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Supreme Court weighs FDA's power to prohibit new vaping products for teens

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Supreme Court weighs FDA's power to prohibit new vaping products for teens

The Supreme Court on Monday did not sound ready to sharply limit the power of the Food and Drug Administration to prohibit the sale of new candy-colored vaping products aimed at teenagers.

Instead, the justices, both conservative and liberal, said Congress in 2009 gave the agency the power to stop the sale of new tobacco products, and it has used this authority in recent years to reject new vaping flavors with names like “Rainbow Road” and “Peachy Strawberry.”

This is exactly the kind of regulatory question that companies hope to get before the conservative Supreme Court, but it was not clear they will win this time.

Justice Brett M. Kavanaugh questioned the vaping industry’s claim of FDA overregulation, saying its objection rests with the law itself.

“You disagree with the statute giving this authority to FDA,” he told an attorney for two companies whose products were denied approval.

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Justice Elena Kagan agreed. “Everyone knows these flavors are particularly dangerous in terms of kids starting the use of smoking product,” she said. “The FDA has been upfront about this. There is not a lot of mystery here.”

The Biden administration defended the FDA’s stance.

The agency admitted it had two related goals. One was to persuade adults to quit smoking by switching to e-cigarettes with appealing flavors, but without encouraging millions of teenagers to start using a product with nicotine.

Eric Heyer, an attorney for two vaping companies, argued the FDA had switched directions and surprised his clients by demanding new studies to prove their products would persuade more adult smokers to switch to e-cigarettes.

His clients won before the conservative 5th Circuit Court in New Orleans, which called the FDA’s decisions “arbitrary” and illegal.
But most of the justices on Monday sounded as though they leaned in favor of the FDA’s view.

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Chief Justice John G. Roberts Jr. and Justice Amy Coney Barrett said they were not convinced the FDA had misled the companies.

Other conservative justices voiced support for the industry.

Justice Clarence Thomas said the FDA’s regulations set a “moving target,” and Justices Samuel A. Alito Jr. and Neil M. Gorsuch voiced a similar skepticism.

It’s unclear if the court’s ruling in the months ahead will settle the controversy.

Twice, the attorney for the vaping companies pointed to an impeding change at the FDA with the election of President-elect Trump.

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“We have a new administration coming in,” he said, and new agency officials may change the policy.

Kavanaugh said the companies are free to try again.
“You can reapply,” he said.

It’s also not clear the FDA disapproval has much impact. Large numbers of e-cigarette flavors are widely available even if they were not approved by the FDA.

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How Robert F. Kennedy Jr. went from outsider to Cabinet pick

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How Robert F. Kennedy Jr. went from outsider to Cabinet pick

He had written more than 20 books, drew healthy audiences speaking across America and attracted coverage from the country’s top newspapers and magazines. Still, by the height of the pandemic, Robert F. Kennedy Jr. said he felt muzzled.

Facebook and Instagram had banned posts by Children’s Health Defense, the Kennedy-founded organization that questions the value of vaccines. The social media sites noted that Kennedy’s group trafficked in medical misinformation, and a science research team labeled him a “superspreader” of bogus claims about COVID-19 vaccines.

But as 2024 loomed, the scion of America’s most famous Democratic family saw a way back into the public eye.

“I started thinking, ‘Well, the one place that they couldn’t censor me was if I was running for president,’ ” Kennedy told the New Yorker. As he prepared to announce his candidacy in 2023, he proclaimed, “The censors are permitting me to talk to Americans again!”

Indeed, a 16-month run for the White House and subsequent two months as a supporter of Republican nominee Donald Trump succeeded in keeping RFK Jr. close to the center of the public’s consciousness. It’s a prominent perch he’s likely to maintain if he succeeds in being confirmed as secretary of the Department of Health and Human Services.

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Loyola Marymount University political scientist Michael A. Genovese said Trump’s designation of Kennedy for the Cabinet post demonstrates “the power of mutual opportunism.”

“RFK revives his failing career. Trump is linked to the glamour of the Kennedy name,” said Genovese, ticking off factors that may have informed Trump’s decision. “RFK gains some measure of respectability. Trump puts Kennedy in a Cabinet position he cares little about. RFK finds a way to stay in the glow of the spotlight. Trump gets an anti-science colleague to complement Trump’s anti-science sentiments.”

Kennedy’s halting ramble from Democratic Party fringe player to fervent MAGA ally did not shock anyone who has watched him closely in recent years. They recall how Kennedy visited Trump Tower shortly before Inauguration Day in 2017 and proclaimed that Trump would make him chair of a commission on vaccine safety and scientific integrity. The Trump administration position never materialized.

Campaigning for the White House this year, Kennedy criticized both major parties, though he saved his most spirited beat-downs for the Democrats. Part of the reason surely was that Democratic nominee Kamala Harris had spurned his overtures. It eventually became clear that Trump — as he had so many times before — was more than willing to strike a strategic alliance with a former adversary.

Kennedy, 70, came with a checkered personal history. Controversial — even bizarre — revelations dotted his presidential run. But several Trump appointees came with unsettling personal histories.

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Kennedy, who declined to be interviewed for this article, has persevered over the course of a life frequently turned upside down by tragedy. He was 14 when his father and namesake was assassinated in 1968 at the Ambassador Hotel in Los Angeles. Not long after, he became addicted to heroin, a habit he did not kick until he was 29. Despite that, he graduated from Harvard and the University of Virginia law school.

His two strongest calling cards as a candidate appeared to be his family name and his career as an attorney who fought to clean up the environment. But both became overshadowed by his later preoccupations.

Kennedy spread the myths — refuted by science — that vaccines commonly injure children and cause autism. He outraged many in 2022 by comparing vaccine mandates to the totalitarianism of Nazi Germany.

When he announced last fall that he would continue his presidential run as an independent rather than as a Democrat, many in his family did not hesitate to heap on their disdain.

“Bobby might share the same name as our father, but he does not share the same values, vision or judgment,” three of the candidate’s sisters and one brother said in a joint statement. “We denounce his candidacy and believe it to be perilous for our country.”

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This spring, nearly 50 of his former colleagues and leaders of the Natural Resources Defense Council Action Fund pilloried Kennedy.

“In nothing more than a vanity candidacy, RFK Jr. has chosen to play the role of election spoiler to the benefit of Donald Trump — the single worst environmental president our country has ever had,” the environmental leaders wrote in a broadside published in several newspapers.

Not unlike the man who would later offer him a Cabinet position, the candidate seemed impervious to criticism, positioning himself as someone who was delivering inconvenient truths to an unyielding establishment.

The candidate liked to quote his famous relatives, suggesting he was living by his father’s words: “Moral courage is a rarer commodity than bravery in battle or great intelligence. Yet it is the one essential, vital quality for those who seek to change a world that yields most painfully to change.”

Not long after the NRDC disowned him, Kennedy suffered another embarrassment. The New York Times reported on a 2012 deposition in which he described his concerns that he might have a brain tumor. A doctor, Kennedy said, had told him that his abnormal brain scans were likely “caused by a worm that got into my brain and ate a portion of it and then died.”

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The revelation made him the butt of a slew of jokes on late-night TV, just as he was trying to assure voters of the seriousness of his candidacy.

Kennedy also took incoming fire from the right. “Kennedy is a Radical Left Democrat, and always will be!!!” Trump posted in April on his Truth Social platform. “It’s great for MAGA, but the Communists will make it very hard for him to get on the Ballot.”

Kennedy accused Trump of “a barely coherent barrage of wild and inaccurate claims.”

Into the summer, Kennedy continued to insist that the American people would eventually turn to him and away from the major party candidates. But while he wanted to talk about the evil of corporate and government elites, his past kept resurfacing in the media.

In July, Vanity Fair reported that a woman accused Kennedy of groping her decades earlier when she was the 23-year-old nanny of his children. Kennedy was married at the time.

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After the story broke, the candidate texted an apology to the woman, while contending that he remembered nothing of the episode.

Not long after that, a video surfaced that raised questions about Kennedy’s long-term commitment to the race. In the recording, posted by his son on social media, the candidate is speaking by phone with Trump, who hints that he wants Kennedy to jump to his side.

“I would love you to do something,” Trump said, without offering further context. “And I think it’ll be so good for you and so big for you. And we’re going to win.” Kennedy’s response: “Yeah.”

Yet in public Kennedy insisted he offered a third way, unattached to the two major parties.

Then in August came a series of events that set the stage for Kennedy’s later emergence as a Cabinet pick. He weathered yet more embarrassing revelations, but also threw his backing behind Trump.

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‘I like him a lot, I respect him a lot.’

— Donald Trump, on Robert F. Kennedy Jr. in August interview

A story in the New Yorker recounted an odd prank that Kennedy had pulled several years prior.

After finding a dead bear cub on a mountain roadside, according to his account, he loaded the carcass into his car and drove into New York City. Kennedy then deposited the body in Central Park, alongside a bicycle. The New Yorker reported: “A person with knowledge of the event said that Kennedy thought it would be funny to make it look as if the animal had been killed by an errant cyclist.”

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Most of the attention from the story surrounded the dead bear, but it also revealed text messages in which Kennedy called Trump a “terrible human being” and “probably a sociopath.” But Kennedy judged that President Biden was “more dangerous to the Republic and the planet.”

Despite Kennedy’s assurances he was running to win, his campaign manager hinted in the profile that he might be willing to take a lesser role. She called the possibility of Kennedy as Trump’s secretary of Health and Human Services “incredibly interesting.”

Kennedy had reached out to Harris, too, CNN reported, expressing interest in a role in her administration. He was rebuffed.

“No one has any intention of negotiating with a MAGA-funded fringe candidate who has sought out a job with Donald Trump in exchange for an endorsement,” Democratic National Committee spokesperson Matt Corridoni told the cable network on Aug. 14.

It became apparent change was afoot six days later when Trump began to publicly flatter Kennedy, while the Democratic National Convention was in full swing and buoyed by Harris’ energetic candidacy.

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“I like him a lot, I respect him a lot,” Trump told CNN. At a campaign event in Arizona, Trump called Kennedy “very smart.”

On Aug. 23, the day after the Democratic convention ended, the Kennedy heir endorsed the Republican, saying that, together, they were going to “Make America Healthy Again.” Trump’s handlers later rhapsodized at how a MAGA crowd in Glendale, Ariz., greeted Kennedy “like a rock star.”

The campaign knew it had a problem with some young female voters, particularly because Trump’s Supreme Court picks had eliminated federal protection of abortion access by overturning of Roe vs. Wade. But some of those same women were won over by Kennedy’s calls for improving healthcare and removing food additives that could harm children, said a senior campaign official who declined to be named. “A lot of that group of young moms loved what Bobby was saying,” said the advisor. “He moved that group for us.”

It’s impossible to know how many voters were moved by such feelings. Or how many were turned off by the continuing drumbeat of Kennedy oddities.

Just three days after Trump and Kennedy took the stage together for the first time, Kennedy faced another embarrassing headline. An old magazine article surfaced in which one of Kennedy’s daughters remembered her father’s strange encounter with a dead whale on Cape Cod.

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Town & Country magazine reported that, many years earlier, Kennedy “ran down to the beach with a chainsaw, cut off the whale’s head, and then bungee-corded it to the roof of the family minivan for the five-hour haul back to Mount Kisco, New York.”

Again, late-night comics had fodder for Kennedy jokes. But, again, Kennedy weathered the storm and went on to campaign vigorously for his new ally.

Kennedy’s path to confirmation is uncertain. Although the incoming GOP majority in the Senate should clear the way, even some Republicans have said the former Democrat will have to answer questions about his vaccine stances and his desire to change how processed foods are made.

Kennedy proclaimed on X his readiness “to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth.”

Though well short of the spot in the Oval Office once held by his uncle and coveted by his father, the Cabinet post would put Kennedy the closest he has ever been to the heart of a federal government that he previously pilloried only from the outside.

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Button batteries pose deadly risks to children. Doctors want them to be made safer

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Button batteries pose deadly risks to children. Doctors want them to be made safer

The round batteries, small as buttons and shiny as coins, are prized for the energy they pack at their size. In households, they have become commonplace, powering remote controls, hearing aids, toys, electric tea lights, wristwatches, greeting cards that play music and other familiar items.

But doctors warn that such “button batteries” can maim and kill. Pop one into your mouth and swallow — as thousands of children do annually — and they can quickly cause devastating injuries.

A growing number of medical associations is pushing for battery manufacturers to head off the threat by making a new product: A button or “coin cell” battery that will not lead to catastrophic injuries when swallowed.

“The only real solution to the battery problem is to make the battery itself safer,” said Dr. Toby Litovitz, founder of the National Capital Poison Center.

When button batteries are lodged in the body, their electrical current breaks down water, driving up alkalinity to dangerous levels akin to bleach. Bodily tissues can begin to liquefy. Physicians say serious injury can happen within two hours, sometimes before a parent has even realized that a battery was swallowed.

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As button batteries have proliferated in common items, the rate of pediatric emergency visits for battery-related injuries has more than doubled in recent decades, according to a study published in the journal Pediatrics. Some children have ended up relying on tubes to breathe or suffered massive hemorrhaging, doctors said.

“Unfortunately, these batteries cause such severe injuries so rapidly,” some of which are impossible for surgeons to repair, said Dr. Kris Jatana, surgical director of clinical outcomes at Nationwide Children’s Hospital in Ohio.

Jatana became alarmed by the risks after caring for a 2-year-old child who ended up needing a tracheostomy to breathe. “It was a moment that motivated me to try to see what we could do to prevent these injuries from happening in the first place.”

Button battery safety

Here are recommendations from Nationwide Children’s Hospital:

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Some battery manufacturers have tried adding bitter coating or saliva-activated dye to tip off parents.

Reese’s Law, a federal statute named for a child who died of serious injuries after swallowing a button battery, now requires compartments for such batteries on consumer products to be harder to open and mandates child-resistant packaging for button batteries.

But advocates say more needs to be done. For instance, Litovitz said that harder-to-open packaging would not address the many injuries caused when children swallow batteries left sitting out or discarded. Among those pushing to develop safer batteries is biotech entrepreneur Bryan Laulicht.

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“What makes them really great for devices is also what makes them so dangerous when you swallow them,” Laulicht said of button batteries. “They’re powerful enough to split water … which spikes the pH up to Drano levels in a matter of minutes.”

Doctors began raising alarms about the threat decades ago as more children began to suffer grave injuries. One study found that between 1985 and 2009, the percentage of button battery ingestions that led to serious or deadly injuries had risen more than sixfold.

Reese Hamsmith suffered grave injuries after swallowing a button battery and died less than two months later. Her mother, Trista Hamsmith, vowed to do everything she could to prevent other children from suffering the same fate.

(Trista Hamsmith)

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Litovitz and other researchers pointed to the rising popularity of the 20-millimeter diameter lithium coin cell battery: Their analysis found that 12.6% of children under the age of 6 who ingested button batteries around that size suffered serious complications or death.

They’re “just the right size to get stuck in the esophagus of a small child, especially a child younger than four years,” Litovitz said in an email. “Further, these lithium coin cells have twice the voltage of other button cells.”

Doctors may not immediately recognize and diagnose the problem if no one realized a battery was swallowed, because the symptoms can initially look like those of other childhood ailments.

The problem has worsened over time: From 2010 through 2019, an average of more than 7,000 children and teens went to emergency rooms annually for injuries related to batteries, according to the Pediatrics study. The rate of such emergency visits had doubled compared with the period of 1990 to 2009.

Button batteries were implicated in the bulk of cases where the battery type was known. Researchers have tallied more than 70 deaths from ingesting button batteries over time, but Litovitz said the true number could be far higher because that figure only includes cases documented in medical research or the media or reported to the National Button Battery Ingestion Hotline, which stopped operating six years ago.

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At Children’s Hospital Los Angeles, doctors see roughly one child a month who has been injured by a button battery, said Helen Arbogast, injury prevention program manager in its division of general pediatric surgery. Children are attracted to shiny things and pick up on the attention that adults pay to electronics, she said.

“Remote controls are really fascinating to them — the buttons, the colors — and part of their natural motor skill development is to learn how to open and close things,” Arbogast said.

She stressed that time is critical. “If a parent suspects their child having swallowed a button battery, it’s important to get them to a hospital right away.”

In Texas, Reese Hamsmith awoke one morning in 2020 congested and wheezing. Her mother, Trista Hamsmith, took the toddler to the pediatrician, who suspected croup. It wasn’t until the next day, after a Halloween night when Reese had remained ill, that her mother realized a button battery was missing from their remote control.

A child in bed hooked up to tubes.

Reese Hamsmith suffered grave injuries after swallowing a button battery and died less than two months later.

(Trista Hamsmith)

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Reese underwent emergency surgery, but the damage continued even after the battery had been removed, burning a hole through her esophagus and trachea, her mother said. In the weeks that followed, she underwent more surgeries, sedation and intubation. Less than two months after her injury, Reese died.

She was a year and a half old. After she died, “I held her again, and I promised to her that I would do everything I could that no kid would die this way again,” Trista Hamsmith said.

The Lubbock mother started a nonprofit, Reese’s Purpose, that successfully pushed for federal legislation that imposed new requirements for battery compartments, childproof packaging and warning labels. Hamsmith was glad to see those rules go into effect, but rued that such protections had not been put in place earlier.

“It shouldn’t have to take what we went through” to spur action, she said. “It definitely should not have to take someone like me screaming at the world.”

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The group is also funding research into a medical device that could detect a swallowed battery without subjecting a child to radiation, which Hamsmith wants to see used whenever a child shows up with possible symptoms. And it worked with Energizer on safety features including a telltale dye that turns blue with saliva.

“The missing ingredient here … has been the ability to alert the caregiver that something has happened,” said Jeffrey Roth, Energizer’s global category leader for batteries and lights. “That’s really what ‘color alert’ does — it gives the caregiver notification that a child might have put something in their mouth that they shouldn’t have.”

Litovitz cautioned, however, that because not all batteries have the blue dye, doctors and parents should not assume that no battery was swallowed if they don’t see that color.

Roth said that in recent years, Energizer has spent tens of millions of dollars on research and other efforts surrounding button battery safety. “We believe that one day we will solve this,” he said. “But it certainly requires a breakthrough innovation.”

Laulicht, cofounder and chief executive of Landsdowne Labs, said his company has been testing an alternative battery with a different kind of casing, intended to shut down inside the body. Tests that involve sandwiching the battery between two pieces of ham do not show the kind of damage inflicted by commercially available button batteries, he said. (Ham is used as a readily available substitute for human gastrointestinal tissue, Laulicht explained.)

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One of their challenges has been getting the same level of battery performance with those alterations, Laulicht said. But as a father of young children, “I would rather a battery that only lasted a year on the shelf … but didn’t kill my kid when they swallowed it.”

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Questions follow massive recall of California raw milk after bird flu testing

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Questions follow massive recall of California raw milk after bird flu testing

Less than a week after California health officers confirmed a finding of bird flu virus in store-bought raw milk, state agriculture officials descended on Mark McAfee’s Raw Farm dairy “like never before” Wednesday and began collecting samples from the farm’s two herds, creamery, bulk milk tanks and trucks, according to the owner.

The visit follows a recall of Raw Farm products, and also comes amid a growing series of H5N1 bird flu outbreaks in state dairy farms. Raw Farm maintains 1,800 head of cattle spread over two herds — one in Fresno, the other outside of Hanford, according to McAfee. The company also owns a Fowler-based creamery.

“I think they are on full attack mode,” he said, describing the search as thorough. In addition to milk, Raw Farm produces cheese and kefir.

As California Department of Food and Agriculture officials collected samples and conducted tests at the dairy Wednesday, some health experts raised questions and concerns about the recent positive test results.

Last week, public health officials in Santa Clara County detected bird flu virus in a store-bought sample of McAfee’s raw milk. Two days later, the California Department of Public Health confirmed the finding.

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But when state agriculture officials tested cows at McAfee’s dairy farm on Monday, they failed to detect the virus.

The fact that none of the animals are known to be infected with the virus has puzzled and concerned public health experts. Generally, once the virus appears on a farm, it spreads and does not just disappear.

“The fact that all the supplemental testing is negative really bothers me,” said John Korslund, a retired U.S. Department of Agriculture veterinarian epidemiologist, in an email.

Officials from the CDFA could not be reached for comment Wednesday, but infectious disease experts told The Times that officials were likely reviewing testing procedures, as well as the actual origin of the sampled milk.

According to testing records, the initial sample of store-bought raw milk carried high levels of the virus, and was found to have a polymerase chain reaction cycle threshold — or Ct — of roughly 25.

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“A herd should not be immediately negative after a reading of 25 if it is truly milk from the same herd, IMO,” Korslund wrote in an email.

Richard Webby, director of the World Health Organization’s Collaborating Center for Studies on the Ecology of Influenza in Animals and Birds, and a researcher in the department of Infectious Diseases at St. Jude’s Children’s Research Hospital in Memphis, Tenn., agreed.

“OK, that’s not a weak positive … and definitely not on the borderline where some tests would be positive and others negative,” he said after reviewing the test records.

Webby, Korslund and other experts say the test that was used only looks for the H5 part of the H5N1 virus, and it can’t determine if the virus is inactive, or alive. A second test — one called a virus isolation test — needs to be done to confirm the sample is H5N1 and that it is active.

State and federal health officials say the H5N1 bird flu virus poses a low risk to the public. However, they have urged people not to drink raw, unpasteurized milk. There has been no reported outbreak in consumers associated with the bird flu in contaminated raw milk.

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The milk was bottled on Nov. 9. Raw Farm LLC has recalled all products associated with the positive sample. McAfee estimates the recall involved roughly 2,000 gallons of half- and quarter-gallon “cream top” whole milk products.

Since the beginning of the outbreak, 461 herds have been infected in California — including herds in Fresno and Kings County, where McAfee’s herds are located.

Early in the H5N1 dairy outbreak, federal health officials tested pasteurized milk samples and found virus in 20% of the samples collected from retail shelves. However, when further testing was conducted — virus isolation — they were able to show it was inactivated virus that had been denatured by heat.

So, why then would a raw milk sample test highly for virus and a dairy herd not test positive?

Korslund acknowledged that testing and sampling can sometimes be compromised, but he was not inclined to doubt the tests in this instance. He said the Ct value — and the lack of subsequent positive tests — suggests a “product integrity issue rather than a herd infection.”

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“What if somewhere in the bottling process, pasteurized shelf milk was spiked into the raw milk to meet inadequate supply demands? In such a scenario, we don’t have a testing issue; rather it’s a product integrity issue that normally would be undetectable,” he said.

This is why virus isolation testing is critical, Korslund said. It would help determine whether the virus in the sample collected was alive or not.

A spokesman for the state’s health department said testing on the sample was complete. He did not say whether viral isolation had been completed, but noted the positive result has been confirmed by state and now federal laboratories.

McAfee said he does not think the virus is present in his herd. The tests that the state’s agriculture department have been regularly conducting — twice a week — on his bulk milk have been negative. In addition, he noted, a test taken on Monday also showed no virus.

In addition, he said, he monitors each cow at his farms with a high-tech device — made by the Austrian company smaXtec — which sits in a cow’s udder and sends real-time information about the animal’s body temperature, milk acidity, etc.

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He said there are no indications that virus is moving through his herd based on that data.

He also said all his equipment — from his trucks, to his bulk tanks and bottling plant — are closed to outside farms and milk; they are used only by Raw Farm, LLC.

He said he’s worried state officials are determined “to find something.”

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