close

News

News

California scorns fossil fuel but can’t keep the lights on without it


“The emphasis that the governor has been making is ‘We’re going to be Climate Leaders; we’re going to do 100 percent clean energy; we’re going to lead the nation and the world,’” said V. John White, executive director of the Sacramento-based Center for Energy Efficiency and Renewable Technologies, a non-profit group of environmental advocates and clean energy companies. “Yet, at least a part of this plan means going the opposite direction.”

That plan was a last-minute addition to the state’s energy budget, which lawmakers in the Democratic-controlled Legislature reluctantly passed. Backers say it’s necessary to avoid the rolling blackouts like the state experienced during a heat wave in 2020. Critics see a muddled strategy on energy, and not what they expected from a nationally ambitious governor who has made climate action a centerpiece of his agenda.

The legislation, which some Democrats labeled as “lousy” and “crappy,” reflects the reality of climate change. Heat waves are already straining power capacity, and the transition to cleaner energy isn’t coming fast enough to meet immediate needs in the nation’s most populous state.

Officials have warned that outages would be possible this summer, with as many as 3.75 million California homes losing power in a worst-case scenario of a West-wide heat wave and insufficient electrical supplies, particularly in the evenings.

It’s also an acknowledgment of the political reality that blackouts are hazardous to elected officials, even in a state dominated by one party.

Newsom emphasized that the money to prop up the power grid, part of a larger $4.3 billion energy spending package, is meant as a stop-gap measure. The bill allows the Department of Water Resources to spend $2.2 billion on “new emergency and temporary generators, new storage systems, clean generation projects, and funding on extension of existing generation operations, if any occur,” the governor said in a statement after signing the bill.

“Action is needed now to maintain reliable energy service as the State accelerates the transition to clean energy,” Newsom said.

Following the signing, the governor called for the state California Air Resources Board to add a set of ambitious goals to its 2022 Scoping Plan, which lays out California’s path for reducing carbon emissions.

Among Newsom’s requested changes is a move away from fossil fuel, asking state agencies to prepare for an energy transition that avoids the need for new natural gas plants.

Alex Stack, a spokesman for the governor, said in a statement that California has been a global leader in reducing pollution, and pointed to Newsom’s recent letter to the Air Resources Board as well as one sent to President Joe Biden outlining how states can work with the federal government to combat climate change.

“California took action to streamline permitting for clean energy projects to accelerate the build out of clean energy that is needed to meet our climate goals and help maintain reliability in the face of extreme heat, wildfires, and drought,” Stack said.

But the prospect of using state money on fossil fuel power, even in the short term, has raised ire among the state’s many environmental advocacy groups, and raised questions about whether California will be able to achieve its goals.

“What is so frustrating about an energy bill like this is that we are at crunch time to meet these goals,” said Mary Creasman, CEO of California Environmental Voters. “And we’re investing a scale of funding into things that exacerbate those goals.”

With climate change-induced drought and high temperatures continuing to ravage the West, California anticipates the demand on the grid will only continue to grow. Despite more than a decade of bold posturing and efforts to transition to solar, wind and hydropower, the state worries it doesn’t have enough renewable energy sources on hand to keep the power on in an emergency right now.

The specter of power outages poses a hazard to Newsom, and Democrats in general, especially ahead of November. While the governor is widely expected to sail to reelection, rolling blackouts are a serious political liability — in 2003, they were the catalyst for recalling Democratic Gov. Gray Davis. A lack of power isn’t just about people sweating in the dark, said Steven Maviglio, a longtime Democratic consultant who served as communications director for Davis, it can affect businesses, travel and have an outsized impact on the economy.

It behooves any state official to keep the power on, but, unlike Davis, Newsom is under serious pressure to make sure the state also adheres to its climate goals.

“Gavin Newsom’s brand is based on climate change and clean air, so it’s a little more difficult for him to say ‘well that’s not as important as keeping the power on,’” Maviglio said.

The same bill effectively ends local government control over those projects, for the time being. It hopes to speed up the state’s production of renewable energy sources by giving exclusive authority over the siting of those projects to a single state agency for the next seven years.

Environmental advocates say the state is now scrambling to address an issue they’ve long known was coming. In 2010, California officials set a schedule to retire a number of coastal gas plants that rely on what’s known as once-through cooling systems, which are damaging to the environment, especially marine life. Many of those plants have been retired since 2010, but others have received extensions.

The remaining plants have various deadlines for when they must cease operations, with the soonest being the end of 2023.

Also at issue is the embattled Diablo Canyon nuclear power plant, California’s largest electricity source. The Pacific Gas & Electric-owned plant is scheduled to close in 2025, but the strain on the grid has officials considering the possibility of seeking an extension. Newsom said earlier this spring he would be open to extending the life of the plant. Doing so would also require federal approval.

The International Brotherhood of Electrical Workers 1245, a labor union, sees the energy package as a way to preserve Diablo Canyon, and jobs at the plant.

“The value to 1245 PG&E members at Diablo Canyon is clear — funding to keep the plant open,” the union said of the bill.

Assemblymember Al Muratsuchi (D-Los Angeles) criticized the bill as “crappy” when it came to the floor in late June, describing it as “a rushed, unvetted and fossil-fuel-heavy response” to the state’s need to bolster the grid.

“The state has had over 12 years to procure and bring online renewable energy generation to replace these once through cooling gas power plants,” Muratsuchi said. “Yet, the state has reneged on its promise to shut down these plants, not once, but twice already.”

Not all details of the state’s energy budget are final. Lawmakers still have $3.8 billion to allocate when they return on Aug. 1 for the final stretch of the year.

Creasman, at California Environmental Voters, said she wants lawmakers to set specific guidelines for how and where it will spend the $2.2 billion when they return in August to dole out the remaining money in the budget. Newsom and legislators also need to ensure that this is the last time California has to spend money on fossil fuel, she said.

“Californians deserve to see what the plan is to make sure we’re not in this position again of having to choose between making climate impacts worse or keeping our lights on,” Creasman said. “That’s a false choice.”



Source link

read more
News

Biden administration making plans to use public health emergency authorities to combat monkeypox


The memo comes as more than 6,600 monkeypox infections have been reported in the United States, a number that has risen sharply over the past weeks. The rapid spread — more than 1,200 cases have been reported in the last three days — has ratcheted up pressure on the Biden administration to declare the outbreak a public health emergency, as critics and health experts accuse the White House of failing to mount an aggressive push to distribute treatments and vaccines.

Even as the Biden administration has pushed people who may be at risk to get vaccinated, shortages have been reported across the country, especially in New York, the epicenter of the country’s outbreak.

HHS announced last week that it expects to ship an additional 800,000 vaccine doses in the coming weeks, though health experts anticipate that will still be well short of the supply needed to contain the outbreak.

The World Health Organization on July 23 declared monkeypox a public health emergency of international concern. Since then, California, Illinois and New York have declared their own states of emergencies.

Federal health officials in recent weeks had debated whether to declare monkeypox a public health emergency. Among the concerns was that the move could further stigmatize the disease, which has overwhelmingly affected men who have sex with men, said one person with knowledge of the matter.

But LGBTQ groups focused on the monkeypox response have voiced support for declaring the outbreak an emergency. And senior health officials ultimately concluded that the emergency declaration could unlock new authorities that might speed distribution of vaccines and treatments for monkeypox that have so far been in short supply.



Source link

read more
News

Why Biden 2024 ties some Democrats in knots


And some can’t understand why the question is even being asked.

“He’s the president. I support him, and the voters decide. He decides. I don’t even understand why that’s a question today,” said Patty Murray, the No. 3 Senate Democratic leader who’s facing a promising GOP recruit this fall in the blue state of Washington.

Sometimes it’s subtle, like a Democrat saying “if” Biden runs they will support him. In rare instances it’s direct, like Minnesota Democratic Reps. Angie Craig and Dean Phillips calling for a “new generation” of Democrats to take over.

Rep. Carolyn Maloney (D-N.Y.) said during a Tuesday debate that she didn’t think Biden is running again, only to later put out multiple statements clarifying that she’d support him if he runs. Her reelection opponent, Rep. Jerry Nadler (D-N.Y.), said at the same debate that it’s “too early to say” if Biden should run.

Swing-state Sen. Mark Kelly (D-Ariz.) said he rarely gets asked about Biden but “if he runs for re-election, I’ll support him.” Kelly described his focus as passing the Democrats’ tax, climate and health care bill: “I don’t spend much time thinking about the top of the ticket.”

Sen. Michael Bennet (D-Colo.), another incumbent the GOP is trying to topple this fall, said simply that Biden has “said that he’s going to run again, and that’s his decision to make.”

“It’s impossible to express the level of gratitude for Joe Biden having run for president to begin with. Because he was the only person of 330 million Americans who could have beaten Donald Trump. And he did beat Donald Trump,” Bennet said.

In the 2020 presidential primary’s early days, Biden accrued a wealth of Hill support that later proved invaluable, particularly from House Majority Whip Jim Clyburn (D-S.C.). Biden powered past a slew of rivals, including several sitting Democratic lawmakers, partly due to his electability advantages over Trump. Polls still show him as perhaps the former president’s biggest threat in a rematch.

“President Biden has emphasized that he intends to run for re-election,” said White House spokesperson Andrew Bates, who added: “Right now his focus is not on himself, but on the stakes for families because of the contrast between our agenda” and Republicans’.

Support for Biden across the party hasn’t exactly been sky-high on Capitol Hill over the last year: Democrats have lashed out against the White House’s failure to get more of its domestic agenda done — and for its messaging flops on what has actually gotten passed. Outbursts about Biden’s handling of inflation or Covid haven’t been uncommon, especially on the House side.

Democratic leaders publicly support Biden, even as they equivocate somewhat on whether the oldest president in U.S. history should try to tack on four more years. Senate Majority Leader Chuck Schumer (D-N.Y.) said “if he runs, I’ll support him.” And House Majority Leader Steny Hoyer (D-Md.) similarly praised Biden for “doing a good job” as president, even as he responded to a question about Biden’s future much like Nadler did: “Getting into this game this early is not very productive.”

The party’s presumptive nominee in the Wisconsin Senate race, Mandela Barnes, similarly says he’s happy to have the conversation after the midterms. And Sen. Joe Manchin (D-W.Va.), who’s finally given Biden the big party-line bill he’s been seeking for a year, has repeatedly declined to back the president for 2024. Manchin told MSNBC on Tuesday that “I’m not going to talk about it.”

While speculation over Biden’s reelection choice remains a popular Washington parlor game, many Democratic lawmakers are aghast that their colleagues would engage with the question publicly. The timing couldn’t be worse, they say, considering Biden’s on the verge of clinching much of his agenda on manufacturing, climate, taxes, deficit reduction and health care while taking out al Qaeda leader Ayman al-Zawahri.

“I don’t understand” why more Democrats aren’t discussing that this “has arguably been the most successful week of his entire presidency,” Rep. Ro Khanna (D-Calif.) said. “There’s almost a conventional wisdom of ‘let’s just get in the press knocking the president.’”

If Biden were to run, some of his previous primary opponents may stand down. Sens. Elizabeth Warren (D-Mass.) says Biden “should be running” and Bernie Sanders (I-Vt.) said he’d back Biden if he runs. Sen. Amy Klobuchar (D-Minn.) said on Wednesday: “The president has said he’s planning to run again, and I plan on supporting him.”

Still, senior Democrats said in interviews that they feared open support for a Biden 2024 bid could become a painful new litmus test for a midterm campaign that’s found many of their vulnerable members already keeping the president at a distance. So far, their party has remained competitive with the GOP on the so-called generic ballot — where the question is just about control of Congress — and they hope to keep it that way.

Throwing the question of 2024 into the midterms, however, could imperil the House’s battleground Democrats. Many of them hold seats where Biden had a double-digit lead in the last election, only to see it all but evaporate now.

Biden’s future is plainly toxic among at-risk House Democrats. One aide to a member in a tough race said their boss wouldn’t go near the issue “with a ten-foot pole.” Another called it a “distraction” that could destroy any chance they have of running hyper-local campaigns designed to deflect from GOP attempts to pin every Democrat to Biden.

So few in the party were surprised when Phillips — who’s criticized Biden previously — said last week that the president shouldn’t run for reelection. Craig, Minnesota’s most vulnerable Democrat and a friend of Phillips, followed shortly after.

Those comments earned some pushback on Capitol Hill on Wednesday. Senate Majority Whip Dick Durbin (D-Ill.) deemed the duo “out of cycle” with their comments and Sen. John Hickenlooper (D-Colo.) declared: “If he decides he wants to run, he deserves our support.”

“I’m a little puzzled by people talking about 2024 when we’ve got November 2022 elections staring us in the face,” said Sen. Tim Kaine (D-Va.), who added that Biden needs to make a re-election call himself. “It just makes me scratch my head.”

Still, it’s not like there’s a ton of clamoring for Biden to get going; in some ways, the Democratic hedging is an echo of the GOP’s public ambivalence about a third Trump run.

“I’m not going to be telling him what he should do or shouldn’t do,” battleground-district Rep. Tom Malinowski (D-N.J.) said recently when asked about Biden. “I think he’s done a lot of good and smart things. I think there’s more that can be done.”

And Sen. Jon Tester (D-Mont.), himself undecided on reelection in 2024, also stayed positive — as well as above the fray.

“That’s Joe Biden’s call. I think Joe Biden’s had a pretty damn good week this week,” he said. “I would want [congressional support] if I was president.”



Source link

read more
News

U.S. says Russia aims to fabricate evidence in prison deaths



The Ukrainian military denied making any rocket or artillery strikes in Olenivka. The intelligence arm of the Ukrainian defense ministry claimed in a statement Wednesday to have evidence that local Kremlin-backed separatists colluded with the Russian FSB, the KGB’s main successor agency, and mercenary group Wagner to mine the barrack before “using a flammable substance, which led to the rapid spread of fire in the room.”

The official, who was not authorized to comment publicly and spoke on the condition of anonymity, said the classified intelligence — which was recently downgraded — shows that Russian officials might even plant ammunition from medium-ranged High Mobility Artillery Rocket Systems, or HIMARS, as evidence that the systems provided by the U.S. to Ukraine were used in the attack.

Russia is expected to take the action as it anticipates independent investigators and journalists eventually getting access to Olenivka, the official added.

Ukraine has effectively used HIMARS launchers, which fire medium-range rockets and can be quickly moved before Russia can target them with return fire, and have been seeking more launchers from the United States.

Earlier Wednesday, United Nations Secretary-General Antonio Guterres said he is appointing a fact-finding mission in response to requests from Russia and Ukraine to investigate the killings at the prison.

Guterres told reporters he doesn’t have authority to conduct criminal investigations but does have authority to conduct fact-finding missions. He added that the terms of reference for a mission to Ukraine are currently being prepared and will be sent to the governments of Ukraine and Russia for approval.

The Ukrainian POWs at the Donetsk prison included troops captured during the fall of Mariupol. They spent months holed up with civilians at the giant Azovstal steel mill in the southern port city. Their resistance during a relentless Russian bombardment became a symbol of Ukrainian defiance against Russia’s aggression.

More than 2,400 soldiers from the Azov Regiment of the Ukrainian national guard and other military units gave up their fight and surrendered under orders from Ukraine’s military in May.

Scores of Ukrainian soldiers have been taken to prisons in Russian-controlled areas. Some have returned to Ukraine as part of prisoner exchanges with Russia, but other families have no idea whether their loved ones are still alive, or if they will ever come home.



Source link

read more
News

How the newest megadonor wants to change Washington


What gets Gabe out of bed — a twin inside a closet-turned-bedroom in a house he also shares with several roommates — is preventing the next pandemic.

Gabe, 27, and Sam, 30, are deeply influenced by “effective altruism,” a philosophical and social movement that’s defined by maximizing good through a data-driven framework — an unusual lens for engaging with politics. Philanthropically, it means testing and measuring efforts through a cost-per-life-saved formula. For example, an experiment showed investing in treating children for intestinal worms did more to improve their educational outcomes than providing schools with extra resources for textbooks.

In politics, that’s led Sam Bankman-Fried to dual objectives. There’s the one he has talked about most: preventing the next pandemic, which he fears could be more lethal than Covid-19 and would pose a huge threat to humanity, an obsession for effective altruists. His other goal is solving the gridlock in Washington by turning down the partisan temperature and supporting candidates who “are just going to take a constructive approach in D.C.,” he said.

“There’s huge amounts of good that can be done by a government that works constructively … versus a zero-sum vision of government,” Bankman-Fried said. And the tone and tenor of government, he continued, has “a massive, massive impact on what life is like in the United States” and the rest of the world.

Effective altruism — whose followers connect through a sprawling network of internet forums, blogs and conferences — was founded in the late 2000s by academics at Oxford University, building off the work of philosophers, like Derek Parfit, who argued that the 21st century would be “the most dangerous and decisive period” of existence for humankind, and Princeton University’s Peter Singer, who pushed for more effective philanthropy.

Bankman-Fried was first drawn into this world through animal welfare. “Quantitatively, you enjoy eating a nice meal for 30 minutes and there’s five weeks of torture that went into producing that,” he said. He went vegan his freshman year at Massachusetts Institute of Technology. He then came to the “earning-to-give” model of philanthropy — working to earn a ton of money in order to give it all away. The money-earning part happened quickly: After college, he worked on Wall Street for several years before founding Alameda Research, a cryptocurrency trading firm, in 2017, and earning millions off of crypto arbitrage.

Another aspect of this movement the Bankman-Frieds believe in is “longtermism” — that humanity has a moral obligation to future generations as well as to those alive now. That makes a global threat, like a pandemic even more lethal than Covid, a five-alarm-fire problem that’s not being broadly addressed by Washington.

“Covid has killed 100 times as many people as [those who died on] 9/11 and we spent a trillion dollars on foreign interventions, created the Department of Homeland Security and radically transformed our foreign policy — and we did nothing after Covid,” Gabe said. “If we really wanted to protect against another pandemic, then … we need the kind of bipartisan cooperation and support for this, for biosecurity in a post-Covid world, that we have for national security and a post-9/11 world.”

Gabe started advocating on behalf of pandemic funding in the Democratic Party’s massive social spending legislation last summer, but he watched in dismay as the number shrank as the package got whittled down. When he’d meet with members of Congress or senior staffers on behalf of his newly founded nonprofit — Guarding Against Pandemics, led by Gabe and seeded by his brother’s cash — Gabe kept hearing that even though they agreed preventing the next pandemic was important, it wasn’t their number one issue.

“No one in the room was sticking up for it,” he said. “It was clear that to build this movement, we needed to start earlier, look upstream.”

Heading upstream meant changing tactics from convincing current lawmakers to electing new ones — endorsing and supporting candidates for open House seats who prioritized pandemic funding and showed a willingness to work in a bipartisan way to get it done. By spring, two super PACs sprang up: Protect Our Future, funded by Sam Bankman-Fried, which focuses exclusively on Democratic House primaries; and American Dream Federal Action, which spends on Republican Senate and House primaries and is funded by his FTX partner, Ryan Salame.

Along with the rapid organizational growth came a growing political staff around the Bankman-Frieds. They work closely with Michael Sadowsky, who serves as the president of Protect Our Future and previously worked with Gabe at Civis Analytics, a Democratic data firm. Dave Huynh, who worked on Kamala Harris’ presidential primary bid, and Sean McElwee, who leads Data For Progress, a Democratic polling firm, are both advising on political projects. This spring, Sam also hired Jenna Narayanan, a longtime adviser to California megadonor Tom Steyer, to work with him on his political giving.

Narayanan’s hiring, in particular, says something about Bankman-Frieds’ ambition to be something more than an ATM for a party. He specifically compared his vision for a political operation more to what Steyer built — starting the climate-focused NextGen, “a policy-based platform” — than the way, say, the late Republican megadonor Sheldon Adelson focused more on distributing money to “purely partisan” political organizations, Bankman-Fried said.

They’ve also gotten office space — a sparse townhouse steps from the U.S. Senate where Gabe runs Guarding Against Pandemics, a physical sign of the group’s long-term ambition to be a presence in Washington. And last month, FTX launched its own corporate PAC, another group in the constellation of political outfits now surrounding Bankman-Fried.

Guarding Against Pandemic has endorsed 22 Democrats and 15 Republicans, a mix of incumbents and first-time candidates. Protect Our Future and American Dream Federal Action have intervened in a subset of those races: Since January, Protect Our Future spent nearly $22 million on TV ads in 17 primaries, while American Dream Federal Action dropped $10 million on TV ads in 15 races, according to the ad-tracking firm AdImpact.

Nearly all of the primaries where Guarding Against Pandemics has endorsed — and where those super PACs spent — are in safe blue and safe red seats. That’s an explicit strategy on behalf of the Bankman-Frieds, who see primaries as a more cost-effective route to building support for pandemic funding — the same way groups like EMILY’s List on the left and the Club for Growth on the right have seen open primaries as an economical way to build power in Washington.

Playing in both parties’ primaries also keeps the effort bipartisan, which Gabe Bankman-Fried described as “very deliberate.”

“We’ve seen people try to only build power within one party and fail at achieving their goals because, frequently, we have a divided government,” Gabe said. Former Rep. Max Rose (D-N.Y.), another Guarding Against Pandemics-endorsed candidate running for his old seat this year, echoed the thought: “I can guarantee that over the course of the next half century, Democrats will have the keys to the castle and Republicans will have the keys to the castle, so when it comes to an existential threat, it has to be bipartisan.”

Through it all, Gabe Bankman-Fried said, “I want to be really clear with D.C., the machine writ large, that we are an issue-based organization.”

“We’re playing a long-run game here, where even if the champions we elect lose power in two years, they’ll gain power again at some point,” Sadowsky added.



Source link

read more
News

‘A movie set’: Former supervisor at baby formula plant says flaws were hidden


“The plant would prep heavily before audits,” the former supervisor said. “The plant basically turned into a movie set where only things the higher ups wanted the FDA to see were seen.”

The revelations come after the plant reopened for production July 1. The plant had been shut down from February to June after the FDA found insanitary conditions in the plant. The plant briefly re-opened then shut down again after a severe storm in mid-June left the plant partially flooded.

Despite the plant reopening and a Biden administration effort to fly formula in from Europe and Australia since May, retail stocks of infant formula have worsened and it’s still common for parents to see shelves that are sparse — five months after reports of infant hospitalizations and deaths sparked a massive recall of Abbott Nutrition products.

Abbott disputed the former employee’s characterization of the plant.

“The claims made by this unnamed source … are either inaccurate or completely taken out of context,” said Scott Stoffel, divisional vice president of external communications and public affairs at Abbott.

Stoffel said that without knowing the identity of the person making the claims it was impossible to verify their employment, what they had knowledge of or the circumstances under which they left the plant.

The FDA, asked to explain why problems were not caught earlier, contended that inspections are just one part of food safety oversight and that ultimately it’s up to manufacturers to assure the safety of their products every day.

“We take seriously our duty to prevent and respond to foodborne illnesses and food contamination events,” an FDA spokesperson said.

Lawmakers on both sides of the aisle have raised questions about the FDA’s handling of the incident, as questions remain about why federal regulators didn’t take action sooner.

After months of investigation, the FDA has said it cannot definitively link the hospitalizations and deaths to the formula plant, nor can it rule out a link. The agency found five strains of Cronobacter in the plant in early 2022, but none of the strains have matched the limited samples the government has to compare them to. One huge challenge for investigators is that Cronobacter sakazakii, the bacteria to blame, is not a reportable condition, which means that illnesses are not routinely reported to the CDC’s public health monitoring system. This means federal officials lack much of the evidence they’d normally have for an investigation like this.

Still, FDA Commissioner Robert Califf in May blasted the plant for having “egregiously unsanitary” conditions.

“Frankly, the inspection results were shocking,” Califf told lawmakers before a House Energy and Commerce subcommittee hearing on the infant formula debacle — a hearing that repeatedly drew on POLITICO’s reporting on the infant formula timeline as well as broader dysfunction within FDA’s food program.

The former supervisor, whom POLITICO independently confirmed worked at the plant, corroborated many of the warnings that had been raised directly to FDA by a separate whistleblower in Oct. 2021, as first reported by POLITICO. The warnings from the first whistleblower were sent to top FDA officials, but it took the agency months to respond to them, during which time FDA received more reports of infant deaths and hospitalizations from a rare bacterial infection. The agency initially blamed the mailroom, contending that agency leadership didn’t receive the documents, but later conceded that it took too long to act. FDA is now reviewing its handling of the incident.

Abbott has pushed back strongly against that whistleblower, claiming repeatedly that the employee was “dismissed due to serious violations of Abbott’s food safety policies.”

“While at the company, the former employee did not bring forward product safety violations to our Office of Ethics & Compliance or others,” Stoffel said, in a new statement, acknowledging that the employee had also filed a complaint to Michigan OSHA about a situation where an employee fired a stun gun at the plant. (The complaint was later dismissed by the state agency.)

The company said the first whistleblower’s lengthy warning to FDA — which was sent to the agency in October, five months before the agency shut down the plant — “added still more allegations, continuing a pattern of ever-evolving, ever-escalating allegations.”

The former supervisor came forward recently citing many of the same concerns outlined by the first whistleblower, including improper cleaning and recordkeeping, but also described an overarching culture of fear, where employees were discouraged from raising concerns about food safety or other problems to management, as well as a history of cost-saving measures that sometimes conflicted with safety.

“Management purposefully took the largest market share they could in a plant that they knew had issues, that they weren’t funding properly — and then when they finally dropped the ball, they left these families that are on fixed incomes with babies completely out to dry,” said the former supervisor.

The former supervisor said they often encountered instances where employees felt they could be fired for raising any type of concern. “I kept hearing over and over and over again, ‘yeah, you’ve got to be careful if you start bringing stuff up. You can just disappear around here,’” the former supervisor said.

The company disputed that the plant had a problematic culture. “Abbott has a customer pledge that we make our products as if they are intended for our own families,” Stoffel said, in an email. “Many of our Sturgis employees come from families who have worked there for generations. They know how important their work is and are committed to quality and safety.”

The Sturgis plant has for the past decade held “daily safety meetings with employees throughout the facility to share information in an open forum about what’s working well and areas for improvement,” Stoffel said.

Management was able to impose a higher level of loyalty because the Abbott Nutrition plant is one of the last large employers in Sturgis, Mich., which has lost other manufacturing jobs, much like the rest of the Rust Belt, the former supervisor said.

Plant management commonly discussed the company’s goals to further dominate the U.S. formula market, they recalled: “Upper management was bragging about it all the time: ‘We’re feeding one in five babies and we’re going to feed one in four and then one in three from this single plant.’”

The company said these comments were “taken completely out of context.”

“We talk about serving one in five American babies to remind ourselves of the critically important role we play in family’s lives,” Stoffel said.

The new details raise additional questions about the rigor of FDA inspections and the agency’s oversight of infant formula, which is supposed to be among the best-regulated foods.

The Sturgis plant often had plenty of notice before FDA inspectors would show up. For four years in a row, from 2016 to 2019, for example, the agency did its annual inspection at around the same time in September, according to a review of inspection records. Inspections are technically unannounced, but scheduling them at the same time for years made the timing predictable. During that period, the plant was largely given a clean bill of health by the agency. In 2019, the plant was cited for one issue: The company wasn’t pulling the right number of samples in its final products to test for bacteria.

For weeks leading up to the FDA’s visits, employees would pull extra overtime cleaning and conduct more frequent internal audits to find and fix any potential issues ahead of time, the former supervisor said. When the FDA did arrive, it was usually just a couple of inspectors and they largely reviewed the plant’s own records — a common practice that checks to see if a plant has the right control systems in place, but can also limit in-person observation. The Sturgis plant is 787,000 square feet — which is the equivalent of more than 13 football fields — and sits on 94 acres.

The company countered that prepping for audits is not unusual.

“Again, this has been taken completely out of context,” Stoffel said. “Our focus 365 days a year is to provide the highest quality formula. Of course, though, you prepare extensively for visitors just as you would if you were having guests over to your home.”

Infant formula plants are generally inspected by the FDA at least once per year because they produce food for a particularly vulnerable population — not just infants, but also children and adults with special medical needs. During the pandemic, the FDA didn’t show up at the Sturgis plant in 2020, which left a two-year gap. The agency had stopped doing nearly all food safety inspections, except for ones that were deemed “mission critical” on a case by case basis.

“FDA acknowledges that Covid-19, particularly during this early period of the pandemic, impacted FDA’s ability to provide the preferred level of inspectional oversight,” an agency spokesperson said in a statement. “FDA’s temporary change in inspection frequency was FDA’s best adaptation at the time to an unprecedented global pandemic that included balancing the safety of FDA and industry staff.”

When two inspectors did return in 2021 — again around the same time in September, the fifth time in a row they had done so — they cited the plant for some problems, including standing water and some equipment issues, but nothing serious enough to warrant regulatory action.

As POLITICO previously reported, those inspectors were coincidentally in the Sturgis plant the very day the FDA was told that a baby had been hospitalized with Cronobacter sakazakii, a bacteria that causes rare and deadly infections in infants, after consuming formula from the plant. After three more infant hospitalizations were reported, including two deaths, and an interview with the first whistleblower in late December, the FDA went back into the plant in late January and found numerous problems that were not listed in the agency’s inspection report from four months earlier.

The plant had notice that FDA would be coming. The agency revealed to Congress this spring that officials had contacted the company on Thursday, Dec. 30, about coming to inspect again on Monday, Jan. 3. The advance notice was given under FDA’s Covid-19 policy, the agency said.

Abbott requested FDA delay the inspection “due to an ongoing COVID-19 outbreak among its staff.” The agency agreed to a delay. By Jan. 11, however, a third Cronobacter complaint landed at the agency. On Thursday, Jan. 27, FDA told Abbott it was coming to inspect on Monday.

When FDA officials arrived Jan. 31 — a full month after the first notice from the agency — they found there were many, many more examples of water problems, among many other issues that were not cited in the agency’s inspection just four months earlier. Officials noted there had been more than 300 “water events,” such as leaks, condensation and standing water in the production area in the past two years, per the company’s own records.

Roof leaks had been a problem at Sturgis for years, the former supervisor said. Leaks were so common, in fact, the plant kept a stash of special plastic tarp catchers that hooked to the ceiling with hoses at the bottom to deal with the water, they recalled: “It leaked so often and in so many different places throughout the entire plant … the plant had a bunch of those in the stock room, because these leaks would just pop up all the time.”

The FDA did not dispute that there were major differences between the agency’s September 2021 routine inspection and the agency’s for-cause inspection in early 2022, but suggested the agency is looking to make improvements to its oversight of infant formula — something that comes amid pressure from Capitol Hill.

“An FDA inspection only provides a single snapshot in time of the operations, preventive controls, and compliance at a firm,” an FDA spokesperson said. “The firm has a responsibility to implement a constant system of sanitation and food safety controls to produce a safe product in compliance with FDA regulations.”

The spokesperson noted that the agency is currently “conducting an evaluation of our response to this incident to determine what additional steps could be taken to ensure the maximum effectiveness of agency programs and policies related to infant formula and medical food complaints, illnesses, and recalls.”  

Abbott disputed that it had constant problems with leaks.

“We have experienced occasional leaks over the years from storms (it’s a 787,000 square-foot facility) but have procedures in place to address immediately and we document in our quality records,” Stoffel said.

It wasn’t just that the roof leaked, the former supervisor said, but water leaks also came from HVAC systems that were not large enough to work properly on a handful of packaging lines.

Employees believed the size issue to be a cost-cutting measure.

“They didn’t want to spend the money to size the HVAC properly,” the former supervisor said. The system would routinely get overloaded and extra water would “overflow back into the line through the wall,” which presented another potential contamination point.

The company pushed back on this, too: “We have more than 100 HVAC units in our 787,000-square foot facility in Sturgis and invest in them to ensure they are functioning properly.” The spokesperson said the HVAC units are all “sized correctly.”

Controlling moisture is important in any food plant, but it’s particularly important in areas that are handling dry material, in this case dry powdered formula destined to be fed to infants without a so-called kill step, which means the formula won’t be cooked or boiled before being consumed.

While poor conditions in the Sturgis plant have been well-documented by the FDA and others, a federal investigation into whether the reported infant illnesses and deaths were caused by formula made in the plant has not been conclusive. Officials have also lacked key pieces of evidence due to holes in public health reporting.

The FDA in June announced it had received a third report of an infant death from Cronobacter. The agency has not yet said whether it determined the latest death was linked to the formula or not. The case is still under investigation, the agency said. The FDA has received reports of nine infant deaths and dozens of other serious injuries, but the agency has determined three of the reported deaths are “associated” with the investigation.

Abbott maintains there is no link between its plant and any of the infant deaths or hospitalizations.

The Sturgis plant, which was originally built in the 1940s and has expanded several times over the years, was still using equipment that’s several decades old, the former supervisor said. One line, known in the plant as “Line 3,” was still packaging product — mostly EleCare, the plant’s signature elemental formula for those with special medical needs — despite having been first put into use in the 1980s.

“Line three was very old and it was poorly designed,” the former supervisor said. “It was up to code in the 80s. It turns out we’ve learned some things since then.”

Abbott had for years planned to bring on a new line, “Line 5,” to replace that old infrastructure, but the new line struggled to perform due to numerous design short cuts, the former supervisor said. The former supervisor recalled being told by quality personnel that the short cuts were taken to save costs.

“They cut corners and they cut the budget,” said the former supervisor, who had reviewed earlier versions of the plans. Some of those cuts were directly related to food safety. The new packaging line had originally been designed to be what’s known as “clean-in-place,” or CIP, an industry term that essentially means equipment can be automatically cleaned with minimal disassembly, reducing the potential for human error.

Abbott did not dispute that Line 5 had some issues, but pushed back on the suggestion that safety measures were inadequate.

The company challenged the claim that the change from clean-in-place was an issue. “CIP is simply a cleaning method,” Stoffel said. “We determined to use a different cleaning method that’s just as thorough.”

The former supervisor also outlined problems with the Line 5 can-seamer — a machine that seals the formula cans. This particular seamer caused many worker safety and food safety issues, they recalled.

The company acknowledged that there had been “some technical challenges” with this seamer and said that it had been replaced.

“We invested tens of millions of dollars to create a state-of-the art production line,” Stoffel said. “Like with any line, we closely monitor to ensure everything is operating properly.”

House Appropriations Chair Rosa DeLauro, who has publicly lambasted both Abbott and the FDA for the infant formula debacle in recent months, praised the former employee for coming forward with new details about conditions in the plant and questionable management.

“Their revelations highlight Abbott’s investment in profit over people — as the company time and time again seemed more interested in cornering its share of the market instead of ensuring the product we give to our babies meets the highest food safety standards,” DeLauro said in a statement to POLITICO.

“This employee’s accounting of events highlights the need to uncover answers as to what went wrong at Abbott as swiftly as possible,” said the Connecticut Democrat. “I will continue to fight for these answers, and to demand accountability for wrongdoing that led to contaminated product that sickened and even killed several babies. We owe it to American families to get to the bottom of this.”



Source link

read more
News

U.S. monkeypox response stirs up anxious memories of AIDS era for activists


A “reason people are feeling the parallels so acutely now is because of the rise in anti-LGBTQ sentiment, which preceded HIV, also,” said France, now a filmmaker whose work includes “How to Survive a Plague,” an Oscar-nominated documentary on the AIDS response.

He and other advocates have increasingly criticized the Biden administration, and the health community worldwide, for moving too slowly on monkeypox testing and vaccines, and failing to clearly communicate the risks of the disease to the community it has overwhelmingly affected: men who have sex with men. This year’s first confirmed U.S. case of monkeypox was recorded on May 18; there are now more than 6,320 nationwide — a number expected to rise significantly.

“I’m angry beyond belief that we’ve let it spread this far, and that the federal government couldn’t get its act together to figure out how to ramp up testing rapidly, to figure out how to do active surveillance to make sure that vaccines and treatments were here when they needed to be,” said Gregg Gonsalves, a global health activist and an epidemiologist at Yale University.

The administration seems to finally be hearing these concerns. On Tuesday, in a move to improve the response and blunt criticism, President Joe Biden named leading officials at the Federal Emergency Management Agency and the Centers for Disease Control and Prevention to head the national monkeypox response.

Robert Fenton, a longtime FEMA official, won the White House’s trust during the Covid vaccine rollout for his help in standing up the administration’s network of Covid vaccine sites. He’s expected to manage the logistics at the center of the response, including efforts to speed distribution of tests and vaccines. Demetre Daskalakis, who will be Fenton’s deputy, helped lead the CDC’s work on HIV/AIDS and is well-known for his work engaging the LGBTQ community on public health issues — expertise that is likely to guide the administration’s bid to slow transmission in the hardest-hit areas.

The question is whether such moves came too late.

Until recent weeks, the White House had largely left it to the health department to direct the monkeypox response. But the department’s leadership has struggled to coordinate the sprawling effort, leading to vaccine and testing shortages and intense criticism from activists and health experts. The response continues to be hampered by difficulties collecting data from individual states, allowing cases to spread throughout the nation largely unseen.

Gonsalves noted that there was a lack of a proactive and cogent response from governments across the world, which he said should have been better prepared after AIDS and especially the Covid-19 pandemic. The U.S. government in particular, he argued, was again caught flat-footed. He blamed “our shitty public health and pandemic preparedness in general, but the sort of wishful thinking out of the White House is just astounding.”

While monkeypox, unlike AIDS, has a vaccine, the disease is spreading rapidly enough to compel people who lived through that past crisis to see parallels to this one. Chief among them, a growing sense among activists that, decades later, public health officials are making missteps that could again leave LGBTQ people feeling like an afterthought.

“This time, they had the tools, right?” France said. “They had the vaccines and they had a connection with the community, which they could message about prevention.”

But there are obvious shortcomings in the parallel too, as Biden administration officials are quick to note. And it’s not just because no one in the United States is known to have died from monkeypox. The disposition of the White House towards the affected community is wildly different, too.

The Biden administration is taking the current outbreak seriously, said Harold Phillips, director of the Office of National AIDS Policy in the White House. He noted during the Reagan administration, the press secretary joked about AIDS with reporters during press briefings.

“There are some similarities between the community that is being impacted by this disease. The pain, suffering, the fear of stigma, but this was not a laughing matter this time in the White House,” Phillips said.

After the first confirmed U.S. case of monkeypox was identified in May, the Biden administration ordered 36,000 doses of vaccines within two days and 300,000 doses within the next month, White House aides said. Despite the initial shipments, shortages have persisted, especially in the hardest hit cities. Within the past week, states of emergency were declared in California, Illinois and New York over the spread of the disease.

“Public health in our country both is underfunded and also fragmented,” Phillips said, noting the current outbreak comes amid an ongoing pandemic and the emergence of increasingly virulent Covid variants.

“We all said during Covid we need to be ready and prepared for the next one. And I don’t think we expected this to come as soon as it did or as quickly as it did,” he said.

The move to add federal coordinators to lead the response has been met with cautious optimism by some advocates. But even health officials and experts concede there’s little at this point they can do to halt the spread of monkeypox until more vaccines come available. The U.S. is expected to have just 2 million shots of a two-dose vaccine by the end of the year, resulting in predictions of prolonged shortages.

The monkeypox outbreak in the meantime has grown exponentially, with case counts doubling each week. If transmission isn’t slowed soon, health experts worry, the country will lose any hope of containing the disease, allowing it to become entrenched as an indefinite threat.

France said increasing vaccines alone won’t be effective unless the administration also better coordinates its messaging to the community being affected. There may be more widely available treatments and more empathy for the afflicted than existed during the AIDS epidemic. But without constructive communication, it wouldn’t work as planned.

“Those of us like me who came up in the plague years of HIV, 15 years before there was any effective treatment, we learned how to put ourselves in ways that were safe and effective,” France said. “Here’s the message. Here’s the solution. Bring them both out at once. Then everybody knows what they need to do and they do it. And right now, that message isn’t there. Nobody knows where those vaccines are, if they’re even going to come, if the second dose is going to come. There’s, there’s nobody.”



Source link

read more
News

A key ingredient to flip the House: A wave of Latino GOP candidates


“The Hispanic community has felt kind of in the middle, ignored,” Ciscomani said. Democrats have taken them for granted, he noted, while Republicans have not often considered them to be persuadable voters.

“I will definitely not do either one of those,” he continued. “I spoke to them yesterday in Spanish in my acceptance victory speech — a good portion of that was devoted in Spanish to let our community know that we’re going to be reaching out.”

Taken altogether, GOP recruiters are working to build a large bench of Latino candidates who will be well-positioned to both win over Hispanic voters becoming increasingly disillusioned with the Biden administration and also offer a unique perspective on policy issues once in office.

“I went through the process of immigrating. My career has been on trade and commerce cross-border, and border security is my No. 1 issue,” Ciscomani said. “That’s what I’m taking to Washington in November.”

Besides Ciscomani, there are a slew of potential new members who could flip Democratic-held seats this fall.

The list includes Monica De La Cruz and Cassy Garcia, who are running for highly competitive two South Texas districts; Lori Chavez-DeRemer, a former mayor running for an open seat in Western Oregon; Yesli Vega, a Prince William County supervisor opposing Rep. Abigail Spanberger (D-Va.); and Michelle Garcia Holmes and Alexis Martinez Johnson, who are challenging two Democratic incumbents in New Mexico.

Congressional Republicans have long had a Latino presence from South Florida, where Cuban American voters have elected Cuban American Republicans to Congress. But this year’s recruits span nearly every region of the country and range from Brazilian to Mexican to Guatemalan descent.

And the party already had an early success in June, when Republican Rep. Mayra Flores won an upset special election victory in South Texas, ending nearly a century of uninterrupted Democratic control of the region. Her win offered both a model and inspiration for other Latino candidates.

“I remember having on my first sign, it said: ‘Familia first,’” Martinez Johnson recalled, worrying that some people in her New Mexico district would find the slogan unprofessional. “But then I saw Mayra Flores and she had it right there: Familia. Patria.”

“It spoke to who she was and it spoke to the community.”

The earliest signs of momentum appeared in 2020, when Latino candidates in Miami and West Texas rode a Trump-fueled surge to Congress. Reps. Carlos Gimenez (R-Fla.), María Elvira Salazar (R-Fla.) and Tony Gonzales (R-Texas) all won seats that swung hard to the right between 2016 and 2020.

Building off that momentum, House Republicans in May formed the Hispanic Leadership Trust, a PAC dedicated to electing more conservative Latino candidates. Led by Reps. Mario Diaz-Balart (R-Fla.) and Gonzales, the group aims to help mentor, recruit and raise money for candidates across the country.

It has the full backing of leadership, including House Minority Leader Kevin McCarthy.

“It’s not just talk, you’re seeing action,” said Gonzales who traveled to Arizona this month to campaign for Ciscomani and Tanya Wheeless, a Latina candidate running in the Phoenix suburbs in a primary where votes are still being counted.

“It’s always been, from both parties, they always show up two weeks before the election, say some broken Spanish and then get on the train and then get out of town,” he said. “This is much different. This is us showing up early, showing up often, being authentic.”

There are currently just a dozen Hispanic Republicans in the House, compared to 30 or so Democrats.

Nearly all of the current Hispanic GOP members are running again. And while a few will have tough races, the lead Rep. Jaime Herrera Beutler (R-Wash.) has staked out in her as-yet uncalled primary was a huge relief to her colleagues.

Some of the Latino candidates running in battlegrounds this year will have an easier path to Congress than others. Ciscomani, for example, is running in a district that is a true tossup.

Others, like the women in New Mexico, face longer odds in seats President Joe Biden won handily. They are also challenging incumbents who have far more campaign money to spend. Some GOP strategists, though, remain optimistic about Martinez Johnson’s district in northern New Mexico, because it was redrawn to include the state’s oil and gas industry and she is challenging Democratic Rep. Teresa Leger Fernandez, a supporter of a Green New Deal.

Martinez Johnson, an environmental engineer by trade, is trying to adopt a stance in the middle: “It’s either you are pro-oil and gas, or you’re all about sustainability. And in reality we have to merge the two,” she said.

Operatives are feeling increasingly positive about an open seat in Oregon where the GOP nominee is Lori Chavez-DeRemer, the first Latina and female mayor of Happy Valley.

In an interview, Chavez-DeRemer said she saw her ability to connect with Hispanics as an asset in the race. The Hispanic population in Oregon is relatively small, but among the fastest growing demographics, she said.

Party leaders encouraged her to run and helped connect her with other Latino candidates. She said keeps in touch the women running in South Texas: “We text back and forth, everybody stays in contact so that we can motivate each other.”

After 2020, she said it was clear the GOP saw her background and life experience as something desperately needed in their ranks.

“That balance of a woman, of a Hispanic woman, of a conservative, a business owner, a mayor, a mom, all those seem to be where the party was headed under this tent of diversity,” Chavez-DeRemer said. “And we saw that last cycle, and now we’ll compound that and add to it.”

A few more Hispanic and Latino Republicans could secure primary wins in August and September, including George Logan, a former state senator challenging Rep. Jahana Hayes (D-Conn.); Anna Paulina Luna, a Trump-backed veteran running for an open seat in Florida; and George Santos, the son of Brazilian immigrants who is running for an open seat on Long Island.

Democrats, particularly in South Texas, have long warned that their party needs to step up its outreach with Latino voters, especially after Flores’ win in the June special election. The Democratic Party is giving the GOP crucial inroads by taking Hispanic voters for granted, they said.

Several Republican Latino candidates running this election year said they or their family members used to be Democrats before the party drifted left. Recruiters claim the increase in Latino candidates is an outgrowth of that movement.

“We’re offering candidates that actually not only look and sound like the district but are focused on the issues that matter most to them,” said Rep. Tom Emmer, the chair of the House GOP campaign arm. “They believe in family, faith and freedom, and the opportunity this country offers. And they see our colleagues on the other side of the aisle killing the American dream.”



Source link

read more
1 414 415 416 417 418 546
Page 416 of 546