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An essential medical device fails people of color. A clinic is suing to fix that

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An essential medical device fails people of color. A clinic is suing to fix that

Roots Community Health Center was slammed in 2020, with lines for its COVID-19 testing stations stretching around the block and exam rooms full of people struggling to breathe.

Patient after patient at the East Oakland clinic extended their fingers so that healthcare workers could clip on a pulse oximeter, a device that measures the degree to which red blood cells are saturated with oxygen. For healthy people, a normal “pulse ox” reading is typically between 95% and 100%.

The Centers for Disease Control and Prevention had instructed providers to give oxygen therapy to any COVID patient with a pulse oximeter reading below 90%. Like their counterparts around the country, Roots doctors advised concerned patients to buy inexpensive pulse oximeters so they could monitor their levels at home.

As the pandemic ground on, it became clear that Black and brown patients were dying of COVID at disproportionately high rates, both across the U.S. and in Roots’ own Alameda County.

In the rare hour when she wasn’t in the clinic, Roots founder and Chief Executive Dr. Noha Aboelata paged through medical research in search of answers that might help her patients, the vast majority of whom were Black or brown.

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One paper in the New England Journal of Medicine stopped her cold. University of Michigan researchers examined records of thousands of hospitalized COVID patients and looked for instances of “occult hypoxia” — a situation when a patient’s pulse oximeter reads in the healthy range, but their actual blood oxygen levels are dangerously low. The researchers found that this happened to Black patients nearly three times as often as it did to white patients.

Dr. Noha Aboelata said it was “devastating” to realize that researchers had known for years that patients with dark skin were more likely to get false readings from pulse oximeters.

(Carolyn Fong)

Aboelata recalled the “devastating feeling” of diving further into the literature and realizing that this disparity was not a new discovery.

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Research dating back to 1990 found that inaccurate pulse oximeter readings were more common in Black patients than non-Black ones. In 2005, detailed lab experiments showed that pulse oximeters frequently overestimated blood oxygen levels in patients with more skin pigmentation.

“This device is really used almost like a vital sign, like you would use a blood pressure cuff,” Aboelata recalled. “How horrified you would feel if you suddenly found out that your blood pressure cuff didn’t work on a certain demographic of your patients?”

She alerted colleagues to the findings and investigated the effect the devices had on the fates of COVID patients of color. She asked the Food and Drug Administration to require pulse oximeter makers to test their devices on people of color and to warn consumers about the heightened risk of false readings. Attorneys for Roots sent letters to companies that made or sold pulse oximeters in California asking them to improve their products and disclose their limitations.

When little changed, Roots filed a lawsuit in November against CVS, Walgreens, GE Healthcare and nine other companies that make, sell or distribute pulse oximeters in California.

“The pigmentation-derived inaccuracies of pulse oximeter readings in people with darker skin consistently skew — or are biased — in one dangerous direction: showing that their blood is more oxygenated than it is in reality,” the lawsuit states. “Individuals with darker skin who use the devices are no less entitled to accurate readings than individuals with lighter skin.”

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The suit asks that the companies either find a fix or place warning labels on the products to alert users that skin pigment may affect results.

Before pulse oximeters were widely adopted in the 1980s, the only way to gauge a patient’s blood oxygen saturation was to draw a sample of blood from their arterial vein, a painful procedure that had to be followed by immediate laboratory analysis. The portable, noninvasive oximeters were “a true innovation,” said Dr. Phil Bickler, a neuroanesthesiologist who directs the Hypoxia Research Laboratory at UC San Francisco.

“It’s arguably one of the most important clinical monitors ever devised,” Bickler said, second only to the thermometer.

Clinical research coordinator René Vargas Zamora opens a drawer of pulse oximeters at UC San Francisco’s Hypoxia Lab.

(Corinne Purtill/Los Angeles Times)

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A pulse oximeter works by shining a light that passes through skin, blood and tissues in the finger and then measuring how much light comes out the other side.

Oxygen-rich blood absorbs more infrared light. So does melanin, the pigment that helps determine skin, hair and eye color. As a result, patients with darker skin tones are more likely to get pulse oximeter readings that show their blood oxygen saturation to be higher than it actually is.

Skin pigment isn’t the only variable that can skew those results. Cold hands, trembling fingers, incorrect probe placement, even nail polish can throw a reading off by a few percentage points too. Knowing this, doctors traditionally used the pulse ox as one data point among many when determining a patient’s course of treatment.

Then COVID-19 hit. As emergency rooms filled and oxygen tanks grew scarce, the CDC anointed pulse oximeter readings as the official standard in its guidelines for COVID care: Below 90%, the patient should be started on oxygen therapy. Above that, it was the doctor’s call.

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As the sheer volume of patients grew, so did the number of people with occult hypoxia. Their pulse ox readings were 92% or higher, yet they often had shortness of breath, erratic heartbeats, headaches, confusion and other symptoms of low oxygen saturation.

Many providers around the country also noted that patients with occult hypoxia were more likely to have darker-toned skin.

“Honestly, we had no idea what to make of it,” said Dr. Michael Sjoding, a pulmonologist at the University of Michigan.

He and his colleagues initially wondered whether something about the SARS-CoV-2 virus itself made it harder to detect hypoxia.

Then Sjoding came across an article by Amy Moran-Thomas, a medical anthropologist at MIT. After spending sleepless nights monitoring her husband’s pulse oximeter readings as he suffered through COVID, Moran-Thomas began digging into the history of the device.

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She found the 1990 paper that noted hypoxic Black patients were more likely to get deceptively high readings. She found the 2005 study from Bickler’s lab noting the devices were more likely to overestimate oxygen saturation in patients with dark skin than in those with light skin, results the lab confirmed in a follow-up study two years later.

“I was shocked, because I’m a pulmonary critical care physician, I’m a lung doctor, and I didn’t know this whole literature,” Sjoding said.

He and his colleagues pulled data from their own hospital and found Black patients had nearly three times the rate of occult hypoxia as white patients. They published their results in December 2020.

After Aboelata read their paper, she scoured her memory for patients the devices might have betrayed.

She recalled a Black man she had tried to get approved for home oxygen therapy prior to the pandemic. Medicare only paid for the treatment if a patient’s oxygen saturation was below 90%, and “his pulse ox reading just looked too good compared to what I was seeing,” Aboelata said. She sent him to the hospital for an arterial blood gas draw. Sure enough, his oxygen was low enough to qualify.

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Patients shared similar stories, “things like, ‘The ambulance didn’t take them to the hospital because they said that their reading was fine,’ or, ‘We were sent home from the emergency department because they said our reading was fine,’” Aboelata said.

In normal times, she said, providers are much more likely to err on the side of caution for a potentially hypoxic patient. But in the worst days of COVID, every bed, oxygen tank and minute was precious. Providers relied on what they believed was the pulse oximeter’s impartial measure to make extremely difficult decisions, unaware that the device did not evaluate all patients equally well.

Aboelata and colleagues from UCSF and Sutter Health’s Institute for Advancing Health Equity published their own study in the American Journal of Epidemiology showing that Black patients whose pulse oximeters overestimated blood oxygen levels waited an extra 4½ hours, on average, to start supplemental oxygen. They were also slightly less likely to be admitted to the hospital or receive oxygen therapy at all.

“There’s just no way to really know how far-reaching this impact is,” Aboelata said. “The likelihood [is] that people were left home to die, or sent home to die.”

In February 2021, the FDA issued a safety notice cautioning users that pulse oximeters can be thrown off by a number of variables, including skin pigment.

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The following year, the FDA convened an advisory committee on the topic. The panel recommended the agency demand better consumer labels and more stringent testing from companies seeking approval for their devices.

Currently, the FDA recommends — but doesn’t require — that pulse oximeter makers ensure that in their clinical trials, either two participants or 15% of total participants are “darkly pigmented” people, a definition open to interpretation.

Clinical research coordinator René Vargas Zamora holds up an example of the Monk Skin Tone Scale at UC San Francisco’s Hypoxia Lab.

(Corinne Purtill/Los Angeles Times)

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This month, the panel advised the FDA to require that new devices be tested on at least 24 people whose skin tones collectively span the Monk Skin Tone scale, a 10-color palette often used to train artificial intelligences to recognize people of different colors. The proposal would divide the scale into three parts, with each part represented by at least 25% of study participants.

To better understand the relationship between skin pigment and pulse ox accuracy, the FDA funded a study at Bickler’s UCSF lab. Results are expected this summer.

“Some companies have posted data showing good performance with darkly pigmented skin for their devices. But I know that those have been tested under ideal conditions,” said Bickler, whose lab investigates the effects of low oxygen on the human body and the devices that measure it. “When pulse oximeters are used in the real world, conditions are not ideal. People are dehydrated, they’re in shock, they’re moving. There’s all kinds of interference that can happen and that get in the way of good performance.”

For Bickler, it’s gratifying to see the government finally address a problem that has been known for decades but that device manufacturers seemed reluctant to address.

“There’s a lot of inertia and denial in the industry,” he said. “It was an inconvenient problem that could be ignored, up until COVID.”

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Dr. Phil Bickler is a neuroanesthesiologist who directs the Hypoxia Research Laboratory at UC San Francisco.

(Corinne Purtill/Los Angeles Times)

The Times reached out to all the defendants being sued by Roots. Those that responded declined to comment on pending litigation.

Only one company has taken actions to address Roots’ concerns. Illinois-based NuvoMed pulled its pulse oximeters from the market in California and agreed to place warning labels on their remaining inventory after receiving Roots’ October letter, said Jonathan Weissglass, the clinic’s attorney.

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“Ideally, we’d like the pulse oximeters to be fixed so that the problem doesn’t occur,” Weissglass said. “In the meantime, we feel there needs to be an adequate warning about the inaccuracies for people with darker skin. … We’ve all seen warning labels that say, ‘Pregnant women should consult with a doctor before using’ or something like that. It’s the same basic idea.”

On a recent afternoon at the clinic, medical assistant Evelyn Rivas clipped a pulse oximeter onto Ja-May Scott’s index finger as she checked his vital signs.

The devices are still an important part of Roots’ toolkit. But “we just view it with more suspicion, frankly, in a lot of our patients,” Aboelata said. “We would really like to be equipped with devices that we know can be accurate for all skin tones. And we feel like in 2024, this shouldn’t be too much to ask.”

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After bold pledge, EPA shelves microplastics testing in U.S. drinking water

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After bold pledge, EPA shelves microplastics testing in U.S. drinking water

For the next five years, the Environmental Protection Agency has indicated it will not require public water utilities to test for microplastics or pharmaceuticals in drinking water, according to a proposed rule published in the Federal Register.

On Friday, the EPA submitted a list of chemicals it plans to test for under the Unregulated Contaminant Monitoring Rule, a mandatory testing program used to collect information about concerning chemicals in drinking water that could be harming human health. It did not include microplastics or pharmaceuticals.

The omissions come after announcements by EPA Administrator Lee Zeldin earlier this year that his agency was designating microplastics and pharmaceuticals priority contaminants for testing.

“This is a direct response to the concern of millions of Americans who have long demanded answers about what they and their families are drinking every day,” he said at an April news conference with Health and Human Secretary Robert F. Kennedy Jr. at EPA headquarters.

Zeldin’s announcement was seen at the time as a move to placate the increasingly disgruntled Make America Healthy Again contingent of Trump supporters.

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Now the agency says it has no validated or standardized method to test for the plastic particles in drinking water, and wouldn’t be able to develop one before December, when testing is required to begin.

Among the 33 chemicals the EPA will require water utilities to test for are seven PFAS, or forever chemicals, and three pesticide residues.

It will be five years before the EPA proposes another list.

The EPA did not respond to a request for comment.

The agency noted in its proposed rule that it will collaborate with other federal agencies to “evaluate risks and exposures” of microplastics for future monitoring.

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Environmentalists reacted with frustration and resignation. They pointed out that the European Union has developed methods to test for the tiny plastic particles, which have been found in people’s blood, brains and lung tissue. California has one in the works.

“The California water board has spent a lot of time and money on how to measure in drinking water,” said Judith Enck, a former EPA regional administrator and president of the anti-plastic environmental group Beyond Plastics. “EPA should give them a call.”

California was required by a 2018 state law to establish a protocol for local water utilities to test for the particles in drinking water. The state has not yet begun reporting its results, but protocols were established in 2021. Blair Robertson, a spokesman for the State Water Resources Control Board, said it’s not “a fully validated, end-to-end regulatory method” yet.

At the April meeting, Zeldin announced that he would place microplastics on what is known as the Contaminant Candidate List, which acts as a preliminary “watch list” of unregulated, priority contaminants in drinking water. Like the mandatory monitoring list, it is updated only every five years. The most recent list was published on April 2 — the day he made his announcement.

“Americans have been ignored as they sound the alarm about plastics in their drinking water,” Zeldin said during the announcement. “That ends today by placing microplastics on the contaminant candidate list for the first time ever. EPA will follow the science, will pursue answers and will hold ourselves to the highest standards to protect the health of Americans.”

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There appears to be no clear association between these two lists, although the contaminant list is supposed to inform the monitoring list. Seventy-five chemicals and four chemical groups (microplastics, pharmaceuticals, PFAS chemicals, and disinfection byproducts) were listed on the 2026 contaminant list. Only seven of those chemicals were also on the proposed monitoring list (as well as seven PFAS chemicals).

When Zeldin announced microplastics as “‘a priority contaminant for regulation,’ and called it ‘a historic action on microplastics,’ he made it seem like the administration was going to take microplastics seriously,” said Mary Grant, water policy director for the environmental group Food & Water Watch.

“By not including them, they made it clear they don’t actually have plans to immediately address this crisis by getting the real-world monitoring data that we need right now to really start correcting ourselves,” she said.

Craig Davis, senior director of plastics chemistry at the American Chemistry Councilthe nation’s largest trade group for chemical companies — said that while his organization supports microplastic research, it also agrees with the EPA’s decision not to include them in the monitoring list.

“National drinking water monitoring should be based on validated, standardized methods that can produce reliable and comparable data,” said Davis in a statement. He said “limited” national monitoring resources should be focused where data can produce “actionable public health information.”

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The public has 60 days to comment once the plan is published in the Federal Register.

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Hospital visits for smoke inhalation spiked during Boyle Heights warehouse fire

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Hospital visits for smoke inhalation spiked during Boyle Heights warehouse fire

The number of Angelenos who went to the hospital with throat pain and concerns about smoke inhalation spiked as a fire burned through the massive Lineage cold storage warehouse in Boyle Heights this month, The Times has learned.

The blaze burned for eight days beginning June 17 and involved solar panels, insulation foam and other industrial materials.

During that time, more than three times as many people went to emergency departments within 10 miles of the warehouse mentioning the fire or smoke inhalation compared with the two weeks prior, according to data from the Los Angeles County Department of Public Health obtained through a public records request.

The agency also noted a near doubling of patients mentioning throat pain within five miles of the fire June 21 — 1.9 times the baseline levels.

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Usually, fewer than 50 people go to the emergency room each day for throat pain, and fewer than 20 people for smoke inhalation, the department said.

The hospitalization data was tracked through the department’s syndromic surveillance project, which monitors trends in what people report when they come to emergency departments in L.A. County, as well as diagnosis codes noted by providers. The system is not as comprehensive as full patient health records, and clinicians may not always include key words about “fire,” “smoke” or other circumstantial information in their diagnoses, the public health department said.

As such, it “cannot capture the true number of [emergency department] visits related to symptoms from the fire and likely underestimates the true burden of fire related symptoms,” the department said.

Perhaps unexpectedly, the department said it did not note a substantial increase in asthma, acute respiratory symptoms or chronic obstructive pulmonary disease-related emergency department visits during the fire.

But even these preliminary findings are concerning, experts said. The fire is believed to have started on the solar array on the roof of the 500,000 square-foot building, which housed 85 million pounds of frozen food. It then reached an ammonia line, prompting two brief shelter-in-place orders for nearby residents.

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Over the next week, the fire continued to burn through dense insulation foam within the building’s walls and other unknown industrial materials, blanketing much of L.A. in acrid smoke. Residents in downtown L.A., northeast L.A., Burbank, the San Gabriel Valley and many other parts of the city and county reported seeing and smelling the fumes.

The South Coast Air Quality Management District issued multiple warnings about unhealthy levels of PM 2.5, or fine particulate matter. The city and county opened two smoke respite shelters in the immediate area so that people could breath cleaner air.

It is still unclear what exactly was in the smoke that people breathed in. Industrial fires release far more materials than the burned wood smoke that is emitted during wildfires.

“The makeup of the smoke can include toxic chemicals, fine particles and other serious risks to lung health depending on fire conditions and what is burned,” Will Barrett, assistant vice president for nationwide clean air policy at the American Lung Assn., said as the fire was burning. Children and elderly people are particularly at risk.

David Eisenman, director of the UCLA Center for Public Health and Disasters, said urban industrial fires also can represent a hazard that standard PM 2.5 warnings don’t always address. Those advisories are “blunt instruments” that don’t adequately capture emissions from burning man-made goods — or convey that the source of pollution may include burning batteries or toxic refrigerants, he said.

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The fact that initial numbers don’t show a spike in asthma attacks is “somewhat reassuring,” Eisenman said. But “people may have gone to their primary care doctors, which this would not capture. This data deserves follow up.”

The air district and the U.S. Environmental Protection Agency deployed air monitors to assess particulate matter, airborne toxic metals and other harmful compounds during the early days of the blaze. The air district said it didn’t find significant levels of air toxics during the first two days of the fire, although it did record significantly elevated concentrations of particulate matter within the plume downwind.

Some of the measurements it took with mobile monitors, which are five-minute snapshots, also showed increased bromine and chlorine, which often are found when buildings burn and were at levels “below short-term health-based exposure thresholds,” the air district said. It began continuous PM 2.5. monitoring at two nearby elementary schools on the third day.

The L.A. Fire Department said it detected low-levels of toxic hydrogen fluoride on the second day of the fire, which can be a byproduct of burning lithium-ion batteries.

Lineage, the tenant-operator of the warehouse, said no concentrations of ammonia were detected in the air at any time.

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“There’s no doubt this fire has had a huge impact on the local community, and we are committed to showing up in every way we can,” company officials wrote in a statement last week. They said Lineage worked closely with the Fire Department during the blaze and delivered masks, air purifiers and other supplies to the community, and will work to ensure the fastest cleanup possible.

The long-term health effects of the fire and its smoke probably won’t be known unless researchers conduct a follow-up study, said Eisenman of UCLA.

For example, there may have been delayed pulmonary effects from the hydrogen fluoride and burning insulation foam that — when combined with the elevated PM 2.5 levels in a dense urban environment — produced health effects that didn’t show up in the emergency room data.

“They will show up in increased primary care office visits and exacerbations of chronic disease over the next few weeks,” he said. “So from a public health standpoint, this fire is not over.”

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Water from Boyle Heights warehouse fire carries foam into L.A. River, sparks testing

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Water from Boyle Heights warehouse fire carries foam into L.A. River, sparks testing

All the water unleashed onto the warehouse fire in Boyle Heights — some of it 480 gallons at a time by helicopter — had to end up somewhere.

That somewhere is the Los Angeles River.

Los Angeles Fire Department crews ripped through 50-foot walls filled with foam insulation to get to the building’s steel skeleton and its storage racks.

Charred chunks of foam have been floating from the burn site, partially blocking storm drains. Now organizers from East Yard Communities for Environmental Justice are teaming up with scientists from UCLA and Columbia University to find out more about what’s in the runoff.

“The community here is really interested in knowing, ‘Are there any contaminants that are potentially making their way down to the L.A. River?’” said Yoshira “Yoshi” Ornelas Van Horne, UCLA assistant professor in environmental health sciences. “We really can’t answer that unless we actually have measures and samples analyzed.”

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Water samples collected directly from the warehouse fire runoff have been shipped to Columbia‘s Multi-Element Trace Analysis Laboratory in New York, which has a spectrometer that can identify trace levels of elements. The lab also has relationships with researchers in Southern California.

1

2 Casey Cooper holds a water sample.

1. Emmanuel Carrera Ruedas, left, and Casey Cooper prep containers to take water samples from the L.A. River. 2. Casey Cooper holds a water sample. (Christina House / Los Angeles Times)

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The data will then come back to UCLA for analysis. For now, the scientists and community advocates only have the money to test for copper, lead and arsenic, Ornelas Van Horne said. Residents have expressed interest in testing for more contaminants.

As the water from the firefighting efforts trickles through the warehouse in rivulets, it forms a stream at the corner of S. Indiana and Noakes streets, that gushed into the storm drain. On a recent visit, the water traversed a smoky 10-foot canyon of charred foam and twisted wall panels on its way to the drain.

From there, the water flows to the L.A. River. Despite the fact that its concrete design is intended to whisk water out of the city as fast as possible, life stubbornly persists in the river and nearby. Recreational swimming is not permitted, yet anglers fishing for tilapia, largemouth bass and carp are a common sight along the rocky sides of the soft-bottom areas.

The L.A. River, and all it carries with it, meets the ocean in Long Beach.

The L.A. County Public Works Department said it has deployed three containment booms — floating barriers — on the L.A. River, and is continuing to monitor the water as it makes its way to the ocean.

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Emmanuel Carrera Ruedas takes a water sample.

Emmanuel Carrera Ruedas takes a water sample.

(Christina House / Los Angeles Times)

Before it gets there, the river passes through the Dominguez wetlands, where Public Works is removing some number of dead fish. The wetland has absorbed toxic runoff from a warehouse fire before, resulting in a fish die-off.

“For so long, the L.A. River has been used as a dumping ground for all kinds of chemicals,” said Emmanuel Carrera Ruedas, a community scientist and member of East Yard Communities for Environmental Justice.

Pollution has plagued the L.A. River, but it does have allies. In the 1980s, the Friends of the LA River pushed to address street runoff and trash that had made the water body infamous. Significant progress from advocacy and government initiatives improved water conditions, but these efforts have not been equally distributed.

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Carrera said the samples represent “proof of what’s actually going on, and accountability, too, for the city, of not just what’s happening in our air, but what’s actually happening in our waterways.”

The first samples for the project were taken last Friday, the second day of the fire.

They were the first of 20 samples the research groups have agreed to test at no cost to see if any exceed regulatory standards and could pose a risk to people nearby.

The warehouse fire represents the latest environmental disaster for people in Boyle Heights and East L.A. Just four weeks ago, a telecommunications crew accidentally struck one of the many oil pipelines beneath the L.A. area, spilling 25,000 gallons of crude oil near Eastern and Cesar Chavez avenues — including into storm drains feeding to the L.A. River.

“I think it really is difficult to see disaster after disaster hit the communities here, with not a lot of talk about how we can move through these disasters together,” said Casey Cooper, a volunteer community scientist involved in the sampling. They were inspired, they said, by the response of neighbors, and how people were supporting one another.

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Results from the laboratory analysis could be back to Ornelas Van Horne within a month.

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