Dear OEM list members,

As a public health scientist and policy analyst very familiar with the PVC toys/phthalates debate, I would like to clarify some issues on the question of phthalates and children’s health. The Weinberg Group, described in the ENDS report entitled "Scientists criticise EU move to ban phthalates" is a third party consultancy hired by industry to find uncertainties and questions in science regarding product hazards and to keep restrictive action from occurring. This organization is by no means independent and unbiased and their scientific integrity is questionable. As can be gleaned from their marketing materials, "The Weinberg Group Inc. applies technical and strategic expertise to support clients with products under scrutiny in legal, public, and government forums."

Secondly, the efforts being undertaken by companies such as Mattel and Exxon and the U.S. Department of Commerce to influence the European Union scientific process are by no means scientific. Documents obtained from the Department of Commerce demonstrate clear political goals in stopping EU action on phthalates in PVC toys. Nonetheless, there is absolutely no reason to believe that EU action on PVC toys would have any effect on this $22 billion industry. PVC toys make up less than 1% of all plastic toys.

On the issue of science, let me say that the fact that this debate is even occurring (arguing over acceptable risk levels for children’s exposure to toxic chemicals) is of great concern to myself and many others in the public health community. We are slowly moving AWAY from the public health principles of primary prevention and first do no harm, espoused by such great practitioners as Ramazzini, Snow, and Hamilton. This is clear in the case of PVC toys. We have good scientific evidence of the following: 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’s 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 children’s 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 chemical. Shouldn’t 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 hope 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.

Regards.

Joel A. Tickner

Work Environment Program

University of Massachusetts Lowell

--

***Please Note new area code effective immediately

Joel A. Tickner

568 Flat Hill Rd.

Lunenberg, MA 01462

tel 1-978-582-3371

fax 1-978-582-3372