Vinyl News Focus More Good News on Phthalates

TIMOTHY F. BURNS

President and CEO The Vinyl Institute Washington, D.C.

hthalate esters, among the most useful and most studied substances on the P market today, received some good news in the early summer. An advisory panel to the Consumer Products Safety Commission (CPSC) gave a green light to the use of diisononyl phthalate (DINP), used exclusively in vinyl toys and other vinyl products.

The good news came on two fronts: cancer risk and reproductive-health risk. The advisory group, known as the Chronic Hazard Advisory Panel ( C W ) , found that “humans do not currently receive DINP doses from DINP-containing consumer products that are plausibly associated with a significant increase in cancer risk,” and that “the risk to reproductive and developmental processes in humans due to DINP exposure is extremely low to non-existent.” The bottom-line conclusion: “For most children, exposure to DINP from DINP-containing toys would be expected to pose a minimal to non-existent risk of injury.”

The panel based its conclusions on an evaluation of studies that looked at pos- sible liver and kidney effects, cancer, reproduction, development, and general health indicators.

The CHAP’S findings stand in line with conclusions reached by other authorita- tive review bodies. For example:

In December 1998, CPSC conducted its first assessment of potential health hazards from exposure to DINP in vinyl toys. Taking a conservative approach, the agency nevertheless concluded that, “Generally, the amount [of DINPI in- gested does not even come close to a harmful level.” The CHAP report builds on this finding. In June 1999, under the auspices of the American Council on Science and Health (ACSH), a blue-ribbon panel headed by former Surgeon General Dr. C. Everett Koop also examined the safety of DINP in vinyl toys and found that, “DINP in flexible toys is unlikely to pose a health risk to children.” Dr. Koop also stated that, “Consumers can be confident that vinyl toys ... are safe.” The Koop Panel did recommend some further evaluation. The CHAP has now responded. In July 2000, the Center for the Evaluation of Risks to Human Reproduction (CERHR) of the National Toxicology Program wrapped up a year-long, expert- panel review of phthalates, including DINP. In its meeting summary, the panel expressed “low concern for potential developmental and reproductive health effects in children who might be exposed to DINP through the mouthing of toys or other DINP-containing objects.” In September 2000, the European Union confirmed that, based on the scientific evidence presented, DINP does not require any classification or labeling for cancer, reproductive (fertility), developmental, or other health effects.

Earlier this year, a few months before the CHAP report came out, the Centers for Disease Control (CDC) released results of a biomonitoring study of the U.S. popula- tion that measured metabolites of more than 20 materials, including DINP and some other phthalates. CDC found essentially no DINP metabolites in most of the

108 JOURNAL OF VINYL & ADDITIVE TECHNOLOGY, SEPTEMBER 2001, Vol. 7, No. 3

Vinyl News Focus

population. This finding clearly undermines claims made by activists that phtha- lates such as DINP leak out of vinyl like “water from a sponge.” (The levels of all the phthalate metabolites detected in the study fell well within the U.S. Environmental F’rotection Agency’s conservative safety levels, known as “reference doses.”)

The string of evidence in support of the safety of DINP is pretty clear. As David Miller, president of the Toy Industries of America, stated after the release of the CHAP report, “We feel vindicated. We think DINP is a good material and we hope it can be used again in children’s products because it‘s the best material out there.”

JOURNAL OF VINYL t!? ADDITIVE TECHNOLOGY, SEPTEMBERZOOl, Vol. 7, No. 3 109