ACTION ALERT
Re: Toxic Additives in PVC Toys

You wouldn't think Americans should have to worry about child safety regulations in Europe. However, when we received internal documents from the Commerce Department that showed extensive lobbying by the Clinton Administration to stop the European Union (EU) from strengthening protections of children from toxic additives in toys, such as teethers and pacifiers, it became all of our business.

Thanks to aggressive lobbying by the Clinton Administration, Exxon, and Mattel, a proposed ban by the EU of young children's toys containing toxic softening agents in vinyl plastic (PVC) has been delayed. Further action is expected this summer.

Background:

In the fall of 1997 Greenpeace released its own test results of children's toys from 17 countries. Most PVC toys contained toxic softening agents known as phthalates. These softeners can make up more than 40% of the product.

Also in the fall of 1997, Greenpeace released test results in the U.S. and Canada showing dangerous levels of lead and cadmium in children's vinyl (PVC) toys. Metals are a necessary additive in PVC products.

In May of this year, under a Freedom of Information Act Request, Greenpeace received internal documents from the U.S. Commerce Department exposing widespread lobbying by the Department along with companies like Exxon and Mattel in a concerted effort to derail a proposal in the EU to ban PVC toys containing toxic softening agents known as phthalates.

In a letter to the Commerce Department Mattel expressed "appreciation for the invaluable work being done.." and praised the Department for "helping the U.S. toy industry defend against recent EU initiatives to ban the use of polyvinyl chloride (PVC) in toys."

Another Commerce Department document said, "WE ARE TOLD BY EXXON CHEMICAL EUROPE INC. THAT THE INPUT WAS VERY EFFECTIVE AND THE WEIGH-IN WAS INVALUABLE."

Meanwhile in Europe, countries, including Austria, Belgium, Denmark, Germany, and the Netherlands have recommended a ban on soft PVC toys, such as teething rings and bath toys. In March, the Spanish government requested action by the EU.

Last August, LEGO made public their program for "phasing out PVC." LEGO stated that PVC currently makes up less than .05% of their use of plastic materials.

And even Mattel in 1992 announced a plan "for the elimination of the substance PVC (Poly Vinyl Chloride)" saying, "children are the most environmentally conscious of all consumers." However this plan was restricted to the packaging of toys, NOT the toys themselves.

Phthalates (eg., DINP & DEHP) are a group of chemicals used primarily as plasticizers added to PVC to make it soft and elastic. Plasticizers account for more than half the weight of some flexible PVC products. About 95% of phthalates are used to make PVC products. Although DEHP has been severely restricted in US toys since 1986 it used elsewhere in the world and would have been prohibited by the EU proposal.

According to a U.S. Consumer Product Safety Commission's March 1998 preliminary report on another PVC additive (DINP), "DINP is toxic to the liver, kidney, and other organs. DINP may be regarded as `toxic' under the [Federal Hazardous Substances Act]... It is conceivable that one or more existing DINP's for which data are unavailable could also be more toxic and/or carcinogenic."

Since they are not chemically bound to the plastic itself, phthalates readily leach out of PVC products. As a result of their continuous release during the production, use and disposal of PVC products, phthalates are often described as the "most abundant man-made environmental pollutants."

European countries who are taking action and those who are proposing action on PVC toys are recognizing a principle enunciated by Vice President Gore in announcing the Administration's Executive Order on children's health: that children deserve greater protection because their developing systems are more vulnerable to environmental poisons and because any developmental effects children might experience are irreversible.

After DEHP was restricted in the U.S. other phthalates were introduced to the market with inadequate studies done on their health effects. PVC is the only large volume plastic that requires so many toxic additives to make it soft and stable.

Why continue to use PVC when there are readily available substitutes already on the market? For example most other plastics are safer and of marginal difference in price.

The lesson is that PVC is a dangerous, obsolete and unnecessary material. By avoiding the use of PVC we also avoid the risks posed throughout its life cycle, including the creation of dioxins from the production of PVC to its disposal in incinerators or fires.

No preventable risk is an acceptable risk.

If you would like to help please call or email the White House and Mattel today:

The White House telephone # is (202) 456-1111, fax is (202) 456-2461 and the email address is: president@whitehouse.gov Mattel's phone # is: (800) 524-8697, their address is: Mattel 333
Continental Blvd, El Segundo, CA 90245-5012

PVC toys contain up to 50% by weight phthalate esters.

The main phthalate used in PVC toys, diisononyl phthalate (DINP) is a poorly characterized chemical consisting of some 100 isomers. However, laboratory experiments on DINP (submitted by the companies themselves in some cases) have found liver and kidney lesions, cell line transformations, liver tumors, and some impacts on the reproductive system. The estrogenicity of DINP is still in question. Yes, there has been some debate over whether the mechanism of action of effects of DINP are applicable to humans (while there has been at least one study showing that peroxisome proliferation is not the mechanism of carcinogenisis). At any rate, in the public health field we have accepted results of animal testing to be applicable to humans for the past 50 years. Those who do not agree with this are often those who do not like the results of the animal tests.

These phthalate esters are not chemically bound to the polymer (even the toy and chemical industries do not dispute that) so that they can leach during normal toy use, even moreso when pressure, such as chewing is applied. The amounts of exposure have varied depending on the testing protocol, however, all of the testing protocols to date have demonstrated significant leaching of phthalates.

The phthalate esters are the most abundant human made contaminants found in the environment. The U.S. Centers for Disease Control are in the process of initiating a wide spread screening of the U.S. population for phthalate levels (monoesters) as a result of finding high levels of phthalates in blood when testing for DDT (DDE) and PCBs. Even if the phthalates are only weakly toxic, human exposure, especially to infants who are ingesting phthalates in infant formula, could be great.

Most importantly, there are alternative plastics and other materials such as cloth and wood that can be used to replace PVC in toys. Some of these include polyethylene and ethylene vinyl acetate. These plastics are not only less polluting throughout their production, use and disposal, the do not require the amount of additives required of PVC (PVC requires plasticizers - mainly phthalates as it is brittle without them) and the additives are more tightly bound to the polymer. Several U.S. and European toy manufacturers, including Mattel, already have PVC alternatives for teething rings and other toys on the market. Exxon, which is a large phthalate ester manufacturer, is positioning itself to be a leader in the sale of metallocene polyolefin plastics, which are widely thought to enter the market as replacements for flexible PVC in coming years.

Despite this evidence, the toy and chemical industries, as well as the Weinberg Consultancy, continue to insist that there is absolutely no hazard to children from PVC toys.

Yes, of course there are significant uncertainties in whether a child ís exposure to phthalate esters will cause harm. However, we all know it is exceptionally difficult in most cases to find a causal relationship between exposure to chemicals and disease, especially when there is exposure as a child. Also, scientists have only just begun to study the impacts of toxic substances on the developing fetus and young, growing children. However, scientists and policy makers in some countries, such as Austria, Spain, and Denmark, feel that there is enough evidence to warrant actions to protect childrenís health.

The main point here is that the benefit of protection under uncertainty is being afforded to a potentially hazardous chemical, NOT to children. It is government authorities (and ultimately children) that have the burden of demonstrating that the phthalates pose a risk, rather than those who stand to profit from phthalate manufacture. Meanwhile children continue to be exposed to phthalates, which could result in possible adverse health effects.

Recent studies by the U.S. EPA and the Environmental Defense Fund, demonstrate just how little is actually known about high production volume chemicals (among which are the phthalates). Even basic toxicological screening data is missing for the vast majority of these chemicals. In the case of DINP, this means that a range of toxicological endpoints may have not even been examined yet.

Our ignorance about the health effects of toxic chemicals, let alone the effects of multiple chemical exposures, leads to one conclusion in the arena of public health protection: the benefit of the doubt under uncertainty needs to rest with those who might be harmed by a toxic hemical. Shouldnít we be affording children the maximum protections possible, when science is inconclusive and their health is potentially at risk?

In the case of PVC toys and phthalate exposure, the debate needs to move >from one based on acceptable levels of risk or acceptable daily intakes, which is uncertain, contentious, and based on limited knowledge to one based on the availability of safer alternatives, which is much more certain. Taking action when you have suggestive evidence of potential harm and opportunities for hazard prevention IS the public health principle of primary prevention. Quibbling over acceptable risks and intakes is NOT.

In the end, if this debate over an acceptable exposure level is to continue, the toy industry could take on some responsibility by, at a minimum, labelling their toys - that they contain a potentially toxic chemical that can leach during use. They have been opposed to even this minimal market measure. In my speaking with mothers, once they understand that a toy is 40% by weight of a chemical that when you purchase it for the laboratory carries hazard labels and instructs the user to wear protective equipment, they think much differently about buying PVC. Mothers and many public health practitioners understand that it is simple COMMONSENSE not to expose a child to a potentially toxic chemical when there are alternatives available. I h

ope this message helps to clarify the PVC toy issue a bit and raise questions about the directions of the public health movement. These types of questions and debates (e.g., what to do in the face of uncertainty regarding harm from toxic chemical exposure) need critical attention from the public health community and are ones that cannot be solved through science alone. As Alvin Weinberg (no relationship to the other group, I believe) states, these are issues of "trans-science" which must be resolved through public policy.