Q&A: OLE GRØNDAHL HANSEN
PVC Debate Migrates to European Level
The most widely used polymer in the medical device industry, polyvinyl chloride (PVC) is present in approximately one-third of all disposable healthcare products. The health impact of the plasticizers that are commonly used in the material and the environmental effects associated with PVC itself have been debated since the early 1980s. The question has again come to the fore as Denmark, "the most radical country in regard to environmental regulations," considers legislation that would curtail use of the material. Ole Grøndahl Hansen, chairman of the Danish Medical Device Association's Environmental Committee and general manager of the PVC Information Council Denmark, reviews the reasons for the Danish PVC policy and its potential consequences for device manufacturers.
Q: Could you briefly explain the health concerns associated with PVC and, in particular, the phthalate DEHP?
A: The question revolves around whether the migration of phthalates into the human body constitutes a potential health hazard. While it is true that laboratory rats that have been exposed to high levels of DEHP develop cancer, studies done on monkey and human cells do not show the same results. Denmark's environmental protection agency, however, claims that there are too many unanswered questions regarding the migration of phthalates and its effect on humans.
Q: The other issue is the environmental impact of PVC.
A: Denmark is probably the world leader when it comes to incinerating its waste, and more than half of the incineration plants filter smoke with lime—what is called a dry or semidry process. This leaves a neutralization residue that contains some heavy metal content, and the quantity of neutralization residue depends partly on the amount of chlorine that is in the waste. This then becomes a disposal problem, because this residue is classified as hazardous waste.
Danish environmental policy is product oriented—in other words, we would rather solve the problem at the cradle than at the grave. Consequently, our EPA has stated that we should avoid using chlorine in products because we will be faced with neutralization problems at the end of the life cycle. In regards to medical devices, the agency has published a handbook for public purchasers that recommends buying non-PVC products whenever feasible. But these guidelines are voluntary, not mandatory.
Q: So the rumours about impending draconian legislation are somewhat exaggerated?
A: Many rumours have been circulating about Danish policy regarding PVC and phthalates, but I can assure you that a phaseout of the material is not under consideration. The Danish minister of the environment has published a so-called action plan to reduce the use of phthalates. I stress the word reduce. That plan provides a range of tools to regulate their use—such as "eco taxes" that would act as an incentive for consumers to choose products made from alternative materials—but it does not affect medical devices. The EPA recognizes that these products are used in very regulated applications, so they would be exempt. Instead, it is seeking to influence the standardization work that is going on at the European level and to lead the discussions in that context.
Q: What is the status of these discussions and how successful has Denmark been in lobbying for a hard-line stance?
A: The European Commission has begun a risk assessment of phthalates and that should be finished by this year. Danish industry has asked our environmental authorities to wait at least until there is European consensus on this matter before doing any more. But, of course, there is a kind of competition related to environmental policy among Scandinavian countries: you look more progressive if you are the first in line. But it is not good for Danish industry.
Q: Simply the cost of specifying and testing alternative materials would be astronomical.
A: Of course. When the minister of the environment first sent out his action plan, he asked the Danish Plastics Federation to conduct a survey to see if it would be possible to find substitutes in all of the current applications where phthalates are used. The federation found that, yes, it is feasible within most applications to change the plasticizer, but it would in most cases double the cost of the product. Under those circumstances, it would be impossible for the device industry to remain competitive.
