Public Concern, Not Science, Prompts Plastics Ban
A new federal ban on chemical compounds used in rubber duckies and other toys isn't necessary, say the government scientists who studied the problem.
The ban, which took effect in February, prohibits making or selling duckies and other children's products that contain chemicals called phthalates, which are used to make plastic soft. Congress passed the ban in 2008 after concluding that the chemicals posed a risk to children who chew on their toys.
The action came despite advice not to enact the ban from scientists at the Consumer Product Safety Commission, which regulates toys.
The commission opposed the ban because "there was not a risk of injury to children," says Dr. Marilyn Wind, deputy associate executive director for health sciences at CPSC.
It reached that conclusion after studying phthalates in toys for more than 25 years and acting several times to make sure children were not exposed to even a slight risk from products that contain the chemicals.
Putting The Study Where The Mouth Is
Wind says that from the beginning, CPSC scientists have focused on products that end up in a child's mouth, including rattles, squeeze toys, teethers and pacifiers. "That's the most exposure," she says, because mouthing and saliva can release phthalates from plastic products.
Back in the 1980s, soft toys made from PVC plastic contained a type of phthalate called DEHP, which has been shown to cause cancer in rodents exposed to high doses.
The commission was concerned enough about DEHP to begin action that would limit kids' exposure to it. Before that happened, though, companies offered to voluntarily remove DEHP from pacifiers, teethers and rattles.
That solved one problem but created another.
Choosing A New Unknown
Instead of using DEHP, companies began softening toys with a phthalate called DINP, which appeared less likely to cause problems in rats and mice.
Then in the late 1990s, Wind says, scientists found evidence that DINP could cause liver problems in rodents.
"We met with industry and made them aware of what we found, and they voluntarily removed DINP from toys that could be mouthed," Wind says.
The commission also convened an expert panel to study DINP. And it began two experiments to figure out how much DINP kids could get from toys they put in their mouths.
The first experiment used volunteers from the commission's staff.
"We gave them DINP-containing piece of PVC to chew on and they then had to spit out their saliva," she says. Scientists measured how much DINP was in the saliva.
The approach was designed to extract more DINP than an infant possibly could from a toy, Wind says.
Do Kids Chew Toys Enough To Be At Risk?
The second experiment, done in 2000 and 2001, sent trained observers into homes and day-care centers. They studied 169 children to find out what they really did with their toys. The experiment did not include pacifiers or teethers, which by that time contained no DINP.
Wind says each observer carried a stopwatch and "every time a child put something in their mouth they recorded it."
Before this study was finished, the CPSC panel concluded, based on the data about chewing and saliva, that children would have to mouth toys containing DINP for at least 75 minutes a day to have even the slightest risk of health problems.
The mouthing experiment showed that even young children kept toys in their mouths less than two minutes a day.
So by 2003, the science was pretty clear, Wind says. "We could not ban DINP because there was not a risk of injury to children."
In testimony before Congress, Wind summarized the research her agency had done on phthalates in children's products and argued against the proposed ban.
An Abundance Of Caution
Scientists from the FDA explained why they, too, had concluded that the ban was not necessary to protect the public.
But lawmakers had other ideas.
Sen. Dianne Feinstein (D-CA) said the ban was needed because phthalates had been "linked to serious reproductive defects."
Rep. Jan Schakowsky (D-IL) talked about "potential harm to testosterone development and the male reproductive tract."
And during hearings, the lawmakers heard from scientists representing groups that want the government to ban all PVC plastics from children's products.
The frightening allegations helped pass the law banning phthalates.
But Wind says she stands by the studies done by government researchers.
"I know that we did really good science," she says. "And sometimes people don't listen to the good science."
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RENEE MONTAGNE, host:
Rubber duckies aren't what they used to be. As of a couple of months ago, they no longer contain plastic softeners called phthalates. Congress banned these additives from children's products, saying they might cause health problems. What's odd about the ban is that the government's scientists who actually studied phthalates in toys found no evidence they posed a risk to children.
NPR's Jon Hamilton has more.
JON HAMILTON: The agency that regulates rubber ducks is the Consumer Product Safety Commission. It's a small outfit - several hundred staffers working in one of those anonymous glass buildings outside Washington, D.C. The commission usually does stuff like recalling toys a child might choke on.
But for more than 25 years now, it's also been studying phthalates, which are used to make PVC plastic soft. And the commission has acted several times to protect children from these chemicals.
Dr. Maryland Wind says it's obvious which products might cause problems.
Dr. MARYLAND WIND (Deputy Executive Director, Health Sciences, Consumer Product Safety Commission): You want to look at something that's the most exposure. And most exposure is the things that kids keep in their mouths. And those would be rattles, squeeze toys, teethers, pacifiers.
HAMILTON: In the 1980s, soft toys contained a phthalate called DEHP. Wind says the commission was worried enough about it to convene a panel of experts.
Dr. WIND: And they concluded that DEHP was a rodent carcinogen. They also concluded that there were developmental and reproductive effects from DEHP.
HAMILTON: Again, in rodents. No one knew what DEHP did to people. So, the commission decided to play it safe and limit the chemical in certain kid's products. Before that could happen, though, companies voluntarily removed DEHP from items meant to be mouthed.
Instead, the industry began softening toys with a different phthalate called DINP. And wind says in the late 1990s scientists found evidence that DINP could cause liver problems in rodents. It didn't look like there was a risk to children, but Wind says the commission went back to industry anyway.
Dr. WIND: We made them aware of what we had found and they voluntarily removed DINP from toys that could mouthed.
HAMILTON: The commission also began some experiments to figure out just how much DINP kids were getting from toys. In one study, scientists had adults chew on soft plastic to make sure they knew how much phthalate got into saliva during a minute in the mouth.
An expert panel used that information to conclude that, even in a worst-case scenario, it would take a child at least 75 minutes a day of chewing or sucking to have the slightest risk from exposure.
In a second experiment, the commission sent trained observers into homes and day care centers to find out what 169 children really did with their toys. Wind says each observer carried a stopwatch.
Dr. WIND: Every time a child put something in their mouth they recorded it, clicked the timer, and when the child took it out of their mouth, they clicked the timer again and recorded the time.
HAMILTON: The study showed that even young children kept toys in their mouths less than two minutes a day. Wind says by 2003 the science was pretty clear.
Dr. WIND: We could not ban DINP because there was not a risk of injury to children.
HAMILTON: Wind summarized the whole story for Congress. The phthalate most likely to pose a risk had been removed from kids' mouths 25 years ago. To be extra cautious, another phthalate was taken out of pacifiers, teethers and rattles ten years ago. And years of study since then had found no danger from using this phthalate in other kids products.
Here's how lawmakers responded:
Senator DIANNE FEINSTEIN (Democrat, California): I have here two rubber duckies.
Representative JAN SCHAKOWSKY (Democrat, Illinois): A rubber duck sold at Walgreen's had 13 times the amount of phthalates now permissible under California law.
Senator JOHN KERRY (Democrat, Massachusetts): And it can be absorbed from those products, during use, into a young child's body.
Former Representative DARLENE HOOLEY (Democrat, Oregon): They're linked to both birth and other serious reproductive defects.
Rep. SCHAKOWSKY: Liver cancer, kidney cancer…
Ms. DARLENE HOOLEY (Former Democratic Representative, Oregon): …potential harm to testosterone development and the male reproductive tract, early onset puberty in girls and thyroid dysfunction.
HAMILTON: That was Senator Dianne Feinstein from California, Senator John Kerry from Massachusetts, former Representative Darlene Hooley from Oregon and Representative Jan Schakowsky from Illinois.
Their statements parroted the fears of consumer and environmental groups that have pushed to ban all PVC plastics in children's products. And it was enough to pass the law banning phthalates. But Wind, from the Consumer Product Safety Commission, says she stands by the studies.
Dr. WIND: I know that we did really good science, and sometimes people don't listen to the good science.
HAMILTON: Even when it comes from the government scientists we pay for good advice.
Jon Hamilton, NPR News. Transcript provided by NPR, Copyright National Public Radio.
