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Republicans Advocate for American Energy on World Stage Energy and Commerce Committee Member August Pfluger (R-TX) led a bipartisan Congressional delegation to Baku, Azerbaijan, for COP29. Members met with world leaders to discuss efforts to build a cleaner energy future. Throughout bilateral meetings and panel discussions on the international stage, E&C Members not only highlighted America's energy leadership but also underscored our commitment to environmental stewardship. Check out these top photos from the trip: At a press conference , Members highlighted how America has led the world in reducing emissions without sacrificing innovation, economic development, or national security. Our allies and partners benefit from America’s energy exports, technological leadership, and environmental stewardship. At a bipartisan panel moderated by Heather Reams, President of Citizens for Responsible Energy Solutions (CRES), Members highlighted how a robust nuclear energy industry is critical for providing affordable clean energy to communities across the country and around the world. Members also underscored the significance of the ADVANCE Act, signed into law July 2024, which will modernize and improve licensing processes at the Nuclear Regulatory Commission (NRC).  Meeting with COP 29 President Minister of Ecology Mukhtar Babayev    and Lead Negotiator Yalchin Rafiyev Meeting with the President of Azerbaijan   Meeting with U.S. Ambassador Mark Libby Meeting with South Korean officials Meeting with Taiwanese officials

“DOE is threatening domestic jobs and economic development, weakening the energy security of European allies, and strengthening our adversaries” Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Energy, Climate, and Grid Security Subcommittee Chair Jeff Duncan (R-SC), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA) sent a letter to Department of Energy (DOE) Secretary Jennifer Granholm demanding the agency stop rushing to prematurely release its anti-liquefied natural gas (LNG) study, which aims to hamstring the incoming Presidential administration. The letter also calls for DOE to lift the pause on LNG exports, which was a politically motivated decision by the Biden administration to appease radical environmental activists at the expense of American energy security and the security of our allies. KEY LETTER EXCERPTS: “Despite DOE’s prior findings and published reviews in favor of U.S. LNG exports, and contrary to DOE’s limited statutory authority under the NGA, the Biden administration’s DOE announced that it would expand its environmental review as part of a ‘managed transition’ to reduce use of fossil fuels. Recent press reports indicate that DOE is racing to complete a study on the climate impacts of LNG exports to hamper the incoming Republican administration and provide opportunities to challenge future project approvals in court.” [...] “ The results of the 2024 presidential election are clear, and DOE leadership will soon change. As a traditional part of the peaceful transfer of power, DOE should immediately stop work on any plans to expand the scope of review or add new conditions to LNG export licenses. DOE should immediately lift the ban on LNG export approvals in compliance with the NGA and the District Court order.” BACKGROUND: January 26, 2024 : The Biden administration announces indefinite “pause” on LNG export permits. Chair Rodgers immediately rebukes the decision, calling it a “gift to Putin.” February 5, 2024 : More than 150 House Republicans demand President Biden ends his de facto ban on American LNG exports. February 15, 2024 : E&C Republicans lead bipartisan passage of H.R. 7176 to reverse President Biden’s LNG export ban. April 8, 2024 : The Subcommittee on Energy, Climate, and Grid Security holds a field hearing in Port Arthur, Texas, with local leaders and energy workers to highlight the economic and public benefits of American energy production, including job creation. November 7, 2024 : Bloomberg Law reports that the “Biden administration is racing to complete a study that could complicate President-Elect Donald Trump’s plan to immediately approve new liquefied natural gas export terminals.” CLICK HERE to read the full letter.

Washington, D.C. — In a new letter to Government Accountability Office Comptroller General Gene Dodaro, House Energy and Commerce Committee Republicans have requested an examination of the structure of laboratory safety programs at the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).  The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA).  KEY LETTER EXCERPT :  This committee remains concerned about the effectiveness of the oversight HHS and its agencies provide to the laboratories they own and operate. In addition to numerous GAO recommendations that remain unimplemented by the FDA, both the CDC and the FDA recently announced organizational reforms to their laboratory safety and security functions, and it is not clear whether these changes will strengthen oversight or create new undue risk. The FDA has, for example, reorganized several of its laboratories such that they now fall within the Office of the Chief Scientist. This raises potential independence concerns, as the FDA’s laboratory safety and security functions report to the same office.  BACKGROUND :  The mission of the U.S. Department of Health and Human Services (HHS) is to enhance the health and well-being of all Americans.   As such, HHS is most directly involved in leading public health preparedness and response efforts, as well as associated research.   However, past safety lapses involving the CDC, the FDA, and the NIH have been the result of multiple breakdowns in compliance with established policies coupled with inadequate oversight.   For example, in July 2014, boxes containing decades-old vials of smallpox and other hazardous biological agents were found in a storage space of an FDA laboratory on the NIH’s campus. GAO and other reviews resulted in numerous findings and recommendations to strengthen laboratory safety and security, which led to changes to the way HHS and its agencies oversee their laboratories.   Likewise, GAO and other reviews have highlighted the importance of laboratory science and security in the handling of federal select agents and other dangerous pathogens in research.  CLICK HERE to read the full letter.

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) today sent letters to five independent federal agencies urging the Biden-Harris administration appointees to abandon partisan efforts and instead focus remaining efforts on bipartisan, consensus items.   The letters state, “The results of the 2024 presidential election are now apparent and leadership of the [agency] will soon change. As a traditional part of the peaceful transfer of power, the [agency] should immediately stop work on any partisan or controversial item under consideration, consistent with applicable law and regulation.”    Click below to read each agency’s letter:   Consumer Product Safety Commission (CPSC) Federal Communications Commission (FCC)   Federal Trade Commission (FTC)   Federal Energy Regulatory Commission (FERC)   Nuclear Regulatory Commission (NRC) Note: In the letter, Chair Rodgers urges NRC to continue timely implementation of the ADVANCE Act. 

Washington, D.C. — In a newly released staff report , House Energy and Commerce Committee Republicans detail how the Biden-Harris Environmental Protection Agency (EPA) is in the process of spending nearly three billion taxpayer dollars on so-called “environmental justice” (EJ) grants. The report uncovers how EJ grants were given to radical environmental activist groups that attempt to exert political influence, engage in progressive election activities, and are backed by billionaires. Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), and Subcommittee on Environment, Manufacturing, and Critical Materials Chair Earl L. “Buddy” Carter (R-GA) issued the following statement: "It couldn’t be more clear: The Biden-Harris administration rewards its environmental special interests at the expense of the American people. As part of its radical rush-to-green agenda, the administration gave hundreds of millions of taxpayer dollars to activists who also engage in political activities. It was empowered to do so by congressional Democrats who jammed through legislation that was designed to rush money out the door as quickly as possible with no guards against waste, fraud, and abuse. Equally as alarming is how these policies benefit the Chinese Communist Party—the world’s worst polluter." BACKGROUND : Passed by congressional Democrats and signed into law by President Biden in 2022, the Inflation Reduction Act (IRA) more than quadrupled the EPA’s budget. Included in that deluge of spending was nearly three billion dollars in EJ grants to be administrated through a variety of programs. One program relies upon a “pass-through” model, which hands $600 million taxpayer dollars out to 11 “grant makers” to then dole out to additional recipients—a process that lacks serious oversight protections. The report exposes how the Biden-Harris EPA funneled public funding to groups that exert political influence, engage in election activities, express anti-Republican sentiment, espouse radical progressive ideologies, and already receive significant funding from wealthy donors.  KEY REPORT EXCERPTS :  Simply put, the EPA is awarding taxpayer dollars to special interest groups committed to a radical energy agenda to “educate” others and drive public outreach, as well as assist those it engages with to influence government policymaking and outcomes. One might consider it akin to a taxpayer-funded lobbying operation. Given these organizations’ existing efforts to sway public opinion, they may use these awards to attempt to indoctrinate members of the communities in which they conduct outreach. [...] Under its EJTCTAC Program, the EPA awarded $10,000,000 to West Harlem Environmental Action, Incorporated (WE ACT) to operate a technical assistance center, the WE ACT Technical Assistance Collaborative. WE ACT lists “[f]ighting [l]iquified [n]atural [g]as and [f]alse [s]olution [i]nfrastructure” among its 2024 policy priorities. It has called on federal agencies to halt new or expanded liquified natural gas operations and vows to continue this “advocacy campaign.” Notably, the Biden-Harris Administration announced a pause on exports of liquified natural gas in January 2024. [...] Some selectees and partners appear to have clear political bias. The Climate Justice Alliance, selected to be a National Grantmaker under the EJTCGM Program issued a press release implying congressional Republicans deserved blame for a potential government shutdown in 2023. EJTCTAC Program selectee WE ACT posted a blog criticizing “Republican gas stove culture wars,” and House GOP Members’ “performative, out-of-touch agenda.” The New York Immigration Coalition, an EJTCGM Program partner, accused the Trump administration of preventing people from voting. Another partner, the Wyoming Outdoor Council, attacked the Trump administration’s “environmental rollbacks” and stated it would “successfully defend the good rules and regulations put in place by the prior administration.” Healthy Gulf urged on its website, “we must ensure that the federal government reinstates common sense, safety, and environmental oversights that the Trump administration rolled back.” CLICK HERE to read the full report. 

Washington, D.C. — Republican Members of the House Energy and Commerce Committee issued the following statements regarding a report that results from a National Institutes of Health (NIH) funded research project are being withheld from the public due to political motives. “This is a clear example of the politicization of science at the expense of children. Research funded by taxpayer dollars through the NIH should be publicly disclosed regardless of the results, and Americans deserve access to the truth,” said Committee Chair Cathy McMorris Rodgers (R-WA) . “For a scientist to withhold findings deliberately because the findings don’t substantiate a preferred outcome further erodes public trust in the NIH and its programs. Our Committee will be launching an investigation into the matter.”  “These recent revelations are a great example of why Congress and the American people are demanding more transparency and accountability from the U.S. public health community,” said Subcommittee on Health Chair Brett Guthrie (R-KY) . “Not publishing the results of taxpayer-funded research in fear of political blowback not only further erodes trust in our public health institutions, but also fundamentally undermines the very nature of scientific research. Most importantly, failing to publish these results to protect one’s own political agenda puts vulnerable children at risk of serious self-harm. I call on the NIH to immediately suspend funding of this study and to immediately publish the study’s results for the American people to see for themselves.” “Delaying the publication of clinical trial studies, funded in part by the federal government, for fear that its findings would be ‘weaponized’ by those who are opposed to invasive transgender procedures in juveniles is irresponsible and inappropriate,” said Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) . “The American people should be allowed to follow the science even when it leads to a conclusion that the scientist doing the study doesn’t like.” “Puberty blockers and sex-change operations harm children, period. It’s outrageous for taxpayer-funded research to be hidden from the public, especially when it is being suppressed by a transgender advocate simply because the findings don’t fit their political agenda,” said Representative Diana Harshbarger (R-TN) . “This is a glaring example of why NIH must be reformed with measures like those initiated by Chair Rogers to ensure transparency, standards of objectivity, and the removal of conflicts of interest in federal taxpayer-funded scientific and medical research. The NIH must release the results of this taxpayer-funded study immediately.”  BACKGROUND : As reported in the New York Times , an NIH-funded researcher and vocal advocate for hormonal gender treatments on minors, who receives millions of dollars of taxpayer funding, is withholding the results of studies because they do not demonstrate clinical benefit of providing such treatments. The United States remains an outlier by providing hormonal-based therapies that delay puberty to minors for the purposes of gender transitioning, while many other developed nations are moving away from the practice. 

$900 million taxpayer dollars used to amplify the Biden-Harris administration’s flawed messaging on COVID-19 pandemic Washington, D.C. — In a new report , House Energy and Commerce Committee Republicans unveiled the failings of a $900 million COVID-19 public relations campaign, issued and overseen by the U.S. Department of Health and Human Services (HHS). It is the culmination of the Committee’s investigation , which was launched in April 2023. “While the Biden-Harris administration’s public health guidance led to prolonged closures of schools and businesses, the NIH was spending nearly a billion dollars of taxpayer money trying to manipulate Americans with advertisements—sometimes containing erroneous or unproven information. By overpromising what the COVID-19 vaccines could do—in direct contradiction of the FDA’s authorizations—and over emphasizing the virus’s risk to children and young adults, the Biden-Harris administration caused Americans to lose trust in the public health system,” said Committee Chair Cathy McMorris Rodgers (R-WA). “Our investigation also uncovered the extent to which public funding went to Big Tech companies to track and monitor Americans, underscoring the need for stronger online data privacy protections.” “I am proud to see this report uncover the truth behind the Biden-Harris administration’s use of $900 million of taxpayer funds to further their own political agenda that sowed distrust in our public health institutions, kept kids out of the classroom, and crushed local economies,” said Subcommittee on Health Chair Brett Guthrie (R-KY ). “American trust in the CDC is at an all time low because the Biden-Harris administration’s flawed pandemic messaging, and this report is the first step in holding CDC and other agencies to account for the harms caused throughout the pandemic and ensure these institutions are operating openly and transparently with the American public during future pandemics.”  “The entire premise of the Biden-Harris ‘Stop the Spread’ campaign was that if you got vaccinated for COVID-19, you could resume daily activities because they said vaccinated people would not spread the disease,” said Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) . “Despite lacking scientific basis, the administration bought into this CDC claim and misled the American public. As a result, vaccination coverage with other vaccines appears to have declined, I believe because of a growing distrust of information coming from our public health institutions.”  BACKGROUND :  The overall goal of this report is to understand why, with the extent of these resources, the HHS public relations campaign (Campaign) and the Biden-Harris administration’s response to the pandemic resulted in a collapse of trust in public health messaging.   Much of the scientific content directly featured in or alluded to in Campaign ads and other promotional material was drawn from CDC recommendations, guidance, and research, critical parts of which proved to be deeply flawed. The CDC’s errors and failures to update recommendations and guidance were reflected in the “We Can Do This” ads and promotional materials:  CDC’s guidance, which the Campaign relied on, went beyond the terms of FDA’s Emergency Use Authorization (EUA) to state, without evidence, that COVID vaccines were highly effective against transmission. This ultimately had a negative impact on vaccine confidence and the CDC’s credibility when proven untrue.   The CDC had inconsistent and flawed messaging about the effectiveness of masks.  The CDC consistently overstated the risk of COVID-19 to children. The CDC continues to recommend COVID-19 vaccines for all Americans ages six months and older, which has made the United States a global outlier in COVID-19 policy.  RECOMMENDATIONS :  Americans cannot afford another botched government response to a future pandemic. To prevent a recurrence of HHS’s failures in public relations management for the COVID-19 pandemic response and to strengthen the nation’s public health preparedness system, the Committee makes the following recommendations:  Congress should consider formally authorizing the CDC and clearly define the agency’s core mission.  HHS and its agencies should abide by the FDA’s product labeling guidelines. HHS and its agencies should be barred from promoting information regarding an FDA-regulated product that does not reflect the FDA-approved label. Congress should consider clarifying responsibility for evaluating the safety of vaccines and streamline existing reporting systems for capturing vaccine injuries and adverse reactions. HHS and its agencies should embrace a culture of transparency and accountability. The CDC and federal public health officials should not attempt to silence dissenting scientific opinions. HHS and its agencies should overhaul their website archival process to mimic that of prior White House administrations. CLICK HERE to read the full report and complete list of recommendations. 

More than a decade has lapsed since the GAO’s last review Washington, D.C. —  In a new letter to the U.S. Government Accountability Office (GAO), bipartisan Energy and Commerce Leaders are requesting that the GAO conduct an extensive review of the Department of Energy’s (DOE) Isotope Program. Led by Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ) as well as Subcommittee on Energy, Climate, and Grid Security Chair Jeff Duncan (R-SC) and Ranking Member Diana DeGette (D-CO), the letter addresses concerns regarding U.S. dependence on Russia for isotopes and other materials critical to American national security, advanced manufacturing, and medicine, especially following Russia’s invasion of Ukraine. KEY LETTER EXCERPT: “The DOE Isotope Program has been working for at least a decade to shore up domestic isotope development and free the United States from a position of dependence, but its progress in doing so is unclear. Current U.S. production still has not replaced our reliance on Russia and possibly other high-risk countries, and several proposed DOE facilities conceived as major contributors to the U.S. domestic supply chain remain in the design phase or, at best, under construction (chief among these is Oak Ridge’s Stable Isotope Production and Research Center, or SIPRC, which is reportedly not expected to start production until 2032). These dynamics raise serious questions and concerns about the security of the U.S. supply chain for these critical isotopes.” BACKGROUND: The DOE’s Isotope Program produces and sells hundreds of high priority isotopes that are rare—but essential—for the production of important commodities in national security, advanced manufacturing, and medicine.  The DOE is often the only, or one of very few, global producers of such isotopes, which are in short supply or represent a supply chain risk. However, the United States still relies on obtaining several materials and commercially produced isotopes from other, sometimes adversarial countries, such as Russia.  The GAO last reviewed the DOE Isotope program in 2012 and has not conducted a review since Russia invaded Ukraine in 2022.  According to a 2022 testimony by the executive director of the Council on Radionuclides and Radiopharmaceuticals, the U.S. still relies nearly exclusively on Russia to obtain 44 isotopes that are critical in industrial applications and cancer treatment.  China has also emerged as a new global supplier of stable isotopes, positioning the U.S. for even further foreign reliance to keep Americans healthy and safe. CLICK HERE to read the full letter.

Committee investigation finds FDA failing to meet safety requirements and implement GAO recommendations Washington, D.C. — In a new letter to Department of Health and Human Services Inspector General Christi Grimm, Energy and Commerce Republicans requested an assessment of the adequacy of the U.S. Food and Drug Administration’s (FDA) support for the Office of Laboratory Safety (OLS). The letter, which comes after a long-standing investigation, is signed by Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA).  KEY LETTER QUOTE:   “We are deeply concerned that the FDA is not meeting important federal safety requirements to protect its employees and the public while also failing to prioritize scientific data quality delivered from FDA laboratories.” BACKGROUND: In July of 2014, an incident related to the discovery of boxes containing vials of smallpox virus and other hazardous biological agents in an FDA laboratory on the National Institutes of Health (NIH) campus served to increase overall safety awareness and leadership engagement in safety programs at the FDA. This led to the launch of the Office of Laboratory Science and Safety (OLSS), now called the Office of Laboratory Safety (OLS), at the FDA. However, the FDA’s course of conduct over the last few years calls into question the adequacy, appropriateness, and legality of the way FDA leadership has supported the OLS. During the 118th Congress, the Committee conducted oversight of the FDA’s laboratory safety program and identified the following concerns: Regarding centralized and independent oversight of its laboratories, the FDA is not complying with Occupational Safety and Health Administration (OSHA) requirements for annual inspections nor with the spirit of OSHA regulations regarding unannounced inspections.  The FDA still has not fully implemented and closed out the recommendations issued four years ago from the Government Accountability Office (GAO) related to the OLS.  The FDA may not be sufficiently supporting its laboratory safety program with adequate funding and resources.  The FDA may not be providing the OLS with the authority and visibility to promote safety.  CLICK HERE to read the letter. OUTLINE OF FDA’S SHORTCOMINGS AS STATED IN THE LETTER INCLUDE: Frequency of Laboratory Inspections and Unannounced Inspections by OLS OSHA has several requirements that apply to FDA oversight of laboratory safety. One of the OSHA regulations requires annual inspections of all laboratories, including sufficient unannounced inspections. The FDA’s August 21, 2023, response indicates that the FDA is not meeting OSHA requirements and best practices.  In its August 21, 2023, response, the FDA stated that “[b]eginning in 2022, OLS began annual inspections of a third of the FDA laboratories on a rotating basis.” In other words, the independent centralized oversight of the laboratories by OLS occurs every three years, not annually. The FDA centers conduct inspections of their own labs in the other two years. However, the FDA inspection surveys produced by the Department of Health and Human Services (HHS) show that OLS inspections make significantly more findings than the FDA center inspections. For example, the Center for Drug Evaluation and Research reported only one finding in 2020 and reported no findings in 2021. In contrast, OLS conducted an inspection in March of 2023 of a Center for Drug Evaluation and Research (CDER) facility and made 19 non-conforming findings. However, OSHA requires annual inspections of all laboratories. According to OSHA regulation 29 CFR 1960.25(c), “[a]ll areas and operations of each workplace, including office operations, shall be inspected at least annually.” The OLSS 2017-2018 Progress Report stated: “FDA is required to comply with Title 21 USC [U.S. Code] and 29 CFR 1960.25 and 1960.26 requirements for conducting annual inspections.” The same report stated: “FDA committed to conducting annual audits to the House Energy and Commerce Committee and GAO to prevent incidents such as the Variola [smallpox] discovery.” The OSHA regulation further states, “Sufficient unannounced inspections and unannounced follow-up inspections should be conducted by the agency to ensure the identification and abatement of hazardous conditions.” To what extent is FDA addressing the GAO recommendations on laboratory safety? In September of 2020, the GAO issued a report on the FDA’s OLS and made five recommendations , including to resolve disagreements over roles and responsibilities, to provide OLS with the authority and access to facilities necessary to oversee laboratory safety, and to take steps to assess and mitigate any independence risks posed by how OLS is funded. HHS agreed with all five recommendations.  According to the GAO website, none of the five recommendations have been fully addressed. In a July 14, 2022, meeting with Chair Rodgers (at the time serving as Committee Republican Leader), FDA Commissioner Robert Califf committed to her that these recommendations would be closed. Our May 24, 2023, letter asked the FDA to respond specifically on the status of each of the five recommendations. The FDA’s response did not directly answer our questions and failed to show that the agency has fully implemented the GAO recommendations.  Is FDA sufficiently supporting its laboratory safety program? Information obtained through the Committee’s oversight raises questions about the adequacy of FDA’s funding and staffing for OLS, especially compared to those of Centers for Disease Control and Prevention (CDC) and NIH. In an August 21, 2023, letter to the Committee, the FDA reported the following about funding and staffing of OLS: With respect to funding, the FDA has worked to reduce OLS’ reliance on funding from the Centers, but receiving such funding has not hindered OLS’ independence in implementing an effective safety program. OLS’ total budget for the current fiscal year is $7.9 million, which includes $5.5 million in appropriations from Congress (compared to an appropriations request of $6.6 million) and additional funding from the FDA to help support preexisting staffing and programs. With respect to historical OLS funding requests and appropriations:  • In FY2019, the FDA requested $6 million for OLS. OLS received $1.5 million in appropriations from Congress. This was an increase of $1.5 million over FY2018 budget authority.  • In FY2020, the FDA requested $4 million for OLS, which is an additional $2.5 million from FY2019 appropriations. OLS received $2.5 million in FY2020 appropriations from Congress. This was an increase of $1.0 million over FY2019 budget authority.  • In FY2021, the FDA requested $2.5 million for OLS. OLS received $2.5 million in FY2021 appropriations from Congress. There was no increase from the FY2020 budget authority.  • In FY2022, the FDA requested $9.1 million for OLS, which is an additional $6.6 million from FY2021 appropriations. OLS received $4.0 million in FY2022 appropriations from Congress. This was an increase of $1.5 million over FY2021 budget authority.  OLS currently has 19 full-time equivalent employees (FTEs), as well as contract support and cross-cutting support within the Agency. These employees are dedicated to the OLS mission and work on a variety of matters, including, but not limited to occupational safety and health, environmental safety, industrial hygiene, radiation safety, and biosafety.  However, the CDC and the NIH provide more staffing and resources for more laboratory spaces, with all of them subject to annual inspection and unannounced inspections.  In a November 9, 2023, letter to the Committee, the CDC reported that the CDC Office of Laboratory Science and Safety had total funding of $23 million with 82 FTEs. CDC inspects about 2100 lab spaces annually.  In a June 2024 briefing to Committee staff, the NIH gave an estimate of $117 million supporting NIH laboratory safety activities. The breakdown includes the following service programs: Division of Occupational Health & Safety ($35.3 million), Division of Radiation Safety ($8.8 million), Division of Emergency Management ($5.7 million), the Fire Marshall ($2.9 million), Division of Fire and Rescue Services ($7.4 million), and Police ($56.7 million). The NIH reported 65 full-time equivalents (FTEs) and 100 contractors allocated for laboratory safety. All 5,000 lab spaces are inspected annually.  Is FDA providing the OLS with the authority and visibility to promote safety? Currently, the FDA Designated Agency Safety and Health Official ( DASHO) is the Director of OLS, a position at least two levels below the assistant secretary level since the Director reports to the Chief Scientist. Federal regulation 29 C.F.R. § 1960.6, published in 1980, requires that the DASHO be located at the assistant secretary or equivalent position, and have sufficient authority and responsibility to effectively represent the Commissioner in managing the FDA’s laboratory safety program. Further, the regulation states that headquarters staff should report directly, or have appropriate access to the DASHO. The current reporting structure contrasts with how the CDC prioritized this reporting relationship, and to past FDA actions and commitments. In July of 2015, the External Laboratory Safety Working Group (ELSW) for laboratory safety improvements at the FDA included a recommendation that the FDA make leadership changes, including hiring a Director of Laboratory Science and Safety with a direct reporting line to the Commissioner. In response to a question on whether the FDA would commit to having the Director of Lab Safety report directly to the Commissioner, the FDA wrote in a September 9, 2016, letter to the Committee: “To support FDA with this critical mission, FDA will realign OLSS such that the Director of OLSS will report directly to the Commissioner.” The establishment of OLSS and its realignment as a direct report to the Commissioner was done through an extensive process over two administrations and formal notice in the Federal Register. According to a June 29, 2017, memorandum from then-FDA Commissioner Scott Gottlieb to then HHS Secretary Thomas Price, in response to this recommendation and advice from an FDA work group, the FDA hired a director of laboratory science and safety in October of 2015. His memorandum stated the OLSS director initially reported to FDA’s Chief Scientist, but after internal deliberation—prompted in part by an oversight letter from Congress—the FDA determined in 2016 that the OLSS director should report directly to the Commissioner. Dr. Gottlieb noted: “This realignment emphasizes [the OLSS Director’s] role in centralizing laboratory science and safety activities, and better enables him to create a culture of responsibility, safety, and accountability across all FDA labs and centers. It is also consistent with sister agency organizational structures and the External Laboratory Safety Workgroup (ELSW) recommendation for direct reporting.” At that time, the Director of OLSS directly reported to the FDA commissioner. In 2018, the FDA again realigned OLSS. Without any formal notice in the Federal Register, the direct-report alignment was reversed during a 2018 Office of Commissioner reorganization. This reversal was purportedly based on a McKinsey consulting report, but the FDA would not produce to the Committee any documentation from the McKinsey report to support the realignment of the OLSS office and placing it back in the Office of Chief Scientist (OCS). In a December 10, 2018, letter from the FDA to the bipartisan committee leadership about OLS, FDA stated: Prior to initiating this action, FDA contracted with a third-party consultant [McKinsey] to conduct a broad, high-level assessment of the Office of the Commissioner (OC). While this contract did not require submission of a final report, the consultants helped in gathering perspectives throughout the Agency. This effort resulted in a formal reorganization package subsequently submitted to HHS for approval. One of the outcomes of the assessment was to realign most of the OLSS functions under the Chief Scientist while moving certain non-laboratory related functions from OLSS to the Office of Operations.  In anticipation of the proposed changes, the Director of OLSS began conditionally reporting to the Chief Scientist in March 2018. The FDA further defended the reorganization stating:  Since then [July 2017], we have had a greater opportunity to observe and evaluate the functions of the office and have determined that laboratory safety would be best served by OCS providing day-to-day leadership [...] This decision was one of many strategic realignments proposed by FDA leadership, based in part on input from the third-party evaluator.  However, as the FDA later noted in a June 28, 2019, email to Committee staff, there was no documented justification for the realignment and renaming of OLS stating, “the requested documents [McKinsey report] pertain to the reorganization in general (and not specifically to OLS), the interview synthesis does not reference OLS at all, and there are very minimal references to OLS in the justification memos (i.e., stating that OLS will be realigned into OCS).” The FDA also did not provide any documentation to support its observation and evaluation that led the FDA to conclude in about eight months that OLSS needed to be downsized and sent back to the Office of Chief Scientist.