npr--2020-12-17--In Historic Move, Biden To Pick Native American Rep. Haaland As Interior Secretary

In Historic Move , Biden To Pick Native American Rep. Haaland As Interior Secretary In a historic first , President-elect Joe Biden will nominate Rep. Deb Haaland to lead the Department of the Interior , his transition team announced Thursday evening .
If confirmed by the Senate , Haaland , a member of the Laguna Pueblo in New Mexico , would be the country 's first Native American Cabinet secretary .
Fittingly , she 'd do so as head of the agency responsible for not only managing the nation 's public lands but also honoring its treaties with the Indigenous @ @ @ @ @ @ @ .
In a statement , the Biden-Harris transition team called Haaland a `` barrier-breaking public servant who has spent her career fighting for families , including in Tribal Nations , rural communities , and communities of color , '' who will be `` ready on day one to protect our environment and fight for a clean energy future . ''
In a tweet , Haaland acknowledged the unique `` voice '' she 'll bring .
`` Growing up in my mother 's Pueblo household made me fierce , '' she wrote .
`` @ @ @ @ @ @ @ us , our planet , and all of our protected land . ''
`` She understands at a very real level — at a generational level , in her case going back 30 generations — what it is to care for American lands , '' says Aaron Weiss , deputy director of the Center for Western Priorities .
Haaland 's nomination is a win for tribal governments , environmental groups and some progressive lawmakers who had been lobbying for the New Mexico lawmaker to lead the Department of the Interior .
Her fellow @ @ @ @ @ @ @ Interior candidate , Rep. Raúl Grijalva , D-Ariz. , wrote a letter to the Congressional Hispanic Caucus recommending Haaland for the post .
`` It is well past time that an Indigenous person brings history full circle at the Department of Interior , '' he wrote .
It 's not the first time Haaland has made history .
In 2018 , she became one of the first two Native women in Congress , alongside Rep. Sharice Davids of Kansas .
The Interior Department upholds the federal government 's responsibilities to the country 's @ @ @ @ @ @ @ Native villages .
Its roughly 70,000-person staff also oversees one-fifth of all the land in the U.S. as well as 1.7 billion acres of the country 's coasts .
It manages national parks , wildlife refuges and other public lands , protecting biologically and culturally important sites while also shepherding natural resource development .
The Biden administration is expected to take a much different approach to natural resources than its predecessor , which championed oil and gas development above all else on federal lands .
Biden has promised to shift the U.S. away @ @ @ @ @ @ @ sources such as wind and solar .
In an interview before her nomination , Haaland told NPR that would be her priority , too .
`` Climate change is the challenge of our lifetime , and it 's imperative that we invest in an equitable , renewable energy economy , '' she said .
A shift in priorities at Interior could have major implications for global climate change and the United States ' outsized contribution to it .
About one-quarter of all U.S. carbon emissions come from fossil fuels extracted on public lands @ @ @ @ @ @ @ .
That includes emissions from drilling , transporting and refining those fossil fuels before they 're burned .
Haaland 's experience as a lawmaker in fossil fuel-dependent New Mexico , and as the former head of the state 's Democratic Party , leaves her well-positioned to navigate that transition , environmental advocates say .
The state has one of the most aggressive climate plans in the country .
`` You have to understand the complexity of public lands management , '' says Demis Foster , executive director of Conservation Voters New Mexico .
@ @ @ @ @ @ @ better representation of that than here in New Mexico .
We have a vast network of public lands .
We have extraordinary biodiversity , and we have a very unique cultural heritage . ''
State lawmakers also have to balance that , she says , with the `` extraordinary force and influence of extractive industry . ''
The New Mexico Oil & Gas Association called on Haaland to take a `` balanced approach . ''
`` Responsible energy development on federal lands is a vital part of our state 's economy , '' @ @ @ @ @ @ @ `` The policies enacted by the next Interior Secretary , '' it said , `` will determine how much or little our state is able to support critical needs like public schools , healthcare , and first responders . ''
Mike Sommers , chief executive of the American Petroleum Institute , said in a statement that oil and gas resources `` will be critical to rebuilding our economy and maintaining America 's status as a global energy leader . ''
Haaland has echoed Biden in saying that a transition to renewable energy is @ @ @ @ @ @ @ a no-brainer during the economic uncertainty spurred by the ongoing coronavirus pandemic .
She 's also sponsored a House bill that would set a national goal of protecting 30 % of U.S. lands and oceans by 2030 , a plan the Biden administration has adopted and made a priority for his environmental agenda .
`` That would protect our wildlife and boost the restoration economy , '' Haaland said , and `` undo some of the damage that this Trump administration has done to our environment . ''
The Biden administration has promised @ @ @ @ @ @ @ undertaken over the past four years , and Interior will play a key role .
President Trump leaned on the agency to help push his broader `` energy dominance '' agenda .
The agency 's current leader , Secretary David Bernhardt , is a former oil and energy lobbyist .
His predecessor , Ryan Zinke , a former congressman from Montana , resigned amid numerous ethics investigations .
Under their leadership , national monuments were cleaved , opening up millions of acres of formally protected land to development .
Millions of acres more @ @ @ @ @ @ @ available for oil and gas leasing .
Regulations were rolled back on methane emissions and imperiled species protections , among others .
Haaland was a vocal critic of many of those moves .
As chair of a House Natural Resources subcommittee that oversees Interior , she has led hearings on everything from the Trump administration 's handling of national park reopenings during the coronavirus pandemic to its treaty-obligated communications with tribal governments for projects that affect their lands .
`` Tribal consultation is basically nonexistent during this Trump administration , '' Haaland said @ @ @ @ @ @ @ consult with tribes , which I think will help immensely with some of the environmental issues that he wants to address . ''
The Intergovernmental Panel on Climate Change found that Indigenous people are disproportionately vulnerable to climate change in the United States .
Alaska Native villagers and a Native American community in south Louisiana are among the first climate refugees in the country .
Both are being relocated due to rising seas .
Indigenous people are also disproportionately affected by environmental pollution , says Kandi White , the Native energy and climate @ @ @ @ @ @ @ .
`` Fossil fuel development , uranium development , clear-cutting of forests — all these things that have been happening on tribal lands were exacerbated under the [ Trump ] administration and need to be looked at , '' she says .
As a member of the Mandan , Hidatsa and Arikara Nation in North Dakota , White says , she 's seen the effects of fracking and other development firsthand .
She thinks it will be impactful to have a Native American woman such as Haaland , who understands the complex government-to-government @ @ @ @ @ @ @ , leading the Department of the Interior .
`` She gets it , '' White says .

In Historic Move, Biden To Pick Native American Rep. Haaland As Interior Secretary
Enlarge this image toggle caption Juan Labreche/AP Juan Labreche/AP
Updated at 9:37 p.m. ET
In a historic first, President-elect Joe Biden will nominate Rep. Deb Haaland to lead the Department of the Interior, his transition team announced Thursday evening.
If confirmed by the Senate, Haaland, a member of the Laguna Pueblo in New Mexico, would be the country's first Native American Cabinet secretary. Fittingly, she'd do so as head of the agency responsible for not only managing the nation's public lands but also honoring its treaties with the Indigenous people from whom those lands were taken.
In a statement, the Biden-Harris transition team called Haaland a "barrier-breaking public servant who has spent her career fighting for families, including in Tribal Nations, rural communities, and communities of color," who will be "ready on day one to protect our environment and fight for a clean energy future."
In a tweet, Haaland acknowledged the unique "voice" she'll bring. "Growing up in my mother's Pueblo household made me fierce," she wrote. "I'll be fierce for all of us, our planet, and all of our protected land."
"She understands at a very real level — at a generational level, in her case going back 30 generations — what it is to care for American lands," says Aaron Weiss, deputy director of the Center for Western Priorities.
Haaland's nomination is a win for tribal governments, environmental groups and some progressive lawmakers who had been lobbying for the New Mexico lawmaker to lead the Department of the Interior. Her fellow House Natural Resources Committee member and rumored Interior candidate, Rep. Raúl Grijalva, D-Ariz., wrote a letter to the Congressional Hispanic Caucus recommending Haaland for the post.
"It is well past time that an Indigenous person brings history full circle at the Department of Interior," he wrote.
It's not the first time Haaland has made history. In 2018, she became one of the first two Native women in Congress, alongside Rep. Sharice Davids of Kansas.
The Interior Department upholds the federal government's responsibilities to the country's 574 federally recognized Indian tribes and Alaska Native villages. Its roughly 70,000-person staff also oversees one-fifth of all the land in the U.S. as well as 1.7 billion acres of the country's coasts. It manages national parks, wildlife refuges and other public lands, protecting biologically and culturally important sites while also shepherding natural resource development.
The Biden administration is expected to take a much different approach to natural resources than its predecessor, which championed oil and gas development above all else on federal lands. Biden has promised to shift the U.S. away from climate-warming fossil fuels toward renewable energy sources such as wind and solar.
In an interview before her nomination, Haaland told NPR that would be her priority, too.
"Climate change is the challenge of our lifetime, and it's imperative that we invest in an equitable, renewable energy economy," she said.
A shift in priorities at Interior could have major implications for global climate change and the United States' outsized contribution to it. About one-quarter of all U.S. carbon emissions come from fossil fuels extracted on public lands, according to the U.S. Geological Survey. That includes emissions from drilling, transporting and refining those fossil fuels before they're burned.
Haaland's experience as a lawmaker in fossil fuel-dependent New Mexico, and as the former head of the state's Democratic Party, leaves her well-positioned to navigate that transition, environmental advocates say. The state has one of the most aggressive climate plans in the country.
"You have to understand the complexity of public lands management," says Demis Foster, executive director of Conservation Voters New Mexico. "And I can't imagine a better representation of that than here in New Mexico. We have a vast network of public lands. We have extraordinary biodiversity, and we have a very unique cultural heritage."
State lawmakers also have to balance that, she says, with the "extraordinary force and influence of extractive industry."
The New Mexico Oil & Gas Association called on Haaland to take a "balanced approach."
"Responsible energy development on federal lands is a vital part of our state's economy," the group said in a statement. "The policies enacted by the next Interior Secretary," it said, "will determine how much or little our state is able to support critical needs like public schools, healthcare, and first responders."
Mike Sommers, chief executive of the American Petroleum Institute, said in a statement that oil and gas resources "will be critical to rebuilding our economy and maintaining America's status as a global energy leader."
Haaland has echoed Biden in saying that a transition to renewable energy is a job creator, which makes it a no-brainer during the economic uncertainty spurred by the ongoing coronavirus pandemic.
She's also sponsored a House bill that would set a national goal of protecting 30% of U.S. lands and oceans by 2030, a plan the Biden administration has adopted and made a priority for his environmental agenda.
"That would protect our wildlife and boost the restoration economy," Haaland said, and "undo some of the damage that this Trump administration has done to our environment."
The Biden administration has promised to undo a number of environmental rollbacks undertaken over the past four years, and Interior will play a key role.
President Trump leaned on the agency to help push his broader "energy dominance" agenda. The agency's current leader, Secretary David Bernhardt, is a former oil and energy lobbyist. His predecessor, Ryan Zinke, a former congressman from Montana, resigned amid numerous ethics investigations.
Under their leadership, national monuments were cleaved, opening up millions of acres of formally protected land to development. Millions of acres more — onshore and offshore — were made available for oil and gas leasing. Regulations were rolled back on methane emissions and imperiled species protections, among others.
Haaland was a vocal critic of many of those moves. As chair of a House Natural Resources subcommittee that oversees Interior, she has led hearings on everything from the Trump administration's handling of national park reopenings during the coronavirus pandemic to its treaty-obligated communications with tribal governments for projects that affect their lands.
"Tribal consultation is basically nonexistent during this Trump administration," Haaland said. "President-elect Biden has promised to consult with tribes, which I think will help immensely with some of the environmental issues that he wants to address."
The Intergovernmental Panel on Climate Change found that Indigenous people are disproportionately vulnerable to climate change in the United States. Alaska Native villagers and a Native American community in south Louisiana are among the first climate refugees in the country. Both are being relocated due to rising seas.
Indigenous people are also disproportionately affected by environmental pollution, says Kandi White, the Native energy and climate campaign director at the Indigenous Environmental Network.
"Fossil fuel development, uranium development, clear-cutting of forests — all these things that have been happening on tribal lands were exacerbated under the [Trump] administration and need to be looked at," she says.
As a member of the Mandan, Hidatsa and Arikara Nation in North Dakota, White says, she's seen the effects of fracking and other development firsthand.
She thinks it will be impactful to have a Native American woman such as Haaland, who understands the complex government-to-government relationship between Indigenous people and the U.S., leading the Department of the Interior.
"She gets it," White says.


npr--2020-12-17--Biden To Pick North Carolina Regulator Michael Regan To Lead EPA

President-elect Joe Biden will name Michael Regan , North Carolina 's environment secretary and a former EPA official , to lead the Environmental Protection Agency , according to a source familiar with the decision who spoke about private conversations on the basis of anonymity .
If confirmed by the Senate , Regan would be the first African American man to run the EPA .
He stands to inherit an agency that has been ground zero as the Trump administration rolled back climate and pollution regulations .
Biden has promised to make climate change a top priority , which would make @ @ @ @ @ @ @ player in the new administration .
The agency regulates pollution released by cars and trucks , industrial facilities , oil and gas wells , and power plants , and keeps track of U.S. emissions of carbon dioxide and other greenhouse gases that cause global warming .
Regan has been the secretary of the North Carolina Department of Environmental Quality since 2017 .
Before then , he worked on clean energy initiatives for the Environmental Defense Fund , a national environmental advocacy group .
If he is confirmed to lead the EPA , Regan @ @ @ @ @ @ @ spent much of his early career , working on air quality for nearly a decade under the Clinton and George W. Bush administrations .
`` Michael operates with the belief that really every North Carolinian deserves clean air and clean water , '' says Hawley Truax , director of the Southeast office of the Environmental Defense Fund , where Regan worked for about eight years .
Truax says Regan has also helped North Carolina address climate change .
`` Secretary Regan recognizes the very real threat that climate change poses to lives and @ @ @ @ @ @ @ During Michael 's tenure as head of the Department of Environmental Quality in North Carolina , the state has launched the most ambitious carbon reduction into clean energy plans in its history . ''
Global greenhouse gas emissions are still rising , and U.S. emissions are falling too slowly to avoid the most catastrophic effects of climate change .
People across the country are already suffering the effects of a hotter Earth .
The cost of hurricanes , floods , wildfires , heat waves and droughts has skyrocketed in recent years , exceeding @ @ @ @ @ @ @ years , according to the National Oceanic and Atmospheric Administration .
North Carolina has been affected by multiple hurricanes in recent years , including Hurricane Florence in 2018 .
Florence was a textbook example of the type of slow-moving , flood-inducing storm that is more likely as the Earth heats up .
It killed at least 40 people in North Carolina .
`` We 're looking forward to a Biden administration and an EPA that uses its resources to push aggressively on key issues like climate change , '' Regan told NPR in @ @ @ @ @ @ @ .
Regan also said that protecting drinking water and working for environmental justice should be priorities for the EPA under the Biden administration .
Poor people and people of color are disproportionately affected by both climate-driven disasters and air and water pollution .
Dominique Browning , the head of the national clean air advocacy group Moms Clean Air Force , reacted positively to the news that Regan might lead the EPA .
`` This nomination signals a high level of ambition for addressing issues of racial inequity in who breathes polluted air , @ @ @ @ @ @ @ us to climate safety , '' she wrote in an email .
During Regan 's tenure , North Carolina has been at the heart of a national fight over a long-lasting and potentially dangerous class of chemicals that have contaminated drinking water .
The chemicals , perfluoroalkyl substances or PFAS , include thousands of different formulations and are used in a wide variety of products .
When humans ingest PFAS , they can linger in tissue for the rest of a person 's life , earning them the nickname `` forever chemicals .
@ @ @ @ @ @ @ states and inside the federal government have grappled with how to regulate the use , release and cleanup of PFAS chemicals in drinking water .
Regan has led one of the most aggressive responses in the country .
Shortly after he took over environmental regulation in North Carolina , a PFAS variant known as GenX showed up in the water of the Cape Fear River .
The state reacted by cracking down on the company that released the chemical .
`` The agency took a position that agencies across the country , and @ @ @ @ @ @ @ '' says Geoff Gisler , an attorney with the Southern Environmental Law Center in North Carolina .
`` The key to dealing with these kinds of chemicals is stopping them where they start . ''
Gisler and his nonprofit environmental law group have represented local residents who rely on the contaminated river for drinking water and pushed Regan 's agency to move more quickly to prevent the chemical from being released into the water .
Gisler says that while the process could have moved faster , he is nonetheless impressed with how Regan @ @ @ @ @ @ @ `` The kinds of results that we expect to see over the next few years are the ones that often take decades to accomplish , '' Gisler says .
At the federal level , the EPA has been waiting for the results of studies about the health effects of PFAS for years and does not require companies that release the chemicals into the environment to stop doing so while safety research is conducted .
Regan will now be in charge of the agency 's approach to regulating such water contaminants .
`` We @ @ @ @ @ @ @ ] set clear , enforceable compliance levels for these harmful pollutants , '' Regan says .
At the EPA , Regan would also be in charge of many of the energy policies that dictate how much carbon dioxide the U.S. emits in the coming years .
Biden has promised to rejoin the Paris climate accord , from which the U.S. formally withdrew this fall , on the first day of his presidency .
Once the U.S. is back in the agreement , it will have a lot of catching up to do .
@ @ @ @ @ @ @ deal in 2015 , the federal government promised to reduce greenhouse gas emissions by about one-quarter by 2025 , compared with 2005 levels .
The U.S. is no longer on track to achieve that target after the Trump administration rolled back limits on emissions from cars and trucks , power plants and fossil fuel facilities , and loosened efficiency standards for household appliances .
And , scientists warn , even if the U.S. were on track , the original emissions target was too weak to avoid catastrophic warming .
`` Regan will take @ @ @ @ @ @ @ most critical moment in the agency 's history , '' Kierán Suckling of the anti-pollution group Center for Biological Diversity wrote in an email .
As a result , rejoining the Paris Agreement will immediately put pressure on the new administration to find ways to cut greenhouse gas emissions dramatically .
That means the EPA leader will have to provide proof of ambitious climate action as the Biden administration works to convince other countries the U.S. is serious about avoiding runaway global warming .
A 2018 report from the Intergovernmental Panel on Climate @ @ @ @ @ @ @ about 50 % in the next decade to achieve that goal , which is inconceivable unless the U.S. drastically reduces its dependence on fossil fuels .
Regan said he believes the U.S. can reduce emissions dramatically by 2030 .
He helped negotiate a plan to reduce power plant emissions in North Carolina by 70 % in the next decade , and said he thinks the country as a whole could meet , or even exceed , a similar target .
`` We need a partnership to be established , a very strong partnership @ @ @ @ @ @ @ as the private sector , to chart these goals , '' Regan said .
`` We have a lot of work to do .
We 've lost four years . ''

Biden To Pick North Carolina Regulator Michael Regan To Lead EPA
Enlarge this image toggle caption North Carolina Department of Environmental Quality North Carolina Department of Environmental Quality
President-elect Joe Biden will name Michael Regan, North Carolina's environment secretary and a former EPA official, to lead the Environmental Protection Agency, according to a source familiar with the decision who spoke about private conversations on the basis of anonymity.
If confirmed by the Senate, Regan would be the first African American man to run the EPA. He stands to inherit an agency that has been ground zero as the Trump administration rolled back climate and pollution regulations.
Biden has promised to make climate change a top priority, which would make the head of the EPA a major player in the new administration. The agency regulates pollution released by cars and trucks, industrial facilities, oil and gas wells, and power plants, and keeps track of U.S. emissions of carbon dioxide and other greenhouse gases that cause global warming.
Regan has been the secretary of the North Carolina Department of Environmental Quality since 2017. Before then, he worked on clean energy initiatives for the Environmental Defense Fund, a national environmental advocacy group. If he is confirmed to lead the EPA, Regan would return to an agency where he spent much of his early career, working on air quality for nearly a decade under the Clinton and George W. Bush administrations.
"Michael operates with the belief that really every North Carolinian deserves clean air and clean water," says Hawley Truax, director of the Southeast office of the Environmental Defense Fund, where Regan worked for about eight years.
Truax says Regan has also helped North Carolina address climate change. "Secretary Regan recognizes the very real threat that climate change poses to lives and livelihoods," he says. "During Michael's tenure as head of the Department of Environmental Quality in North Carolina, the state has launched the most ambitious carbon reduction into clean energy plans in its history."
Global greenhouse gas emissions are still rising, and U.S. emissions are falling too slowly to avoid the most catastrophic effects of climate change. People across the country are already suffering the effects of a hotter Earth. The cost of hurricanes, floods, wildfires, heat waves and droughts has skyrocketed in recent years, exceeding $530 billion in the last five years, according to the National Oceanic and Atmospheric Administration.
North Carolina has been affected by multiple hurricanes in recent years, including Hurricane Florence in 2018. Florence was a textbook example of the type of slow-moving, flood-inducing storm that is more likely as the Earth heats up. It killed at least 40 people in North Carolina.
"We're looking forward to a Biden administration and an EPA that uses its resources to push aggressively on key issues like climate change," Regan told NPR in an interview before his appointment was announced.
Regan also said that protecting drinking water and working for environmental justice should be priorities for the EPA under the Biden administration.
Poor people and people of color are disproportionately affected by both climate-driven disasters and air and water pollution. Dominique Browning, the head of the national clean air advocacy group Moms Clean Air Force, reacted positively to the news that Regan might lead the EPA. "This nomination signals a high level of ambition for addressing issues of racial inequity in who breathes polluted air, and what can be done to get us to climate safety," she wrote in an email.
During Regan's tenure, North Carolina has been at the heart of a national fight over a long-lasting and potentially dangerous class of chemicals that have contaminated drinking water. The chemicals, perfluoroalkyl substances or PFAS, include thousands of different formulations and are used in a wide variety of products. When humans ingest PFAS, they can linger in tissue for the rest of a person's life, earning them the nickname "forever chemicals."
Regulators in more than a dozen states and inside the federal government have grappled with how to regulate the use, release and cleanup of PFAS chemicals in drinking water. Regan has led one of the most aggressive responses in the country. Shortly after he took over environmental regulation in North Carolina, a PFAS variant known as GenX showed up in the water of the Cape Fear River. The state reacted by cracking down on the company that released the chemical.
"The agency took a position that agencies across the country, and the EPA, should be taking," says Geoff Gisler, an attorney with the Southern Environmental Law Center in North Carolina. "The key to dealing with these kinds of chemicals is stopping them where they start."
Gisler and his nonprofit environmental law group have represented local residents who rely on the contaminated river for drinking water and pushed Regan's agency to move more quickly to prevent the chemical from being released into the water. Gisler says that while the process could have moved faster, he is nonetheless impressed with how Regan's office has handled the contamination.
"The kinds of results that we expect to see over the next few years are the ones that often take decades to accomplish," Gisler says.
At the federal level, the EPA has been waiting for the results of studies about the health effects of PFAS for years and does not require companies that release the chemicals into the environment to stop doing so while safety research is conducted. Regan will now be in charge of the agency's approach to regulating such water contaminants.
"We need EPA to step in [and] set clear, enforceable compliance levels for these harmful pollutants," Regan says.
At the EPA, Regan would also be in charge of many of the energy policies that dictate how much carbon dioxide the U.S. emits in the coming years. Biden has promised to rejoin the Paris climate accord, from which the U.S. formally withdrew this fall, on the first day of his presidency.
Once the U.S. is back in the agreement, it will have a lot of catching up to do. When the U.S. originally helped broker the deal in 2015, the federal government promised to reduce greenhouse gas emissions by about one-quarter by 2025, compared with 2005 levels. The U.S. is no longer on track to achieve that target after the Trump administration rolled back limits on emissions from cars and trucks, power plants and fossil fuel facilities, and loosened efficiency standards for household appliances.
And, scientists warn, even if the U.S. were on track, the original emissions target was too weak to avoid catastrophic warming.
"Regan will take the EPA's helm at perhaps the most critical moment in the agency's history," Kierán Suckling of the anti-pollution group Center for Biological Diversity wrote in an email.
As a result, rejoining the Paris Agreement will immediately put pressure on the new administration to find ways to cut greenhouse gas emissions dramatically. That means the EPA leader will have to provide proof of ambitious climate action as the Biden administration works to convince other countries the U.S. is serious about avoiding runaway global warming.
A 2018 report from the Intergovernmental Panel on Climate Change says global emissions must fall by about 50% in the next decade to achieve that goal, which is inconceivable unless the U.S. drastically reduces its dependence on fossil fuels.
Regan said he believes the U.S. can reduce emissions dramatically by 2030. He helped negotiate a plan to reduce power plant emissions in North Carolina by 70% in the next decade, and said he thinks the country as a whole could meet, or even exceed, a similar target.
"We need a partnership to be established, a very strong partnership with state and local governments as well as the private sector, to chart these goals," Regan said. "We have a lot of work to do. We've lost four years."


npr--2020-12-17--U.S. Cyber Agency: Computer Hack Poses 'Grave Risk'

Updated on Dec. 17 at 5:45 p.m .
ET The U.S. Cybersecurity and Infrastructure Security Agency on Thursday delivered an ominous warning about a major computer intrusion , saying it `` poses a grave risk '' to federal , state and local governments as well as private companies and organizations .
The Trump administration has said relatively little since the hack on government computers at multiple agencies was first announced last weekend .
But the CISA , which is part of the Department of Homeland Security , offered a broad overview in its latest comments .
The agency noted the @ @ @ @ @ @ @ ongoing — meaning the malware that 's been placed on computers may still be capturing valuable information .
In addition , CISA said that removing the malware will be `` highly complex and challenging for organizations . ''
Russia 's foreign intelligence service , the SVR , is believed responsible , according to cybersecurity experts who cite the extremely sophisticated nature of the attack .
But the Trump administration has not formally blamed Russia , and Russia has denied involvement .
`` How could I prove that I 'm innocent if I did @ @ @ @ @ @ @ together .
Let 's discuss .
Let 's restart our dialogue , '' Russian Ambassador Anatoly Antonov said Wednesday in a Zoom call from the Russian Embassy in Washington .
U.S. intelligence agencies have started briefing members of Congress , and Sen. Richard Blumenthal , a Connecticut Democrat , said the information clearly pointed to Cozy Bear , a hacking group widely considered to be Russian foreign intelligence .
`` Russia 's cyberattack left me deeply alarmed , in fact downright scared .
Americans deserve to know what 's going on , '' @ @ @ @ @ @ @ related to the hack .
Blumenthal said he will be pushing to make more information public .
So far , the list of affected U.S. government entities reportedly includes the Commerce Department , the Department of Homeland Security , the Pentagon , the Treasury Department , the U.S .
Postal Service and the National Institutes of Health .
In a statement Thursday , the Department of Energy acknowledged its computer systems had been compromised , though it said `` at this point '' its investigation shows the malware `` isolated to business networks @ @ @ @ @ @ @ mission essential national security functions of the Department , including the National Nuclear Security Administration . ''
Attention has focused on the breach of U.S. government networks , but the malware has also likely infected computers at thousands of private companies and organizations , according to government officials and cybersecurity experts .
The FBI , the Department of Homeland Security and the Office of the Director of National Intelligence announced Wednesday they have formed a special unified team , saying they will `` coordinate a whole-of-government-response to this significant cyber incident . ''
@ @ @ @ @ @ @ mention of the hack .
The hackers targeted software from SolarWinds , a company based in Austin , Texas .
Many federal agencies and thousands of companies use SolarWinds ' Orion software to monitor their computer networks .
CISA issued an emergency directive on Sunday , telling federal agencies `` to immediately disconnect or power down affected SolarWinds Orion products from their network . ''
The incident is the latest in what has become a long list of suspected Russian electronic incursions into other nations – particularly the U.S. – under President Vladimir @ @ @ @ @ @ @ Russia of using hackers , bots and other means in attempts to influence elections in the U.S. and elsewhere .
U.S. national security agencies made major efforts to prevent Russia from interfering in the 2020 election .
But those same agencies seem to have been blindsided by the hackers who have had months to dig around inside U.S. government systems .
`` It 's as if you wake up one morning and suddenly realize that a burglar has been going in and out of your house for the last six months , '' @ @ @ @ @ @ @ National Security Agency 's general counsel from 2015 to 2020 .
Here 's what we know about the attack : SolarWinds has some 300,000 customers , but it said `` fewer than 18,000 '' installed the version of its Orion products that appears to have been compromised .
The victims include government , consulting , technology , telecom and other entities in North America , Europe , Asia and the Middle East , according to the security firm FireEye , which helped raise the alarm about the breach .
`` We believe this @ @ @ @ @ @ @ aimed at both the government and private sector , '' Microsoft said as it shared some details about what it called `` the threat activity we 've uncovered over the past weeks . ''
After studying the malware , FireEye said it believes the breaches were carefully targeted : `` These compromises are not self-propagating ; each of the attacks require meticulous planning and manual interaction . ''
How did the hack work ?
Hackers exploited the way software companies distribute updates , adding malware to the legitimate package .
Security analysts said @ @ @ @ @ @ @ backdoor '' — a foothold in their targets ' computer networks — which they then used to gain elevated credentials .
SolarWinds traced the `` supply chain '' attack to updates for its Orion network products between March and June .
`` After an initial dormant period of up to two weeks , it retrieves and executes commands , called 'Jobs , ' that include the ability to transfer files , execute files , profile the system , reboot the machine , and disable system services , '' FireEye said .
The malware @ @ @ @ @ @ @ in ways that would masquerade as normal activity , FireEye said .
It added that the malicious software could also identify forensic and anti-virus tools that might threaten it .
And it said the credentials it used to move within the system were `` always different from those used for remote access . ''
After gaining access , Microsoft said , the intruder also made changes to ensure long-term access , by adding new credentials and using administrator privileges to grant itself more permissions .
FireEye is calling the `` Trojanized '' SolarWinds @ @ @ @ @ @ @ of malware – which it said had never been seen before — TEARDROP .
What are investigators doing now ?
SolarWinds said it is cooperating with the FBI , the U.S. intelligence community and other investigating agencies to learn more about the malware and its effects .
The company and security firms also said any affected agencies or customers should update to the latest software to lessen their exposure to the vulnerability .
Describing some of the detective work that 's now taking place , Gerstell said , `` You 'd have to @ @ @ @ @ @ @ to see what was taken , what might have been touched .
And of course , that 's just a horrifying thought . ''
The intruders were careful to cover their tracks , he said .
`` You could n't tell that they came in , you could n't tell that they left the backdoor open .
You could n't even tell necessarily when they came in , took a look around and when they left . ''
Microsoft has now taken control of the domain name that hackers used to communicate with @ @ @ @ @ @ @ update , according to security expert Brian Krebs .
That access can help reveal the scope of the hack , he said .
The intrusion could simply be a case of espionage , he said , of one government trying to understand what its adversary is doing .
This story was first published Dec. 15 and has been updated .

What We Know About Russia's Alleged Hack Of The U.S. Government And Tech Companies
Enlarge this image toggle caption Bill Clark/CQ-Roll Call, Inc via Getty Imag Bill Clark/CQ-Roll Call, Inc via Getty Imag
A massive computer breach allowed hackers to spend months exploring numerous U.S. government networks and private companies' systems around the world. Industry experts say a country mounted the complex hack — and government officials say Russia is responsible.
The hackers attached their malware to a software update from SolarWinds, a company based in Austin, Texas. Many federal agencies and thousands of companies worldwide use SolarWinds' Orion software to monitor their computer networks.
SolarWinds says that nearly 18,000 of its customers — in the government and the private sector — received the tainted software update from March to June of this year.
Here's what we know about the attack:
Who is responsible?
Russia's foreign intelligence service, the SVR, is believed to have carried out the hack, according to cybersecurity experts who cite the extremely sophisticated nature of the attack. Russia has denied involvement.
President Trump has been silent about the hack and his administration has not attributed blame. However, U.S. intelligence agencies have started briefing members of Congress, and several lawmakers have said the information they've seen points toward Russia.
Included are members of the Senate Armed Services Committee, where Chairman James Inhofe, a Republican from Oklahoma, and the top Democrat on the panel, Jack Reed of Rhode Island, issued a joint statement Thursday saying "the cyber intrusion appears to be ongoing and has the hallmarks of a Russian intelligence operation."
After several days of saying relatively little, the U.S. Cybersecurity and Infrastructure Security Agency on Thursday delivered an ominous warning, saying the hack "poses a grave risk" to federal, state and local governments as well as private companies and organizations.
In addition, CISA said that removing the malware will be "highly complex and challenging for organizations."
The episode is the latest in what has become a long list of suspected Russian electronic incursions into other nations under President Vladimir Putin. Multiple countries have previously accused Russia of using hackers, bots and other means in attempts to influence elections in the U.S. and elsewhere.
U.S. national security agencies made major efforts to prevent Russia from interfering in the 2020 election. But those same agencies seem to have been blindsided by the hackers who have had months to dig around inside U.S. government systems.
"It's as if you wake up one morning and suddenly realize that a burglar has been going in and out of your house for the last six months," said Glenn Gerstell, who was the National Security Agency's general counsel from 2015 to 2020.
Who was affected?
So far, the list of affected U.S. government entities reportedly includes the Commerce Department, the Department of Homeland Security, the Pentagon, the Treasury Department, the U.S. Postal Service and the National Institutes of Health.
The Department of Energy acknowledged its computer systems had been compromised, though it said malware was "isolated to business networks only, and has not impacted the mission essential national security functions of the Department, including the National Nuclear Security Administration."
SolarWinds has some 300,000 customers, but it said "fewer than 18,000" installed the version of its Orion products that appears to have been compromised.
The victims include government, consulting, technology, telecom and other entities in North America, Europe, Asia and the Middle East, according to the security firm FireEye, which helped raise the alarm about the breach.
After studying the malware, FireEye said it believes the breaches were carefully targeted: "These compromises are not self-propagating; each of the attacks require meticulous planning and manual interaction."
Microsoft, which is helping investigate the hack, says it identified 40 government agencies, companies and think tanks that have been infiltrated. While more than 30 victims are in the U.S., organizations were also hit in Canada, Mexico, Belgium, Spain, the United Kingdom, Israel and the United Arab Emirates.
"The attack unfortunately represents a broad and successful espionage-based assault on both the confidential information of the U.S. government and the tech tools used by firms to protect them," Microsoft's President Brad Smith wrote.
"While governments have spied on each other for centuries, the recent attackers used a technique that has put at risk the technology supply chain for the broader economy," he added.
How did the hack work?
Hackers exploited the way software companies distribute updates, adding malware to the legitimate package. Security analysts said the malicious code gave hackers a "backdoor" — a foothold in their targets' computer networks — which they then used to gain elevated credentials.
SolarWinds traced the "supply chain" attack to updates for its Orion network products between March and June.
"After an initial dormant period of up to two weeks, it retrieves and executes commands, called 'Jobs,' that include the ability to transfer files, execute files, profile the system, reboot the machine, and disable system services," FireEye said.
The malware was engineered to be stealthy, operating in ways that would masquerade as normal activity, FireEye said. It added that the malicious software could also identify forensic and anti-virus tools that might threaten it. And it said the credentials it used to move within the system were "always different from those used for remote access."
After gaining access, Microsoft said, the intruder also made changes to ensure long-term access, by adding new credentials and using administrator privileges to grant itself more permissions.
FireEye is calling the "Trojanized" SolarWinds software Sunburst. It named another piece of malware – which it said had never been seen before — TEARDROP.
What are investigators doing now?
SolarWinds said it is cooperating with the FBI, the U.S. intelligence community and other investigating agencies to learn more about the malware and its effects. The company and security firms also said any affected agencies or customers should update to the latest software to lessen their exposure to the vulnerability.
Microsoft has now taken control of the domain name that hackers used to communicate with systems that were compromised by the Orion update, according to security expert Brian Krebs. That access can help reveal the scope of the hack, he said.
What's next for the agencies and companies that were hacked?
Kevin Mandia, CEO of FireEye, told NPR that as companies and agencies learn they've been compromised, there's much to do: They must investigate the scale and scope of the attack, and eradicate the attackers from their network if they're still active. Even if they're not still active, he predicts months of remediation ahead.
For the U.S. government, Mandia says, there are bigger questions to be addressed — including a doctrine on what the U.S. expects nations' rules of engagement to be, and what the response will be to those who violate that doctrine.
This story was first published Dec. 15 and has been updated.


npr--2020-12-17--How Will Moderna Meet The Demand For Its COVID-19 Vaccine?

How Will Moderna Meet The Demand For Its COVID-19 Vaccine ?
Moderna 's COVID-19 vaccine is expected to become the second to get the Food and Drug Administration 's green light .
A decision could come within days .
But compared with pharmaceutical giant Pfizer , which was granted emergency use authorization last week , upstart Moderna does n't have a track record when it comes to mass production .
Pfizer makes hundreds of medicines and vaccines and operates at least 40 manufacturing facilities registered with the FDA around the world .
Despite being founded a decade ago , Moderna @ @ @ @ @ @ @ approval .
And it only has one factory registered with the FDA — and the registration occurred just this week .
`` As the CEO I am always thinking about the next game , and the next game is manufacturing , '' Moderna 's Stéphane Bancel told Technology Review .
`` This is a big week at the FDA .
But I am not worried about the EUA [ emergency-use authorization ] , because the data is the data .
I am worried about making more product . ''
So how will Moderna @ @ @ @ @ @ @ contracted to provide the federal government for $ 3.2 billion by the end of June ?
A big part of the answer is outsourcing production to contract manufacturers that will make the vaccine on Moderna 's behalf .
Moderna is ultimately responsible for making sure the vaccine is made in compliance with regulations , and the FDA periodically inspects facilities around the world to make sure they are up to snuff .
Still , the use of multiple companies to help make and package the vaccine stretches the supply and production chain and @ @ @ @ @ @ @ orders .
Vice President Mike Pence traveled to Bloomington , Ind.
, on Tuesday to tour Catalent , a contract manufacturing facility expected to help produce millions of Moderna coronavirus vaccines in the coming weeks and months .
Catalent is probably the biggest drugmaker you 've never heard of .
It has dozens of factories around the world and makes more than 70 billion doses of all kinds of drugs each year .
The company 's facility in Pence 's home state is working with Moderna on filling vials with the vaccine and @ @ @ @ @ @ @ people of this facility are working tirelessly to deliver on that promise , volunteering for a production shift over Thanksgiving , over Christmas , '' Catalent president and COO Alessandro Maselli told Pence during a discussion after the tour .
`` Because everybody understands the mission we are on at this facility . ''
Catalent is processing 500,000 doses per day , but the factory is hoping to ramp up to a million doses a day to fulfill its contractual obligations and deliver 100 million doses by the end of March , Denis @ @ @ @ @ @ @ , told the vice president .
It 's a big job , but Catalent and the other contract manufacturers have long histories of doing it .
`` There are no fly-by-night new manufacturing facilities that are being set up to make these products by definition , because there are only so many manufacturers who could make these products to begin with , '' says Rena Conti , a health economics professor at Boston University whose research includes the pharmaceutical supply chain .
`` And many of them are known .
They 've been @ @ @ @ @ @ @ a very long time and have a proven safety record and quality record . ''
Still , FDA inspectors visited Catalent 's Bloomington facility in October 2019 , and found that it had problems with making sure sterile products were n't contaminated with bacterial or fungal particles .
Inspectors also wrote that the facility had problems storing pharmaceuticals at the right temperature and humidity levels .
That could mean problems for the quality of the plant 's products , Conti says .
`` There were production and process control failures that make it @ @ @ @ @ @ @ what it purports to be , '' Conti says .
`` So the safety identity , the strength , the quality or the purity of the product that is being manufactured may not meet the specifications or the attestation the company is making to the U.S. public that the product is what it says it is .
So this is quite serious . ''
However , the findings did n't result in more serious punitive steps by the FDA , which can include formal warning letters and , in rare cases , injunctions @ @ @ @ @ @ @ , of course , the Catalent facility was n't working on coronavirus vaccines .
But the company announced that it would be helping Moderna make its vaccine in June of this year .
In September , the Indiana facility received another visit from the FDA .
Inspectors again found that the employees were n't following rules to prevent microbial contamination .
For example , employees were n't making sure sterile forceps did n't touch non-sterile surfaces , and they did n't follow rules around sanitizing gloved hands in certain situations involving vials and @ @ @ @ @ @ @ is fixable .
It 's a simple lapse in training , says Dinesh Thakur , a former drug company executive turned whistleblower .
The fact that Catalent did n't appear to have fixed its microbial contamination procedures a year earlier is what bothers him .
`` These are easy to fix , '' says Thakur , who raised the alarm about quality-control problems at generics drugmaker Ranbaxy , resulting in a 2013 guilty plea and a $ 500 million settlement .
`` This is like , you know , within a week , @ @ @ @ @ @ @ wrapped up properly . ''
He called it `` really concerning . ''
`` If you 're told in 2019 to fix it , you have a year to fix it and we have to make the same observation another time ?
Then that would cause me to become a little concerned . ''
Catalent spokesperson Chris Halling told NPR in an email that the facility was able to resolve its findings and satisfy the FDA in 2019 and 2020 .
`` The Agency 's latest Establishment Inspection Report ( EIR ) does @ @ @ @ @ @ @ finding of the earlier observation , and relates to a different concern for a process in a different part of the facility .
Catalent takes its responsibility to comply with CGMPs [ Current Good Manufacturing Practices ] extremely seriously , and hosts hundreds of audits each year , including those by customers , the U.S. FDA , and other global regulatory bodies .
The company utilizes regulators ' observations as a means to continuously improve its operations and to assure ongoing compliance to all appropriate standards .
Catalent is on track to manufacture @ @ @ @ @ @ @ 's vaccine candidate by the end of this month , and the facility in Bloomington , IN , is ramping up production to supply another 100 million doses in the first quarter of 2021 .
Globally , the company is working on more than 75 Covid-19-related programs including antivirals , vaccines and treatments . ''
Moderna declined to comment , and suggested NPR speak with officials with the FDA and Operation Warp Speed , the more than $ 12 billion federal effort to make a vaccine widely available in record time .
Operation @ @ @ @ @ @ @ billion on researching and developing the Moderna vaccine as well as buying 100 million doses to be delivered by the end of March and another 100 million to be delivered by the end of June .
Operation Warp Speed did n't respond to requests for comment , and the FDA said it typically does n't comment on `` compliance matters . ''
Catalent is filling vials and getting them ready to send around the country , but other facilities are responsible for making the mRNA , the key substance at the heart of @ @ @ @ @ @ @ those vials .
Another well-known contract manufacturing company , Lonza , told investors in October that it is working with Moderna to make its coronavirus vaccine drug substance .
Lonza is using two sites : one in Portsmouth , N.H. , and another in Visp , Switzerland , and was aiming to complete the first batches by late October and early November , respectively .
Following an FDA inspection in February 2018 , Lonza 's plant in Portsmouth did not receive a document detailing observations called a Form 483 , implying inspectors mostly @ @ @ @ @ @ @ Sanna Fowler says it was also inspected in October 2020 , and has an `` exemplary track record '' with the FDA and international regulatory bodies that conduct similar inspections .
`` The FDA have used the Portsmouth site as a training site for their inspectors , given its high standards , '' she wrote in an email to NPR .
`` Should the FDA decide an inspection of the Moderna facility is required , we are of course ready to receive them . ''
The other Lonza facility 's inspection was n't @ @ @ @ @ @ @ FDA inspectors found problems with microbial control during certain plant processes .
They also found inadequacies in the way the plant measured impurities like toxins released by bacteria .
The facility has received several 483s in recent years as well as two import refusals , meaning the FDA twice detained drug product shipments for being out of compliance .
To do work on the Moderna vaccine , Lonza is setting up operations in `` a new premises '' in Visp , Switzerland , rather than using its existing facility there , Fowler says @ @ @ @ @ @ @ FDA has found problems at its existing facility , they did n't result in a warning letter from the agency .
Instead the inspectors ' findings were `` successfully resolved . ''
She says the import refusals were the results of problems further up the supply chain , rather than because of problems at the Lonza plant .
Furthermore , the Moderna vaccine substance the new Swiss that facility makes wo n't be bound for the United States , according to Fowler .
Instead , it will go to the European Union and @ @ @ @ @ @ @ said that it 's using a relatively new facility in Norwood , Mass.
, to make the vaccine .
`` The vast majority of the U.S. production will be done in Massachusetts , '' Moderna co-founder Noubar Afeyan told NPR member station WGBH News in a Dec. 1 story .
Although the facility was built in 2018 , it was n't registered with the FDA until this week and has never been inspected , records show .
Typically , new facilities need to be inspected before the agency will allow their products to @ @ @ @ @ @ @ of the facility is based on current standards for biotechnology facilities , it has not been reviewed or pre-approved by any regulatory agency , nor has the facility been inspected by any regulatory agency such as the FDA , '' the company wrote in a June 2020 regulatory filing .
`` We have only recently begun producing drug substance and drug product at the MTC [ Moderna Technology Center ] for our preclinical and clinical use , '' the filing continues .
`` We could incur delays in implementing the full operational state @ @ @ @ @ @ @ clinical supply or extended use of third-party service providers , resulting in unplanned expenses .
In constructing the MTC facility , we have incurred substantial expenditures , and expect to incur significant additional expenditures in validating and operating the facility in the future . ''
The FDA does n't speak publicly about specific compliance matters except with the firms involved .
However , agency spokesperson Alison Hunt said that the FDA regularly interacts with manufacturers to help resolve regulatory compliance issues when they crop up , and it has a number of tools @ @ @ @ @ @ @ is weighing whether to grant emergency use authorization of a COVID-19 vaccine , it takes manufacturing into account , she wrote in an email to NPR .
`` FDA expects manufacturers to submit sufficient data to ensure the quality and consistency of the vaccine product , '' Hunt wrote .
`` FDA uses available tools and information , including records reviews , site visits , on-site investigations and previous compliance history to assess compliance with current good manufacturing practice ( cGMP ) requirements . ''
You can contact NPR pharmaceuticals correspondent Sydney Lupkin @ @ @ @ @

How Will Moderna Meet The Demand For Its COVID-19 Vaccine?
Enlarge this image toggle caption Joseph Prezioso/AFP via Getty Images Joseph Prezioso/AFP via Getty Images
Moderna's COVID-19 vaccine is expected to become the second to get the Food and Drug Administration's green light. A decision could come within days.
But compared with pharmaceutical giant Pfizer, which was granted emergency use authorization last week, upstart Moderna doesn't have a track record when it comes to mass production.
Pfizer makes hundreds of medicines and vaccines and operates at least 40 manufacturing facilities registered with the FDA around the world. Despite being founded a decade ago, Moderna has never had a product win FDA approval. And it only has one factory registered with the FDA — and the registration occurred just this week.
"As the CEO I am always thinking about the next game, and the next game is manufacturing," Moderna's Stéphane Bancel told Technology Review. "This is a big week at the FDA. But I am not worried about the EUA [emergency-use authorization], because the data is the data. I am worried about making more product."
So how will Moderna make the 200 million doses it has contracted to provide the federal government for $3.2 billion by the end of June? A big part of the answer is outsourcing production to contract manufacturers that will make the vaccine on Moderna's behalf.
Moderna is ultimately responsible for making sure the vaccine is made in compliance with regulations, and the FDA periodically inspects facilities around the world to make sure they are up to snuff. Still, the use of multiple companies to help make and package the vaccine stretches the supply and production chain and could add some risk to fulfillment of orders.
Producing finished vaccines
Vice President Mike Pence traveled to Bloomington, Ind., on Tuesday to tour Catalent, a contract manufacturing facility expected to help produce millions of Moderna coronavirus vaccines in the coming weeks and months. Catalent is probably the biggest drugmaker you've never heard of. It has dozens of factories around the world and makes more than 70 billion doses of all kinds of drugs each year. The company's facility in Pence's home state is working with Moderna on filling vials with the vaccine and preparing them for distribution.
"Two-thousand people of this facility are working tirelessly to deliver on that promise, volunteering for a production shift over Thanksgiving, over Christmas," Catalent president and COO Alessandro Maselli told Pence during a discussion after the tour. "Because everybody understands the mission we are on at this facility."
Enlarge this image toggle caption Darron Cummings/AP Darron Cummings/AP
Catalent is processing 500,000 doses per day, but the factory is hoping to ramp up to a million doses a day to fulfill its contractual obligations and deliver 100 million doses by the end of March, Denis Johnson, Catalent Bloomington's general manager, told the vice president.
It's a big job, but Catalent and the other contract manufacturers have long histories of doing it.
"There are no fly-by-night new manufacturing facilities that are being set up to make these products by definition, because there are only so many manufacturers who could make these products to begin with," says Rena Conti, a health economics professor at Boston University whose research includes the pharmaceutical supply chain. "And many of them are known. They've been making vaccines for the U.S. population for a very long time and have a proven safety record and quality record."
Still, FDA inspectors visited Catalent's Bloomington facility in October 2019, and found that it had problems with making sure sterile products weren't contaminated with bacterial or fungal particles. Inspectors also wrote that the facility had problems storing pharmaceuticals at the right temperature and humidity levels.
That could mean problems for the quality of the plant's products, Conti says.
"There were production and process control failures that make it possible that the product itself is not what it purports to be," Conti says. "So the safety identity, the strength, the quality or the purity of the product that is being manufactured may not meet the specifications or the attestation the company is making to the U.S. public that the product is what it says it is. So this is quite serious."
However, the findings didn't result in more serious punitive steps by the FDA, which can include formal warning letters and, in rare cases, injunctions and product seizures.
At the time, of course, the Catalent facility wasn't working on coronavirus vaccines. But the company announced that it would be helping Moderna make its vaccine in June of this year. In September, the Indiana facility received another visit from the FDA.
Inspectors again found that the employees weren't following rules to prevent microbial contamination. For example, employees weren't making sure sterile forceps didn't touch non-sterile surfaces, and they didn't follow rules around sanitizing gloved hands in certain situations involving vials and syringes.
By itself, the finding is fixable. It's a simple lapse in training, says Dinesh Thakur, a former drug company executive turned whistleblower. The fact that Catalent didn't appear to have fixed its microbial contamination procedures a year earlier is what bothers him.
"These are easy to fix," says Thakur, who raised the alarm about quality-control problems at generics drugmaker Ranbaxy, resulting in a 2013 guilty plea and a $500 million settlement. "This is like, you know, within a week, you can try and get this thing wrapped up properly."
He called it "really concerning." "If you're told in 2019 to fix it, you have a year to fix it and we have to make the same observation another time? Then that would cause me to become a little concerned."
Catalent spokesperson Chris Halling told NPR in an email that the facility was able to resolve its findings and satisfy the FDA in 2019 and 2020.
"The Agency's latest Establishment Inspection Report (EIR) does not reflect that it was a repeat finding of the earlier observation, and relates to a different concern for a process in a different part of the facility.
Catalent takes its responsibility to comply with CGMPs [Current Good Manufacturing Practices] extremely seriously, and hosts hundreds of audits each year, including those by customers, the U.S. FDA, and other global regulatory bodies. The company utilizes regulators' observations as a means to continuously improve its operations and to assure ongoing compliance to all appropriate standards.
Catalent is on track to manufacture and package 20 million doses of Moderna's vaccine candidate by the end of this month, and the facility in Bloomington, IN, is ramping up production to supply another 100 million doses in the first quarter of 2021. Globally, the company is working on more than 75 Covid-19-related programs including antivirals, vaccines and treatments."
Moderna declined to comment, and suggested NPR speak with officials with the FDA and Operation Warp Speed, the more than $12 billion federal effort to make a vaccine widely available in record time. Operation Warp Speed has committed spending $4.1 billion on researching and developing the Moderna vaccine as well as buying 100 million doses to be delivered by the end of March and another 100 million to be delivered by the end of June.
Operation Warp Speed didn't respond to requests for comment, and the FDA said it typically doesn't comment on "compliance matters."
Making the key ingredients
Catalent is filling vials and getting them ready to send around the country, but other facilities are responsible for making the mRNA, the key substance at the heart of the vaccine, that Catalent puts in those vials.
Another well-known contract manufacturing company, Lonza, told investors in October that it is working with Moderna to make its coronavirus vaccine drug substance. Lonza is using two sites: one in Portsmouth, N.H., and another in Visp, Switzerland, and was aiming to complete the first batches by late October and early November, respectively.
Following an FDA inspection in February 2018, Lonza's plant in Portsmouth did not receive a document detailing observations called a Form 483, implying inspectors mostly liked what they saw.
Lonza spokesperson Sanna Fowler says it was also inspected in October 2020, and has an "exemplary track record" with the FDA and international regulatory bodies that conduct similar inspections. "The FDA have used the Portsmouth site as a training site for their inspectors, given its high standards," she wrote in an email to NPR. "Should the FDA decide an inspection of the Moderna facility is required, we are of course ready to receive them."
The other Lonza facility's inspection wasn't as spotless. In October 2019, FDA inspectors found problems with microbial control during certain plant processes. They also found inadequacies in the way the plant measured impurities like toxins released by bacteria. The facility has received several 483s in recent years as well as two import refusals, meaning the FDA twice detained drug product shipments for being out of compliance.
To do work on the Moderna vaccine, Lonza is setting up operations in "a new premises" in Visp, Switzerland, rather than using its existing facility there, Fowler says. She points out that although the FDA has found problems at its existing facility, they didn't result in a warning letter from the agency. Instead the inspectors' findings were "successfully resolved." She says the import refusals were the results of problems further up the supply chain, rather than because of problems at the Lonza plant.
Furthermore, the Moderna vaccine substance the new Swiss that facility makes won't be bound for the United States, according to Fowler. Instead, it will go to the European Union and Canada, for example.
Using a new facility
Moderna has said that it's using a relatively new facility in Norwood, Mass., to make the vaccine.
"The vast majority of the U.S. production will be done in Massachusetts," Moderna co-founder Noubar Afeyan told NPR member station GBH News in a Dec. 1 story.
Although the facility was built in 2018, it wasn't registered with the FDA until this week and has never been inspected, records show. Typically, new facilities need to be inspected before the agency will allow their products to be released.
"While the design of the facility is based on current standards for biotechnology facilities, it has not been reviewed or pre-approved by any regulatory agency, nor has the facility been inspected by any regulatory agency such as the FDA," the company wrote in a June 2020 regulatory filing.
"We have only recently begun producing drug substance and drug product at the MTC [Moderna Technology Center] for our preclinical and clinical use," the filing continues. "We could incur delays in implementing the full operational state of the facility, causing delays to clinical supply or extended use of third-party service providers, resulting in unplanned expenses. In constructing the MTC facility, we have incurred substantial expenditures, and expect to incur significant additional expenditures in validating and operating the facility in the future."
The FDA doesn't speak publicly about specific compliance matters except with the firms involved. However, agency spokesperson Alison Hunt said that the FDA regularly interacts with manufacturers to help resolve regulatory compliance issues when they crop up, and it has a number of tools to accomplish this.
When the FDA is weighing whether to grant emergency use authorization of a COVID-19 vaccine, it takes manufacturing into account, she wrote in an email to NPR.
"FDA expects manufacturers to submit sufficient data to ensure the quality and consistency of the vaccine product," Hunt wrote. "FDA uses available tools and information, including records reviews, site visits, on-site investigations and previous compliance history to assess compliance with current good manufacturing practice (cGMP) requirements."
You can contact NPR pharmaceuticals correspondent Sydney Lupkin at slupkin@npr.org.


npr--2020-12-17--Trump Bemoaned Water Pressure. Now His Administration Has Eased Standards

Trump Bemoaned Water Pressure .
Now His Administration Has Eased Standards The U.S. Department of Energy has finalized two new rules that offer a win to President Trump in his personal crusade to roll back water efficiency standards on appliances like showerheads .
Trump frequently has bemoaned what he views as insufficient water pressure with newer appliances .
The new rules , announced Tuesday , loosen water regulations on showerheads and for washers and dryers .
The Trump administration heralded the standards as a victory for the `` quality of life '' of Americans .
`` [ These ] final @ @ @ @ @ @ @ can make their lives easier , more comfortable , and save them time , '' Deputy Secretary of Energy Mark Menezes said in a statement .
`` That time and effort saved can be better spent on the more important things in life . ''
In the 1990s , Congress set a 2.5 gallon-per-minute maximum flow rate for showerheads , in order to conserve water .
The ruling was updated under the Obama administration to ensure that 2.5 gallons per minute was the total water output , regardless of how many nozzles were @ @ @ @ @ @ @ new rule allows every individual nozzle on a showerhead to use 2.5 gallons of water per minute .
`` It is a big deal because potentially you have showerheads that are using five , seven and a half gallons a minute , and that 's a lot of water , '' said Andrew deLaski , the executive director of the Appliance Standards Awareness Project , a coalition of environmental consumer groups supporting strong efficiency standards .
And contrary to the Energy Department , he says the rules could actually negatively affect consumer experience @ @ @ @ @ @ @ that uses that much water , you 're going to run out of hot water within as little as 10 minutes in the house , '' deLaski told NPR .
`` So whoever is second in line for the shower is going to get a cold shower . ''
He also said more water usage equals higher water utility bills .
`` We estimate that a typical household today is already saving about $ 500 per year because of existing standards for a range of appliances used in the home , including plumbing @ @ @ @ @ @ @ If you start rolling back these standards , that means higher bills for consumers . ''
The Energy Department also finalized a ruling that creates a separate product class for residential washers and dryers that have cycle times of fewer than 30 minutes ( and 45 minutes for front-loading washers ) , which deLaski says essentially set them up to be used without energy limits .
He adds he 's hopeful the Biden administration will reverse the new rules .
President-elect Joe Biden has promised to redo a host of environmental regulations the @ @ @ @ @ @ @ also expects some states to continue setting their own efficiency standards .
`` As federal requirements get looser , more and more states are going to set their own standards because water conservation is serious business throughout much of the American West , where states are faced with long-term droughts , '' he said .
The issue of water pressure and standards has been top of mind for Trump this past year .
Last December , he told reporters during a roundtable on reducing red tape in government that he instructed his administration @ @ @ @ @ @ @ and other elements of bathrooms where you turn the faucet on . ''
`` You turn on the faucet , you do n't get any water , '' he proclaimed .
`` [ People ] take a shower and water comes dripping out .
It 's dripping out , very quietly dripping out .
People are flushing toilets 10 times , 15 times , as opposed to once . ''
It 's a topic he even brought on the campaign trail , lamenting what he views as inadequate water pressure to rallygoers in @ @ @ @ @ @ @ .
`` The shower , the worst .
Do you ever get under a shower where no water comes out ?
And me , I want that hair to be so beautiful .
I want the hair to look good , '' he exclaimed .

Trump Bemoaned Water Pressure. Now His Administration Has Eased Standards
Enlarge this image toggle caption Saul Loeb/AFP via Getty Images Saul Loeb/AFP via Getty Images
The U.S. Department of Energy has finalized two new rules that offer a win to President Trump in his personal crusade to roll back water efficiency standards on appliances like showerheads.
Trump frequently has bemoaned what he views as insufficient water pressure with newer appliances.
The new rules, announced Tuesday, loosen water regulations on showerheads and for washers and dryers. The Trump administration heralded the standards as a victory for the "quality of life" of Americans.
"[These] final rulemakings allow consumers to choose products that can make their lives easier, more comfortable, and save them time," Deputy Secretary of Energy Mark Menezes said in a statement. "That time and effort saved can be better spent on the more important things in life."
In the 1990s, Congress set a 2.5 gallon-per-minute maximum flow rate for showerheads, in order to conserve water. The ruling was updated under the Obama administration to ensure that 2.5 gallons per minute was the total water output, regardless of how many nozzles were featured on a single showerhead.
This new rule allows every individual nozzle on a showerhead to use 2.5 gallons of water per minute.
"It is a big deal because potentially you have showerheads that are using five, seven and a half gallons a minute, and that's a lot of water," said Andrew deLaski, the executive director of the Appliance Standards Awareness Project, a coalition of environmental consumer groups supporting strong efficiency standards.
And contrary to the Energy Department, he says the rules could actually negatively affect consumer experience.
"If you have a shower that uses that much water, you're going to run out of hot water within as little as 10 minutes in the house," deLaski told NPR. "So whoever is second in line for the shower is going to get a cold shower."
He also said more water usage equals higher water utility bills.
"We estimate that a typical household today is already saving about $500 per year because of existing standards for a range of appliances used in the home, including plumbing products," he said. "If you start rolling back these standards, that means higher bills for consumers."
The Energy Department also finalized a ruling that creates a separate product class for residential washers and dryers that have cycle times of fewer than 30 minutes (and 45 minutes for front-loading washers), which deLaski says essentially set them up to be used without energy limits.
He adds he's hopeful the Biden administration will reverse the new rules. President-elect Joe Biden has promised to redo a host of environmental regulations the Trump administration has rolled back.
deLaski also expects some states to continue setting their own efficiency standards.
"As federal requirements get looser, more and more states are going to set their own standards because water conservation is serious business throughout much of the American West, where states are faced with long-term droughts," he said.
The issue of water pressure and standards has been top of mind for Trump this past year.
Last December, he told reporters during a roundtable on reducing red tape in government that he instructed his administration to look into "sinks and showers and other elements of bathrooms where you turn the faucet on."
"You turn on the faucet, you don't get any water," he proclaimed. "[People] take a shower and water comes dripping out. It's dripping out, very quietly dripping out. People are flushing toilets 10 times, 15 times, as opposed to once."
It's a topic he even brought on the campaign trail, lamenting what he views as inadequate water pressure to rallygoers in Carson City, Nev., in October.
"The shower, the worst. Do you ever get under a shower where no water comes out? And me, I want that hair to be so beautiful. I want the hair to look good," he exclaimed.


npr--2020-12-17--Biden-Harris Team Briefed On Cyber Breaches To Government Networks

President-elect Joe Biden says his transition team has been briefed on the massive cyber intrusions recently identified by the U.S. government .
`` There 's a lot we do n't yet know , but what we do know is a matter of great concern , '' Biden said in a statement on Thursday .
`` I have instructed my team to learn as much as we can about this breach , and Vice President-elect [ Kamala ] Harris and I are grateful to the career public servants who have briefed our team on their findings , and who are working @ @ @ @ @ @ @ '' The full scope of the attack , which apparently took place over several months , is still unknown .
The Department of Homeland Security and the Pentagon are among the entities affected .
Cybersecurity experts say the style of attack points to Russia 's foreign intelligence service , but the Trump administration has not publicly made that accusation , and President Trump has not made a statement on the breach .
Biden vowed to make cybersecurity `` a top priority at every level of government — and we will make dealing with @ @ @ @ @ @ @ moment we take office . ''
Biden 's statement came after the Cybersecurity and Infrastructure Security Agency , or CISA , issued a statement saying the breach `` poses a grave risk to the Federal Government and state , local , tribal , and territorial governments as well as critical infrastructure entities and other private sector organizations . ''
CISA says that the breach began in at least March and that the hackers have `` demonstrated patience , operational security , and complex tradecraft in these intrusions . ''
The chairs of the @ @ @ @ @ @ @ several related subcommittees sent a letter to the Director of National Intelligence John Ratcliffe , FBI Director Christopher Wray and acting Homeland Security Secretary Chad Wolf calling for a classified , interagency briefing on Friday .
The committees also asked the agencies to `` provide any damage assessments of the attack , including interim analyses , as soon as practicable . ''

Biden-Harris Team Briefed On Cyber Breaches To Government Networks
Enlarge this image toggle caption Chip Somodevilla/Getty Images Chip Somodevilla/Getty Images
President-elect Joe Biden says his transition team has been briefed on the massive cyber intrusions recently identified by the U.S. government.
"There's a lot we don't yet know, but what we do know is a matter of great concern," Biden said in a statement on Thursday. "I have instructed my team to learn as much as we can about this breach, and Vice President-elect [Kamala] Harris and I are grateful to the career public servants who have briefed our team on their findings, and who are working around-the-clock to respond to this attack."
The full scope of the attack, which apparently took place over several months, is still unknown. The Department of Homeland Security and the Pentagon are among the entities affected.
Cybersecurity experts say the style of attack points to Russia's foreign intelligence service, but the Trump administration has not publicly made that accusation, and President Trump has not made a statement on the breach.
Biden vowed to make cybersecurity "a top priority at every level of government — and we will make dealing with this breach a top priority from the moment we take office."
Biden's statement came after the Cybersecurity and Infrastructure Security Agency, or CISA, issued a statement saying the breach "poses a grave risk to the Federal Government and state, local, tribal, and territorial governments as well as critical infrastructure entities and other private sector organizations."
CISA says that the breach began in at least March and that the hackers have "demonstrated patience, operational security, and complex tradecraft in these intrusions."
The chairs of the House Oversight and Homeland Security committees and several related subcommittees sent a letter to the Director of National Intelligence John Ratcliffe, FBI Director Christopher Wray and acting Homeland Security Secretary Chad Wolf calling for a classified, interagency briefing on Friday.
The committees also asked the agencies to "provide any damage assessments of the attack, including interim analyses, as soon as practicable."


npr--2020-12-17--Google Hit With Another Lawsuit Challenging Its Dominance

Google Hit With Another Lawsuit Challenging Its Dominance When you search on Google , do you get the best results ?
Or the results that are best for Google ?
That question is at the heart of the latest lawsuit to challenge the tech giant 's dominance over Internet search and advertising .
On Thursday , a bipartisan group of 38 attorneys general hit Google with the company 's third antitrust complaint in less than two months , zeroing in on its role as `` the gateway to the Internet . ''
`` Google sits at the crossroads of so @ @ @ @ @ @ @ has used its dominance to illegally squash competitors , monitor nearly every aspect of our digital lives , and profit to the tune of billions , '' New York Attorney General Letitia James said in a statement .
The new lawsuit adds to an emerging portrait by state and federal officials of a company that has capitalized on deep troves of data about what people do online to gain unrivaled positions in search and advertising .
`` It 's not , 'People use Google . '
Google uses people , '' said Nebraska @ @ @ @ @ @ @ takes broad aim at Google 's biggest and most lucrative businesses : its search engine , which is used for nearly 90 % of Internet queries in the U.S. , and its search advertising juggernaut , which brought in almost $ 100 billion in revenue last year .
The AGs accuse Google of giving its own products priority in search results over more specialized rivals , such as Yelp , which focuses on local businesses , and Tripadvisor , for travel listings .
And they allege Google gives itself an unfair advantage over @ @ @ @ @ @ @ 's Bing , in the ads that appear in search results .
The states ' complaint echoes one filed by the U.S. Justice Department in October .
Both object to deals that , they allege , Google struck to ensconce itself in users ' lives .
Notably , both suits point to a pact that made Google 's search engine the default on Apple devices .
The AGs go further , however , warning that Google is trying to lock in similar deals to dominate search on newer technologies such as smart speakers @ @ @ @ @ @ @ The states are asking for their complaint to be consolidated with the Justice Department 's suit and litigated together .
Google says its search results are designed to give people the most useful information .
`` This lawsuit seeks to redesign Search in ways that would deprive Americans of helpful information and hurt businesses ' ability to connect directly with customers , '' Adam Cohen , Google 's director of economy policy , wrote in a blog post responding to Thursday 's lawsuit .
`` We look forward to making that case in @ @ @ @ @ @ @ a high-quality search experience for our users , '' he added .
Google has previously said it faces plenty of competition and that people use its products and services because they want to , not because of a lack of alternatives .
Yelp , which has long complained about Google 's behavior , said it applauded the AGs ' move .
`` We hope today 's action is the beginning of a return to a more vibrant and open internet , '' said Luther Lowe , Yelp 's head of public policy , @ @ @ @ @ @ @ couple of geeks in a garage '' to Big Tech The legal challenges follow state and federal investigations of Google that stretch back more than a year , amid widening scrutiny of the tech industry .
Separately , on Wednesday , 10 Republican state attorneys general filed a complaint taking aim at Google 's might in digital advertising technology .
With Silicon Valley giants now holding so much sway over many aspects of daily life , from communications and entertainment to shopping , education and work , government officials have shown a new @ @ @ @ @ @ @ more aggressive approach follows years in which they allowed companies like Google to grow largely unchecked .
Earlier this month , the Federal Trade Commission and 48 attorneys general called for Facebook to be broken up because of illegal behavior towards rivals .
Officials are also probing Apple and Amazon , and fresh scrutiny of the American tech giants is underway in Europe , where regulators this week proposed new curbs on their activities .
The joint efforts by federal agencies and state prosecutors to take on Google and Facebook `` speaks volumes @ @ @ @ @ @ @ going on here and the importance of what we 're doing , '' Peterson , the Nebraska AG , said .
The new posture in Washington and state capitals towards Silicon Valley represents a significant shift from just a few years ago , said David Dinielli , a former special counsel at the Justice Department 's antitrust division .
After a long period in which tech companies were `` romanticized as simply a couple of computer geeks in a garage , '' regulators and politicians now recognize they `` have much greater force @ @ @ @ @ @ @ lives , our family lives , and frankly , the working of our democracy , '' Dinielli said .
The cascade of lawsuits is `` a remarkable coalescence that we have been remiss in examining the ways in which these companies have gained a foothold in every aspect of our lives and are operating for profit , '' he added .
Google is a particularly ripe target because of its starring role in that most fundamental online activity : looking something up .
After all , the word `` Google '' has become @ @ @ @ @ @ @ Internet , '' the Justice Department said in its lawsuit .
`` This is different than going to the card catalogue at the local library , '' Dinielli said .
`` Google has decided what to put on that first screen for Google 's interests , not for ours . ''
The latest spotlight on Big Tech inevitably evokes comparisons to the last time the federal government and states took on the dominant force in technology : Microsoft , in the 1990s .
Like in that case , the lawsuits against Google and @ @ @ @ @ @ @ years , and will involve difficult questions about whether the companies should be broken apart .
While Microsoft avoided being split up , it 's widely agreed that the legal battle did change the company 's behavior — and gave rise to a new generation of tech stars .
`` Some people argue that if we had n't brought the case , there would not have been a Google , '' said Iowa Attorney General Tom Miller , who led the states involved in the Microsoft case .
( Miller became the longest-serving @ @ @ @ @ @ @ this year . )
`` Of course , there is some irony if we produced Google and now Google is the monolith that we have to sue , '' he laughed .
Editor 's note : Google , Facebook , Microsoft , Apple and Amazon are among NPR 's financial supporters .

Google Hit With Another Lawsuit Challenging Its Dominance
Enlarge this image toggle caption Bloomberg/Bloomberg via Getty Images Bloomberg/Bloomberg via Getty Images
Updated at 6:32 p.m. ET
When you search on Google, do you get the best results? Or the results that are best for Google?
That question is at the heart of the latest lawsuit to challenge the tech giant's dominance over Internet search and advertising.
On Thursday, a bipartisan group of 38 attorneys general hit Google with the company's third antitrust complaint in less than two months, zeroing in on its role as "the gateway to the Internet."
"Google sits at the crossroads of so many areas of our digital economy and has used its dominance to illegally squash competitors, monitor nearly every aspect of our digital lives, and profit to the tune of billions," New York Attorney General Letitia James said in a statement.
The new lawsuit adds to an emerging portrait by state and federal officials of a company that has capitalized on deep troves of data about what people do online to gain unrivaled positions in search and advertising.
"It's not, 'People use Google.' Google uses people," said Nebraska Attorney General Doug Peterson.
Challenging the heart of Google's business: Search results
The lawsuit takes broad aim at Google's biggest and most lucrative businesses: its search engine, which is used for nearly 90% of Internet queries in the U.S., and its search advertising juggernaut, which brought in almost $100 billion in revenue last year.
The AGs accuse Google of giving its own products priority in search results over more specialized rivals, such as Yelp, which focuses on local businesses, and Tripadvisor, for travel listings. And they allege Google gives itself an unfair advantage over rival search engines, such as Microsoft's Bing, in the ads that appear in search results.
The states' complaint echoes one filed by the U.S. Justice Department in October. Both object to deals that, they allege, Google struck to ensconce itself in users' lives. Notably, both suits point to a pact that made Google's search engine the default on Apple devices.
The AGs go further, however, warning that Google is trying to lock in similar deals to dominate search on newer technologies such as smart speakers, voice assistants and connected cars. The states are asking for their complaint to be consolidated with the Justice Department's suit and litigated together.
Google says its search results are designed to give people the most useful information.
"This lawsuit seeks to redesign Search in ways that would deprive Americans of helpful information and hurt businesses' ability to connect directly with customers," Adam Cohen, Google's director of economy policy, wrote in a blog post responding to Thursday's lawsuit.
"We look forward to making that case in court, while remaining focused on delivering a high-quality search experience for our users," he added.
Google has previously said it faces plenty of competition and that people use its products and services because they want to, not because of a lack of alternatives.
Yelp, which has long complained about Google's behavior, said it applauded the AGs' move.
"We hope today's action is the beginning of a return to a more vibrant and open internet," said Luther Lowe, Yelp's head of public policy, in a statement.
From "a couple of geeks in a garage" to Big Tech
The legal challenges follow state and federal investigations of Google that stretch back more than a year, amid widening scrutiny of the tech industry. Separately, on Wednesday, 10 Republican state attorneys general filed a complaint taking aim at Google's might in digital advertising technology.
With Silicon Valley giants now holding so much sway over many aspects of daily life, from communications and entertainment to shopping, education and work, government officials have shown a new willingness to challenge that power. Their more aggressive approach follows years in which they allowed companies like Google to grow largely unchecked.
Earlier this month, the Federal Trade Commission and 48 attorneys general called for Facebook to be broken up because of illegal behavior towards rivals. Officials are also probing Apple and Amazon, and fresh scrutiny of the American tech giants is underway in Europe, where regulators this week proposed new curbs on their activities.
The joint efforts by federal agencies and state prosecutors to take on Google and Facebook "speaks volumes as to the magnitude of what's going on here and the importance of what we're doing," Peterson, the Nebraska AG, said.
The new posture in Washington and state capitals towards Silicon Valley represents a significant shift from just a few years ago, said David Dinielli, a former special counsel at the Justice Department's antitrust division.
After a long period in which tech companies were "romanticized as simply a couple of computer geeks in a garage," regulators and politicians now recognize they "have much greater force in our political lives, our personal lives, our family lives, and frankly, the working of our democracy," Dinielli said.
The cascade of lawsuits is "a remarkable coalescence that we have been remiss in examining the ways in which these companies have gained a foothold in every aspect of our lives and are operating for profit," he added.
Google is a particularly ripe target because of its starring role in that most fundamental online activity: looking something up. After all, the word "Google" has become a verb meaning "to search the Internet," the Justice Department said in its lawsuit.
"This is different than going to the card catalogue at the local library," Dinielli said. "Google has decided what to put on that first screen for Google's interests, not for ours."
The latest spotlight on Big Tech inevitably evokes comparisons to the last time the federal government and states took on the dominant force in technology: Microsoft, in the 1990s.
Like in that case, the lawsuits against Google and Facebook are likely to go on for years, and will involve difficult questions about whether the companies should be broken apart.
While Microsoft avoided being split up, it's widely agreed that the legal battle did change the company's behavior — and gave rise to a new generation of tech stars.
"Some people argue that if we hadn't brought the case, there would not have been a Google," said Iowa Attorney General Tom Miller, who led the states involved in the Microsoft case. (Miller became the longest-serving state attorney general in U.S. history earlier this year.)
"Of course, there is some irony if we produced Google and now Google is the monolith that we have to sue," he laughed.
Editor's note: Google, Facebook, Microsoft, Apple and Amazon are among NPR's financial supporters.