Shampoos, cleaners among 1,400 household products with likely carcinogen 1,4-dioxane granted NYS waivers
More than 1,400 household products that contain a chemical classified as a likely human carcinogen have received temporary waivers from the state, allowing their manufacturers to avoid new standards that went into effect four months ago.
The products, which include brand-name shower gels, shampoos and cleaners, contain the chemical 1,4-dioxane — all at levels above New York State's limit. 1,4-dioxane, a byproduct in necessities such as soap and detergent, has been found in both groundwater and drinking water on Long Island, particularly near former industrial sites. The chemical has been linked to cancers in laboratory animals, as well as to liver and kidney damage.
"There is growing concern of 1,4-dioxane contamination of groundwater and surface water from so-called down-the-drain disposal of personal care products, cosmetics, and other household products,” said Rita Loch-Caruso, professor emerita of toxicology at the University of Michigan School of Public Health.
The push for limits on 1,4-dioxane in personal care, household cleaning products and cosmetics comes as part of a larger effort to monitor and remove emerging contaminants from the water supply, including a separate group of "forever chemicals" known as PFAS.
Clean water advocates worry the state is issuing waivers too easily, allowing hundreds of products to remain on store shelves despite levels of 1,4-dioxane above the state limit of 2 parts per million. Several Olay body washes have nearly 5 parts per million, many Pantene shampoos more than 6 ppm, and Safeguard hand soap over 3 ppm, according to the list posted on the state Department of Environmental Conservation website.
“The New York Legislature did an important thing by adopting this protective law, but it is outrageous that New York DEC is offering close to 1,500 waivers,” said Judith Enck, a former EPA regional administrator and president of Beyond Plastics, a group focused on reducing plastic waste. “The legislature needs to ask them why, because I think it’s undercutting the purpose of the law.”
The DEC said the law allows waivers and noted it has rejected some applications for exemptions. In a statement, the agency said it is committed to preventing exposure to 1,4-dioxane and other contaminants.
Groups representing manufacturers have argued there are only trace levels of 1,4-dioxane in their products and that the health risks found in studies involved much higher concentrations of the chemical, usually over a long period of time. They said they're working to bring the products into compliance.
“Consumers can continue to use these products,” said Brian Sansoni, senior vice president of communications with the American Cleaning Institute, a trade association representing companies that produce and supply household and commercial cleaning products. “They are formulated to be used safely and effectively and go safely down the drain.”
Products receiving waivers with the highest concentrations of 1,4-dioxane include Nature's Promise fabric softener, at 177 ppm, followed by Maintenance One hand soap, at 154 ppm, and Pinol detergent, at 129 ppm. For personal care items, Paul Mitchell Awapuhi shampoo topped the list at nearly 35 ppm, with Soapbox Sea Mineral and Blue Iris body wash both at 24 ppm, and Soapbox Argan Oil body wash at nearly 23 ppm.
1,4-dioxane is a synthetic industrial chemical used in several commercial and industrial processes, such as a stabilizer in certain chlorinated solvents, paint strippers, greases and waxes. The chemical is also a byproduct in the manufacture of consumer products, according to the EPA, and often is not listed as an ingredient on labels. In some cases, it may be listed under different names, including PEG, polyethylene and polyoxyethylene, according to the Centers for Disease Control and Prevention.
The federal Environmental Protection Agency has said that 1,4-dioxane does not “readily biodegrade in the environment.”
The U.S. Department of Health and Human Services and EPA have classified 1,4-dioxane as "reasonably anticipated to be a human carcinogen" and "likely to be carcinogenic to humans." A carcinogen is a substance capable of causing cancer.
In recent years, New York has become the first state to set maximum contaminant levels for 1,4-dioxane in both drinking water, personal care, household cleaning products and makeup.
The state law requiring household cleaning, personal care and cosmetic products sold in New York to have limited levels of 1,4-dioxane was approved in 2019 but went into effect at the end of last year. The threshold of 2 parts per million will drop to 1 ppm by the end of this year. For cosmetics, a 10 ppm limit went into effect at the end of 2022.
In a statement, the DEC said the agency conducts a "comprehensive review" of applications for waivers. Manufacturers must provide proof that they have taken steps to reduce the concentration of 1,4-dioxane in their products, but need more time to comply with the limits.
Dr. Robert Schwaner, chief of the division of toxicology at Stony Brook University Hospital’s Department of Emergency Medicine, said the public should be aware of 1,4-dioxane levels and limit their exposures when possible, but doesn't need to panic.
“They would not be giving these waivers if there was hard evidence, for example, that 5 ppm … absolutely caused cancer,” he said.
Enck said she believes even trace amounts should be avoided.
“As a rule, we don’t want any likely carcinogens in shampoo or soap or anything that comes in contact with our body,” she said. “We particularly don’t want likely carcinogens in personal care products used by children and pregnant women.”
The Long Island Water Conference, which represents water providers, has estimated it will cost more than $1.5 billion to build treatment systems to meet the limits recently set by the state for 1,4-dioxane and PFAS treatments. PFAS are known as "forever chemicals" because they are difficult to break down.
Loch-Caruso said conventional wastewater treatments do not break down 1,4-dioxane, allowing the chemical to be discharged into the environment. The chemical properties of 1,4-dioxane allow it to persist and accumulate in groundwater and surface water.
While 1,4-dioxane has been found to cause cancer in laboratory animals, human studies linking 1,4-dioxane and cancer are limited to small studies following industrial exposure, Loch-Caruso said.
“Adverse health effects occur when 1,4-dioxane gains entry into the body,” she said, noting that many personal care products and cosmetics with amounts under 10 ppm have a relatively low rate of absorption by intact skin. When the chemical is accidentally swallowed or inhaled, especially in poorly ventilated areas, the amount that gets into a person's body increases.
The chemical can be inhaled during showers, said Vasilis Vasiliou, director of the Yale Superfund Research Center, who has studied 1,4-dioxane. “Then it goes down the drain … It can end up in rivers, lakes, the water table and even your drinking water.”
Vasiliou said he would advise people to minimize their contact with 1,4-dioxane.
“The best way to avoid toxicity is to avoid exposures,” he said. “Whatever ways you can find to minimize exposures, the better.”
Sansoni said manufacturers are doing their best to comply with the new limits.
“Either products have been reformulated or manufacturing processes have changed, and there's a lot of testing going on to ensure the levels are in compliance and the products work to meet the high expectations of consumers,” Sansoni said. “If this was easy, it would have been done a long time ago.”
Procter & Gamble, which manufactures Olay, Pantene and Safeguard products, said in a statement that it "is committed to complying with the New York State Department of Environmental Conservation’s requirements on 1,4-dioxane." Asked about specific products, the company said: "We have received an extension to continue selling products to avoid potential shortages for New York consumers."
The Personal Care Products Council, a trade group, said its members “take their responsibility for product safety and the trust families put in these products very seriously,” according to a statement from Tom Myers, executive vice president of legal & regulatory affairs.
The companies the Personal Care Products Council represent “are managing 1,4-dioxane by tightening specifications in their raw material controls and ensuring supplier testing of raw materials,” Myers said.
Myers pointed out that the DEC has not yet outlined test methodology to measure 1,4-dioxane levels in a finished consumer product.
“Companies working to comply with the legislatively mandated timeline could find themselves out of compliance [or in over-compliance] if the final regulations are put into effect with different testing requirements,” Myers said.
DEC officials acknowledged they are still in the process of creating rules to implement the law, including what information manufacturers will need to provide to determine compliance.
“We think it's important that the testing methodology used to measure 1,4-dioxane should be consistent and of high quality,” Sansoni said. “Sometimes we will see some organizations do measurements claiming certain products are over the state limits at very high levels, and we are not sure of those test methods.”
The list of companies and their products that received waivers, as well as their 1,4-dioxane content, is updated monthly on the DEC website, the agency said.
Adrienne Esposito, executive director and co-founder of the Citizens Campaign for the Environment, which advocated passage of the law to limit the chemical in home-care products, said she's concerned that the waiver list doesn't capture every product containing the chemical.
“We’re shocked to see what’s on the list, and we are suspicious about what’s not on the list,” she said.
Esposito’s group conducted tests in 2018 and 2019 to highlight 1,4-dioxane levels in common household items such as laundry detergent and shampoos. The group found that 65 of 80 household products selected contained 1,4-dioxane. The group plans to conduct more testing when the law's 1 ppm limit goes into effect next year.
Schwaner, the toxicologist from Stony Brook, said the strict limits in personal care and cleaning products are an “appropriate step forward.” But he said there's still uncertainty in the science.
“I’m not saying the studies won’t come out,” Schwaner said. “The direct [cancer] link to humans is not there right now … if there is a question, especially in a byproduct, it makes sense to try to limit exposure."
Esposito said she believes people should be concerned about products on the waiver list that show smaller amounts above the limits.
“This list tells the tale of how much exposure we have,” she said. “We use multiple products a day … your bath gel, your shampoo, your dish soap, your laundry soap happening each day and every day … The science on this needs to catch up with the reality.”
More than 1,400 household products that contain a chemical classified as a likely human carcinogen have received temporary waivers from the state, allowing their manufacturers to avoid new standards that went into effect four months ago.
The products, which include brand-name shower gels, shampoos and cleaners, contain the chemical 1,4-dioxane — all at levels above New York State's limit. 1,4-dioxane, a byproduct in necessities such as soap and detergent, has been found in both groundwater and drinking water on Long Island, particularly near former industrial sites. The chemical has been linked to cancers in laboratory animals, as well as to liver and kidney damage.
"There is growing concern of 1,4-dioxane contamination of groundwater and surface water from so-called down-the-drain disposal of personal care products, cosmetics, and other household products,” said Rita Loch-Caruso, professor emerita of toxicology at the University of Michigan School of Public Health.
The push for limits on 1,4-dioxane in personal care, household cleaning products and cosmetics comes as part of a larger effort to monitor and remove emerging contaminants from the water supply, including a separate group of "forever chemicals" known as PFAS.
WHAT TO KNOW
The state has issued waivers to more than 1,400 household products that contain 1,4-dioxane, a likely carcinogen, allowing the products to be sold despite limits that went into effect this year.
Clean water advocates said the list shows how frequently 1,4-dioxane is found in common household products and questioned how the state granted waivers.
The state noted the law allows waivers while manufacturers try to bring products into compliance.
Clean water advocates worry the state is issuing waivers too easily, allowing hundreds of products to remain on store shelves despite levels of 1,4-dioxane above the state limit of 2 parts per million. Several Olay body washes have nearly 5 parts per million, many Pantene shampoos more than 6 ppm, and Safeguard hand soap over 3 ppm, according to the list posted on the state Department of Environmental Conservation website.
“The New York Legislature did an important thing by adopting this protective law, but it is outrageous that New York DEC is offering close to 1,500 waivers,” said Judith Enck, a former EPA regional administrator and president of Beyond Plastics, a group focused on reducing plastic waste. “The legislature needs to ask them why, because I think it’s undercutting the purpose of the law.”
The DEC said the law allows waivers and noted it has rejected some applications for exemptions. In a statement, the agency said it is committed to preventing exposure to 1,4-dioxane and other contaminants.
Groups representing manufacturers have argued there are only trace levels of 1,4-dioxane in their products and that the health risks found in studies involved much higher concentrations of the chemical, usually over a long period of time. They said they're working to bring the products into compliance.
“Consumers can continue to use these products,” said Brian Sansoni, senior vice president of communications with the American Cleaning Institute, a trade association representing companies that produce and supply household and commercial cleaning products. “They are formulated to be used safely and effectively and go safely down the drain.”
Products receiving waivers with the highest concentrations of 1,4-dioxane include Nature's Promise fabric softener, at 177 ppm, followed by Maintenance One hand soap, at 154 ppm, and Pinol detergent, at 129 ppm. For personal care items, Paul Mitchell Awapuhi shampoo topped the list at nearly 35 ppm, with Soapbox Sea Mineral and Blue Iris body wash both at 24 ppm, and Soapbox Argan Oil body wash at nearly 23 ppm.
1,4-dioxane is a synthetic industrial chemical used in several commercial and industrial processes, such as a stabilizer in certain chlorinated solvents, paint strippers, greases and waxes. The chemical is also a byproduct in the manufacture of consumer products, according to the EPA, and often is not listed as an ingredient on labels. In some cases, it may be listed under different names, including PEG, polyethylene and polyoxyethylene, according to the Centers for Disease Control and Prevention.
The federal Environmental Protection Agency has said that 1,4-dioxane does not “readily biodegrade in the environment.”
Feds: Likely carcinogenic to humans
The U.S. Department of Health and Human Services and EPA have classified 1,4-dioxane as "reasonably anticipated to be a human carcinogen" and "likely to be carcinogenic to humans." A carcinogen is a substance capable of causing cancer.
In recent years, New York has become the first state to set maximum contaminant levels for 1,4-dioxane in both drinking water, personal care, household cleaning products and makeup.
The state law requiring household cleaning, personal care and cosmetic products sold in New York to have limited levels of 1,4-dioxane was approved in 2019 but went into effect at the end of last year. The threshold of 2 parts per million will drop to 1 ppm by the end of this year. For cosmetics, a 10 ppm limit went into effect at the end of 2022.
In a statement, the DEC said the agency conducts a "comprehensive review" of applications for waivers. Manufacturers must provide proof that they have taken steps to reduce the concentration of 1,4-dioxane in their products, but need more time to comply with the limits.
Dr. Robert Schwaner, chief of the division of toxicology at Stony Brook University Hospital’s Department of Emergency Medicine, said the public should be aware of 1,4-dioxane levels and limit their exposures when possible, but doesn't need to panic.
“They would not be giving these waivers if there was hard evidence, for example, that 5 ppm … absolutely caused cancer,” he said.
Enck said she believes even trace amounts should be avoided.
“As a rule, we don’t want any likely carcinogens in shampoo or soap or anything that comes in contact with our body,” she said. “We particularly don’t want likely carcinogens in personal care products used by children and pregnant women.”
$1.5B to remove contaminants
The Long Island Water Conference, which represents water providers, has estimated it will cost more than $1.5 billion to build treatment systems to meet the limits recently set by the state for 1,4-dioxane and PFAS treatments. PFAS are known as "forever chemicals" because they are difficult to break down.
Loch-Caruso said conventional wastewater treatments do not break down 1,4-dioxane, allowing the chemical to be discharged into the environment. The chemical properties of 1,4-dioxane allow it to persist and accumulate in groundwater and surface water.
While 1,4-dioxane has been found to cause cancer in laboratory animals, human studies linking 1,4-dioxane and cancer are limited to small studies following industrial exposure, Loch-Caruso said.
“Adverse health effects occur when 1,4-dioxane gains entry into the body,” she said, noting that many personal care products and cosmetics with amounts under 10 ppm have a relatively low rate of absorption by intact skin. When the chemical is accidentally swallowed or inhaled, especially in poorly ventilated areas, the amount that gets into a person's body increases.
The chemical can be inhaled during showers, said Vasilis Vasiliou, director of the Yale Superfund Research Center, who has studied 1,4-dioxane. “Then it goes down the drain … It can end up in rivers, lakes, the water table and even your drinking water.”
Vasiliou said he would advise people to minimize their contact with 1,4-dioxane.
“The best way to avoid toxicity is to avoid exposures,” he said. “Whatever ways you can find to minimize exposures, the better.”
Manufacturers attempt to comply
Sansoni said manufacturers are doing their best to comply with the new limits.
“Either products have been reformulated or manufacturing processes have changed, and there's a lot of testing going on to ensure the levels are in compliance and the products work to meet the high expectations of consumers,” Sansoni said. “If this was easy, it would have been done a long time ago.”
Procter & Gamble, which manufactures Olay, Pantene and Safeguard products, said in a statement that it "is committed to complying with the New York State Department of Environmental Conservation’s requirements on 1,4-dioxane." Asked about specific products, the company said: "We have received an extension to continue selling products to avoid potential shortages for New York consumers."
The Personal Care Products Council, a trade group, said its members “take their responsibility for product safety and the trust families put in these products very seriously,” according to a statement from Tom Myers, executive vice president of legal & regulatory affairs.
The companies the Personal Care Products Council represent “are managing 1,4-dioxane by tightening specifications in their raw material controls and ensuring supplier testing of raw materials,” Myers said.
Myers pointed out that the DEC has not yet outlined test methodology to measure 1,4-dioxane levels in a finished consumer product.
“Companies working to comply with the legislatively mandated timeline could find themselves out of compliance [or in over-compliance] if the final regulations are put into effect with different testing requirements,” Myers said.
DEC officials acknowledged they are still in the process of creating rules to implement the law, including what information manufacturers will need to provide to determine compliance.
“We think it's important that the testing methodology used to measure 1,4-dioxane should be consistent and of high quality,” Sansoni said. “Sometimes we will see some organizations do measurements claiming certain products are over the state limits at very high levels, and we are not sure of those test methods.”
Advocate 'shocked' by list
The list of companies and their products that received waivers, as well as their 1,4-dioxane content, is updated monthly on the DEC website, the agency said.
Adrienne Esposito, executive director and co-founder of the Citizens Campaign for the Environment, which advocated passage of the law to limit the chemical in home-care products, said she's concerned that the waiver list doesn't capture every product containing the chemical.
“We’re shocked to see what’s on the list, and we are suspicious about what’s not on the list,” she said.
Esposito’s group conducted tests in 2018 and 2019 to highlight 1,4-dioxane levels in common household items such as laundry detergent and shampoos. The group found that 65 of 80 household products selected contained 1,4-dioxane. The group plans to conduct more testing when the law's 1 ppm limit goes into effect next year.
Schwaner, the toxicologist from Stony Brook, said the strict limits in personal care and cleaning products are an “appropriate step forward.” But he said there's still uncertainty in the science.
“I’m not saying the studies won’t come out,” Schwaner said. “The direct [cancer] link to humans is not there right now … if there is a question, especially in a byproduct, it makes sense to try to limit exposure."
Esposito said she believes people should be concerned about products on the waiver list that show smaller amounts above the limits.
“This list tells the tale of how much exposure we have,” she said. “We use multiple products a day … your bath gel, your shampoo, your dish soap, your laundry soap happening each day and every day … The science on this needs to catch up with the reality.”
Health effects of 1,4-dioxane
- People can be exposed to 1,4-dioxane through breathing contaminated air, eating contaminated food and drinking water, as well through the skin while using products that contain small amounts of the chemical, according to the Centers for Disease Control and Prevention's Agency for Toxic Substances and Disease Registry.
- Exposure to high levels of 1,4-dioxane in the air can result in nasal cavity, liver and kidney damage, while ingestion or dermal contact with high levels of 1,4-dioxane can result in liver and kidney damage, the agency said.
- Laboratory studies showed rats and mice with long-term exposure to 1,4-dioxane developed cancer. Several regulatory agencies, including the U.S. Department of Health and Human Services and the U.S. Environmental Protection Agency have classified 1,4-dioxane as "reasonably anticipated to be a human carcinogen" and "likely to be carcinogenic to humans."
- Drinking water standards set in 2020 include a maximum contaminant level of 1 part per billion for 1,4-dioxane.
- A federal survey of water districts found 1,4-dioxane is more prevalent in Long Island’s water than any other location in the state and exceeds the national average. Higher levels of 1,4-dioxane, which was used in solvents, were detected near former industrial sites.
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