Science
New drug's potentially fatal side effects obscured by 'soothing acronym,' doctors say
Seventy-nine-year-old Genevieve Lane volunteered to take the Alzheimer’s drug Leqembi in a clinical trial because she was forgetting words and misplacing her keys.
Infusions of the drug gave her headaches so severe they sent her to bed. A week after the third dose, she was at a restaurant with her best friend when her speech slurred and she had a seizure. Five days later she was dead.
An autopsy found that Lane died of a mysterious side effect that has a name that sounds like it might be part of an Italian opera, but has doctors on edge.
The complication called ARIA has nothing to do with music. It is a term adopted by an influential group of pharmaceutical executives and academic scientists to describe potentially fatal bleeding and swelling in the brain caused by drugs like Leqembi.
“Mom believed the drug would help slow progression of her memory problems or do nothing,” said Lane’s daughter, Yvonne Battaglia. “She didn’t know it might kill her.”
Genevieve Lane, 79, of The Villages, Fla., not long before she died in September, 2022. An autopsy blamed Leqembi, a drug for Alzheimer’s disease.
(Lane family)
Lane’s death, and that of two other trial participants, has raised concerns among some doctors, who question whether Leqembi’s risks are worth its benefits, particularly for the population of older adults it was approved for.
Some of these doctors are urging that a new name be given to the drug’s potential side effects to better alert healthcare professionals to its risks.
ARIA is short for “amyloid-related imaging abnormalities,” with imaging referring to the MRI scans needed to find the brain bleeding and swelling.
“Clearly, it is more than just an imaging abnormality,” said Dr. Matthew Schrag, a Vanderbilt University neurologist, who helped with an autopsy that concluded Lane died of brain swelling and bleeding that was likely caused by Leqembi.
“My feeling is that ARIA is too euphemistic of a term. It conveys that this isn’t serious, and it certainly can be,” he said.
Leqembi, known generically as lecanemab, is a monoclonal antibody that works to remove a protein called amyloid from the brain. It received full Food and Drug Administration approval in July.
Eisai, a Japanese drugmaker that has partnered with Biogen, is promoting Leqembi to doctors and people concerned about their memories.
“Get ahead & stay ahead for longer,” an Eisai website says about the drug. It also says that “ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.”
In a recent article, a Stanford neurologist and his colleagues detailed their concerns about ARIA, which they called a “soothing acronym” for brain bleeding and swelling.
“It does certainly have the ring of something that a pharmaceutical company or public relations person would come up with,” Dr. Michael Greicius said in an interview.
Leqembi is approved for mild dementia and also a diagnosis known as mild cognitive impairment, where patients have more memory problems than others their age but can compensate and continue their daily activities. People with MCI have been found to be at greater risk for developing dementia; but in many cases, their memory problems stay the same or even improve.
The FDA has required that the company warn doctors about ARIA. The agency says the condition, which affected more than 20% of those taking the drug in a large trial, can be managed by requiring patients to get repeated MRI scans to look for bleeding and swelling.
“The FDA maintains that the benefits of Leqembi outweigh its risks when used according to the approved labeling,” said Dr. Teresa Buracchio, director of the FDA’s neuroscience office.
Libby Holman, an Eisai spokesperson, called ARIA “globally established nomenclature.”
Because of the risk of ARIA, some Los Angeles medical centers are taking extra precautions.
At Keck Medicine of USC, a neurologist is available 24/7 to take calls from families of those taking Leqembi, since a headache or sudden confusion can be a sign of ARIA, said Dr. Helena Chui, chair of the neurology department.
At UCLA and Cedars-Sinai Medical Center, warnings pop up in a patient’s electronic health record to ensure that all medical staff know the patient is taking Leqembi, because it can interact with certain other medications to make brain bleeding far worse.
And at all three medical centers it takes more than a single doctor to prescribe the drug. Each patient’s case must be reviewed by a panel of doctors and other staff — similar to how complex cancer cases are evaluated.
“We want to keep safety first,” said Dr. Keith Vossel, UCLA professor of neurology. “This is the most complicated, complex drug that we’ve prescribed in the dementia field.”
Other physicians say they won’t prescribe the drug.
“If there was a medication that worked, I would be the first person to use it,” said Dr. Clifford Sigel, a neurologist in Santa Monica. “But I won’t be using this in my practice.”
He pointed to a large clinical trial of Leqembi that led to its approval. It found that patients who took the drug saw their memory decline 27% more slowly — or less than half a point on an 18-point cognitive scale — than their counterparts who took a placebo. Sigel and other doctors doubt patients or their families would notice the difference.
Eisai’s Holman disputed claims that the drug does not work. She noted that a panel of outside experts convened by the FDA had voted unanimously that trial data confirmed its clinical benefit.
The name ARIA traces to July 2010 when “turmoil ensued” at an international scientific conference that the Alzheimer’s Assn. holds each year, according to an article by two scientists working in the field.
The FDA had proposed that companies testing new anti-amyloid drugs exclude any volunteer from clinical trials who had more than two brain microbleeds, according to an Alzheimer’s Assn. report. The tiny hemorrhages are sometimes found in healthy people and those with Alzheimer’s or other illnesses.
The agency also said it would require any volunteer who experienced a brain microbleed during the clinical trial to cease taking the drug.
The companies and academics working on the trials viewed the new FDA requirements as “excessively restrictive,” said the report by the association, a nonprofit that has become a powerful force in dementia science.
The industry and academic scientists feared the FDA proposal would stall research on the experimental drugs, the report said, and limit their use.
The drug companies asked the association to debate the FDA’s guidance at its Research Roundtable. Pharmaceutical and medical testing companies can become members of the roundtable by paying the association a $50,000 annual fee.
The association said that “one key question” taken up by the roundtable was whether ARIA was a temporary symptom of the new drug — much the way nausea and hair loss are side effects of chemotherapy — or evidence that anti-amyloid medicines may have more serious adverse effects. That question was never settled.
“Current knowledge doesn’t provide definitive answers to this critical question,” the association said in the 2011 report explaining the roundtable’s work.
Despite the unknowns, the roundtable proposed that volunteers be allowed into the trials even if they had as many as four brain microbleeds. The group said volunteers could keep getting the drug infusions if they developed brain bleeding as long as they did not have significant worsening of symptoms such as headaches and confusion.
The roundtable also proposed calling the brain bleeding and swelling ARIA.
The FDA “subsequently revised and updated the original advice…in a manner consistent” with the roundtable’s suggestions, wrote three of its members.
“Scientific evidence at the time led the workgroup to propose excluding people who have four or more microbleeds from clinical trials,” the association told The Times in a statement. “The FDA agreed.”
The association declined to answer questions on whether the name ARIA should be changed.
An FDA official told The Times that the industry group’s advice was just one of the factors the agency considered before it revised its 2010 guidelines.
More than a decade later, little more is known about why ARIA occurs or how to recognize it.
One problem is that a patient with ARIA can look like they’re having a stroke. And when stroke patients are taken to an emergency room, the first treatment doctors often consider is a clot-dissolving medicine called tPA, which can make brain bleeding worse.
That’s what happened to a 65-year-old woman taking Leqembi in a trial who arrived at a Chicago ER with stroke-like symptoms, according to a report published in February 2023. Doctors gave her tPA.
“As soon as they put it in her, it was like her body was on fire,” the woman’s husband said in a news story in the journal Science. “She was screaming, and it took like eight people to hold her down.”
The woman died, and an autopsy showed extensive bleeding in her brain, leading doctors to conclude the combination of the two drugs may have caused her death.
Knowing about that risk, Southern California doctors have been teaching emergency room staff to find out if patients thought to be suffering a stroke may be taking Leqembi.
“We’ve had to train and discuss this with the ER, the neuroradiology team and urgent care,” said Dr. Sarah Kremen, who leads Cedars Sinai’s Alzheimer’s clinical trial program. “You must ask this person, ‘Are you taking this medication?’”
An FDA database that collects reports of adverse drug reactions from doctors and others shows 23 deaths of patients taking Leqembi.
Holman at Eisai said it would be incorrect to assume the deaths were caused by Leqembi. She noted that Alzheimer’s patients have a higher risk of death because of the natural course of the disease.
In the large trial, less than 1% of patients died — the same rate whether they were taking the drug or the placebo.
Buracchio at the FDA said the agency takes “all adverse event reports seriously.” But she said the agency’s evaluation of the reports “must take the treated population into account,” which in this case is typically older or elderly adults.
To teach doctors about ARIA, Eisai created a website called understandingaria.com. It tells doctors that ARIA “usually resolves without intervention or treatment modification.”
In a brochure for healthcare providers, Eisai assures physicians that infusions may continue if an MRI turns up evidence of microbleeds as long as there are four or fewer and that the discomfort doesn’t disrupt the patient’s activities.
For Genevieve Lane, an MRI discovered four brain microbleeds before she started taking Leqembi in the trial.
After Lane died, an autopsy found more than 30 microbleeds in her brain, including some that could not be seen on the MRI, according to a report in Nature Communications.
The report’s authors, who included Schrag at Vanderbilt, questioned whether the pre-treatment limit of four brain microbleeds was stringent enough and called for higher standards.
The FDA told The Times that the agency had reviewed the available data and had not identified a specific number of preexisting microhemorrhages that would make it unsafe for patients to take anti-amyloid drugs like Leqembi.
“However, we will continue to monitor the accruing safety data,” the agency said.
Other doctors have questioned what happens to the memories of those who suffer ARIA, even if the bleeding and swelling appears to resolve.
Dr. Madhav Thambisetty, a senior researcher at the National Institute of Aging, said he was concerned by a report in a French medical journal about two women with mild dementia who experienced serious ARIA during a trial. One suffered severe seizures; 11 months later, her memory score dropped by nine points on a 30-point scale. The other patient developed a brain bleed described as “massive”; she lost a significant part of her vision, and her memory score declined by 12 points on the same scale.
An FDA scientist reviewing reports of patients who suffered high numbers of microbleeds in the clinical trial also noted the possible harm to their cognition in her January 2023 report on Leqembi.
One of the patients that Dr. Deniz Erten-Lyons pointed to was a 68-year-old man who had four microbleeds before starting the infusions. After treatment, he began to lose his vision and was hospitalized because of a seizure. An MRI found 96 microbleeds.
Thambisetty said he and Dr. Rob Howard of University College London wrote to Eisai last year to request information about what happened to the cognition of those who suffered ARIA in trials.
Eisai has not responded to their request, he said.
“I’m concerned about the lack of full and transparent reporting,” Thambisetty said. “It’s really important to know what happens to these patients.”
Holman said the company’s analysis of trial data showed that ARIA did not impact cognition.
“Eisai is transparent,” she said. The company follows guidelines for sharing clinical data established by PhRMA, the industry trade association, Holman said.
Greicius, the Stanford professor, also asked Eisai for trial data that would break down results for each volunteer to better understand ARIA and whether patients benefited as more amyloid was removed from their brains.
The response from Eisai, he said, was, “Thanks for your interest, but we can’t release the data.”
California lawmakers are taking aim at proposed rules to implement a state law aimed at curbing plastic waste, saying the draft regulations proposed by CalRecycle undermine the letter and intent of the legislation.
In a letter to Gov. Gavin Newsom and two of his top administrators, the lawmakers said CalRecycle exceeded its authority by drafting regulations that don’t abide by the terms set out by the law, Senate Bill 54.
“While we support many changes in the current draft regulations, we have identified several provisions that are inconsistent with the governing statute … and where CalRecycle has exceeded its authority under the law,” the lawmakers wrote in the letter to Newsom, California Environmental Protection agency chief Yana Garcia, and Zoe Heller, director of the state’s Department of Resources Recycling and Recovery, or CalRecycle.
The letter, which was written by Sen. Catherine Blakespear (D-Encinitas) and Sen. Benjamin Allen (D-Santa Monica), was signed by 21 other lawmakers, including Sen. John Laird (D-Santa Cruz) and Assemblymembers Al Muratsuchi (D-Rolling Hills Estates) and Monique Limón (D-Goleta).
CalRecycle submitted informal draft regulations two weeks ago that are designed to implement the law, which was authored by Allen, and signed into law by Newsom in 2022.
The lawmakers’ concerns are directed at the draft regulations’ potential approval of polluting recycling technologies — which the language of the law expressly prohibits — as well as the document’s expansive exemption for products and packaging that fall under the purview of the U.S. Department of Agriculture and the Food and Drug Administration.
The inclusion of such blanket exemptions is “not only contrary to the statute but also risks significantly increasing the program’s costs,” the lawmakers wrote. They said the new regulations allow “producers to unilaterally determine which products are subject to the law, without a requirement or process to back up such a claim.”
Daniel Villaseñor, a spokesman for the governor, said in an email that Newsom “was clear when he asked CalRecycle to restart these regulations that they should work to minimize costs for small businesses and families, and these rules are a step in the right direction …”
At a workshop held at the agency’s headquarters in Sacramento this week, CalRecycle staff responded to similar criticisms, and underscored that these are informal draft regulations, which means they can be changed.
“I know from comments we’ve already been receiving that some of the provisions, as we have written them … don’t quite come across in the way that we intended,” said Karen Kayfetz, chief of CalRecycle’s Product Stewardship branch, adding that she was hopeful “a robust conversation” could help highlight areas where interpretations of the regulations’ language differs from the agency’s intent.
“It was not our intent, of course, to ever go outside of the statute, and so to the extent that it may be interpreted in the language that we’ve provided, that there are provisions that extend beyond … it’s our wish to narrow that back down,” she said.
These new draft regulations are the expedited result of the agency’s attempt to satisfy Newsom’s concerns about the law, which he said could increase costs to California households if not properly implemented.
Newsom rejected the agency’s first attempt at drafting regulations — the result of nearly three years of negotiations by scores of stakeholders, including plastic producers, package developers, agricultural interests, environmental groups, municipalities, recycling companies and waste haulers — and ordered the waste agency to start the process over.
Critics say the new draft regulations cater to industry and could result in even higher costs to both California households, which have seen large increases in their residential waste hauling fees, as well as to the state’s various jurisdictions, which are taxed with cleaning up plastic waste and debris clogging the state’s rivers, highways, beaches and parks.
The law is molded on a series of legislative efforts described as Extended Producer Responsibility laws, which are designed to shift the cost of waste removal and disposal from the state’s jurisdictions and taxpayers to the industries that produce the waste — theoretically incentivizing a circular economy, in which product and packaging producers develop materials that can be reused, recycled or composted.
As promised, federal health officials have dropped longstanding recommendations that healthy children and healthy pregnant women should get the COVID-19 vaccines.
“The COVID-19 vaccine schedule is very clear. The vaccine is not recommended for pregnant women. The vaccine is not recommended for healthy children,” the U.S. Department of Health and Human Services said in a post on X on Friday.
In formal documents, health officials offer “no guidance” on whether pregnant women should get the vaccine, and ask that parents talk with a healthcare provider before getting the vaccine for their children.
The decision was done in a way that is still expected to require insurers to pay for COVID-19 vaccines for children should their parents still want the shots for them.
The new vaccine guidelines were posted to the website of the U.S. Centers for Disease Control and Prevention late Thursday.
The insurance question
It wasn’t immediately clear whether insurers will still be required under federal law to pay for vaccinations for pregnant women.
The Trump administration’s decision came amid criticism from officials at the nation’s leading organizations for pediatricians and obstetricians. Some doctors said there is no new evidence to support removing the recommendation that healthy pregnant women and healthy children should get the COVID vaccine.
“This situation continues to make things unclear and creates confusion for patients, providers and payers,” the American College of Obstetricians and Gynecologists said in a statement Friday.
Earlier in the week, the group’s president, Dr. Steven Fleischman, said the science hasn’t changed, and that the COVID-19 vaccine is safe during pregnancy, and protects both the mom-to-be and their infants after birth.
“It is very clear that COVID-19 infection during pregnancy can be catastrophic,” Fleischman said in a statement.
Dr. Susan Kressly, president of the American Academy of Pediatrics, criticized the recommendation change as being rolled out in a “conflicting, confusing” manner, with “no explanation of the evidence used to reach their conclusions.”
“For many families, the COVID vaccine will remain an important way they protect their child and family from this disease and its complications, including long COVID,” Kressly said in a statement.
Some experts said the Trump administration should have waited to hear recommendations from a committee of doctors and scientists that typically advises the U.S. Centers for Disease Control and Prevention on immunization recommendations, which is set to meet in late June.
California’s view
The California Department of Public Health on Thursday said it supported the longstanding recommendation that “COVID-19 vaccines be available for all persons aged 6 months and older who wish to be vaccinated.”
The changes come as the CDC has faced an exodus of senior leaders and has lacked an acting director. Typically, as was the case during the first Trump administration and in the Biden administration, it is the CDC director who makes final decisions on vaccine recommendations. The CDC director has traditionally accepted the consensus viewpoint of the CDC’s panel of doctors and scientists serving on the Advisory Committee on Immunization Practices.
Even with the longstanding recommendations, vaccination rates were relatively low for children and pregnant women. As of late April, 13% of children, and 14.4% of pregnant women, had received the latest updated COVID-19 vaccine, according to the CDC. About 23% of adults overall received the updated vaccine, as did 27.8% of seniors age 65 and over.
The CDC estimates that since October, there have been 31,000 to 50,000 COVID deaths and between 270,000 and 430,000 COVID hospitalizations.
Here are some key points about the CDC’s decision:
New vaccination guidance for healthy children
Previously, the CDC’s guidance was simple: everyone ages 6 months and up should get an updated COVID vaccination. The most recent version was unveiled in September, and is officially known as the 2024-25 COVID-19 vaccine.
As of Thursday, the CDC, on its pediatric immunization schedule page, says that for healthy children — those age 6 months to 17 years — decisions about COVID vaccination should come from “shared clinical decision-making,” which is “informed by a decision process between the healthcare provider and the patient or parent/guardian.”
“Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances,” the CDC says.
The vaccine-skeptic secretary of Health and Human Services, Robert F. Kennedy Jr., contended in a video posted on Tuesday there was a “lack of any clinical data to support the repeat booster strategy in children.”
However, an earlier presentation by CDC staff said that, in general, getting an updated vaccine provides both children and adults additional protection from COVID-related emergency room and urgent care visits.
Dr. Peter Chin-Hong, a UC San Francisco infectious diseases expert, said he would have preferred the CDC retain its broader recommendation that everyone age 6 months and up get the updated vaccine.
“It’s simpler,” Chin-Hong said. He added there’s no new data out there that to him suggests children shouldn’t be getting the updated COVID vaccine.
A guideline that involves “shared decision-making,” Chin-Hong said, “is a very nebulous recommendation, and it doesn’t result in a lot of people getting vaccines.”
Kressly, of the American Academy of Pediatrics, said the shared clinical decision-making model is challenging to implement “because it lacks clear guidance for the conversations between a doctor and a family. Doctors and families need straightforward, evidence-based guidance, not vague, impractical frameworks.”
Some experts had been worried that the CDC would make a decision that would’ve ended the federal requirement that insurers cover the cost of COVID-19 vaccines for children. The out-of-pocket cost for a COVID-19 vaccine can reach around $200.
New vaccine guidance for pregnant women
In its adult immunization schedule for people who have medical conditions, the CDC now says it has “no guidance” on whether pregnant women should get the COVID-19 vaccine.
In his 58-second video on Tuesday, Kennedy did not explain why he thought pregnant women should not be recommended to get vaccinated against COVID-19.
Chin-Hong, of UCSF, called the decision to drop the vaccination recommendation for pregnant women “100%” wrong.
Pregnancy brings with it a relatively compromised immune system. Pregnant women have “a high chance of getting infections, and they get more serious disease — including COVID,” Chin-Hong said.
A pregnant woman getting vaccinated also protects the newborn. “You really need the antibodies in the pregnant person to go across the placenta to protect the newborn,” Chin-Hong said.
It’s especially important, Chin-Hong and others say, because infants under 6 months of age can’t be vaccinated against COVID-19, and they have as high a risk of severe complications as do seniors age 65 and over.
Not the worst-case scenario for vaccine proponents
Earlier in the week, some experts worried the new rules would allow insurers to stop covering the cost of the COVID vaccine for healthy children.
Their worries were sparked by the video message on Tuesday, in which Kennedy said that “the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule.”
By late Thursday, the CDC came out with its formal decision — the agency dropped the recommendation for healthy children, but still left the shot on the pediatric immunization schedule.
Leaving the COVID-19 vaccine on the immunization schedule “means the vaccine will be covered by insurance” for healthy children, the American Academy of Pediatrics said in a statement.
How pharmacies and insurers are responding
There are some questions that don’t have immediate answers. Will some vaccine providers start requiring doctor’s notes in order for healthy children and healthy pregnant women to get vaccinated? Will it be harder for children and pregnant women to get vaccinated at a pharmacy?
In a statement, CVS Pharmacy said it “follows federal guidance and state law regarding vaccine administration and are monitoring any changes that the government may make regarding vaccine eligibility.” The insurer Aetna, which is owned by CVS, is also monitoring any changes federal officials make to COVID-19 vaccine eligibility “and will evaluate whether coverage adjustments are needed.”
Blue Shield of California said it will not change its practices on covering COVID-19 vaccines.
“Despite the recent federal policy change on COVID-19 vaccinations for healthy children and pregnant women, Blue Shield of California will continue to cover COVID-19 vaccines for all eligible members,” the insurer said in a statement. “The decision on whether to receive a COVID-19 vaccine is between our member and their provider. Blue Shield does not require prior authorization for COVID-19 vaccines.”
Under California law, health plans regulated by the state Department of Managed Health Care must cover COVID-19 vaccines without requiring prior authorization, the agency said Friday. “If consumers access these services from a provider in their health plan’s network, they will not need to pay anything for these services,” the statement said.
Sacramento — Want to know what constitutes an acceptable form of recycling in California under CalRecycle’s new draft guidelines for the state’s landmark plastic waste law?
It’ll cost you roughly $187, and even then you may not find your answer.
The issue arose this week when CalRecycle held a Sacramento workshop on its proposed regulations to implement Senate Bill 54, the 2022 law designed to reduce California’s single-use plastic waste.
In the regulations’ latest iteration, the agency declared that it will only consider recycling technologies that follow standards issued by the International Organization for Standardization, or ISO, the Geneva-based group that sets standards for a variety of industries, including healthcare and transportation.
According to the draft regulations: “A facility’s use of a technology that is not a mechanical recycling technology … shall not be considered recycling unless the facility operates in a manner consistent with ISO 59014:2024.”
To access ISO 59014:2024, one must purchase the report for about $187.
That’s not fair, said Nick Lapis, director of advocacy for Californians Against Waste. “Copies of those ISO standards should be publicly available,” he said.
Lapis and others also noted that the law, as written, expressly prohibits chemical and nonmechanical forms of recycling.
Officials at CalRecycle, also known as the California Department of Resources Recycling and Recovery, didn’t respond to the criticism or to questions from The Times.
ISO 59014:2024 turns out to be a 38-page report titled “Environmental management and circular economy — Sustainability and traceability of the recovery of secondary materials — Principles, requirements and guidance.”
A copy of the report reviewed by The Times offered no specifics on recycling technologies, or information about the operation of a recycling plant.
The word “recycling” is only used five times in the “Annex,” a 13-page supplementary section of the report. And there it is mentioned only in the context of establishing definitions or examples of “organizations engaged in the recovery of secondary materials” or “collection system types.”
For instance, “Commercial waste and recycling companies” are listed as examples of a type of organization that collects waste. Other waste collectors, according to the report, include municipalities, retailers and reuse organizations such as nonprofit reuse operators.
“The draft calls on aligning facilities with this ISO standard,” said Monica Wilson, senior director of global programs at the Global Alliance for Incinerator Alternatives. “That ISO standard is not about recycling. It’s not about chemical recycling, it’s just not an appropriate comparison for us to be referring to.”
Lapis also found the report hard to decipher.
“Maybe I should go back and look at it again, but it’d be helpful if you’re citing ISO standards … that you identify what parts” are being cited, he said.
Karen Kayfetz, chief of CalRecycle’s Product Stewardship branch, didn’t respond to questions or concerns about the inclusion of a report that is not freely available to the public to review.
During this week’s workshop, she said the agency’s use of the ISO standard “is not meant … to be a measure of whether you are recycling, but rather just one of multiple criteria that an entity needs to be measured against.”
She said the SB 54 statute requires that CalRecycle exclude recycling technologies that produce significant amounts of hazardous waste and tasks the agency with considering environmental and public health impacts of these technologies.
“The ISO standard for the operation of facilities does address some of the best practices that would help to ameliorate and measure those impacts. … It is meant to be one of multiple criteria that can be utilized as a measure and to help set a floor but not a ceiling,” she said.
Anna Ferrera, a spokeswoman for the Wine Institute, which represents more than 1,000 wineries and affiliates across the state, was among those with no complaints about the proposed new regulations.
“We believe it incorporates common-sense changes that would reduce costs and ensure that products are appropriately recycled,” Ferrera said.
Tina Andolina, the chief of staff for state Sen. Ben Allen (D-Santa Monica), SB 54’s author, said the inclusion of the report and other items in the draft regulations suggests that CalRecycle is considering how to manage these polluting technologies — instead of forbidding them, as the law requires.
“The regulations unlawfully shift the standard from the production of hazardous waste as required by the statute to its management,” she said, reading from a letter Allen had written to the staff.
Anja Brandon, director of plastic policy at the Ocean Conservancy, added that along with not being freely available, the ISO standard “does not satisfy SB 54’s requirements to exclude the most hazardous technologies and to minimize the generation of hazardous waste and environmental, environmental justice and public health impacts.”
SB 54, which was signed by Gov. Gavin Newsom in 2022, requires that by 2032, 100% of single-use packaging and plastic food ware produced or sold in the state must be recyclable or compostable, that 65% of it can be recycled, and that the total volume is reduced by 25%.
The law was written to address the mounting issue of plastic pollution in the environment and the growing number of studies showing the ubiquity of microplastic pollution in the human body — such as in the brain, blood, heart tissue, testicles, lungs and various other organs.
Last March, after nearly three years of negotiations among various corporate, environmental, waste, recycling and health stakeholders, CalRecycle drafted a set of finalized regulations designed to implement the single-use plastic producer responsibility program under SB 54.
But as the deadline for implementation approached, industries that would be affected by the regulations including plastic producers and packaging companies — represented by the California Chamber of Commerce and the Circular Action Alliance — began lobbying the governor, complaining that the regulations were poorly developed and might ultimately increase costs for California taxpayers.
Newsom allowed the regulations to expire and told CalRecycle that it needed to start the process over.
These new draft regulations are the agency’s latest attempt at issuing guidelines by which the law can be implemented.
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