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High Demand for Drug to Prevent Covid in the Vulnerable, Yet Doses Go Unused

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High Demand for Drug to Prevent Covid in the Vulnerable, Yet Doses Go Unused

Sasha Mallett, Sue Taylor and Kimberly Cooley all have immune deficiencies that make them particularly susceptible to Covid-19, and all have tried to get the identical factor: a brand new therapy that may forestall the illness in individuals who both can’t produce antibodies after receiving a coronavirus vaccine or can’t get vaccinated in any respect.

Ms. Cooley, a liver transplant recipient in Duck Hill, Miss., obtained the antibody drug, known as Evusheld, from her transplant crew on the College of Mississippi Medical Heart with no hassle. However Ms. Taylor, of Cincinnati, was denied the therapy by two hospitals close to her house. And Dr. Mallett, a doctor in Portland, Ore., needed to drive 5 hours to a hospital prepared to present her a dose.

As a lot of the nation unmasks amid plummeting caseloads and contemporary hope that the pandemic is fading, the Biden administration has insisted it should proceed defending the greater than seven million Individuals with weakened immune methods who stay susceptible to Covid. Evusheld, which was developed by AstraZeneca with monetary assist from the federal authorities, is crucial to its technique.

However there may be a lot confusion in regards to the drug amongst well being care suppliers that roughly 80 p.c of the accessible doses are sitting unused in warehouses and on pharmacy and hospital cabinets — whilst sufferers like Ms. Taylor, 67, and Dr. Mallett, 38, go to nice lengths, usually with out success, to get them.

As a result of they’ve a weakened response to the coronavirus vaccine and should not be capable to battle off Covid-19, many immunocompromised folks have continued to isolate themselves at house and really feel left behind because the nation reopens. Evusheld, which is run in two consecutive injections, seems to supply long-lasting safety — maybe for half a 12 months — giving it appreciable enchantment for this group.

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For now, although, the drug is in brief provide. As a result of it’s approved just for emergency use, it’s being distributed by the federal authorities. The Biden administration has bought 1.7 million doses — sufficient to completely deal with 850,000 folks — and had almost 650,000 doses prepared for distribution to the states as of this previous week, based on a senior federal well being official. However solely about 370,000 doses have been ordered by the states, and fewer than 1 / 4 of these have been used.

“There’s so many different people who find themselves scrapping and driving for hours to get Evusheld,” Ms. Cooley, 40, mentioned, “when in Mississippi it’s sitting on the cabinets.”

Interviews with medical doctors, sufferers and authorities officers counsel the explanations the drug goes unused are assorted. Some sufferers and medical doctors have no idea Evusheld exists. Some have no idea the place to get it. Authorities pointers on who ought to be prioritized for the drug are scant. In some hospitals and medical facilities, provides are being reserved for sufferers on the highest threat, reminiscent of latest transplant recipients and most cancers sufferers, whereas doses in different areas of the nation are being given out by means of a lottery or on a first-come, first-served foundation.

Hesitance can be a difficulty. Some medical doctors and different suppliers have no idea learn how to use Evusheld and are thus loath to prescribe it. The truth that it’s an antibody therapy will be complicated, as a result of most such remedies are used after somebody will get Covid quite than for preventive care.

Including to the confusion are revised Meals and Drug Administration pointers for Evusheld, launched final month, that known as for doubling the preliminary really useful dose after information confirmed the drug could also be much less efficient towards sure variants.

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“It’s overwhelming and it’s all new,” mentioned Dr. Mitchell H. Grayson, chief of the allergy and immunology division at Nationwide Kids’s Hospital in Columbus, Ohio. “Suppliers are undoubtedly making an attempt to maintain up, it’s simply — I don’t understand how properly everybody’s doing with that.”

Roughly 3 p.c of Individuals are characterised by well being professionals as immunocompromised as a result of they’ve a illness that weakens their physique’s immune response or are receiving a therapy that does so. They embrace transplant recipients and folks with circumstances like most cancers, lupus and rheumatoid arthritis.

Evusheld’s arrival in December instantly set off a scramble. In Fb teams and on-line messages, sufferers and their family members started swapping details about learn how to get it. Authorities information units about Evusheld’s availability have been so advanced and complicated {that a} software program developer within the Seattle space, Rob Relyea, developed his personal mapping instrument that tracks how a lot of the drug is accessible and which suppliers have it.

“Individuals ought to know the place to go to get in line,” he mentioned.

Mr. Relyea, 51, had a vested curiosity: His spouse, Rebecca, is in remission from most cancers. They tried 10 hospitals unsuccessfully however then obtained the drug by means of luck, as Ms. Relyea’s identify was picked in a lottery for Evusheld at a hospital close to their house in early February, he mentioned.

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However they haven’t heard something but about scheduling a second dose, which Ms. Relyea wants primarily based on the brand new suggestions.

Dr. Mallett, in Oregon, was one in all many who have been determined to get the drug. She has frequent variable immunodeficiency, a situation that retains her immune system from making sufficient antibodies. Her son began attending kindergarten in individual final fall, and when the Omicron variant surged, his instructor and classmates started testing constructive for Covid.

To seek out Evusheld, Dr. Mallett scoured a web based authorities database of shipments and spent weeks cold-calling hospitals, pharmacies and well being organizations that acquired the drug.

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When she lastly discovered a hospital in La Grande, Ore., prepared to present her a dose, she labored together with her doctor to enroll as a affected person there. Then she dropped the whole lot and drove to the hospital within the rain, acquired the pictures and instantly turned again — an 11-hour journey in whole.

Dr. Mallett is extremely educated, medically savvy, rich and simply capable of take time away from her job — privileges that helped her get a dose, however that many others don’t have.

“I undoubtedly have lots of lingering moral qualms about how I went about getting this remedy,” she mentioned. “Did I make the most of our damaged system?”

Most of the well being staff Dr. Mallett known as whereas she was looking for a dose had not even heard of Evusheld — even when their workplaces had the drug in inventory.

Some consultants argue that Evusheld ought to go first to individuals who can’t get vaccinated due to extreme allergic reactions and to those that produce the fewest antibodies in response to coronavirus vaccines. However antibodies are just one part of the immune system, and the Facilities for Illness Management and Prevention nonetheless recommends towards utilizing exams that decide antibody ranges to evaluate somebody’s immunity.

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“The most important drawback is that there’s completely no steering or prioritization or any rollout in place in any respect, and it’s been a large number,” mentioned Dr. Dorry Segev, a transplant surgeon at N.Y.U. Langone Well being who has been finding out coronavirus vaccines in transplant sufferers. “With out formal pointers, you actually can’t do something.”

The Biden administration is making an attempt to handle the confusion. Prime federal well being officers have been working to lift consciousness amongst state well being officers, suppliers and sufferers. They convened a name this previous week with advocates for the disabled to debate the revised dosing steering; in addition they urged affected person teams to companion with the administration on outreach and schooling efforts.

“I really feel actually strongly that this remedy has nice potential to assist the immune suppressed who don’t all the time reply to vaccinations,” mentioned Dr. Rachel Levine, the assistant secretary for well being within the Division of Well being and Human Companies, who spoke on the decision. However Dr. Levine mentioned she didn’t anticipate that the C.D.C.’s steering on antibody exams would change.

Sufferers who can’t be vaccinated are apparent candidates for Evusheld. However among the many vaccinated, Dr. Segev and different consultants say, the calculations turn into far murkier — and might contain assessments of different underlying circumstances or threat elements.

For sufferers who handle to get Evusheld, consultants say it’s nonetheless unclear precisely how a lot safety the remedy provides. It’s tough to gauge the affect of the drug in defending immunocompromised sufferers, as a result of many recruited for research have been avoiding dangerous behaviors and it will have been unethical to ask them to not. Researchers could not know the precise effectiveness of the drug for a lot of months.

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Evusheld was discovered to supply safety akin to vaccines in a medical trial, however the variety of members who have been immunocompromised was by no means disclosed. Including to the uncertainty, AstraZeneca studied the drug earlier than Omicron surfaced. Analysis over the previous few months exhibits that Evusheld protects towards the variant, however it’s unclear to what diploma.

The shortage of strong data has annoyed Ms. Cooley, the liver transplant recipient in Mississippi. She continues to be taking the identical precautions as she did earlier than receiving Evusheld, reminiscent of getting groceries delivered, staying at house and seeing just a few trusted relations with masks on. That’s as a result of she cares for her aged mom and has seen numerous different aged folks, together with her grandmother, die from Covid-19 in her neighborhood, the place many individuals have chosen to not get vaccinated.

Some who can’t discover a dose of Evusheld have turned to on-line communities as an alternative of well being care organizations. They’re in search of assist from different immunocompromised folks, reminiscent of Dr. Vivian G. Cheung, 54, a doctor in Bethesda, Md., who has a genetic situation that impacts her immune system.

Dr. Cheung obtained a dose in January after calling numerous medical establishments for 2 weeks, and he or she has been serving to others navigate the method since then. She receives as much as 10 requests for assist daily, however she estimates that solely 1 / 4 of those that have reached out have succeeded in getting Evusheld.

Ms. Taylor, the girl in Cincinnati, has frequent variable immunodeficiency. However proper now, one hospital close to her is limiting its provide of Evusheld to its transplant sufferers, whereas one other just isn’t but accepting sufferers from outdoors its system. She is unable to look elsewhere; she mentioned she was uncomfortable driving lengthy distances due to her underlying well being circumstances.

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Ms. Taylor mentioned that she didn’t wish to take a dose away from somebody who may want it extra, however that she would really feel much less “panic-stricken” if she might get Evusheld. She may be capable to begin seeing her youngsters indoors once more and inch again to the life she had earlier than Covid.

For now, she is in a holding sample of isolating, masking and hoping a dose will turn into accessible quickly.

Rebecca Robbins contributed reporting.

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Video: Two Americans Are Awarded the Nobel Prize for Medicine

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Video: Two Americans Are Awarded the Nobel Prize for Medicine

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Two Americans Are Awarded the Nobel Prize for Medicine

Victor Ambros and Gary Ruvkun were awarded the Nobel Prize in Physiology or Medicine for their discovery of microRNA, which plays a role in organism development and gene regulation.

The Nobel Assembly at Karolinska Institutet has today decided to award the 2024 Nobel Prize in Physiology or Medicine jointly to Victor Ambros and Gary Ruvkun for the discovery of microRNA and its role in post-transcriptional gene regulation. Here are the two laureates.

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Sex, radiation and mummies: How farms are fighting a pesky almond moth without pesticides

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Sex, radiation and mummies: How farms are fighting a pesky almond moth without pesticides

In a windowless shack on the far outskirts of Fresno, an ominious red glow illuminates a lab filled with X-ray machines, shelves of glowing boxes, a quietly humming incubator and a miniature wind tunnel.

While the scene looks like something straight out of a sci-fi movie, its actually part of an experimental program to prevent a damaging almond pest from successfully mating.

A moth trap hangs from the branch of an almond tree.

(Gary Kazanjian / For The Times)

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With California almond growers reeling from dropping nut prices and rising costs, the pests have only added to their woes.

Every year, the navel orangeworm eats through roughly 2% of California’s almonds before they can make it to grocery store shelves. Last year, it was almost double that.

While that might seem small, if you do the math “it’s going to be a lot of millions of dollars lost to this pest,” said David Haviland, a Kern County farm advisor with University of California Agriculture and Natural Resources. “And that’s despite the control methods that people use,” he said.

California produces 80% of the world’s almonds, yet in 2022 the production value of the nut fell 34% compared with the previous year.

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Scientists say climate change could make the navel orangeworm problem even worse, with hotter temperatures allowing the moths to reproduce even faster. (Despite its name, the insect has largely left citrus farms unbothered and is in fact a moth.)

Traditionally, nut farmers have tackled the insect with chemical pesticides, or by destroying “mummies” — almonds left over after harvest. Mummies are a favorite winter shelter for the bugs.

However, research is increasingly showing that chemical pesticides are not only harmful to the environment but to people as well. One new study found that the impact of nearby pesticide use on cancer incidence “may rival that of smoking.”

“When you have to don a spacesuit, basically, to apply something, you’re definitely thinking, ‘This is not good,’” said Houston Wilson, an entomologist with UC ANR’s Kearney Agricultural Research and Extension Center and the mastermind behind the sci-fi shack.

“Across the board, folks want to get away from chemical controls,” he said.

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So farmers and researchers have been searching for other non-pesticide alternatives.

Removing almost every last mummy from every tree in an orchard can be effective, but since it must be done manually, it can become too expensive and complex for some growers.

Another tactic that’s been used since around 2010 is to cover orchards with disorienting levels of sex pheromones to confuse horny moths — a technique known as “mating disruption.”

But with limited budgets and climate change threatening to make the pest situation worse, researchers are studying another yet-to-be-proven approach: sterilizing almost a million moths a day with radiation and dropping them out of planes.

Houston Wilson looks over trapped moths at the Kearney Agricultural Research and Extension Center in Parlier, Calif.

Houston Wilson looks over trapped moths at the Kearney Agricultural Research and Extension Center in Parlier, Calif.

(Gary Kazanjian / For The Times)

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The idea behind the technique is that by flooding orchards with sterilized insects, they will mate with fertile insects and produce no offspring, reducing the overall population.

The simplest way to sterilize the bugs is to use radiation. Since their reproductive genes tend to mutate faster, the right dose can leave them relatively unfazed but unable to reproduce.

At the request of almond and pistachio farmers, the California Department of Food and Agriculture has been working with the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture since 2018 to source sterilized moths from a Phoenix lab.

An X-ray machine designed to sterilize moths is shown at the Kearney Agricultural Research and Extension Center.

An X-ray machine designed to sterilize moths is shown at the Kearney Agricultural Research and Extension Center.

(Gary Kazanjian / For The Times)

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The lab sterilizes about 750,000 bugs per day, then chills the moths to put them to sleep and ships them off to California. The bugs are dropped from an airplane hundreds of feet in the air. Often too sleepy to fly, the insects crash into the hard ground or almond trees.

From there, the survivors have only one job: have sex.

Through this test program, the USDA hopes to perfect the best ways to get moths to reproduce in the lab and give them the right dose of radiation that will sterilize them but not severely injure or disorient them.

The program has yet to put a significant dent in the moth population, though, because they can’t produce enough sterile bugs.

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Right now, researchers are only finding a couple of sterile insects in traps for every hundred wild fertile moths. For the technique to be effective, they’ll need to deploy dozens of sterile bugs for every wild one.

Anisa Bel Guzman counts moths at the Kearney Agricultural Research and Extension Center in Parlier, Calif.

Anisa Bel Guzman counts moths at the Kearney Agricultural Research and Extension Center in Parlier, Calif.

(Gary Kazanjian / For The Times)

Matthew Aubuchon, national policy manager at the USDA’s Animal and Plant Health Inspection Service, estimated that the Phoenix facility could produce up to 8 million moths per day with enough staff working around the clock.

While opening more facilities in California would help, the program uses cobalt to produce high-energy radiation to sterilize the bugs — which is expensive and requires the lab to take extensive safety and security measures.

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Wilson’s sci-fi shack at Kearney might hold a solution that is cheaper and easier to scale.

Instead of using cobalt or other radioactive materials, Wilson’s team uses an X-ray machine to irradiate the pests. (Unlike a radioactive substance, an X-ray machine will not emit radiation when it is turned off.)

Then, the team puts their X-rayed bugs and the sterilized insects from Phoenix through a series of tests to determine which methods produce the healthiest, sterile moths.

The tests include gluing moths to the end of a stick suspended in the air. The stick rotates like a carousel as the moths flutter around and researchers record how well they can fly.

A red glow fills an insect wind tunnel.

Houston Wilson looks into an insect wind tunnel as researchers look for innovative ways to manage an invasive almond pest.

(Gary Kazanjian / For The Times)

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The researchers also place moths in a wind tunnel and release sex pheromones to see if the excited bugs are able to locate the smell. (Unfortunately for the insects, there are no potential mates at the end of the tunnel.)

While the team doesn’t yet produce enough X-rayed moths to test them in a full-blown almond orchard, they do send the Phoenix moths into their final test: releasing them into their seven-acre almond farm on the Kearney campus to see how good they are at actually finding fertile moths to mate with.

Houston Wilson looks over a navel orangeworm trap in an almond field in Parlier.

Houston Wilson looks over a navel orangeworm trap in an almond field in Parlier.

(Gary Kazanjian / For The Times)

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The researchers at Kearney may be in a race against time, however.

Scientists say it’s possible that climate change will continue to tip the weather in the moths’ favor. The metabolism of navel orangeworms — like many agricultural pests — is tied to temperature. The hotter it is, the faster they grow and reproduce.

A 2021 study found that the moths, which can have life cycles as short as just one month, may be able to squeeze in another generation each summer before holing up in nuts for the winter.

“For each additional generation, their population is increasing at an exponential rate,” said Tapan Pathak, an author on the study and a professor at UC Merced.

“If this additional generation is coinciding with … harvest,” Pathak said, “then they become unmarketable. That’s a huge economic loss.”

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However, the food web is complicated, and just because the warmer weather benefits the moths on paper doesn’t mean the moths will end up on top.

A closeup of an almond growing on a tree branch.

Every year, navel orangeworms eat through roughly 2% of California’s almonds before they can make it to grocery store shelves.

(Gary Kazanjian / For The Times)

“Navel orangeworm could be a nightmare … but it could also become less of a problem because all the things that eat it benefit more from the heat than the navel orangeworm,” said Haviland. “The crystal ball is certainly not clear enough to know what will happen.”

Researchers stress that successful pest control will require multiple measures.

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“What we’ve learned through integrated pest management is that the timing of one or staggering of different approaches together yields results for the growers,” said Aubuchon.

The tried-and-true non-pesticide method growers have been using since the moths’ unannounced arrival in the 1940s is to simply ensure all the almonds are either harvested or destroyed by the time winter arrives.

But for this method to be effective, there must be no more than two almonds left on every tree in an orchard. This can be hard to achieve in wet weather.

Rain makes almond branches soggy and flexible, which makes it hard to snap nuts off using an industrial shaker. Damp earth can also make it difficult for machines to get close to the trees.

Instead, workers must use poles to knock almonds off manually. As effective as this is, increasing labor costs mean some farms just can’t afford it.

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Anisa Bel Guzman counts moths at the Kearney Agricultural Research and Extension Center in Parlier.

Anisa Bel Guzman counts moths at the Kearney Agricultural Research and Extension Center in Parlier.

(Gary Kazanjian / For The Times)

While researchers say the sterile insect technique still has a lot of hurdles to clear before it will be widely effective, they say it holds great promise.

“You’re literally managing a pest by preventing it from being born in the first place,” said Haviland of both sterile insect technique and pheromone mating disruption. “To think that something like that was possible 10 or 15 years ago — nobody could imagine that growers would be using such innovative techniques as those.”

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The Tijuana River smells so bad, the CDC is coming to investigate

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The Tijuana River smells so bad, the CDC is coming to investigate

San Diego County residents will have an opportunity to share their pollution concerns about the Tijuana River when officials from the Centers for Disease Control and Prevention arrive later this month to conduct a health survey.

This is the first time that a federal agency is investigating the potential harm caused by millions of gallons of raw sewage pouring through the Tijuana River that have caused beach closures of more than 1,000 days. Residents living near the river say they have been suffering unexplained illnesses, including gastrointestinal issues and chronic breathing problems, because of the stench of hydrogen sulfide.

“We’re continuing to lean in and listen in on what our community residents are feeling,” said Dr. Seema Shah, the interim deputy public health officer with San Diego County. Supervisor Nora Vargas first wrote to the CDC back in May, formally asking the U.S. Department of Health and Human Services to look into the health complaints.

This week, the county began reaching out to thousands of residents to inform them that the CDC is coming in the hope that they will be more receptive to answering questions. “This is our chance to be able to communicate [pollution concerns] on a national level,” Shah added.

As part of what the CDC calls a Community Assessment for Public Health Emergency Response, 210 households will be surveyed about their mental and physical health, as well as the pollution’s effects on property values. The families will be randomly selected from 30 clusters of neighborhoods where San Diego County has identified air pollution complaints in the Tijuana River Valley.

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Around 30 officials from the CDC and 50 graduate student volunteers from San Diego State University’s School of Public Health will be going door to door to conduct interviews with local residents over a three-day period. Here are the times when the survey will be conducted:

  • Thursday, Oct. 17, 2024, from 2 p.m. to 7 p.m.
  • Friday, Oct. 18, 2024, from 2 p.m. to 7 p.m.
  • Saturday, Oct. 19, 2024, from 10 a.m. to 7 p.m.

The goal is to accommodate people’s schedules and, officials hope, catch them after work, Shah said. The volunteers are helping to bridge the language barriers with Spanish-speaking families.

“A lot of students, many of whom are bilingual, are from the community themselves,” said Paula Granados, an associate professor at San Diego State University’s School of Public Health, who’s been testing the Tijuana River for contaminants over the past month. “Our students are super excited. They want to help.”

The CDC could take weeks to months to release even the preliminary results from the survey, but for longtime residents like Bethany Case, this renewed attention already feels like a breath of hope.

“I just really want [this survey] to inform policy so that we don’t have to worry about our kids being sick,” said Case, the mother of two who’s lived in Imperial Beach for 16 years. For seven years she’s been an activist fighting to clean up the river as a volunteer with Surfrider, a nonprofit that works to preserve ocean access and cleanliness.

“I’m hoping that their survey shows that oftentimes it doesn’t just smell like sewage,” Case added. She doesn’t want the focus on the sewage to distract from the industrial waste that is dumped into the river that could be making people ill. “Oftentimes it smells like a chemical, it smells like a bite in the air, it burns your sinuses.”

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Granados said the CDC’s survey is only a snapshot of what was going on when the data were collected, and conditions could worsen for residents when rainy seasons flood the river once more. Granados wants residents to know that even if they aren’t picked to respond to this survey, SDSU will be conducting its own yearlong survey that they can answer multiple times at tjriver.sdsu.edu.

“There’s research that’s still ongoing,” Granados said, and all that data will help policy decisions in the future. “We’re just committed to the long haul, whatever it takes to support the community.”

The county and other federal and state representatives have been working to raise awareness around the pollution to a national level.

Next week, the San Diego County Board of Supervisors will consider a proposal by Supervisor Terra Lawson-Remer to petition the Environmental Protection Agency to label the Tijuana River a Superfund site in need of remediation.

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