EPA proposes new regulations on toxic gas used to sterilize spices and medical equipment | CNN



CNN
 — 

The US Environmental Protection Agency on Tuesday proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices.

The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk.

Communities exposed to ethylene oxide gas have been pushing the EPA to put tighter controls on plants that use ethylene oxide gas.

In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process.

The EPA issued the report on the new risks without issuing a news release, as it had done for the same report in years past. Some affected communities learned of the risk through a health assessment conducted by the Agency for Toxic Substances and Disease Registry, a division of the US Centers for Disease Control and Prevention, and media reports. A report from the EPA’s Office of the Inspector General found that some communities weren’t alerted to their risk by EPA at all.

The elevated risk became apparent after a two-decade long review of the toxicity of ethylene oxide by scientists in EPA’s Integrated Risk Information System (IRIS) program.

While the EPA acknowledged that ethylene oxide was more dangerous that had been previously understood, it continued to use an older set of rules to regulate facilities that released ethylene oxide as well as companies that manufacture it.

The proposed rules aim to better align regulations on the producers and users of ethylene oxide with the cancer risk posed by the chemical. They follow a set of proposed rules issued by EPA last week that would put new controls on facilities that manufacture ethylene oxide.

Taken together, the two sets of rules would remove 77 tons of ethylene oxide emissions a year, an 84% reduction compared with 2020 levels, EPA Deputy Administrator Janet McCabe said in a call with reporters on Tuesday.

Environmental watchdog groups applauded the proposed restrictions, but noted that they don’t go far enough to protect vulnerable communities, where residents are often low-income and disproportionately people of color.

“These regulations are long overdue, by almost a decade. I’m relieved and pleased that the EPA has finally issued proposed standards that are based on their own scientists’ recommendations on an updated, higher cancer risk value. If enacted, these updated regulations would reduce emissions in fenceline communities,” said Darya Minovi, a senior researcher scientist at the Union of Concerned Scientists.

“When the EPA issues the final rule, they should throw the net wider. The standard should cover a larger range of facilities to include off-site warehouses that often store recently sterilized equipment that continue to release ethylene oxide, but aren’t regulated for their air emissions.”

Minovi also said the EPA should require fenceline monitors – devices that constantly read the air outside of facilities to make sure that toxic gas isn’t drifting into neighborhoods.

Jaime Rukstales, a member of the Illinois grassroots advocacy group Stop EtO in Lake County – one of the communities impacted by ethylene oxide pollution – says the EPA needs to impose tougher restrictions on “all types of facilities that impact the health of our communities … including sterilizers, manufacturers and warehouses near our homes, schools and businesses.”

Some off-site warehouses used to store newly sterilized products have registered high levels of ethylene oxide due to off-gassing of the products.

Meanwhile, chemical manufacturers sued the EPA in February over its updated hazard assessment for ethylene oxide. The industry wants the agency to use a less protective standard developed by the Texas Commission on Environmental Quality.

AdvaMed, a group that lobbies for the interests of medical device manufacturers, warned that more regulations could pose problems for patients.

“If new EPA regulations force sterilization facilities to close, patients could face treatment delays as sterile technology supplies, such as pacemakers and surgical equipment, fall short,” Scott Whitaker, president and CEO of AdvaMed, said in a comment posted on the group’s website.

The EPA said some commercial sterilizers have already made the planned changes.

“Many sterilization and health care facilities are already taking the steps outlined in the proposal and have seen emissions drop significantly,” McCabe said.

Most facilities have taken action to control ethylene oxide blown out of sterilization chambers through exhaust vents known as “back vents” but only 25% to 33% of sterilizers are controlling so-called fugitive emissions, ethylene oxide that escapes or leaks into room air, said Jonathan Witt, an environmental engineer and technical lead on EPA’s review of the National Emissions Standards for Hazardous Air Pollutants.

“So we think it’s a good sizable chunk of the industry, but still a little ways to go,” Witt said on a call with reporters.

If the rules go into effect, sterilizers would have 18 months to make the changes, which the EPA said is an accelerated time frame under the Clean Air Act.

AdvaMed’s Whitaker says that’s not enough time.

“It could take many months for abatement equipment to arrive. Supply chains and manufacturing are still recovering from the pandemic,” he noted in the statement.

In issuing the proposed rules, the EPA said it aimed to strike a balance between lowing cancer risks for impacted communities and workers who use ethylene oxide while preserving “critical sterilization capabilities.”

The proposed rules would apply to 86 commercial sterilization facilities in the United States that use ethylene oxide gas to fumigate spices and medical devices.

The EPA says 20 billion medical devices – mostly single-use, disposable items used in health care such as catheters, gloves and surgical gowns – are sterilized using ethylene oxide.

The US Food and Drug Administration is actively exploring alternatives to the use of the gas, the EPA said on Tuesday, but some devices still can’t be sterilized any other way.

In proposing the new rules, EPA said its new analysis found that exposure to ethylene oxide, or EtO, on the job significantly increased cancer risks for workers in sterilization facilities and those who apply ethylene oxide in health care facilities.

“Now, a new EPA analysis shows that there may also be significant risks to workers who handle [ethylene oxide] and people who live, work or go to school near places where EtO is used in sterilization. And failing to take action to address these risks is simply unacceptable,” EPA Administrator Janet McCabe said on a call with reporters.

The additional lifetime cancer risk for a worker exposed to ethylene oxide for eight hours a day, 240 days a year for 35 years was between 1 in 10 and 1 in 36 for workers in sterilization facilities; and between 1 in 12 and 1 in 25 for workers exposed to ethylene oxide in health care facilities.

To help lower those risks, the proposed rules require greater use of personal protective equipment for workers and new controls to decrease the amount of ethylene oxide in indoor air.

Whitaker from AdvaMed, the medical device industry group, said the cancer risk for employees exposed to ethylene oxide on the job is overstated and disregards “the strong employee protections already in practice.”

Companies will also be required to use new real-time monitoring methods to confirm that these pollution controls are working inside facilities. These controls can measure ethylene oxide in indoor air down to 10 parts per billion. If ethylene oxide levels climb above this threshold, everyone in the workplace would be required to wear protective equipment.

They will also lower the amount of ethylene oxide that can be used for each sterilization cycle. The EPA is proposing to limit the application rate for ethylene oxide to no more than 500 milligrams per liter of air.

The rules would eliminate some niche uses of ethylene oxide where alternatives exist, including its use in museums, archival settings, beekeeping, some cosmetics, and in musical instruments.

The EPA will take public comment on the new rules for 60 days. The agency will also host a virtual public webinar on May 1 to discuss its proposed rules and new risk assessment.

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Many firefighters who responded to Ohio train derailment didn’t have the needed training, equipment | CNN



CNN
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Many of the first responders who helped fight the fire that erupted after the train derailment in East Palestine, Ohio, last month were ill-equipped and untrained to fight the massive chemical blaze that some now call “the hell fire.”

In testimony Wednesday before the US Senate’s Commerce, Science and Transportation Committee, lawmakers heard about myriad issues that snarled the response and that put firefighters who rushed to the scene at greater immediate risk – and may raise risks to their health throughout their lives.

About 300 firefighters from 50 departments dashed to the scene of the derailment in East Palestine on the night of February 3. Many of them were volunteers without hazmat training or specialized equipment.

Officials investigating the derailment testified that these first responders weren’t able to access information about the chemicals that were in 11 overturned cars carrying hazardous materials.

Jennifer Homendy, chair of the National Transportation Safety Board, the agency investigating the crash, urged senators to consider meaningful changes to help inform exposed communities and first responders.

“People deserve to know what chemicals are moving through their communities and how to stay safe in an emergency, That includes responders who risk their lives for each of us every single day. They deserve to be prepared,” Homendy said.

Studies have shown that firefighters have a higher rates of cancer compared with members of the general population because of toxic chemicals they’re exposed to on the job. These cancers include digestive, oral, lung and bladder cancers. A rare type of cancer called malignant mesothelioma is about twice as common in firefighters than in the general population, probably due to exposure to asbestos in burning buildings, for example.

Cancer is now the leading cause of death for working firefighters, according to the International Association of Fire Fighters.

Ohio Gov. Mike DeWine said Wednesday that he is very concerned about the long-term health of the firefighters who responded to the derailment.

“They all need to be assessed,” he said. “There needs to be established a baseline, and they need to be assured that in five years or 10 years, there’s still a place where they could go.”

“We look to the railroad to establish that fund,” DeWine said in testimony before the committee.

The derailment occurred about 9 p.m. February 3, and the night air quickly filled with smoke. Visibility was poor, and some of the placards on overturned railcars had burned away, leaving responders clueless about what chemicals were spilling and catching fire around them.

There’s an app, AskRail, meant to give users more information about the what’s on trains involved in accidents, but none of the first responders to the derailment in East Palestine had access to it, Homendy said.

Even if they had been able to use it, the app lists what is in cars by their order on the train, and its information may have been of limited help to firefighters on the scene who were looking at cars that were “bunched up” and not in their normal order, said David Comstock, chief of the Ohio Western Reserve Fire District.

There are better ways of getting urgent information to first responders, he told the senators.

After auto accidents, for example, some telematic systems in cars transmit information about the crash to emergency dispatchers who can then send it to crews responding to the scene.

“So en route to a motor vehicle accident, I know the car has flipped three times, airbags gone out, and it has information about that car – whether it’s an electric car, things I have to worry about,” Comstock said.

No information like that was available to crews responding to the derailed train.

“They didn’t have the information for quite a long time on what was on the train,” Homendy said.

Facing criticism over its role in the response, the company that owns and operates the train, Norfolk Southern, has announced that it will create a new regional training center for first responders. CEO Alan Shaw repeated that pledge in his testimony Wednesday before the committee.

The company also intends to expand its Operation Awareness & Response program, which travels its 22-state network to teach first responders how to stay safe after train accidents.

Comstock testified that more training is important, but so is more gear. He said most fire stations in the area are lucky if they can supply each member of their crew with a single set of turnout gear: the protective coat, pants, boots, gloves and helmets firefighters wear.

“When I have to wash that, I’m out of service,” he said. “In response to the derailment, I had three firefighters who were exposed. Their gear is contaminated. I can’t use it.”

It takes six months to order replacement gear, he said.

“That means I have three firefighters who are out of service for six months who can’t respond to auto accidents or structure fires,” he said.

Even then, that basic gear isn’t designed to stand up to hazardous materials like the chemicals on the Norfolk Southern train.

For that kind of incident, firefighters need hazmat suits, which can cost $15,000 each, Comstock testified, along with specialized monitoring equipment.

“It’s unrealistic for the federal government to provide that to every department, but we do need to look at a regional approach so we can call in those teams that can supplement what we’re trying to do,” he said.

Comstock said he hopes the committee will consider the needs of firefighters as it drafts legislation to right the wrongs of the East Palestine incident.

“This incident has emphasized the need to better train and equip firefighters to respond to hazardous material incidents, specifically to derailments in rural areas, which are mostly served by volunteer fire departments that often lack sufficient resources, tax base and manpower,” he said.

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Common kinds of air pollution led to changes in teens’ blood pressure, study says | CNN



CNN
 — 

Scientists know that air pollution can make it difficult to breathe and may ultimately cause serious health problems like cancer, but a new study shows that it might also have a negative impact on teens’ blood pressure.

Exposure to higher levels of nitrogen dioxide was associated with lower blood pressure in teens, according to the study, published Wednesday in the journal PLOS One. Exposure to particulate matter 2.5, also known as particle pollution, was associated with higher blood pressure.

The researchers say the impact is “considerable.”

Other studies have found a connection between blood pressure changes and pollution, but much of that work focuses on adults. Some research has also found negative associations with pollution exposure and younger children, but little has focused on teens.

Generally, low blood pressure can cause immediate problems like confusion, tiredness, blurred vision and dizziness. High blood pressure in adolescence can lead to a lifetime of health problems including a higher risk of stroke or heart attack. It’s a leading risk factor for premature death worldwide.

The study did not look at whether the teens had symptoms or health effects from the change in blood pressure.

The scientists saw this association between pollution and blood pressure in data from the Determinants of Adolescent Social Well-Being and Health study, which tracks the health of a large and ethnically diverse group of children in London over time.

The researchers took data from more than 3,200 teens and compared their records to their exposures to pollution based on annual pollution levels where they lived.

Nitrogen dioxide pollution is most commonly associated with traffic-related combustion byproducts. Nitrogen may help plants grow, but it can impair a person’s ability to breathe and may cause damage to the human respiratory tract. In this study, the nitrogen was thought to be coming predominantly from diesel traffic.

The particle pollution in the study is so tiny – 1/20th of a width of a human hair – that it can travel past the body’s usual defenses. Instead of being carried out when a person exhales, it can get stuck in the lungs or go into the bloodstream. The particles cause irritation and inflammation and may lead to a whole host of health problems.

Particle pollution can come from forest fires, wood stoves, power plants and coal fires. It can also come from traffic and construction sites.

In this study, the link between pollution exposure and changes in blood pressure was stronger in girls than in boys. The researchers can’t determine why there is a gender difference, but they found that 30% of the female participants got the least amount of exercise among the group and noted that that can have an effect on blood pressure.

“It is thus imperative that air pollution is improved in London to maximise the health benefits of physical exercise in young people,” the study says.

Although the study also can’t pinpoint why teens’ blood pressure changed with pollution exposure, others have found that exposure to air pollution may affect the central nervous system, causing inflammation and damage to the body’s cells. Additionally, exposure to particle pollution can disrupt a person’s circadian rhythms, which could affect blood pressure. Particle pollution exposure may also reduce the kidneys’ ability to excrete sodium during the day, leading to a higher nighttime blood pressure level, the study says.

When it came to nitrogen dioxide pollution, the researchers had previously done a crossover study that involved the blood pressure of 12 healthy teen participants who were exposed to nitrogen oxide from a domestic gas cooker with lit burners. Their blood pressure fell compared with participants exposed to only room air.

In the new study, the associations between pollution and blood pressure were consistent. Body size, socieoecomonic status and ethnicity didn’t change the results.

However, it looks only at teens in London, and only 8% of them were people of color. Those children were exposed to higher levels of pollution than White children, the study found.

Levels of pollution in London are also well above what World Health Organization guidelines suggest is safe for humans. However, the same could be said for most any area in the world. In 2019, 99% of the world’s population lived in places that did not meet WHO’s recommended air quality levels.

Earlier work has shown that pollution can damage a young person’s health and may put them at a higher risk for chronic diseases like heart problems later in life. Studies in adults found that exposure to air pollution can affect blood pressure even within hours of exposure.

Pollution caused 1 in 6 deaths worldwide in 2019 alone, another study found.

Some experts suggest that one way to reduce a teen’s risk of pollution-related health problems is to invest in portable air cleaners with HEPA filters that are highly effective at reducing indoor air pollution. However, the filters can’t remove all of the problem, and experts say communitywide solutions through public policy are what’s needed.

Dr. Panagis Galiatsatos, an assistant professor in pulmonary and critical care medicine at Johns Hopkins Medicine, said research like this is important to generate a hypothesis about what these pollutants are doing to people. Galiatsatos, a volunteer medical spokesperson with the American Lung Association, was not involved with the new study.

“A lot of these air pollutions tend to cluster in economically disadvantaged neighborhoods, so it’s one of the big reasons we want to always keep a close eye on this, as it disproportionately impacts certain populations more than others,” he said.

Blood pressure is an important marker to track for health because it is a surrogate to understand the more complex processes that might be happening in the body.

“My big takeaway is that these toxins clearly seem to have some physiological impact on the cardiovascular system, and any manipulation should be taken into the context of a concern,” Galiatsatos said.

Study co-author Dr. Seeromanie Harding, a professor of social epidemiology at King’s College London, said she hopes it will lead to more research on the topic.

“Given that more than 1 million under 18s live in [London] neighborhoods where air pollution is higher than the recommended health standards,” she said in a news release, “there is an urgent need for more of these studies to gain an in-depth understanding of the threats and opportunities to young people’s development.”

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FDA proposes new levels for lead in baby food, but critics say more action is needed | CNN



CNN
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The allowable levels of lead in certain baby and toddler foods should be set at 20 parts per billion or less, according to new draft guidance issued Tuesday by the US Food and Drug Administration.

“For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods,” said FDA Commissioner Dr. Robert Califf in a statement.

The

Baby foods covered by the new proposal – which is seeking public comment – include processed baby foods sold in boxes, jars, pouches and tubs for babies and young children younger than 2 years old, the agency said.

While any action on the part of the FDA is welcome, the suggested levels of lead are not low enough to move the needle, said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures, a coalition of advocates committed to reducing babies’ exposures to neurotoxic chemicals.

“Nearly all baby foods on the market already comply with what they have proposed,” said Houlihan, who authored a 2019 report that found dangerous levels of lead and other heavy metals in 95% of manufactured baby food.

That report triggered a 2021 congressional investigation, which found leading baby food manufacturers knowingly sold products with high levels of toxic metals.

“The FDA hasn’t done enough with these proposed lead limits to protect babies and young children from lead’s harmful effects. There is no known safe level of lead exposure, and children are particularly vulnerable,” Houlihan said.

The director of food policy for Consumers Reports, Brian Ronholm, also expressed concerns. In 2018, Consumer Reports analyzed 50 baby foods and found “concerning” levels of lead and other heavy metals. In fact, “15 of them would pose a risk to a child who ate one serving or less per day,” according to Consumer Reports.

“The FDA should be encouraging industry to work harder to reduce hazardous lead and other heavy metals in baby food given how vulnerable young children are to toxic exposure,” Ronholm said in a statement.

Exposure to toxic heavy metals can be harmful to the developing brain of infants and children. “It’s been linked with problems with learning, cognition, and behavior,” according to the American Academy of Pediatrics.

Lead, arsenic, cadmium and mercury are in the World Health Organization’s top 10 chemicals of concern for infants and children.

As natural elements, they are in the soil in which crops are grown and thus can’t be avoided. Some crop fields and regions, however, contain more toxic levels than others, partly due to the overuse of metal-containing pesticides and ongoing industrial pollution.

The new FDA guidance suggests manufactured baby food custards, fruits, food mixtures — including grain and meat-based blends — puddings, vegetables, yogurts, and single-ingredient meats and vegetables contain no more than 10 parts per billion of lead.

The exception to that limit is for single-ingredient root vegetables, such as carrots and sweet potatoes, which should contain no more than 20 parts per billion, according to the new guidance.

Dry cereals marketed to babies and toddlers should also not contain more than 20 parts per billion of lead, the new FDA guidance said.

However, the FDA didn’t propose any lead limit for cereal puffs and teething biscuits, Houlihan said, even though the products account for “7 of the 10 highest lead levels we’ve found in over 1,000 baby food tests we have assessed.”

The limit set for root vegetables will be helpful, Houlihan added. Because they grow underground, root vegetables can easily absorb heavy metals. For example, sweet potatoes often exceed the 20 parts per billion limit the FDA has proposed, she said.

Prior to this announcement, the FDA had only set limits for heavy metals in one baby food — infant rice cereal, Houlihan said. In 2021, the agency set a limit of 100 parts per billion for arsenic, which has been linked to adverse pregnancy outcomes and neurodevelopmental toxicity.

There is much more that can be done, according to Scott Faber, senior vice president of government affairs for the Environmental Working Group, a nonprofit environmental health organization.

“We can change where we farm and how we farm to reduce toxic metals absorbed by plants,” Faber said. “We also urge baby food manufacturers to conduct continuous testing of heavy metals in all their products and make all testing results publicly available.”

Companies can require suppliers and growers to test the soil and the foods they produce, and choose to purchase from those with the lowest levels of heavy metals, Houlihan added.

“Growers can use soil additives, different growing methods and crop varieties known to reduce lead in their products,” she said.

What can parents do to lessen their child’s exposure to toxic metals? Unfortunately, buying organic or making baby food at home isn’t going to solve the problem, as the produce purchased at the grocery store can also contain high levels of contaminants, experts say.

A 2022 report by Healthy Babies, Bright Futures found lead in 80% of homemade purees or store-bought family foods. Arsenic was found in 72% of family food either purchased or prepared at home.

The best way to lessen your child’s exposure to heavy metals, experts say, is to vary the foods eaten on a daily basis and choose mostly from foods which are likely to have the least contamination. Healthy Babies, Bright Futures created a chart of less to most contaminated foods based on their testing.

Fresh bananas, with heavy metal levels of 1.8 parts per billion, were the least contaminated of foods tested for the report. After bananas, the least contaminated foods were grits, manufactured baby food meats, butternut squash, lamb, apples, pork, eggs, oranges and watermelon, in that order.

Other foods with lower levels of contamination included green beans, peas, cucumbers and soft or pureed home-cooked meats, the report found.

The most heavily contaminated foods eaten by babies were all rice-based, the report said. Rice cakes, rice puffs, crisped rice cereals and brown rice with no cooking water removed were heavily contaminated with inorganic arsenic, the more toxic form of arsenic.

After rice-based foods, the analysis found the highest levels of heavy metals in raisins, non-rice teething crackers, granola bars with raisins and oat-ring cereals. But those were not the only foods of concern: Dried fruit, grape juice, arrowroot teething crackers and sunflower seed butter all contained high amounts of at least one toxic metal, according to the report.

While buying organic cannot reduce the levels of heavy metals in infant food, it can help avoid other toxins such as herbicides and pesticides, Dr. Leonardo Trasande, director of environmental pediatrics at NYU Langone Health told CNN previously.

“There are other benefits to eating organic food, including a reduction in synthetic pesticides that are known to be as bad for babies, if not even more problematic,” Trasande said.

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