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Kratom regulations shelved in California amid battle between advocacy groups

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Kratom regulations shelved in California amid battle between advocacy groups

A California bill that would have imposed regulations on kratom products was quietly shelved Thursday following a clash between advocacy groups focused on the burgeoning industry.

Kratom products are derived from the leaves of a tree that grows in Southeast Asia, where kratom has long been chewed and brewed into teas. As it has gained more popularity around the globe, greenish capsules, powders and extracts have popped up in vape and smoke shops in California.

Scientists are still learning about its complex effects, which can range from stimulant to sedative and stem from chemical compounds called alkaloids. The Food and Drug Administration has warned against using kratom for medical treatment and says it is “not appropriate for use as a dietary supplement.” Among the reported side effects have been seizures, vomiting and heart problems. Kratom has also been involved in a small share of overdose deaths, although most also involved other drugs, analyses have found.

A bill proposed by Assemblymember Matt Haney (D-San Francisco) would have required kratom products to be registered with the state, and to carry mandated labeling and warnings. It also would have prohibited sales to anyone under 21.

In addition, Assembly Bill 2365 would have banned products containing synthesized versions of kratom alkaloids. And it would have prohibited ones in which a specific chemical makes up more than 1% of its alkaloid content.

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That chemical is 7-hydroxymitragynine, also known as 7-OH. It is typically found in the dried kratom leaf in very low concentrations, although a more common alkaloid in the plant — mitragynine — breaks down in the human body to create 7-OH as well.

Scientists have raised concerns about its effects: One study in the Journal of Medical Toxicology said 7-OH “is likely to be a major contributing factor to the addictive potential of kratom.” Another article published in Addiction Biology said 7-OH “should be considered a kratom constituent with high abuse potential.”

Kirsten Smith, an assistant professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins University, said that because 7-OH appears naturally at very low levels in the kratom leaf, products with much higher levels of 7-OH are “easily identifiable as being manipulated and man-made.”

“It’s no longer the botanical as it’s been used in nature,” Smith said, adding that she didn’t consider synthesized 7-OH products to be kratom at all.

Kratom advocacy groups were split over the California bill. It was backed by the Global Kratom Coalition, whose executive director, Matthew Lowe, argued kratom products should have an alkaloid content similar to the natural plant that has long been used. The coalition was joined by law enforcement groups in backing AB 2365.

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In the opposing camp were the American Kratom Assn., which has fought bans on kratom products throughout the country and backed other state regulations, and Holistic Alternative Recovery Trust, which wants 7-OH to be explored as an alternative to opioids for pain relief.

The American Kratom Assn. contended that the regulatory structure needed for the California bill would be so costly that few companies would be able to pay the needed fees. State officials estimated it could cost over $4 million annually to regulate kratom under the bill.

AB 2365 “is promoted by one company who will benefit from the onerous provisions … to the detriment of small and mid-sized kratom manufacturers,” said Mac Haddow, its senior fellow on public policy. He argued Botanic Tonics — a beverage company listed as a supporter of the Global Kratom Coalition — had enough market presence that for them, the registration fees would not be prohibitive.

The Holistic Alternative Recovery Trust argued for a higher limit on 7-OH, saying that California should avoid being so restrictive that the products would lose therapeutic benefits.

Lowe said that the level they were pushing for — 2% of dry weight rather than 1% of the alkaloid content — was vastly higher and would threaten consumer safety. As for concerns about fees, Lowe said the focus should be “how the provisions in the bill inform and protect consumers, rather than the cost on the industry.”

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“The Global Kratom Coalition is not looking to support any single vendor. We’re looking to ensure that kratom products are safe,” Lowe said. He added that the bill envisioned a tiered system for fees related to annual sales in California, which would allow lower fees for smaller companies.

AB 2365 stalled in the state Senate’s appropriations committee as lawmakers culled hundreds of bills on the so-called suspense file. The process allows legislative leaders to quietly halt bills that would have significant costs or pose challenging political dynamics, averting the need for many lawmakers to have to weigh in.

Haney said that “Californians are not safer by leaving kratom entirely unregulated in our state,” calling it “a total free-for-all.” The lawmaker said he plans to reach out to the California Department of Public Health to weigh next steps and hopes the FDA will take action, rather than leaving the matter to states.

“I have no interest in benefiting any particular player” in the kratom industry, but chose to err on the side of less potency, to the chagrin of “people who want to sell much stronger versions of kratom,” Haney said. He said if discussions continue, he would like the Department of Public Health to help define what is “synthetic.”

The public health department, which would have handled product registration under the bill, said it has not conducted any scientific assessment of the safety risks of 7-OH in kratom products.

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The Global Kratom Coalition spent $15,000 on lobbying related to the bill, according to financial disclosures available as of Thursday. It also contributed $5,500 in political donations to Haney, who introduced AB 2365, and $36,400 to Atty. Gen. Rob Bonta, who supported it, according to state records.

Botanic Tonics, in turn, reported spending $90,000 on lobbying during this legislative session, including $30,000 during a period it was advocating on AB 2365. The company said other expenses were for “advice and counsel on the regulatory and legislative landscape specific to California.”

Holistic Alternative Recovery Trust reported spending $18,000 on lobbying over AB 2365. The American Kratom Assn. said it had not hired a lobbyist until the end of July and would report its spending after that point.

And the bill also drew interest from the kratom company MIT45 Inc., which reported spending $60,000 on lobbying. A company leader did not immediately clarify its position on the bill.

The National Institute on Drug Abuse says that “much is still unknown about chemical compounds related to kratom,” its health impacts and possible therapeutic uses, complicating discussions among regulators in California and across the country.

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The Global Kratom Coalition has funded research on kratom at the University of Florida college of pharmacy, where researcher Christopher McCurdy and others have raised concerns about “semi-synthetic, isolated” alkaloids. Lowe said his group provided $500,000 total this year. Advancing research on kratom is part of its mission and “ensures that regulations are led by the evolving science,” he said.

McCurdy said the coalition and “many independent kratom vendors” had helped fund research there, but “no one that donates has any influence on what studies we conduct” and “they all understand that we will publish our findings without their review or consent.”

Smith said she had done consulting for the Global Kratom Coalition in the past, but that her research was funded by NIDA, not the coalition or any other groups connected to the kratom industry.

“We are in such early, early days of research” on kratom, she said.

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What Elmo — and his human friends — learned by asking Americans about their mental health

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What Elmo — and his human friends — learned by asking Americans about their mental health

Remember when Elmo went viral in January by asking folks on the Internet how they were doing and briefly became the unofficial therapist of X?

“The world is burning, Elmo,” an X user who goes by Not the Bee told the usually upbeat “Sesame Street” character. “No amount of tickles can fix this.”

“This world is full of pain, anger, violence, disease, power grabbing despots and poverty,” a user with the handle LiveLifeLikeSomeoneLeftTheGateOpen added in a long post. “The chasm is widening as HG Wells put it, between the ‘haves’ and ‘have nots.’”

And those were just two of the 20,000-plus replies.

Christina Vittas, Elmo’s social media manager, was bowled over by the unexpected outpouring and told The Times she was thankful that the Muppet’s simple question “opened up conversations about the serious mental health crisis in our country.”

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Six months later, Elmo’s creators at Sesame Workshop have collaborated with the Harris Poll to conduct a more thorough check-in on the state of Americans’ mental health. They conducted 2,012 online interviews in May on an array of topics with a nationally representative sample of Americans ages 16 and up.

The resulting State of Well-Being Report was released this week. Among the findings:

• 27% of respondents said their mental or emotional health, or that of someone in their family, was negatively impacting their well-being. That was essentially tied with the 28% who were negatively impacted by a problem with physical health. The only issue taking a greater toll on survey participants was economic security and personal finances, a worry reported by 41%.

• Mental and emotional health were a particular burden on teens, with 54% of the 16- and 17-year-olds who took the survey saying the psychological issues had a negative impact on their overall well-being. So did 32% of parents and 41% of people who identified as LGBTQ+.

• When asked about their top concerns for their future well-being, 90% cited their and their family’s mental and emotional health as either somewhat or very important. For the sake of comparison, 89% said the same about physical health, economic security and personal finances, and having “a safe place to call home.”

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• 77% of people told pollsters that to improve the well-being of future generations, the U.S. should prioritize investments in emotional and mental health. That was only slightly less than the 80% who called for more investments in economic security and slightly more than the 76% who said the country should prioritize high-quality education and learning opportunities.

• 44% of all respondents said their families were “still experiencing negative effects from the COVID19 pandemic.” That includes 57% of Black Americans and 56% of Latino Americans who took the survey. It also includes 63% of respondents who are members of Gen Z (between the ages of 18 and 27) and 57% of those who are millennials (between the ages of 28 and 43).

• When presented with a list of adjectives to describe the average American adult, only 37% selected “kind,” 35% selected “compassionate” and 33% selected “empathetic.” However, 56% said this hypothetical adult was “anxious” and 44% said they were “difficult.”

• The survey found overwhelming support for the notion that kindness is essential to the well-being of society. Fully 91% of people agreed that “kindness fosters stronger bonds between people,” making them more empathetic and supportive.

• 82% of respondents said their own mental well-being would improve if kindness were more common, and 89% said a kinder society would be better for children.

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• 93% of those surveyed said they had committed at least one act of kindness in the past three months. More specifically, 57% said they had helped a friend or family member in need, 57% said they listened to someone else in a nonjudgmental way, 39% gave money to charity, 35% helped a stranger and 22% volunteered their time in support of a cause, among other activities.

• Despite this outpouring of kindness, most people said they didn’t see much of the same in others, with 55% of respondents agreeing that “being kind is not a priority to most people.” In addition, 64% agreed that “most people don’t go out of their way to help others.”

• 73% of Americans said they wished they had learned more about how to manage their emotions when they were children. So did 84% of those who are parents.

• 67% of Americans also wish their parents had been more transparent about their own struggles with mental health. That was particularly true for younger Americans, with 77% of teens, 77% of Gen Zers and 78% of millennials sharing that sentiment.

Sesame Workshop described the report as “a first-of-its-kind index” and said it will continue to check in with Americans “to keep a pulse on the well-being of Americans and their families.”

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Opinion: A route to safer chemotherapy

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Opinion: A route to safer chemotherapy

I have been a cancer doctor for 40 years and have seen our treatments evolve to embrace precision medicine and immunotherapy, which can be less harmful to patients than conventional forms of chemotherapy. And yet conventional cytotoxic chemotherapy — designed to attack and kill rapidly dividing cells — is still a mainstay of cancer treatment for millions of patients globally.

Cytotoxic drugs kill cancer cells, but they also kill normal cells, leading to a host of serious and even life-threatening side effects. Bone marrow suppression, a common side effect of chemotherapy, reduces the number of white cells needed to fight bacterial infections. Chemotherapy can destroy cells lining the bowel and around the mouth, making eating and even drinking nearly impossible.

Generally, these side effects are reversible as the normal white blood cells are replenished, but in the most severe cases, they can be fatal if, for example, bacteria from the gut escape into the bloodstream through a weakened bowel wall and white cell counts are too low to fight the infection. Sepsis in such a case could be catastrophic.

The toxic death rate, where chemotherapy is directly responsible for a patient’s death, can range from 0.5% to 3.1% but has been reported as high as 13%, depending on the intensity of the chemotherapy regimen, age and fitness of the patient and their genetic makeup.

We can reduce this terrible result with greater use of pharmacogenetics, which studies how our genes affect the way we respond to medications in terms of toxicity and effectiveness. It is becoming more possible to devise genetic tests that can indicate whether an individual would be likely to suffer very serious side effects. This would permit healthcare providers to tailor dosages to avoid the worst hazards of chemotherapy drugs and lessen the number of patients dealing with potentially deadly side effects.

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One prominent example involves two related and widely used anticancer drugs, 5-fluorouracil, or 5-FU, and capecitabine (which functions like 5-FU), often used to treat colorectal, breast, stomach and pancreatic cancer.

In the United States, about 275,000 patients with cancer receive 5-FU each year. As many as 25% of those patients require hospitalization with severe side effects, and more than 1,300 patients are estimated to die each year from the drug’s toxicity.

The side effects are most severe for patients who have low levels of dihydropyrimidine dehydrogenase, an enzyme that is produced by the liver and that breaks down 5-FU in the body. This enzyme, also known as DPD, is usually caused by inherited changes in a particular gene. Currently, there are internationally accepted dosing guidelines for 5-FU, adjusted according to DPD genetic test results, ranging from avoiding the drug completely (risk of death is high) to conventional dosing.

While the genetic DPD tests are not perfect — they may miss some patients — nevertheless they have been shown to save lives, reduce the number of patients admitted to hospitals and reduce healthcare costs.

In the United Kingdom, the National Health Service now requires that all new patients receiving 5-FU or capecitabine take some form of a pharmacogenetic test, a policy change that was driven by pressure from families who lost a loved one and advocacy from professional medical societies.

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In March, the U.S. Food and Drug Administration approved safety labeling changes regarding DPD deficiency for 5-FU, but that alone isn’t sufficient. It did not issue a national policy to require pharmacogenetic or related tests to detect the problem.

The National Health Service sets a sound example that the FDA could follow. Mandating a simple genetic blood test could help cancer patients get the care they need and better protect them from medical tragedies brought on by the treatment itself.

David Kerr is a professor of cancer medicine at the University of Oxford in Great Britain.

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Explosion of power-hungry data centers could derail California clean energy goals

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Explosion of power-hungry data centers could derail California clean energy goals

Near the Salton Sea, a company plans to build a data center to support artificial intelligence that would cover land the size of 15 football fields and require power that could support 425,000 homes.

In Santa Clara — the heart of Silicon Valley — electric rates are rising as the municipal utility spends heavily on transmission lines and other infrastructure to accommodate the voracious power demand from more than 50 data centers, which now consume 60% of the city’s electricity.

And earlier this year, Pacific Gas & Electric told investors that its customers have proposed more than two dozen data centers, requiring 3.5 gigawatts of power — the output of three new nuclear reactors.

Vantage Data Center in Santa Clara is equipped with its own electrical substations.

(Paul Kuroda / For The Times)

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While the benefits and risks of AI continue to be debated, one thing is clear: The technology is rapacious for power. Experts warn that the frenzy of data center construction could delay California’s transition away from fossil fuels and raise electric bills for everyone else. The data centers’ insatiable appetite for electricity, they say, also increases the risk of blackouts.

Even now, California is at the verge of not having enough power. An analysis of public data by the nonprofit GridClue ranks California 49th of the 50 states in resilience — or the ability to avoid blackouts by having more electricity available than homes and businesses need at peak hours.

“California is working itself into a precarious position,” said Thomas Popik, president of the Foundation for Resilient Societies, which created GridClue to educate the public on threats posed by increasing power use.

The state has already extended the lives of Pacific Gas & Electric Co.’s Diablo Canyon nuclear plant as well as some natural gas-fueled plants in an attempt to avoid blackouts on sweltering days when power use surges.

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Worried that California could no longer predict its need for power because of fast-rising use, an association of locally run electricity providers called on state officials in May to immediately analyze how quickly demand was increasing.

The California Community Choice Assn. sent its letter to the state energy commission after officials had to revise their annual forecast of power demand upward because of skyrocketing use by Santa Clara’s dozens of data centers.

A large data center rises in an urban business district.

A large NTT data center rises in a Santa Clara neighborhood.

(Paul Kuroda / For The Times)

The facilities, giant warehouses of computer servers, have long been big power users. They support all that Americans do on the internet — from online shopping to streaming Netflix to watching influencers on TikTok.

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But the specialized chips required for generative AI use far more electricity — and water — than those that support the typical internet search because they are designed to read through vast amounts of data.

A ChatGPT-powered search, according to the International Energy Agency, consumes 10 times the power as a search on Google without AI.

And because those new chips generate so much heat, more power and water is required to keep them cool.

“I’m just surprised that the state isn’t tracking this, with so much attention on power and water use here in California,” said Shaolei Ren, associate professor of electrical and computer engineering at UC Riverside.

Ren and his colleagues calculated that the global use of AI could require as much fresh water in 2027 as that now used by four to six countries the size of Denmark.

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Driving the data center construction is money. Today’s stock market rewards companies that say they are investing in AI. Electric utilities profit as power use rises. And local governments benefit from the property taxes paid by data centers.

Transmission lines are reflected on the side of a building.

Transmission lines are reflected on the side of the NTT data center in Santa Clara.

(Paul Kuroda / For The Times)

Silicon Valley is the world’s epicenter of AI, with some of the biggest developers headquartered there, including Alphabet, Apple and Meta. OpenAI, the creator of ChatGPT, is based in San Francisco. Nvidia, the maker of chips needed for AI, operates from Santa Clara.

The big tech companies leading in AI, which also include Microsoft and Amazon, are spending billions to build new data centers around the world. They are also paying to rent space for their servers in so-called co-location data centers built by other companies.

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In a Chicago suburb, a developer recently bought 55 homes so they could be razed to build a sprawling data center campus.

Energy officials in northern Virginia, which has more data centers than any other region in the world, have proposed a transmission line to shore up the grid that would depend on coal plants that had been expected to be shuttered.

In Oregon, Google and the city of The Dalles fought for 13 months to prevent the Oregonian from getting records of how much water the company’s data centers were consuming. The newspaper won the court case, learning the facilities drank up 29% of the city’s water.

By 2030, data centers could account for as much as 11% of U.S. power demand — up from 3% now, according to analysts at Goldman Sachs.

“We must demand more efficient data centers or else their continued growth will place an unsustainable strain on energy resources, impact new home building, and increase both carbon emissions and California residents’ cost of electricity,” wrote Charles Giancarlo, chief executive of the Santa Clara IT firm Pure Storage.

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Santa Clara a top market for data centers

Boys ride their bikes on Main Street near a large data center in Santa Clara.

Boys ride their bikes on Main Street near a large data center in Santa Clara.

(Paul Kuroda / For The Times)

California has more than 270 data centers, with the biggest concentration in Santa Clara. The city is an attractive location because its electric rates are 40% lower than those charged by PG&E.

But the lower rates come with a higher cost to the climate. The city’s utility, Silicon Valley Power, emits more greenhouse gas than the average California electric utility because 23% of its power for commercial customers comes from gas-fired plants. Another 35% is purchased on the open market where the electricity’s origin can’t be traced.

The utility also gives data centers and other big industrial customers a discount on electric rates.

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While Santa Clara households pay more for each kilowatt hour beyond a certain threshold, the rate for data centers declines as they use more power.

The city receives millions of dollars of property taxes from the data centers. And 5% of the utility’s revenue goes to the city’s general fund, where it pays for services such as road maintenance and police.

An analysis last year by the Silicon Valley Voice newspaper questioned the lower rates data centers pay compared with residents.

“What impetus do Santa Clarans have to foot the bill for these environmentally unfriendly behemoth buildings?” wrote managing editor Erika Towne.

In October, Manuel Pineda, the utility’s top official, told the City Council that his team was working to double power delivery over the next 10 years. “We prioritize growth as a strategic opportunity,” he said.

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He said usage by data centers was continuing to escalate, but the utility was nearing its power limit. He said 13 new data centers were under construction and 12 more were moving forward with plans.

“We cannot currently serve all data centers that would like to be in Santa Clara,” he said.

A data center rises many stories into the sky.

Dozens of data centers have been built for artificial intelligence and the internet in Santa Clara.

(Paul Kuroda / For The Times)

To accommodate increasing power use, the city is now spending heavily on transmission lines, substations and other infrastructure. At the same time, electric rates are rising. Rates had been increasing by 2% to 3% a year, but they jumped by 8% in January 2023, another 5% in July 2023 and 10% last January.

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Pineda told The Times that it wasn’t just the new infrastructure that pushed rates up. The biggest factor, he said, was a spike in natural gas prices in 2022, which increased power costs.

He said residential customers pay higher rates because the distribution system to homes requires more poles, wires and transformers than the system serving data centers, which increases maintenance costs.

Pineda said the city’s decisions to approve new data centers “are generally based on land use factors, not on revenue generation.”

Loretta Lynch, former chair of the state’s public utilities commission, noted that big commercial customers such as data centers pay lower rates for electricity across the state. That means when transmission lines and other infrastructure must be built to handle the increasing power needs, residential customers pick up more of the bill.

“Why aren’t data centers paying their fair share for infrastructure? That’s my question,” she said.

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PG&E eyes profits from boom

The grid’s limited capacity has not stopped PG&E from wooing companies that want to build data centers.

“I think we will definitely be one of the big ancillary winners of the demand growth for data centers,” Patricia Poppe, PG&E’s chief executive, told Wall Street analysts on an April conference call.

Poppe said she recently invited the company’s tech customers to an event at a San José substation.

“When I got there, I was pleasantly surprised to see AWS, Microsoft, Apple, Google, Equinix, Cisco, Western Digital Semiconductors, Tesla, all in attendance. These are our customers that we serve who want us to serve more,” she said on the call. “They were very clear: they would build … if we can provide.”

In June, PG&E revealed it had received 26 applications for new data centers, including three that need at least 500 megawatts of power, 24 hours a day. In all, the proposed data centers would use 3.5 gigawatts. That amount of power could support nearly 5 million homes, based on the average usage of a California household of 6,174 kilowatts a year.

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In the June presentation, PG&E said the new data centers would require it to spend billions of dollars on new infrastructure.

Already PG&E can’t keep up with connecting customers to the grid. It has fallen so far behind on connecting new housing developments that last year legislators passed a law to try to shorten the delays. At that time, the company told Politico that the delays stemmed from rising electricity demand, including from data centers.

In a statement to The Times, PG&E said its system was “ready for data centers.”

The company said its analysis showed that adding the data centers would not increase bills for other customers.

Most of the year, excluding extreme hot weather, its grid “is only 45% utilized on average,” the company said.

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“Data centers’ baseload will enable us to utilize more of this percentage and deliver more per customer dollar,” the company said. “For every 1,000 MW load from data centers we anticipate our customers could expect 1-2% saving on their monthly electricity bill.”

The company added that it was “developing tools to ensure that every customer can cost-effectively connect new loads to the system with minimal delay.”

Lynch questioned the company’s analysis that adding data centers could reduce bills for other customers. She pointed out that utilities earn profits by investing in new infrastructure. That’s because they get to recover that cost — plus an annual rate of return — through rates billed to all customers.

“The more they spend, the more they make,” she said.

In the desert, cheap land and green energy

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Dusk settles over the low Salton Sea.

A geothermal plant viewed from across the Salton Sea in December 2022.

(Gina Ferazzi / Los Angeles Times)

The power and land constraints in Santa Clara and other cities have data center developers looking for new frontiers.

“On the edge of the Southern California desert in Imperial County sits an abundance of land,” begins the sales brochure for the data center that a company called CalEthos is building near the south shore of the Salton Sea.

Electricity for the data center’s servers would come from the geothermal and solar plants built near the site in an area that has become known as Lithium Valley.

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The company is negotiating to purchase as much as 500 megawatts of power, the brochure said.

Water for the project would come from the state’s much fought over allotment from the Colorado River.

Imperial County is one of California’s poorest counties. More than 80% of its population are Latino. Many residents are farmworkers.

Executives from Tustin-based CalEthos told The Times that by using power from the nearby geothermal plants it would help the local community.

“By creating demand for local energy, CalEthos will help accelerate the development of Lithium Valley and its associated economic benefits,” Joel Stone, the company’s president, wrote in an email.

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“We recognize the importance of responsible energy and water use in California,” Stone said. “Our data centers will be designed to be as efficient as possible.”

For example, Stone said that in order to minimize water use, CalEthos plans a cooling system where water is recirculated and “requires minimal replenishment due to evaporation.”

Already, a local community group, Comite Civico del Valle, has raised concerns about the environmental and health risks of one of the nearby geothermal plants that plans to produce lithium from the brine brought up in the energy production process.

One of the group’s concerns about the geothermal plant is that its water use will leave less to replenish the Salton Sea. The lake has been decreasing in size, creating a larger dry shoreline that is laden with bacteria and chemicals left from decades of agricultural runoff. Scientists have tied the high rate of childhood asthma in the area to dust from the shrinking lake’s shores.

James Blair, associate professor of geography and anthropology at Cal Poly Pomona, questioned whether the area was the right place for a mammoth data center.

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“Data centers drain massive volumes of energy and water for chillers and cooling towers to prevent servers from overheating,” he said.

Blair said that while the company can tell customers its data center is supported by environmentally friendly solar and geothermal power, it will take that renewable energy away from the rest of California’s grid, making it harder for the state to meet its climate goals.

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