugees and those seeking asylum in its hiring practices.[37] As of February 2025, that case has now been dropped.[38]
Department of Agriculture
The Department of Agriculture oversees a wide variety of policies critical to consumers, including those related to food, nutrition, animal welfare, natural resources and more.[39] The current department leadership has indicated a strong willingness to comply with Musk’s destructive DOGE project, with Secretary of Agriculture Brooke Rollins announcing in February, “I welcome DOGE’s efforts at USDA.” Further, she told her staff, “I will expect full access and transparency to DOGE in the days and weeks to come.”[40]
Indeed, USDA has already complied with DOGE efforts by canceling $132 million in contracts and firing workers.[41] One analysis also found that USDA office closures make up about one in seven all federal office shutterings resulting from DOGE actions.[42]
Musk has minor contractual interests at USDA. SpaceX has received $1.1 million in USDA funding since 2003.[43]
More notably, one of Musk’s businesses has previously come under scrutiny by USDA’s inspector general. Neuralink is a medical device company founded and helmed by Musk that produces brain implants. Per the request of a federal prosecutor, USDA’s inspector general launched an investigation of Neuralink in 2022.[44] Reportedly, the company’s employees were growing increasingly concerned about Neuralink’s escalating animal testing practices that had resulted in about 1,500 killed animals, including hundreds of monkeys, pigs and sheep. Employees alleged that Musk was unnecessarily accelerating these tests, resulting in numerous errors, botched experiments, potentially questionable data, and excessive animal suffering and death. USDA’s Inspector General was reportedly still evaluating Neuralink for possible violations of the Animal Welfare Act through its animal testing practices when she was physically escorted from her office after refusing to leave when the Trump administration mass fired her along with several other inspectors general in January 2025.[45]
Department of Energy
DOGE has been particularly active at the Department of Energy. The Musk-led project’s incursion began in February when Energy Secretary Chris Wright welcomed a 23-year-old SpaceX intern-turned-DOGE representative and granted him IT access.[46] Subsequently, a SpaceX engineer was embedded within the department as chief information officer, earning access to personnel data. He served for less than two months before being replaced by a different DOGE loyalist in the same position.[47] At least one more DOGE delegate has since secured a more official role within DOE.[48]
The department has also undertaken DOGE-encouraged staff purges. Alarmingly, this included the firing of hundreds of staff from the National Nuclear Security Administration (NNSA), an agency housed within the Department of Energy that is tasked with overseeing the nation’s nuclear weapons stockpile.[49] These hasty and harmful terminations were later walked back.[50]
Musk’s businesses have long interacted with the Department of Energy. Tesla previously received a $465 million loan from DOE that it considered critical to its continued operations in 2010, a time when its finances were not stable.[51]
The Department of Energy is also another entity holding private data that could be of value to Elon Musk’s corporate interests.[52] DOE is home to the Loan Programs Office, which operates the Advanced Technology Vehicles Manufacturing Program that finances loans to producers of electric vehicles (EVs). The Advanced Technology Vehicles Manufacturing Program holds proprietary information about rivals of Musk’s Tesla, a major producer of EVs. If Musk were able to access and use information from the program, it could give Tesla an unfair advantage in the market.
National Highway Traffic Safety Administration
NHTSA – an agency with a mandate to oversee auto safety – is another agency feeling the fallout from DOGE’s actions.[53] An email laying off agency employees in an effort that multiple employees described as initiated by DOGE, resulted in a 4 percent staff reduction in a single day.[54] Broader resignations and firings resulting from the Musk-back effort to reduce the federal government that is being targeted at every agency caused NHTSA to lose an overall 10 percent decline in staffing.[55]
NHTSA is the agency that oversees autonomous cars like the ones sold by Musk’s company, Tesla. This includes the Office of Defects Investigation, which has enforcement authority to investigate safety problems and issue recalls.[56] Musk has previously railed against NHTSA as impeding Tesla’s innovation, tweeting in 2014 that “The word ‘recall’ should be recalled.”[57] Reporting indicates Musk had previously directly threatened NHTSA regulators with litigation and caused his online fans to harass them in the course of their investigation into deaths resulting from failures of Tesla’s Autopilot driver-assistance technology.[58]
The Office of Automation Safety is specifically tasked with regulating self-driving cars and only had seven employees before the DOGE-led firings. The office now is down to four staff – about half of its original capacity.[59]
One of the terminated engineers said of the specialized knowledge required to put safeguards around autonomous vehicles, “The amount of people in the federal government who are able to understand this adequately is very small. Now it’s almost nonexistent.”[60]
Prior to the Trump administration that swept Musk into power, there were eight pending NHTSA probes into Tesla.[61]
Food and Drug Administration
Through DOGE’s purge of the federal workforce, Elon Musk has been positioned to displace people directly tasked with regulating his businesses. That includes the FDA, which, in addition to overseeing actual food and drugs, evaluates medical devices for safety and efficacy. DOGE initiatives reportedly resulted in the firing of around 1,000 FDA employees early in 2025 before Health and Human Services Secretary Robert F. Kennedy, Jr., took over and initiated still more firings across health agencies.[62] Additionally, the agency reportedly has been inundated with requests related to DOGE’s work to gather and report on detailed technical information.[63]
This is significant for DOGE purposes because FDA has direct regulatory authority over Musk’s Neuralink company’s brain implant technologies.[64] Musk must get the FDA’s approval for Neuralink to take certain steps that are necessary to develop the brain implant device for medical use. This has previously included the FDA’s green light for Neuralink’s human clinical trial and its awarding to the company a designation meant to help speed up the development and review process for one of its devices.[65]
Now, because of DOGE, the very same people at the FDA overseeing Neuralink activities are being terminated. Musk’s DOGE has clipped the FDA as it swings a metaphorical axe through the government claiming “efficiency.” At the FDA, this has meant a reduction of workers through DOGE firings of probationary employees.[66] About 20 of those fired worked in the office of neurological and physical medicine devices, which works on Neuralink.[67] A former FDA official called these terminations “intimidating to the FDA professionals who are overseeing Neuralink’s trial.”
Federal Aviation Administration
The FAA is the lead agency tasked with ensuring air traffic safety. It is an agency of particular importance to Musk’s SpaceX company which primarily provides rocket launch services.
Now, as Musk helms DOGE, about 400 personnel have been laid off from the FAA.[68] Additionally, a team of SpaceX employees were temporarily placed directly inside the FAA, working with FAA email addresses.
The FAA actively conducts oversight of SpaceX and engages in enforcement actions where it deems violations of safety standards have taken place. As such, there are pending FAA fines against SpaceX, including one for proceeding with a rocket launch in July 2023 after the FAA flagged that essential safety checks had not been completed.[69] The FAA also more recently ordered SpaceX to investigate a botched Starship rocket test flight that resulted in dangerous debris falling to earth.[70]
Musk previously called the FAA’s enforcement actions against SpaceX “improper” and “politically-motivated behavior.”[71] Musk’s perceived vendetta against the FAA and his potentially improper influence had already raised questions from Senator Elizabeth Warren when FAA chief Michael Whitaker resigned on the last day of the Biden administration, despite enjoying broad bipartisan support.[72] Musk had previously called for Whitaker’s resignation as retaliation for the FAA’s enforcement actions against SpaceX.
Musk’s Starlink is a significant FAA contractor. His Starlink company has been thought by many, including leading Democratic lawmakers, to be on the cusp of securing a new $2.4 billion contract through the FAA to upgrade its aging internet connectivity system that was originally awarded to Verizon.[73] This speculation has been fueled in part by Musk retweeting an X post urging exactly such a role for Starlink, Transportation Secretary Duffy criticism of Verizon for “not moving fast enough” in its upgrades, and the FAA conducting testing of Starlink systems at several of its agency sites.[74] Starlink insists it does not intend to take over this contract, and the acting head of the FAA Chris Rocheleau testified before Congress that DOGE is not involved in this or other decisions around the agency’s use of Starlink technology.[75]
Securities and Exchange Commission
The SEC’s mission is to protect investors and enforce federal securities laws.[76] In keeping with this mandate, the agency has taken actions against Musk’s businesses.
In February, a DOGE-affiliated social media account solicited help from the public in identifying “waste, fraud and abuse relating to the Securities and Exchange Commission.”[77] Politico reported that DOGE is indeed slated to focus its efforts on the SEC, with one anonymous source stating “They are at the gates.”[78] Already, the SEC has offered buyouts to employees willing to resign or retire early in keeping with DOGE’s purge of the federal workforce.[79]
The SEC has ongoing enforcement actions targeting Musk companies. There are pending SEC fines against Musk for as much as $150 million for failing to file required disclosures that likely resulted in his underpaying for Twitter stock.[80] The SEC sued Musk in January to recover these fines.[81] Further, the agency has been investigating Musk’s Twitter takeover and had indicated it will seek sanctions over his failure to testify on the matter.[82] The SEC also has a pending investigation against Neuralink, similar to the USDA’s investigation, for its alleged mistreatment of animals during testing.[83]
The SEC’s enforcement actions against Musk’s businesses has often raised his ire. Right before Trump’s inauguration, Musk’s attorney sent a letter to then-SEC Chair Gary Gensler alleging “six years of harassment of Mr. Musk by the Commission and its Staff” and demanding to know who was directing the SEC’s enforcement actions against Musk and his businesses.[84]
National Aeronautics and Space Administration
SpaceX leadership has long attributed the company’s success to NASA’s early investments, going so far as to say in 2013, “[T]his is as much NASA as it is SpaceX here.”[85] Indeed, the Musk-led company has approximately $15 billion in contracts from NASA, although it is impossible to calculate the current amount precisely, as much of the company’s business with NASA – including the budget overseeing those activities – is classified.[86]
DOGE has now set its sights on the agency that has helped fill Musk’s pockets. Acting NASA administrator Janet Petro said, “We are going to have DOGE come. They’re going to look – similarly (to) what they’ve done in other agencies – at our payments and what money has gone out.”[87] Petro also stated that “hundreds” of NASA employees have accepted DOGE-offered buyouts to leave their jobs.
Musk has publicly opposed the Trump administration’s cuts to NASA’s scientific work and stated that he has not been involved in those budget decisions because of conflicts of interest.[88] Nonetheless, like so many other agencies, Musk both stands to profit by the decisions that NASA makes about its expenditures and resources, and has the potential to influence or even make those same decisions himself as part of his DOGE project.
Indeed, the New York Times reports that Musk has pressed NASA to focus on Mars, an endeavor that will open up new opportunities for SpaceX contracting.[89]
U.S. Agency for International Development
USAID leads American global humanitarian and economic development efforts. Since Russia’s invasion of Ukraine, two of Musk’s companies have contracted with USAID to provide expanded internet access to Ukrainians via Starlink terminals and SpaceX satellites. Toward the end of the Biden administration, USAID was re-evaluating this arrangement, according to the agency’s inspector general.[90] USAID was investigating whether Russians had improperly gained access to Starlink, even though Musk had made assurances that the system was secure.[91]
One of DOGE’s earliest casualties was USAID, with 90 percent of the agency’s contracts suspended and most staffers terminated.[92] Musk stated that he and President Trump discussed USAID early in the new administration and “agreed that we should shut it down.”[93] These actions are currently being challenged through litigation, including by Public Citizen.[94]
Indeed, not long after USAID announced it was probing Musk’s business interests, the agency’s very future now appears uncertain. Most recently, Secretary of State Rubio announced that 83 percent of the agency’s programs are to remain shuttered, and the remainder moved under the auspices of the Department of State.[95]
Conclusion
The wealthiest man in the world is working to dismantle the very same federal departments and agencies tasked with overseeing and placing checks on his businesses. He also now is adjacent to and could potentially access sensitive and potentially proprietary information from his biggest competitors in the various industries that have made him wealthy. He also has personal business interests that could shape what his DOGE project considers ripe for cuts.
How is this glaring potential corruption being addressed? The White House has stated that Elon Musk will self-police by recusing himself when his DOGE and business interests collide.[96] This system places entirely in Musk’s hands the discretion to decide what constitutes a conflict of interest and when recusal is merited.
This is not sufficient. With Elon Musk having a direct business interest in at least 70% of the departments and agencies targeted by his DOGE project, action must be taken.
Congress should push to tighten conflict of interest rules on “special government employees” such as Musk, including prohibiting them from holding active government contracts. Members should also hold hearings, request documents, and otherwise conduct aggressive oversight of the potential corruption and conflicts posed by Elon Musk holding such immense power to make personnel and monetary decisions on behalf of the government and ransack sensitive information from which he stands to benefit.
But no procedural remedies will be sufficient. Elon Musk never should have been given a role inside of government – he has rampant, uncurable conflicts of interest; he has overseen a rogue operation that has violated norms and, allegedly, laws designed to protect the privacy of American’s personal information; and he has shepherded a government agency-destruction mission that imperils Americans’ safety and well-being but will, in many cases, benefit his companies. The man who never should have been hired should be fired immediately.
Appendix I
Table 1 – Cabinet and Large Independent Agencies Where DOGE Has Impacted Operations
All sources for Table 1 are included in the full report PDF.
Federal Agency Targeted by DOGE | Agency Type | Musk Conflict? | Company Creating Conflict | Conflict Description |
---|---|---|---|---|
Department of Defense (DoD) | Cabinet | Yes | SpaceX | SpaceX has received $7.6 billion in funding from DoD since 2003, including ongoing contracts. |
SpaceX’s Starshield business entered into a $1.8 billion contract in 2021 with the DoD’s National Reconnaissance Office. | ||||
In 2020, SpaceX was awarded a $150 million contract by DoD’s Space Development Agency | ||||
Department of Agriculture (USDA) | Cabinet | Yes | SpaceX, Neuralink | In 2022, Reuters reported that Neuralink was the subject of a probe by USDA’s Inspector General over potential animal welfare violations. |
SpaceX has received $1.1 million in funding from the Department of Agriculture since 2003. | ||||
Department of Commerce (DOC) | Cabinet | Yes | SpaceX | The Washinton Post estimates the Commerce Department is responsible for $3.6 million in funding to SpaceX since 2003. |
NOAA has awarded SpaceX contracts for Starlink services in the past. | ||||
In 2024, NASA (on behalf of NOAA) awarded SpaceX a contract valued at $113 million. | ||||
Department of Justice (DOJ) / Attorney General | Cabinet | Yes | Tesla, SpaceX | DOJ investigated Tesla in 2023 over exaggerated claims about the company’s autopilot and “full self-driving” capabilities. The agency also investigated Tesla that year over plans to construct a glass house for Musk in Texas. |
DOJ sued SpaceX in 2023 for “discriminating against asylees and refugees in hiring.” | ||||
Department of Energy (DOE) | Cabinet | Yes | Tesla | Musk wants to end EV tax credits to help Tesla. “Take away the subsidies. It will only help Tesla,” Musk posted on X in July 2024. |
A 2010 Department of Energy loan of $465 million helped save Tesla. | ||||
Health and Human Services (HHS) | Cabinet | Yes | Neuralink | Musk’s Neuralink is regulated by the FDA. FDA staff members involved in reviewing Nueralink were reportedly fired by DOGE. |
Department of Homeland Security (DHS) | Cabinet | Yes | SpaceX | SpaceX has received $1 million in funding from DHS since 2003. |
Department of Interior (DOI) | Cabinet | Yes | SpaceX | DOI has been responsible for $1 million in funding for SpaceX since 2003. |
SpaceX has received hundreds of thousands of Starlink contracts from DOI, including many that are ongoing. | ||||
Department of State | Cabinet | Yes | SpaceX, Tesla | USAID inspector General began an investigation into Starlink in 2024. |
According to a Washington Post analysis, SpaceX has received $4.5 million in funding from the State Department while Tesla has received just under $400,000. | ||||
Department of Transportation (DOT) | Cabinet | Yes | Tesla, SpaceX, Neuralink | Nearly half of the NHTSA team tasked with regulating autonomous vehicles was cut by DOGE. |
The FAA has fined SpaceX for safety violations. After the FAA penalized SpaceX $633,000 for safety violations last year, Musk said SpaceX would sue the agency for “regulatory overreach.” | ||||
Neuralink was fined for violating rules related to hazardous materials. | ||||
Treasury | Cabinet | Yes | Tesla | Tesla has received nearly $327 million in funding from Treasury since 2007. |
Department of Veterans Affairs (VA) | Cabinet | Yes | SpaceX | SpaceX has an ongoing contract with the agency for nearly $470,000. |
General Service Administration (GSA) | Independent | Yes | Tesla | Tesla has received $947,000 in funding from GSA since 2007 and has ongoing contracts with the agency. |
Environmental Protection Agency (EPA) | Independent | Yes | Tesla | Tesla and SpaceX have both been fined by the EPA for violations. |
Just last year, SpaceX was fined $148,000 by the EPA for violations of the Clean Water Act. | ||||
The Post reports that SpaceX has received EPA funding. | ||||
Consumer Financial Protection Bureau (CFPB) | Independent | Yes | Tesla, X | Tesla car loans fall under the CFPB’s purview. |
X recently announced plans to allow users to transfer money on X using an “X Money Account.” This type of service would be regulated by the CFPB. | ||||
Securities and Exchange Commission (SEC) | Independent | Yes | Tesla, X | SEC is investigating Musk’s takeover of X recently sought sanctions on Musk for his failure to testify. Musk recently called the SEC a “totally broken organization.” |
The SEC investigated Tesla in 2023 over allegations it has used company funds to build Musk a house. | ||||
In 2024, the SEC examined Telsa to see whether Musk mislead investors with his statements over the company’s autopilot capabilities. | ||||
National Aeronautics and Space Administration (NASA) | Independent | Yes | SpaceX | NASA has been responsible for $14.9 billion in funding for SpaceX since 2003, including numerous ongoing contracts. |
Equal Opportunity Employment Commission (EEOC) | Independent | Yes | Tesla | In 2023, the EEOC sued Tesla charging the company with racial discrimination in its’ California factory. The suit alleges that Black workers were subjected to racial slurs and other harassment. |
National Labor Relations Board (NLRB) | Independent | Yes | SpaceX | A complaint filed in 2022 alleges that SpaceX illegally fired employees for signing a public letter critical of Musk. SpaceX responded by suing the agency. |
Federal Communications Commission (FCC) | Independent | Yes | SpaceX | The agency has some oversight responsibilities related to Starlink. In March 2025, the FCC announced it would grant a waiver allowing T-Mobile and Starlink to operate a cell service at higher power levels. |
Federal Trade Commission (FTC) | Independent | Yes | X | Musk’s X, formally known as Twitter, is regulated in part by the FTC. Recent reporting revealed that in 2022 Musk came close to violating an FTC consent order. |
National Science Foundation (NSF) | Independent | Yes | SpaceX | SpaceX regularly works with NSF and has received funding from the agency in the past. |
Department of Education (ED) | Cabinet | No | ||
Department of Housing and Urban Development (HUD) | Cabinet | No* | ||
U.S. Agency for Global Media (USAGM) | Independent | No | ||
Social Security Administration (SSA) | Independent | No | ||
Office of Personnel Management (OPM) | Independent | No | ||
Federal Deposit Insurance Corporation (FDIC) | Independent | No | ||
National Credit Union Administration (NCUA) | Independent | No | ||
National Archives and Records Administration (NARA) | Independent | No | ||
Small Business Administration (SBA) | Independent | No |
Sources
[1] Elena Moore, Camila Domonoske, Jeongyoon Han, Trump Taps Musk to Lead a ‘Department of Government Efficiency’ with Ramaswamy, NPR (Nov. 12, 2024), https://citizen.short.gy/to4iyy and Presidential Actions, Establishing and Implementing the President’s “Department of Government Efficiency”, The White House (Jan.20, 2025), https://citizen.short.gy/8rRTaA.
[2] Sasha Rogelberg, Top Hires in Trump’s Office of Personnel Management Reportedly Include a 21-year-old and a Freshly Graduated High-Schooler, Fortune (Jan. 29, 2025), https://citizen.short.gy/bWmPx4.
[3] Ellen Knickmeyer, Trump administration plans to slash all but a fraction of USAID jobs, officials say, AP (Feb. 6, 2025), https://citizen.short.gy/hAi42t.
[4] Ribert Weissman, DOGE Delusions, Public Citizen (Jan. 15, 2025), https://www.citizen.org/article/doge-delusions/.
[5] How Musk Built DOGE: Timeline and Key Takeaways, The New York Times (Feb. 28, 2025), https://citizen.short.gy/LnpMzs
[6] Craig Holman, Ethics Rules, or Lack Thereof, that Apply to “Special Government Employees” (SGE) and Elon Musk, in Particular, Public Citizen, https://citizen.short.gy/WQtjE9.
[7] Nathan Bomey, Elon Musk says he’s Taking a step back from DOGE after Tesla “Blowback”, Axios (April 22, 2025), https://citizen.short.gy/8V0BGj.
[8] Vittoria Elliott, Elon Musk Lackeys Have Taken Over the Office of Personnel Management, Wired (Jan. 28, 2025), https://citizen.short.gy/47j4xO and Brian Barrett, DOGE Email Throws Federal Agencies Into Chaos and Confusion, Wired (Feb. 22, 2025), https://citizen.short.gy/vJf7QY, and Chris Megerian, Michelle L. Price, Trump Administration Tells Government Agencies to lay off new Workers, Potentially Cutting Hundreds of Thousands, Fortune (Feb. 14, 2025), https://citizen.short.gy/vlqtO6.
[9] Open Government Data, United States Office of Personnel Management, https://citizen.short.gy/8ERHuQ.
[10] See the Appendix for a full list.
[11] Rohit Chopra, Opening Statement of Director Rohit Chopra before the House Financial Services Committee, The Consumer Financial Protection Bureau (June 13, 2024), https://citizen.short.gy/2A3hsI.
[12] See https://x.com/elonmusk/status/1861644897490751865 and https://x.com/allenanalysis/status/1888981864993694172.
[13] Stacy Cowley, Jessica Silver-Greenberg and Kate Conger, With Attack on Consumer Bureau, Musk Removes Obstacle to His ‘X Money’ Vision, The New York Times (Feb. 13, 2025), https://citizen.short.gy/BaYsOr.
[14] NTEU v. Vought, Public Citizen, https://www.citizen.org/litigation/nteu-v/.
[15] Aislinn Murphy, Elon Musk’s X and Visa ink Deal as it pursues Becoming the ‘Everything’ App, Fox News (Jan. 28, 2025), https://citizen.short.gy/6xEwya.
[16] Hugh Son and MacKenzie Sigalos, Elon Musk’s X Begins its Push into Financial Services with Visa Deal, CNBC (Jan. 28, 2025), https://citizen.short.gy/FkwygK.
[17] CFPB Orders Tech Giants to Turn Over Information on their Payment System Plans, The Consumer Financial Protection Bureau (Oct. 21, 2021), https://citizen.short.gy/ZzDf1W.
[18] Supervisory Highlights: Special Edition Auto Finance, The Consumer Financial Protection Bureau (Fall 2024), https://citizen.short.gy/DLzK1d.
[19] Matt Egan, Elon Musk is Waging War on a Key Check on his Business Empire, CNN (Feb. 11, 2025), https://citizen.short.gy/uHhFB6.
[20] Eric Lipton and Kirsten Grind, Elon Musk’s Business Empire Scores Benefits Under Trump Shake-Up, The New York Times (Feb. 11, 2025), https://citizen.short.gy/NGT2hY and Consumer Complaint Database, search for “Tesla, Inc.”, The Consumer Financial Protection Bureau, https://citizen.short.gy/Yjsvo9.
[21] Elon Musk’s US Department of Defense contracts, Reuters (Feb. 11, 2025), https://citizen.short.gy/u1RaNk.
[22] Makena Kelly, Former Palantir and Elon Musk Associates Are Taking Over Key Government IT Roles, Wired (Feb. 12, 2025), https://citizen.short.gy/xalPyw and Savannah Wooten, Deadly and Imminent: The Pentagon’s Mad Dash for Silicon Valley’s AI Weapons, Public Citizen (Nov. 22, 2024), https://www.citizen.org/article/deadly-and-imminent-report/.
[23] Danielle Wallace, Hegseth says DOGE Welcome at Pentagon as Defense Department Reviews Military Posture globally, Fox News (Feb. 11, 2025), https://citizen.short.gy/EbyBu6
[24] Danielle Wallace, Pentagon Clips Civilian Employees’ Credit Cards in Line with DOGE Cuts, Fox News (March 11, 2025), https://citizen.short.gy/JRyrwZ.
[25] See https://x.com/DODResponse/status/1896706407166337227.
[26] Spencer Ackerman, Musk and DOGE Might Soon Have Access to the Most Lucrative Defense-Contract Database of All, Zeteo (Feb. 18, 2025), https://citizen.short.gy/ThamHb.
[27] Stephen Sorace, Pentagon fails 7th audit in a row, unable to fully account for $824B budget, Fox 10 Phoenix (Nov. 17, 2024), https://citizen.short.gy/AgLW2t and Valerie Insinna, The Pentagon is battling the clock to fix serious, unreported F-35 problems, Defense News (June 12, 2019), https://citizen.short.gy/gd4iub.
[28] Eric Lipton, Musk Is Positioned to Profit Off Billions in New Government Contracts, The New York Times (March 23, 2025), https://citizen.short.gy/hOQVGX.
[29] Anthony Capaccio, Hegseth Set to Seek 8% Spending Shift at Pentagon, Bloomberg (Feb. 14, 2025), https://archive.ph/ZX2Eq and Michael T Klare, Welcome to the New Military-Industrial Complex, The Nation (Feb. 24, 2025), https://citizen.short.gy/q5vTXG.
[30] Jenna McLaughlin, A whistleblower’s disclosure details how DOGE may have taken sensitive labor data, NPR (April 15, 2025), https://citizen.short.gy/iI4rwm.
[31] Eric Lipton and Kirsten Grind, Elon Musk’s Business Empire Scores Benefits Under Trump Shake-Up, The New York Times (Feb. 11, 2025), https://citizen.short.gy/NGT2hY.
[32] Chris Isidore, Elon Musk’s dream comes true: The federal board that protects workers does not exist, at least for now, CNN (Feb. 15, 2025), https://citizen.short.gy/eD8x7y.
[33] Will Steakin, Katherine Faulders, and Alexander Mallin, AG Pam Bondi forms internal team to work with DOGE on DOJ cost-cutting efforts: Sources, ABC News (March 13, 2025), https://citizen.short.gy/J7GstI.
[34] Glenn Thrush, Top DOGE Officials Moved From Social Security Administration to Justice Dept, The New York Times (April 18, 2025), https://citizen.short.gy/3nAyaR and Shawn Musgrave, DOGE Installs a Former Tesla Employee at the FBI, The Intercept (April 18, 2025), https://citizen.short.gy/ebPEwg.
[35] Rick Claypool, Elon Musk’s Self-Serving Election Influence: Tilting the 2024 Election to Escape Corporate Accountability, Public Citizen (Oct. 21, 2024), https://citizen.short.gy/dh3stK.
[36] Tom Krisher, Tesla says Justice Department is expanding investigations and issuing subpoenas for information, AP (Oct. 23, 2023), https://citizen.short.gy/X9U2Ta and Mike Spector and Chris Prentice, Exclusive: In Tesla Autopilot probe, US prosecutors focus on securities, wire fraud, Reuters (May 8, 2024), https://citizen.short.gy/NfrJXO.
[37] Rick Claypool, Elon Musk’s Self-Serving Election Influence: Tilting the 2024 Election to Escape Corporate Accountability, Public Citizen (Oct. 21, 2024), https://citizen.short.gy/dh3stK.
[38] Qasim Nauman, Justice Dept. to Drop Discrimination Case Against Elon Musk’s SpaceX, The New York Times (Feb. 20, 2025), https://citizen.short.gy/4PdN8X.
[39] General Information, U.S. Department of Agriculture, https://citizen.short.gy/OjVTAY.
[40] Press Release, Secretary Rollins Takes Bold Action to Stop Wasteful Spending and Optimize USDA to Better Serve American Agriculture, U.S. Department of Agriculture (Feb. 14, 2025), https://citizen.short.gy/qpoqjP.
[41] Grace Yarrow and Samuel Benson, Sen. Tina Smith: DOGE efforts at USDA are ‘completely wrong’, U.S. Department of Agriculture (March 13, 2025), https://citizen.short.gy/k1MIyt.
[42] Chris Clayton, USDA Faces 111 Office Leases Canceled as DOGE Touts Savings, Progressive Farmer (March 14, 2025), https://citizen.short.gy/EMql3t.
[43] Desmond Butler, et. al, Elon Musk’s business empire is built on $38 billion in government funding, The Washington Post (Feb. 26, 2025), https://citizen.short.gy/FGbHX2.
[44] Rachael Levy, Exclusive: Musk’s Neuralink faces federal probe, employee backlash over animal tests, Reuters (Dec. 6, 2022), https://citizen.short.gy/ejzVOJ.
[45] Rachael Levy, Exclusive: USDA inspector general escorted out of her office after defying White House, Reuters (Jan. 29, 2025), https://citizen.short.gy/6dkwZk.
[46] Ella Nilsen and Sean Lyngaas, Trump energy secretary allowed 23-year-old DOGE rep to access IT systems over objections from general counsel, CNN (Feb. 7, 2025), https://citizen.short.gy/DJQXW1.
[47] Energy appoints Twitter, Google and DOGE alum as new CIO, NextGov (March 13, 2025), https://citizen.short.gy/yFBZRw.
[48] Hannah Northey and Christa Marshall, Third DOGE official crops up at Energy Department, E&E News by Politico (Feb. 10, 2025), https://citizen.short.gy/Q1M8kB.
[49] Tara Copp and Anthony Izaguirre, Trump administration tries to bring back fired nuclear weapons workers in DOGE reversal, AP (Feb. 16, 2025), https://citizen.short.gy/MOeOBT.
[50] Rene Marsh and Ella Nilsen, Trump officials fired nuclear staff not realizing they oversee the country’s weapons stockpile, sources say, CNN (Feb. 14, 2025), https://citizen.short.gy/PF4EqJ.
[51] Desmond Butler, et. al, Elon Musk’s business empire is built on $38 billion in government funding, The Washington Post (Feb. 26, 2025), https://citizen.short.gy/FGbHX2.
[52] Letter to Chris Wright, https://citizen.short.gy/SeXXsN.
[53] Ian Duncan, DOGE employee cuts fall heavily on agency that regulates Musk’s Tesla, The Washington Post (Feb. 7, 2025), https://citizen.short.gy/uQ9ECn.
[54] Tom Carter, The agency that regulates vehicle safety — and Elon Musk’s Tesla — is another target of DOGE layoffs, Business Insider (Feb. 24, 2025), https://archive.ph/opZKC.
[55] Ian Duncan, DOGE employee cuts fall heavily on agency that regulates Musk’s Tesla, The Washington Post (Feb. 7, 2025), https://citizen.short.gy/uQ9ECn.
[56] Resources Related to Investigations and Recalls, National Highway Traffic Safety Transportation Administration, https://www.nhtsa.gov/resources-investigations-recalls.
[57] Kimberly Kindy and Brian Slodysko, Here are all the ways Tesla could benefit from Elon Musk’s close relationship with Donald Trump, The AP and Fortune (Feb. 11, 2025), https://citizen.short.gy/ArcnaL.
[58] Faiz Siddiqui, Musk’s fury over a Tesla investigation foreshadowed his war on Washington, The Washington Post (April 17, 2025), https://citizen.short.gy/PPb3ss.
[59] Tom Carter, DOGE job cuts will slow down robotaxi rollout, says fired federal worker, Business Insider (March 3, 2025), https://citizen.short.gy/3zOZAO.
[60] Ian Duncan, DOGE employee cuts fall heavily on agency that regulates Musk’s Tesla, The Washington Post (Feb. 7, 2025), https://citizen.short.gy/uQ9ECn.
[61] Stephen Morris et. al, Musk’s Doge fired self-drive car safety experts at agency that regulates Tesla, Financial Times (April 10, 2025), https://citizen.short.gy/Nq4n2k.
[62] Patrick Wingrove, Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs, Reuters (March 27, 2025), https://citizen.short.gy/iZHLzg and Ahmed Aboulenein and Sriparna Roy, Kennedy to slash 10,000 jobs in major overhaul of US health agencies, Reuters (March 27, 2025), https://citizen.short.gy/W5YrV0.
[63] Madison Alder, FDA tech officials complied with DOGE’s requests for data. The staff reductions still came, Fedscoop (April 21, 2025), https://citizen.short.gy/S8IhTE.
[64] Rachael Levy, Marisa Taylor and Akriti Sharma, Elon Musk’s Neuralink wins FDA approval for human study of brain implants, Reuters (March 26, 2023), https://citizen.short.gy/wqU1L2.
[65] Musk’s Neuralink gets FDA’s breakthrough device tag for ‘Blindsight’ implant, Reuters (Sept. 18, 2024), https://citizen.short.gy/HOzswR.
[66] Meg Kinnard, A comprehensive look at DOGE’s firings and layoffs so far, AP (Feb. 21, 2025), https://citizen.short.gy/5VSZam.
[67] Rachael Levy and Marisa Taylor, Exclusive: FDA staff reviewing Musk’s Neuralink were included in DOGE employee firings, sources say, Reuters (Feb. 18, 2023), https://citizen.short.gy/VEPMHJ.
[68] Tara Copp, Some of the 400 jobs that were cut at the FAA helped support air safety, a union says, AP (Feb. 19, 2025), https://citizen.short.gy/qOozTf.
[69] Eric Lipton and Kirsten Grind, Elon Musk’s Business Empire Scores Benefits Under Trump Shake-Up, The New York Times (Feb. 11, 2025), https://citizen.short.gy/qsUD76.
[70] William Harwood, FAA orders investigation after SpaceX Starship breaks up and showers debris, CBS News (Jan. 17, 2025), https://citizen.short.gy/94nQCJ.
[71] See, https://x.com/SpaceX/status/1836765012855287937.
[72] Warren Presses Musk for Answers on His Role in Resignation of FAA Administrator, Office of Senator Elizabeth Warren (Feb. 1, 2025), https://citizen.short.gy/1qvMcc and Roll Call Vote 118th Congress – 1st Session, On the Nomination (Confirmation: Michael G. Whitaker, of Vermont, to be Administrator of the Federal Aviation Administration), United States Senate (Oct. 24, 2023), https://citizen.short.gy/55i29U.
[73] Sara Dorn, Musk Reportedly Planning New Starlink Deal With FAA—Raising New Conflict-Of-Interest Concerns, Forbes (Feb. 28, 2025), https://citizen.short.gy/iyTYCw and Ian Duncan, Hannah Natanson, Lori Aratani and Faiz Siddiqui, FAA targeting Verizon contract in favor of Musk’s Starlink, sources say, The Washington Post (Feb. 26, 2025), https://citizen.short.gy/lH26B3.
[74] See https://x.com/elonmusk/status/1895129237478162621, David Shepardson, USDOT says Verizon not moving fast enough on $2.4 billion FAA contract, Reuters (March 11, 2025), https://citizen.short.gy/LpBH3Y and David Shepardson, Musk’s Starlink denies it wants to take over FAA US air traffic contract, Reuters (March 5, 2025), https://citizen.short.gy/BSOOtq.
[75] David Shepardson, DOGE team is not involved in FAA decision on Starlink terminals, acting chief says, Reuters (March 22, 2025), https://citizen.short.gy/2RjDbx.
[76] Mission, Securities and Exchange Commission, https://www.sec.gov/about/mission.
[77] See https://x.com/DOGE_SEC/status/1891519437951365238.
[78] Declan Harty, Musk’s DOGE expected to arrive at SEC in coming days, Politico (Feb. 17, 2025), https://citizen.short.gy/6qSnX0.
[79] Chris Prentice, US SEC offers staff $50,000 to resign or retire, memo says, Reuters (March 3, 2025), https://citizen.short.gy/Q3yqIg.
[80] Eric Lipton and Kirsten Grind, Elon Musk’s Business Empire Scores Benefits Under Trump Shake-Up, The New York Times (Feb. 11, 2025), https://citizen.short.gy/qsUD76 and Litigation Releases, Elon R. Musk, Securities and Exchange Commission, https://citizen.short.gy/H07bGD.
[81] Complaint, Securities and Exchange Commission v. Elon R. Musk, Securities and Exchange Commission, https://citizen.short.gy/oKejt8.
[82] Clare Duffy, Elon Musk didn’t show up for testimony in a probe over his $44 billion Twitter takeover. Now the SEC wants sanctions, CNN (Sept. 20, 2024), https://citizen.short.gy/S3bnNO.
[83] Eric Lipton and Kirsten Grind, Elon Musk’s Business Empire Scores Benefits Under Trump Shake-Up, The New York Times (Feb. 11, 2025), https://citizen.short.gy/qsUD76.
[84] See https://x.com/elonmusk/status/1867357433493872874?s=46.
[85] NASA Johnson Space Center Oral History Project Commercial Crew & Cargo Program Office Edited Oral History Transcript, NASA (Jan. 15, 2013), https://citizen.short.gy/Y3l79n.
[86] Joey Roulette, Acting NASA chief says DOGE to review space agency spending as hundreds take buyout, Reuters (Feb. 13, 2025), https://citizen.short.gy/cJLuI0.
[87] Id.
[88] Giselle Ruhiyyih Ewing, Musk Is Positioned to Profit Off Billions in New Government Contracts, The New York Times (March. 23, 2025), https://citizen.short.gy/OxTwQS.
[89] Eric Lipton, Elon Musk’s Business Empire Scores Benefits Under Trump Shake-Up, The New York Times (Feb. 11, 2025), https://citizen.short.gy/MCBEhT.
[90] Project Announcement: Inspection of USAID’s Oversight of Starlink Terminals Provided to the Government of Ukraine, USAID Office of Inspector General (May 14, 2024), https://oig.usaid.gov/node/6814 and Theo Burman, Alleged USAID Probe Into Starlink Raises Elon Musk Conflict Concerns, Newsweek (Feb. 6, 2025), https://citizen.short.gy/iwgIOE.
[91] Id.
[92] Gary Fields and Ellen Knickmeyer, USAID workers clear their desks in Trump’s final push to dismantle the agency, AP (Feb. 27, 2025), https://citizen.short.gy/qjlppn.
[93] Elizabeth Chuck, What is USAID? How it works and what could happen if Trump and Musk shut it down, AP (Feb. 27, 2025), https://citizen.short.gy/YtsEJ9.
[94] American Foreign Service Ass’n v. Trump, Public Citizen, https://citizen.short.gy/WWloPh.
[95] Ellen Knickmeyer, Secretary of State Rubio says purge of USAID programs complete, with 83% of agency’s programs gone, AP (March 10, 2025), https://citizen.short.gy/7lUMjs.
[96] Press Secretary Karoline Leavitt Briefs Members of the Medica Feb. 5, 2025, Rev (Feb 5, 2025), https://citizen.short.gy/8TiLgx.
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Senate: Do Not Ratify Trump’s Crypto Grift
Public Citizen leads group letter from honest government organizations and individuals
Honorable Members of Congress
Dear Member,
We, the undersigned organizations and individuals committed to honest government, believe President Donald J. Trump’s sprawling personal cryptocurrency ventures may constitute flagrant violations of anti-conflict statutes. As such, we urge you to accord special scrutiny as you consider legislation involving stablecoins. Voting to approve this bill will serve to ratify what may be perhaps the most conspicuous corruption in presidential history.
Trump once dismissed bitcoin, the most popular crypto, as “based on thin air.” It is a “scam.” It can facilitate unlawful behavior, including drug trade and other illegal activity.” Now, he’s the self-proclaimed crypto president.
Last week, the Trump family announced an agreement with a fund backed by Abu Dhabi that “would be making a $2 billion business deal using the Trump firm’s digital coins,” according to the New York Times. This deal involves a forthcoming stablecoin. The Constitution (Article 1, Section 9) forbids accepting money (specifically a “present” or “emolument”) or anything of value from any “king, prince, or foreign state.”
Before this, Trump promised a presidential dinner to the largest new buyers of his crypto “meme,” called “Trump.” He restated this “gala” opportunity May 5. Federal law strictly regulates payments to government officials, including gifts. Although the president may receive gifts, he may not “solicit” gifts. These prohibitions begin with the Constitution’s Emoluments Clause and are reiterated in the anti-bribery statute, 18 U.S.C. § 201, and federal regulations, 5 C.F.R. § 2635. Although section 2635.205 lists several exemptions from the prohibition, none exempts soliciting purchases for personal gain.
As to why the public might be interested in sending money, the website explains: “This Trump Meme celebrates a leader who doesn’t back down, no matter the odds.” Under the Trump meme website’s question, “What is a meme?” the website explains: “Merriam-Webster’s meme noun: 1: an idea, behavior, style, or usage that spreads from person to person within a culture.”
The website states that “Trump Memes . . . are not intended to be, or to be the subject of, an investment opportunity, investment contract, or security of any type.” Trump’s Securities and Exchange Commission also stated that meme coins have “no use.” Other cryptocurrency observers deride memes generally as without value. Former aide Anthony Scaramucci said Trump’s effort demeans broader cryptocurrency efforts, calling it “Idi Amin level corruption.” Another commenter said that the Trump meme “is effectively a ‘for sale’ sign on the White House.” Some, including an author in the Washington Post, characterized this token as a “sh—coin.”
In short, it appears Trump is not soliciting money in exchange for an investment or tangible product (such as a Bible, sports shoes, or a guitar), but soliciting money in exchange for nothing—that is, asking for a gift that will benefit him personally.
Already, Trump has profited millions from the meme and other ventures. His initial sale generated nearly $100 million. The latest salvo in April brought in roughly $100 million more. Some new buyers come through the Binance exchange, legally barred for US investors, meaning that Trump may well be violating the emoluments clause with this venture as well.
The dangers inherent in the Trump meme portend ominously. Should the president be allowed to enrich himself in this way, other politician might follow this path, rendering the prohibition on solicitation in 18 U.S.C. § 201 and the prohibitions on receipt of gifts by officials other than the president meaningless.
Paradoxically, while this Trump meme is worthless (by his own estimation) Trump managed to create an earlier crypto that is worth less. In October, 2024, he became the “chief crypto advocate” for World Liberty Financial, a nascent cryptocurrency firm. The World Liberty Trump crypto is worse because it cannot be resold. This Trump crypto buys only “governance,” but only a minority share. Trump controls the majority of the governance tokens.
Now, Congress considers twin bills on stablecoins. Perhaps not coincidental for a president who calls himself a “stable genius,” one bill is called the STABLE Act, and the other, the GENIUS Act. Stablecoins typically tie to the US dollar—one dollar buys one token.
At the very least, Congress must bar the president along with all elected officials and their families from owning, buying or otherwise trafficking in stablecoins. Americans must be assured that policy won’t be fashioned by those profiting from the shape of the legislation.
Further, Congress should approve an amendment that restates conflict laws that already apply to the president. Namely, he may not solicit gifts; he may not accept gifts from a foreign sovereign; he may not sell political favors.
Sincerely,
Accountable.US/Accountable.NOW
Virginia Canter
Center for Biological Diversity
Consumer Federation of America
Ambassador Norman Eisen (RET), former White House Ethics Czar
End Citizens United
Free Speech for People
Prof. Richard W. Painter
Project on Government Oversight (POGO)
Public Citizen
State Democracy Defenders Action
Prof. James A. Thurber
20/20 Vision
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2nd Challenge of Blackstone’s Effort To Buy Potomac Energy Center For Data Centers
By Tyson Slocum
Today in Federal Energy Regulatory Commission docket EC25-46 we filed a follow up protest to our February 24 challenge.
Congress instructs the Commission to only approve Section 203 transactions that are “consistent with the public interest”.[1] Blackstone seeks to acquire an 800 MW power facility in a market where it simultaneously owns and controls significant data center load—but failed to disclose details of this data center control in both the application and as part of its Competitive Analysis Screen. Two recent data center load loss events in the same market as the Potomac Energy Center (in July 2024 and February 2025) underscore the potential anti-competitive and public interest issues that the Commission is bound by law and policy to address in this proceeding.
Blackstone’s March 6 answer does not deny our contention that it controls and operates a large number of data centers in proximity to the Potomac Energy Center. But Blackstone has neither confirmed exactly which data centers it owns, nor stated the load size in megawatts of such facilities, let alone divulge whether it is in the process of building additional data center capacity in the region.
Both the Commission and the North American Electric Reliability Corporation (NERC) have raised significant concerns about the impact voltage sensitive large loads—such as data centers—have on disrupting power markets, and Blackstone’s failure to disclose details of its control over data centers or include them in its Competitive Analysis Screen is a material omission.
On March 19, Reuters reported that PJM nearly experienced cascading power outages after 30% of the data centers in Virginia’s data center alley went offline, with a NERC official noting that “As these data centers get bigger and consume more energy, the grid is not designed to withstand the loss of 1,500-megawatt data centers. At some level it becomes too large to withstand unless more grid resources are added,” with the incident resulting in NERC establishing a special task force to study the impact data centers have on the grid.[3]
This July 2024 incident was confirmed in the April 17 presentation of Mark Lauby, NERC’s Senior Vice President and Chief Engineer, who disclosed a second, even larger event in February 2025 involving 1800 MW of data center load in Virginia’s Loudoun and Fairfax counties.[4] The NERC presentation supports our February 24 contention that Blackstone could utilize its control over data centers and the Potomac Energy Center to disrupt regional energy markets in anti-competitive ways.
This Section 203 proceeding is the only appropriate venue for the Commission to address and resolve any anti-competitive or public interest issues involving Blackstone’s simultaneous control over a large power facility in the same market as where it controls data centers.
As we noted in this proceeding on March 7, 18 CFR § 2.26(b) provides the Commission the flexibility required to ensure Section 203 transactions are consistent with the public interest, allowing it to “consider other factors” in addition to those specified. Such additional factors would necessarily include an applicant’s control of data centers that consume disruptive amounts of electricity in the same exact market as a planned power plant acquisition.
Our request that joint applicants’ include a Competitive Analysis Screen of Blackstone’s control over large loads in the same market as a planned power plant acquisition cannot be construed as an effort to restrict capital investment to serve critical infrastructure needed to support data centers. That’s because this transaction does not feature Blackstone committing capital to add new generation capacity; rather the private equity firm is paying a premium to acquire an existing, financially viable asset. The 800 MW power plant subject to this application began in 2008 as the Stonewall facility proposed by a local Loudoun County firm (Green Energy Partners) that conducted early community engagement meetings and secured initial permits. In 2013, the private equity firm Panda Power obtained a majority stake funded primarily through $571 million of debt financing, along with $75 million in equity from Siemens Financial Services, with Ares Management providing an additional $100 million credit facility to Panda in 2015. The total cost to bring Panda Stonewall into commercial operation in 2017 was less than $800 million. Panda Power’s overreliance on debt financing forced it into financial restructuring to avoid bankruptcy, with Ares Management assuming the project’s debt in exchange for control over the facility in 2021, renaming it Potomac Energy Center. The fact that Blackstone is willing to pay $1 billion for the facility that cost less than $800 million to build may be an indication of the windfall profits the firm expects to earn operating in the same market in which it controls significant data center load, as the firm boasts on its website that “[a]s data center owners, we benefit from significant barriers to new supply.”
Requiring disclosure and market analysis of Blackstone’s data center portfolio in PJM does not constitute a regulatory burden. Blackstone already publicly linked the Potomac Energy Center to “its unparalleled access to data centers in Virginia,” and Blackstone’s counsel in this proceeding, Kirkland & Ellis, emphasized the link between the transaction and Blackstone’s financial interest in data centers when the law firm wrote that the Potomac Energy Center acquisition “represents Blackstone’s most recent investment in the power infrastructure supporting data centers and AI revolution.”
Joint applicant’s decision to conceal from the Commission Blackstone’s control over significant data center load in the same market as the Potomac Energy Center is a material omission, and the application must be deemed deficient.
Read the full filing here 2ndPotomacEnergyCenter
[1] 16 USC § 824b(4).
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Comments on the FDA’s Proposed Order Regarding Removal of Oral Phenylephrine
Comments Regarding the Food and Drug Administration’s Notice of Proposed Administrative Order To Remove Oral Phenylephrine Products As Nasal Decongestants Due to Their Ineffectiveness
(FDA-2024-N-4734-0001)
Submitted electronically
Public Citizen submits the below comments in strong support of the Food and Drug Administration’s (FDA’s) notice of proposed administrative order (proposed order) OTC000036, “Amending Over-the-Counter [OTC] Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use.”[1] Published in the Federal Register on November 8, 2024, this proposed order, if finalized, would remove orally administered phenylephrine hydrochloride and effervescent phenylephrine bitartrate as nasal-decongestant active ingredients from the OTC monograph M012 because they are ineffective.
Public Citizen is a research-based nonprofit consumer advocacy organization with more than 500,000 members and supporters nationwide. We have advocated for the removal of ineffective and unsafe drugs from the U.S. market since 1971. We do not have any financial conflicts of interest and do not accept government or industry funding.
We are deeply concerned that, for almost fifty years, the FDA has maintained the “generally recognized as safe and effective” (GRASE) status of oral phenylephrine for nasal congestion in the OTC monograph for cold, cough, allergy, bronchodilator, and antiasthmatic drugs despite compelling research evidence against its effectiveness. Although there are no safety concerns for oral phenylephrine products, U.S. consumers would not be served by leaving such placebo-like products on the market.[2]
With more than 700 unique oral phenylephrine-containing products (such as DayQuil, Sudafed PE, other brands, and generics) on shelves as of 2021, the drug has become the most common oral decongestant in the United States.[3] Prior to 2006, the drug was not commonly used.
The surge in phenylephrine products occurred after the FDA revoked the GRASE status of phenylpropanolamine in 2000 due to its risk of hemorrhagic strokes and moved pseudoephedrine (Sudafed and generics) behind the counter in 2006 to decrease its illicit use to produce methamphetamine. These FDA actions left OTC manufacturers with no GRASE-designated oral nasal-congestion drugs other than phenylephrine, an option that they have pursued fully.
Even before oral phenylephrine became the only available oral OTC decongestant, there was consistent evidence challenging its efficacy. For example, a well-conducted 1971 study at Columbia University demonstrated that oral phenylephrine (at doses of 10, 20, or 40 milligrams [mg]) is no better than placebo on nasal airway resistance (NAR) over a four-hour period.[4] In contrast, the study found that oral pseudoephedrine and phenylpropanolamine were effective in decreasing NAR.
In 2006 Dr. Ronald Eccles, a Cardiff University professor, wrote in an article published in the British Journal of Clinical Pharmacology that “[t]here is support in the literature for the efficacy of [pseudoephedrine] as an orally administered nasal decongestant [sic]… but no support [exists] for the efficacy of oral [phenylephrine].”[5]
In 2007 a meta-analysis was conducted by researchers at the University of Florida (UF) who evaluated eight unpublished efficacy studies for the 10-mg dose (the monographed dose) of oral phenylephrine in reducing NAR in participants with nasal congestion.[6] These studies were conducted between 1959 and 1975, cited in the Federal Register and obtained by the researchers through a Freedom of Information Act request to the FDA. Contrary to common assumptions, the meta-analysis did not find oral phenylephrine to be efficacious. Therefore, in 2015 two of the UF researchers petitioned the FDA to remove oral phenylephrine from the OTC monograph.[7]
In September 2023 an FDA Nonprescription Drugs Advisory Committee unanimously voted (16-0) that the current dosage of orally administered phenylephrine is not effective for nasal congestion relief.[8] The committee’s decision was based on consistent and compelling scientific evidence presented by FDA scientists that oral phenylephrine does not work.
The FDA scientists conducted a new analysis of the original efficacy studies supporting the GRASE status of oral phenylephrine. The scientists uncovered many methodological and statistical problems that make these studies equivalent to phase 1 studies by current standards.[9] Notably, two of these original studies generated unbelievable “near textbook perfect results” that were not duplicated in other similar studies by the same sponsor, according to the agency’s scientists.
Furthermore, FDA clinical scientists examined publicly available data from three adequately controlled, industry-sponsored clinical trials conducted since a 2007 Nonprescription Drugs Advisory Committee meeting that discussed the efficacy and safety of oral phenylephrine. These trials represent the largest and most well-designed available studies evaluating the efficacy of oral phenylephrine for nasal congestion. The trials illustrated the lack of efficacy of oral immediate-release phenylephrine at doses up to 40 mg and extended-release doses of 30 mg.
In addition, FDA clinical pharmacologists have confirmed that based on updated technological methods, the bioavailability of phenylephrine when taken orally is less than 1% because the drug is broken down during absorption. These scientists also have concluded that the half-life of oral phenylephrine is significantly shorter than the current four-hour dosing interval.
Therefore, Public Citizen urges the FDA to promptly move forward with finalizing its proposed order to revoke the GRASE designation of oral phenylephrine for relief of nasal congestion and remove it from the OTC monograph.
The decades-long availability of oral phenylephrine products on shelves has been a huge disservice to the American people because it had misled countless patients and delayed their access to effective relief of nasal congestion while wastefully enabling drug companies to profiteer from these placebo drugs.
In the meantime, to allay concerns from the public, the FDA should inform consumers about the merits of removing oral phenylephrine from the market through a public messaging campaign. Until multi-ingredient allergy and cold OTC products that contain phenylephrine are reformulated, patients can utilize prescription oral pseudoephedrine as an effective alternative. Those with contraindications for pseudoephedrine can use intranasal phenylephrine (Neo-Synephrine, other brands, and generics) or oxymetazoline (Afrin, other bands, and generics).
The oral-phenylephrine saga is unacceptably reminiscent of the snake oil era. Therefore, the FDA should seek to uphold the statutory standards of efficacy and safety by expanding its nonprescription drug review process to include evidence supporting other potentially ineffective or unsafe products that have been grandfathered into OTC monographs.
Thank you for your consideration of our comments regarding this important issue.
Sincerely,
Azza AbuDagga, M.H.A., Ph.D.
Health Services Researcher
Public Citizen’s Health Research Group
—
[1] Food and Drug Administration. Proposed administrative order (OTC000036). Amending over-the-counter monograph M012: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-Counter human use. November 8, 2024. https://www.regulations.gov/document/FDA-2024-N-4734-0001. Accessed May 6, 2025.
[2] Public Citizen. Testimony before the FDA’s nonprescription drugs advisory committee regarding the efficacy of oral phenylephrine as a nasal congesant. September 11, 2023. https://www.citizen.org/article/testimony-before-the-fdas-nonprescription-drugs-advisory-committee-regarding-the-efficacy-of-oral-phenylephrine-as-a-nasal-congestion/. Accessed May 6, 2025.
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[7] Hendeles L, Hatton RC. Citizen’s petition 2015-P-4131-0001 requesting a final rule removing oral phenylephrine from the final monograph for OTC nasal decongestant products. November 13, 2015. https://www.regulations.gov/document/FDA-2015-P-4131-0001. Accessed May 6, 2025.
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