Regulation and Deregulation of Industry

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      From AI to Musk’s Brain Chip, the F.D.A.’s Device Unit Faces Rapid Change

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      The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology.There are now artificial intelligence programs that scan M.R.I.s for signs of cancer, Apple AirPods that work as hearing aids and devices that decode the electrical blips of the brain to restore speech to those who have lost it.Medical device technology is now deeply entrenched in many patients’ health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration.Dr. Michelle Tarver, a 15-year-veteran of the agency, is stepping into that spotlight at a critical time. She is taking the reins of the F.D.A.’s device division from Dr. Jeffrey Shuren, who forged deep ties with the device industry, sped up the pace of approvals and made the agency more approachable to companies. Some of those device makers were represented by Dr. Shuren’s wife and her law firm, posing ethical conflicts for him that continue to draw scrutiny.Dr. Michelle Tarver, an ophthalmologist and a 15-year veteran of the F.D.A.’s medical device division.U.S. Food and Drug AdministrationMore broadly, congressional lawmakers and consumer advocates have become increasingly concerned about the device industry’s influence over the sprawling division, which has a budget of about $790 million and a staff of 2,500. Device safety and standards for agency approvals of products as intimate as heart valves or neural implants will be at the forefront of the division’s mission in the coming years. Among the issues Dr. Tarver will encounter:Brains, computers and Elon MuskFew devices will require such intense oversight as one of the most breathtaking technologies in development: brain-computer interfaces that dip into the surface layers of the brain to decode its electrical noise — and return function to people who have lost it.Researchers from a number of teams have demonstrated the capability to restore the voice and speech of a California man with ALS, to enable a paralyzed man to walk and to help a man who is paralyzed below the neck to play Mario Kart by simply thinking about steering left or right.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Why a Memphis Community Is Fighting Elon Musk’s Supercomputer

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      Residents say Mr. Musk’s data center for artificial intelligence is compounding their pollution burden and adding stress on the local electrical grid.Elon Musk, the world’s richest man, is building what he says will be the world’s largest supercomputer. Its electricity needs will rival those of 100,000 homes.The supercomputer’s neighbors in southwest Memphis have a problem with that.The project, part of Mr. Musk’s xAI artificial intelligence business, sits in an old manufacturing plant on more than 550 acres. Before beginning operations there in July, xAI rolled in flatbed trucks loaded with almost 20 mobile power plants, fueled by natural gas, to help meet its electricity demands.Residents of the heavily industrial community — already home to an oil refinery, a steel mill and chemical plants — see no upside. They contend that Mr. Musk’s project has made pollution worse in an area already enveloped in smog.“We’re getting more and more days a year where it is unhealthy for us to go outside,” said KeShaun Pearson, president of Memphis Community Against Pollution and a lifelong resident of the area near the xAI site.The xAI supercomputer center in Memphis is being built at the site of a former appliance factory.Whitten Sabbatini for The New York TimesThe center is to be used to train artificial intelligence models on thousands of powerful computer servers.Whitten Sabbatini for The New York TimesSo far, xAI is using the Memphis facility to develop its artificial intelligence models on a network of thousands of high-powered computer servers. Some of its models are trained on data from Mr. Musk’s social media platform, X.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      How a Tiny Panel, Up for Election, Could Steer Arizona Away From Clean Power

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      The vote, in a sunny state with huge solar potential, reflects a growing nationwide fight over America’s energy transition.As Arizona voters go the polls, they have more control over their state’s power plants and climate policies than they might realize.This year three of the five seats are up for grabs on the Arizona Corporation Commission, which regulates electric utilities. The commission has authority over how electricity is generated, among other things, and what customers pay.In recent years, it has taken steps toward rolling back a clean-energy mandate passed by a previous Republican-led board. It has also made it harder to build community solar in a state renowned for its sunniness, its critics say, and easier to build new fossil-fuel-burning power plants.These boards exist in states nationwide, and while most are appointed, similarly contentious races playing out in states like Louisiana and Montana, where they’re debating the future of coal power, which is particularly dirty, and what role natural gas, another fossil fuel, should have.“It’s a fourth branch of government that nobody knows about who’s in your pocket every day,” said Robert Burns, a Republican who served on Arizona’s commission for eight years.Starting two decades ago, the Republican-controlled commission had encouraged a transition to renewable energy based on simple economics: Renewables were getting cheaper than fossil fuels. It initially required utilities it regulates to become 15-percent renewable by 2025 and later, during Mr. Burns’s tenure, he sought to eliminate greenhouse-gas emissions from power plants by 2050.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      ‘No Smoking’ Sign on Planes Won’t Need Off Switch After FAA Rule Change

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      The Federal Aviation Administration did away with a rule that had required an off switch for the sign even though smoking on U.S. flights ended years ago.The days of airplane cabins hazy with cigarette smoke are long gone, but a reminder of that era is still visible inside commercial jets.Smoking has been banned on commercial flights in the United States for decades, but the Federal Aviation Administration is only just updating an outdated rule to reflect that reality. Starting on Tuesday, the illuminated overhead “No Smoking” sign no longer requires an off switch.That obsolete requirement had become “time-consuming and burdensome” for airlines and airplane manufacturers to comply with, the F.A.A. said in a rule enacting the change. In February, for example, United Airlines was briefly unable to use a handful of new Airbus planes because the “No Smoking” signs on board couldn’t be shut off, causing the airline to delay a few flights. The issue was resolved after the F.A.A. granted United an exemption.Dozens of such exemptions have allowed that requirement to live on while the agency focused on more pressing matters. But the long life of the mandate also reflects how entangled smoking once was with commercial flights, which began in the 1910s.“The rise of aviation literally parallels the rise of the cigarette,” said Alan Blum, the director of the University of Alabama’s Center for the Study of Tobacco and Society.Pipes, cigars and chewing tobacco were once more popular than cigarettes, but that began to change in the early 20th century, according to Dr. Blum. During World War I, cigarettes were added to rations for American soldiers fighting abroad.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      American Business Cannot Afford to Risk Another Trump Presidency

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      Throughout American history, business leaders have been able to assume that an American president of either party would uphold the rule of law, defend property rights and respect the independence of the courts. Implicit in that assumption is a fundamental belief that the country’s ethos meant their enterprises and the U.S. economy could thrive, no matter who won. They could keep their distance from the rough-and-tumble of campaign politics. No matter who won, they could pursue long-term plans and investments with confidence in America’s political stability.In this election, American business leaders cannot afford to stand passive and silent.Donald Trump and his Democratic opponent, Vice President Kamala Harris, have sketched out versions of their parties’ traditional positions on issues like taxation, trade and regulation that are well within the give-and-take of politics. In this election, however, stability itself is also at stake.Mr. Trump denies the legitimacy of elections, defies constitutional limits on presidential power and boasts of plans to punish his enemies. And in these attacks on America’s democracy, he is also attacking the foundations of American prosperity. Voting on narrow policy concerns would reflect a catastrophically nearsighted view of the interests of American business.Some prominent corporate leaders — including Elon Musk, a founder of Tesla; the investors David Sacks and Bill Ackman; and the financier Stephen Schwarzman — have been supportive of Mr. Trump’s candidacy. Beyond pure cynicism, it’s nearly impossible to understand why.Business leaders, of course, may be skeptical of Ms. Harris’s policies, uneasy because they don’t feel they know enough about how she would govern or worried that she may not be open to hearing their concerns — a frequent criticism of the Biden administration. They may be reluctant to offend or alienate employees, customers or suppliers who have different political views. Most of all, they may be afraid of angering Mr. Trump, who has a long track record of using the levers of power to reward loyalty.They should be more afraid of the consequences if he prevails.This week Donald Trump provided a stark reminder that this election is different. In remarks that ought to alarm any American committed to the survival of our democratic experiment, the Republican nominee again refused to commit to accepting the results of the 2024 election. That comes on the heels of remarks in which he declared that he regards his political opponents as an “enemy from within” and that he would consider deploying the military against them merely for opposing his bid for the presidency. The implication is that participation in the democratic process is treason, and the threat is a fresh indication that if he is elected to a second term, Mr. Trump intends to deploy government power in new and dangerous ways.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Tesla Self-Driving System Will Be Investigated by Safety Agency

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      The National Highway Transportation Safety Administration said it was looking into what Elon Musk’s electric car company called the full self-driving system.Tesla’s plan to build fleets of self-driving cars suffered a setback on Friday when the main federal auto safety regulator said it was investigating whether the technology was to blame for four collisions, including one that killed a pedestrian.The regulator, the National Highway Transportation Safety Administration, said it was examining whether the software, which Tesla calls supervised full self-driving, had safeguards in place to require drivers to retake control of their cars in situations the autonomous technology could not handle on its own.As sales of Tesla’s electric cars have slowed, Elon Musk, the company’s chief executive, has staked the company’s future on software that allows cars to navigate, steer and brake without human supervision. Last week, the company held an event at the Warner Bros. studios near Los Angeles to unveil what it called a cybercab, which Mr. Musk promised would be able to ferry passengers without a human driver.But such software has faced persistent criticism from regulators and safety experts who say it does not do enough to make sure drivers remain alert and ready to take over if the system makes a mistake. Tesla faces numerous lawsuits from people who blame the software for injuries or deaths of loved ones.Tesla did not respond to a request for comment.The crashes highlighted by the safety agency on Friday took place when road visibility may have been limited by glare from the sun, fog or dust, the federal safety agency said. Tesla’s self-driving software depends on cameras to operate, unlike other manufacturers who also use radar or laser technology that are often better at detecting objects and people when the view is obscured by poor weather or bright sunshine.The agency said it would “examine the system’s potential failure to detect and disengage in specific situations where it cannot adequately operate.”In one of the collisions, a pedestrian died. In another, a person was injured, the agency said.The investigation covers 2.4 million Tesla vehicles, including cars manufactured as far back as 2016. All of Tesla’s passenger models are involved, the agency said, including the Model 3 and Model S sedans, the Model X and Model Y sport utility vehicles, and the Cybertruck.Federal officials have also been investigating a less capable Tesla system known as Autopilot for several years. These investigations may not survive if former President Donald J. Trump is elected next month. Mr. Trump has said he will appoint Mr. Musk, one of his most prominent supporters in the business world, to lead a “government efficiency commission.” More

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      U.S. Outlines Google Search Changes It’s Weighing in Antitrust Case

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      They include making Google’s data available to rivals and forcing it to break off parts of the company, the Justice Department said in a court filing.The Justice Department said Tuesday night that it was considering asking a federal court to force Google to break off parts of the company or change its practices in order to eliminate its monopoly in search, moves that could redefine the $2 trillion company’s core business.In a filing, the government said it could ask the court to require Google to make the underlying data that powers its search engine available to competitors.It said it was considering asking for “structural” changes to Google to stop the company from leveraging the power of its Chrome browser, Android operating system or Play app store to benefit its search business. But it stopped short of identifying what those changes could be.“Google’s anticompetitive conduct resulted in interlocking and pernicious harms that present unprecedented complexities in a highly evolving set of markets,” the government said in its filing in the U.S. District Court for the District of Columbia. “These markets are indispensable to the lives of all Americans, whether as individuals or as business owners, and the importance of effectively unfettering these markets and restoring competition cannot be overstated.”Lee-Anne Mulholland, Google’s vice president of regulatory affairs, said in a blog post in response to the filing that the company was concerned the Justice Department was “already signaling requests that go far beyond the specific legal issues in this case.”In a landmark ruling in August, a judge on that court, Amit P. Mehta, said Google “is a monopolist, and it has acted as one to maintain its monopoly.” It crossed a line when it paid companies like Apple and Samsung billions of dollars to be the automatic search engine in web browsers and on smartphones, Judge Mehta ruled in the case, U.S. et al. v. Google.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Biden to Sign Bill Allowing Chip Projects to Skirt Key Environmental Review

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      The legislation, which would weaken federal environmental reviews for certain semiconductor manufacturing projects, has divided Democrats.More than two years ago, President Biden signed a law that aimed to ramp up the nation’s production of semiconductors by offering generous subsidies and tax credits to companies. Since then, chip manufacturers have invested billions of dollars into new plants across the country.But industry groups, along with federal officials, have long warned that lengthy federal environmental reviews could delay manufacturing projects for months or years, which could slow the country’s ability to scale up its chip manufacturing capacity.In the coming days, Mr. Biden is set to sign a bill that would weaken federal environmental reviews for certain semiconductor manufacturing projects that receive subsidies through the 2022 CHIPS and Science Act. The bill, which has divided Democrats, underscores the challenges facing Mr. Biden as he tries to advance his economic agenda alongside his ambitious climate goals.The legislation would exempt qualifying chip projects from reviews under the National Environmental Policy Act, or NEPA, which requires federal agencies to assess the potential environmental effects of proposed major federal actions before they can proceed. The House passed the bill last week, and the Senate unanimously passed it in December.Proponents say the legislation would help to expedite the construction of chip manufacturing facilities, which would strengthen the U.S. economy and help to reduce the nation’s dependence on other countries for critical chips that can power items as varied as smartphones, cars and weapons systems. They say that projects will still have to comply with various federal, state and local environmental regulations and permitting requirements.Democrats who oppose the bill, however, say it would allow companies to skirt an important step aimed at reducing potential harms to the environment and workers. They argue that taxpayer-funded projects should be subject to a more holistic federal environmental review process, which would allow for more transparency and community input.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More