Now that President Obama has signed legislation to overhaul the nation's primary chemical safety law, the Environmental Protection Agency is facing a crucial decision: Of the myriad industrial chemicals that pose health risks and pervade Americans' lives, which should it tackle first?
The EPA’s answer will provide an early signal of how well the new law will protect Americans from harmful chemicals in consumer products. The EPA could propose to ban or restrict notorious "bad actor" chemicals such as asbestos – still in use decades after researchers indisputably showed that the smallest exposures can be deadly. The agency could go after emerging threats such as bisphenol A, a hormone disrupter linked to reproductive harm and cancer, which is used to coat the inside surfaces of billions of cans.
Until last month, the Toxic Substances Control Act, or TSCA, had not been updated since it was originally passed in 1976. It was widely regarded as the weakest federal environmental law on the books. The new law – the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which the president signed June 22 – was hailed by the chemical industry and its supporters in Congress as a major step forward.
But most public health and environmental groups, including EWG, believe it doesn't go nearly far enough. The bill may not provide the EPA with the resources or clear legal authority it needs to quickly review and, if necessary, ban dangerous chemicals linked to cancer and other serious health problems.
To be sure, the new law strengthens the EPA's ability to regulate new chemicals. It also requires, for the first time, that the EPA systematically evaluate the safety of existing chemicals, and take action on those found unsafe in order to reduce health risks.
Of some 85,000 known chemicals, many of which are likely no longer in use, the EPA says that about 1,000 chemicals, many used in everyday consumer products, are in need of re-evaluation using new scientific tools and knowledge.1 The agency has placed 90 chemicals known to pose health risks on a list called the TSCA Work Plan.
The EPA has conducted safety reviews, technically called risk assessments, for about a dozen of the chemicals on the Work Plan. Some aren’t complete and are awaiting additional studies. For three chemicals,2 the EPA expects to propose regulations by the end of the year.
EWG scientists scrutinized the chemicals listed on the TSCA Work Plan, analyzed studies by researchers in the U.S. and around the world, and consulted experts in environmental health. They considered each chemical's health risks, the number of Americans exposed to it and the likelihood of EPA action under the terms of the new law.
With so many hazardous chemicals in use, any list of chemicals posing the greatest risks would be subjective and incomplete. But the vast catalogue of chemicals that have never been evaluated for safety make it urgent for the EPA move quickly to tackle the backlog. Here are 10 chemicals for which EWG urges the EPA to begin or complete review and regulate as soon as possible, plus 10 more that should be priorities for early action.
10 chemicals EPA should act on now
Source: EWG, from EPA's 2014 TSCA Work Plan
Asbestos is the poster child for the failures of the old TSCA. Many Americans mistakenly believe it was banned decades ago, as it has been in 55 other nations. But U.S. industry still imports, uses and sells asbestos and asbestos products, including automobile brake pads and clutches, vinyl tile and roofing materials. The Occupational Safety and Health Administration says there is no safe level or duration of exposure to any kind of asbestos.3 Inhalation or ingestion of asbestos fibers can cause lung cancer, mesothelioma – a rare and incurable cancer – and asbestosis, a scarring of the lungs that often leads to heart failure. Asbestos-related diseases, which may not appear for decades after exposure, kill 12,000 to 15,000 Americans per year.
In 1989, after a 10-year study, the EPA ordered a phase out and ban of 90 percent of products containing asbestos. But the asbestos industry sued, and in 1991, the U.S. Court of Appeals for the Fifth Circuit ruled that the EPA had not proven a ban was the "least burdensome alternative" for protecting the public. This decision not only overturned most parts of the ban, but also set a precedent that made it almost impossible for the EPA to ban any other dangerous chemical. New evidence of asbestos’ dangers shows up weekly, yet the EPA’s hands remain tied. Under the new law, the EPA must still consider costs, but the agency no longer must prove a regulation to be the least burdensome method.
Asbestos is on the TSCA Work Plan chemical list, but the EPA has not scheduled an updated risk assessment. Although its use has significantly declined, asbestos still poses a grave risk. The EPA should finish the job and ban this killer.
Tetrachlorethylene, also called perchloroethylene and PERC, is a solvent used as a dry cleaning fluid and in household products such as water repellents, spot removers, wood cleaners, adhesives and silicone lubricants.
The National Toxicology Program says PERC is "reasonably anticipated" to cause cancer, and it's on California's official list of known carcinogens. The National Institute for Occupational Safety and Health says levels of PERC in workplace air should be as low as possible. The EPA has set a very low limit for PERC in drinking water – half of the limit for arsenic. The Centers for Disease Control and Prevention has detected the compound in the blood of about 16 percent of a representative sample of Americans.
No risk assessment of PERC is scheduled. The EPA should expedite an assessment, drawing on the already established scientific data, use its authority to order manufacturers to provide additional data if needed, then move quickly to reduce risk or ban the chemical.
Phthalates make plastics more flexible and harder to break. They're in food packaging and other plastic household items such as shower curtains and flooring tiles made from polyvinyl chloride, or PVC, identifiable by recycling label #3. (Vinyl chloride, the building block of PVC plastic, is discussed below.)
Phthalates are hormone disrupters, and some may cause male reproductive problems such as infertility, sperm damage and damage to the testicles.4 They have been linked to changes in the timing of puberty in girls.5 The Consumer Product Safety Commission has banned six phthalates in children's toys, and in bottles, cups and pacifiers for children 3 years old and under. The European Union has banned certain phthalates in cosmetics, toys and child care articles. The CDC has found two breakdown products of phthalates in more than 90 percent of Americans tested.
The EPA has developed an action plan for a group of eight phthalates but has not implemented it. In 2013, the agency withdrew a proposal to list phthalates as "chemicals of concern," saying further study was needed.6 The agency should expedite a new risk assessment that considers all relevant data, order manufacturers to provide more data if needed, and move quickly to reduce risks or ban these chemicals.
Bisphenol A, or BPA, is a key component of the epoxy coating inside most of the 126 billion food cans manufactured in the U.S. each year. Recently, EWG unveiled a database that draws on a food industry list, showing that BPA is in the linings or lids of glass jars for baby food, pickles, jelly, salsa and other condiments; aerosol cans for whipped toppings and non-stick sprays; bottles of cooking oil; aluminum beverage cans, coffee cans and even beer kegs. It's used to coat cash register receipts and drinking water pipes, and is used in construction. A handful of companies manufactured over 2.25 billion pounds of BPA for non-food contact uses in 2011, the most recent year reported.7 But the names of companies who produced or imported more than 90 percent of the BPA were kept confidential by the EPA.
In the body, BPA mimics estrogen. Independent research has linked it to cancer, infertility, diabetes, obesity, and brain, nervous system and cardiovascular abnormalities, among other serious disorders.8 It's considered especially risky for pregnant women and children in critical stages of development. The CDC has detected BPA in more than 90 percent of urine samples of people 6 years old and older. Tests commissioned by EWG were the first to find BPA in the umbilical cords of nine out of 10 infants sampled.
The Food and Drug Administration no longer allows BPA-based plastics in baby bottles and sippy cups or BPA-based coatings in packaging for infant formula9 – a rule made after manufacturers had already abandoned materials containing the chemical. The FDA has denied a petition to ban BPA in all food and beverage packaging. Thirteen states, the District of Columbia and a few local jurisdictions have banned or restricted BPA use in reusable food containers, children’s cups and baby bottles, and containers of infant formula and baby food.
The EPA has developed an action plan for BPA but has not acted on it, saying more studies are needed. The National Toxicology Program is nearing completion of a large set of coordinated studies of BPA toxicity. Once this is done, the EPA should expedite a risk assessment, order more data from manufacturers if needed, and move quickly to reduce exposure by banning BPA for its most risky uses.
Chlorinated phosphate flame retardants
The Work Plan groups together three similar chemicals called chlorinated phosphate esters. TCEP, TCIPP and TDCIPP are used as flame retardants in foam cushions, upholstered furniture and baby products such as car seats. TCIPP is also used in building insulation. Over 50 million pounds of these chemicals were imported or manufactured by more than 10 companies in 2011.10
ICL Industrial Products of Gallipolis Ferry, W. Va., manufactured the majority of the reported TCPP and imports TBBPA and 1-bromopropane, discussed below. Albemarle Corporation of Baton Rouge, La., reported importing TCPP and manufacturing TBBPA and 1-bromopropane. Lanxess Corporation imported TCPP along with DEHA and either manufactured or imported brominated phthalate fire retardants.
California lists TDCIPP, commonly known as Tris, and TCEP as carcinogens. At the request of the Consumer Product Safety Commission, the National Toxicology Program is conducting animal studies that aim to determine whether TCIPP is carcinogenic.11 Studies show that some of these compounds are toxic to nerve cells and could harm the neurodevelopment of fetuses, infants and young children.12 TCEP and TDCIPP are banned in New York, Maryland and Washington state.
In 2014, a study by EWG and Duke University researchers detected a breakdown product of TDCIPP in the urine of all 48 mothers and children tested, with levels in the children almost five times those in the mothers. In a follow-up study of mothers and children from California, published this month, children's exposure to TDCIPP was even higher. A breakdown product of TCIPP was also detected in all California study participants.
The EPA has reviewed data on chlorinated phosphate flame retardants and is missing information critical to ensuring a robust risk assessment. The agency should fill in these data gaps and use its authority to order additional tests by manufacturers, including on their potential developmental harm, before it attempts to assess the risks of these chemicals.
Brominated flame retardants
The seven chemicals in this group are phthalates, used as flame retardants for polyurethane foam in furniture, baby products, gymnastics landing pits and carpet padding. The group includes chemicals known as TBB and TBPH, two flame retardants found in a mixture marketed under the name Firemaster® 550. In EPA documents, the identities of two chemicals in this group are hidden as trade secrets.
Endocrine-disrupting PBDEs were phased out more than a decade ago. Firemaster® 550 is one product used as a substitute, without adequate toxicity testing. Its potential human health effects are unknown, but animal tests indicate the brominated components may harm development.13 Some Firemaster® 550 chemicals are structurally similar to the phthalates DEHP and DBP, which have been researched in depth and are listed by California as causing male reproductive harm.
In 2014, EWG and Duke University researchers measured breakdown products of one brominated phthalate in children and their mothers. The researchers detected the chemical in 27 percent of mothers and 70 percent of children, with levels notably higher in children.
The EPA's preliminary review of brominated phthalates determined that more data is needed. But the agency has not gone far enough. A federal panel recommended in 2011 that the EPA gather data on human exposures, but the agency has not done so.14 The EPA should exercise its authority under TSCA to require manufacturers to study Americans' exposure to brominated phthalates, move swiftly to conduct a risk assessment and regulate these substances.
TBBPA and related chemicals
Tetrabromobisphenol A, or TBBPA, is the brominated form of BPA. It is the most widely produced flame retardant in the world, used in the circuit boards of electronics and in plastic casings for TVs and computers. Five companies including Albemarle, Sabic, ICL Industrial Products and LG Chemical in the U.S. manufactured over 120 million pounds of TBBPA in 2011. EPA says there is little to no public information on how much TBBPA is imported in treated products.15
In 2009, an EWG-commissioned study found TBBPA in the umbilical cord of newborns. Independent researchers in the U.S., Canada, Europe and Asia have found TBBPA in breast milk, fat, blood and hair.16
A study by the National Toxicology Program found that TBBPA caused “aggressive” uterine cancer in lab animals.17 Scientists with this interagency program concluded that TBBPA is likely a human carcinogen. California’s state biomonitoring program identifies TBBPA as a concern based on its endocrine toxicity, neurotoxicity, reproductive toxicity, and bioaccumulation and persistence in the environment.18
The EPA has reviewed data on TBBPA and is missing information critical to ensuring a robust risk assessment. The agency should fill in these data gaps, and order manufacturers to supply information to help assess exposures and risks. It should then use that data to expedite a complete risk assessment.
1-Bromopropane, or 1-BP, is a solvent used in aerosol cleaners and adhesives, dry cleaning, spot removers, coin cleaners and for a variety of industrial applications. The CDC has detected it in more than three-quarters of Americans sampled. U.S. production has increased from under 500,000 pounds in 1990 to over 15 million pounds in 2011, as 1-BP replaced other hazardous solvents.19
The National Toxicology Program classifies 1-BP as reasonably expected to be a human carcinogen. California lists it as a chemical known to cause reproductive harm. State regulators have determined it meets the criteria to be considered a carcinogen but have not yet officially listed it as such. The EPA says it's particularly risky for women who are pregnant or of childbearing age, on the grounds that even short-term exposure could harm a developing fetus.20
Last February, the EPA issued a draft risk assessment for 1-BP, which is now undergoing peer review and public comment. The EPA should take steps to improve its assessment, such as considering cumulative exposure to other solvents and estimating the risk for additional exposed populations. The agency should then expedite completion of the final risk assessment, and move quickly to reduce risks or ban the chemical.
Bis(2-ethylhexyl) adipate, or DEHA, is a softener used in some brands of plastic wrap for packaging food in grocery stores and for home use. It is used to make PVC plastics.
A study by the National Toxicology Program showed that DEHA exposure increased the incidence of liver tumors in rats and mice.21 The EPA has classified DEHA as a possible human carcinogen. It is not a phthalate but has chemical similarities to the phthalate DEHP, which it has replaced in plastic items such as food packaging and children’s toys. Testing shows DEHA can migrate out of these products.22
The EPA has not scheduled a risk assessment for DEHA. The agency should expedite an assessment using available scientific data, order more data from manufacturers if needed, and move quickly to reduce risks or ban the chemical if necessary.
P-dichlorobenzene is an insecticide used in moth balls, as a deodorant blocker for toilets and garbage cans, and to manufacture other chemicals. Between 50 and 100 million pounds of the chemical were produced in 2011.23 The CDC has detected it in the bodies of almost half of Americans surveyed.
The National Toxicology Program says it is reasonably anticipated to be a human carcinogen, based on studies that found exposure caused kidney and liver tumors in mice and rats. Long-term exposures can damage the liver and central nervous system.24 California has banned the chemical in solid deodorizers.
The EPA has not scheduled a risk assessment for p-dichlorobenzene. The agency should expedite this effort, using the already established scientific data, ordering more data from manufacturers if needed, and moving quickly to reduce risks or ban the chemical.
10 more chemicals for early action
Lead contamination of drinking water is not regulated by TSCA, but rather the federal Safe Drinking Water Act. But lead is also in children's toys, jewelry, batteries, ammunition and the paint in some older houses. Exposure to lead in the womb or early childhood in even the smallest concentrations slows brain development and causes learning deficits.25 The CDC has detected lead in the blood of almost all Americans sampled. The EPA has not scheduled a risk assessment.
Formaldehyde is used in laminate flooring, carpeting, paints and varnishes. It's a well-established human carcinogen. Industry maneuvers have stalled the EPA's efforts to reassess its carcinogenicity under a process known as the Integrated Risk and Information System, or IRIS.
Vinyl chloride is the key ingredient in making PVC plastic. Vinyl chloride gas can off-gas from new shower curtains. It is a source of the distinctive "new car smell." The National Toxicology Program says it is a known human carcinogen. The CDC has found it in about 60 percent of Americans tested. The EPA has not scheduled a risk assessment.
Bromoform, also known as tribromomethane, is primarily used in chemical manufacturing, as a flame retardant and in making rubber. The EPA considers it a probable human carcinogen. The CDC has found it in about one-third of Americans tested. The EPA has not scheduled a risk assessment.
Chromium-6 is the chemical at the center of the "Erin Brockovich" case, as recounted in the 2000 film about the contamination of drinking water in a small California desert town. It is used in chrome plating, in dyes and pigments, and in preservatives for leather and wood. Chromium-6 is well-established as a carcinogen when inhaled, but a decision on whether it is carcinogenic when ingested is stalled in the EPA's IRIS program.26
Styrene is the key ingredient in Styrofoam, and is used in making plastics and rubber. The National Toxicology Program says it's reasonably anticipated to be a human carcinogen, and the CDC has found it in about 40 percent of Americans. The EPA has not scheduled a risk assessment.
This legendary poison is found in rice cereal and many other foods, which are not regulated by EPA but by the FDA. Until the early 2000s, it was in almost all pressure-treated wood, much of which may still be in use in decks, picnic tables and playground equipment. The CDC has found arsenic in almost all Americans. The EPA has not scheduled a risk assessment.
Ethylbenzene is used in gasoline, paints, inks, pesticides and glues, and is a component of tobacco smoke. It is a well-established neurotoxin. California and the World Health Organization list it as a known human carcinogen. The CDC has found it in almost three-quarters of Americans. The EPA has not scheduled a risk assessment.
Cadmium is a toxic metal found in some imported children’s products, including jewelry, clothing accessories and paints on toys. It has been linked to delayed brain development, kidney and bone damage, and cancer.27 The CDC has found it in more than three-quarters of Americans. The EPA has not scheduled a risk assessment.
1,4-Dioxane is an industrial chemical used in paint strippers, dyes, greases, varnishes and waxes. The National Toxicology Program says it is reasonably anticipated to be a human carcinogen. Animal studies show that 1,4-dioxane can target the liver, kidneys and respiratory system, and that prenatal exposure can cause developmental harm. 28 The EPA has completed an initial risk assessment, and is conducting additional analysis on risks for workers and the general population.
By Melanie Benesh, Legislative Attorney
The nation’s new chemical safety law promises to make big changes in the way the Environmental Protection Agency regulates existing chemicals. But the devil will be in the details.
When Congress enacted the Toxic Substances Control Act in 1976, it grandfathered in more than 60,000 known chemicals already in commerce. The law exempted the substances on this list, known as the TSCA inventory, from any initial EPA review and from the requirement that chemical makers notify the EPA when they begin manufacturing or importing a new chemical.
Once a new chemical has gone through the notification process, it is added to the TSCA inventory, now numbering about 85,000 chemicals, many of which are no longer in use.
Chemicals on the TSCA inventory are regulated under TSCA Section 6, a weak and ineffectual part of the law rarely invoked by regulators. Since TSCA was passed, the agency has used its authority to attempt to ban or restrict only five grandfathered substances, on account of their danger to human health and the environment: asbestos, polychlorinated biphenyls, chlorofluorocarbons, one member of the dioxin family and hexavalent chromium. In four of these cases, the EPA achieved some restrictions under TSCA or other environmental laws.
In the fifth case, that of asbestos in 1991, the U.S. Court of Appeals for the Fifth Circuit overturned the EPA’s ban of the cancer-causing substance on grounds that compliance would be too costly for the industry. This case set a dangerous precedent, requiring the EPA to find the “least burdensome” solution for the industry and undertake onerous cost-benefit calculations before issuing regulations. The agency stopped trying to regulate existing chemicals under Section 6 until recently.
The new law, The Frank R. Lautenberg Chemical Safety for the 21st Century Act, takes the unprecedented step of requiring the EPA to evaluate the safety of chemicals already on the TSCA inventory. A new Section 6 lays out this review process in four phases: prioritization, risk evaluation, risk management and implementation.
The prioritization section requires the EPA to designate chemicals as either high or low priority. The agency must give high priority to chemicals that could pose an unreasonable risk to Americans' health or to the environment. It can assign chemicals less likely to meet its safety criteria. lower priority. To determine priority, the EPA must consider:
- Does the chemical build up in people’s bodies or persist in the environment?
- Are vulnerable populations like children, pregnant women, the elderly and workers exposed?
- Is the chemical stored near significant sources of drinking water?
- How is the chemical used, and in what volume?
- What is the hazard and exposure potential?
The substances most likely to be investigated first are the 90 chemicals on the EPA’s TSCA Work Plan, a priority list of substances that known to pose risks. Within that list, EPA must give special priority to chemicals that build up in people’s bodies and persist in the environment, are known human carcinogens, or have high acute and chronic toxicity. Half of all the chemicals EPA designates as high priority must come from the TSCA Work Plan.
Once the EPA begins to consider whether a chemical is high or low priority, it has nine to 15 months to decide if the chemical could pose an unreasonable risk to the public or the environment. If the agency gives the chemical low priority, it does not have to take further action. If it gives the chemical high priority, it must launch a risk evaluation.
Evaluations of risks and regulations
Within 180 days of the new law’s effective date – June 22 – the EPA must have chosen 10 Work Plan chemicals for risk evaluation. After three and a half years, EPA should be in the process of evaluating 20 high-priority chemicals, and must have relegated 20 more chemicals to the low-priority list.
What we don’t know is how the EPA will conduct its risk evaluations: The law says the agency must establish the process through rulemaking within one year. Each time the EPA starts a risk evaluation, it must define within six months the hazards, exposures, conditions of use and potentially exposed vulnerable populations to be considered. The EPA has three years to complete each risk assessment, with a possible six-month extension.
If the risk assessment process concludes that a chemical meets the EPA’s safety threshold, the agency won’t issue regulations. But if it does not meet that threshold, the EPA is required to draft regulations restricting that chemical’s use. The EPA has one year to propose regulations and two years to finalize them, with a possible two-year extension only for chemicals not on the Work Plan.
The EPA must then publish a statement that addresses the health and environmental effects of the proposed rule, the magnitude of exposure, benefits for various uses and the “reasonably ascertainable” economic consequences of restrictions.
To determine the economic effects, the law says the EPA must look at effects on the national economy, small businesses, technological innovation, the environment and public health, as well as the costs and benefits and cost-effectiveness of both the proposed regulation and at least one other alternative regulation. The EPA must consider whether there are “technically and economically feasible” alternatives to the proposed regulation.
The final phase of the process is implementation. Each regulation promulgated under Section 6 is supposed to take effect as soon as practicable, but within five years at most. The law makes an exception, however, for the most draconian proposals, which would to ban or phase out chemicals entirely. Because taking a chemical off the market can be complicated, the law allows the EPA to start the process within five years but does not set a deadline for a ban.
Persistent bioaccumulative chemicals
So-called PBTs – Work Plan chemicals that are persistent, bioaccumulative and toxic – get more aggressive treatment. EPA must propose regulations for these chemicals within three years of the law’s enactment. The law gives the agency 18 months to seek comment and finalize a regulation. After that, it gets five years to implement the new regulation. If the agency is proposing to ban or phase out the chemical, it gets an indefinite window in which to act.
The new law should mean federal regulation of more chemicals. But there's a tradeoff: EPA action on a chemical could prevent states and local governments from adopting their own regulations. In the past, frustrated with the slow pace of EPA action, some states took the lead in restricting or banning harmful chemicals. State regulations in place before the new federal law took effect will remain in force. In the future, once the EPA begins reviewing a chemical and has defined the scope of review a state cannot take action until EPA’s risk evaluation is complete, although it can seek a waiver allowing state and local level regulation.