EPA Urged To Conduct Cumulative Risk Assessment Of Phthalates

The Environmental Protection Agency should conduct a cumulative human health risk assessment of phthalates as soon as possible, the Environmental Working Group says in comments to the agency.

"We believe that a cumulative human health risk assessment for phthalates is needed to protect public health, is supported by the science, and is feasible using standard risk assessment techniques," the environmental and consumer advocacy group adds.

The effort should be undertaken soon since "the impact of EPA's continued failure to conduct such an assessment is felt by states, companies and consumers nationwide," the organization says.

EWG VP-Research Jane Houlihan presented the comments during the first meeting of EPA's National Research Council on the Health Risks of Phthalates in Washington D.C. Dec. 18-19.

During the meeting, the EPA's new advisory committee accepted input on whether and how it should recommend that the agency conduct a cumulative risk assessment on the substances.

EWG expressed frustration that EPA's safety standards - which found phthalates safe under certain concentrations - were set nearly 20 years ago and assessed the risks only of individual phthalates or one source of adverse effect.

However, recent studies have identified exposure to multiple phthalates and have indicated the substances are present in most people. In support of its position, EWG pointed to a 2005 assessment from the Centers for Disease Control and Prevention that found phthalates in urine samples from all but 12 of 2,790 people tested, "with six or more phthalates found in 84% of people tested."

Additionally, several studies examined the effects of additive doses of multiple phthalates, including one in 2007 demonstrating additive effects of dibutyl phthalate and di-2-ethylhexyl phthalate on reproductive malformations.

"This data demonstrates that EPA's past assessments of phthalate risk, with the implicit assumption that humans are exposed to just one phthalate at a time, may significantly underestimate risk and result in health standards that fail to adequately protect health," EWG says.

The Personal Care Products Council argues with EWG's stance, saying it "generalizes and draws conclusions in an area that is much more complicated than they acknowledge and brings together what they are representing as public health concerns, product areas where really there is not a concern," Exec VP for Science John Bailey said.

For one, Bailey suggested, EWG is approaching the issue by "lumping" all phthalates together into one group of "risky" substances that have the same properties, uses and exposures.

"You can't draw the types of conclusions [they] are representing to include the phthalates that are being used in personal care products," Bailey added, noting diethyl phthalate, commonly used in fragrances, and dibutyl phthalate, used in nail polishes, have been studied extensively and found safe by authoritative bodies, including the EU's Scientific Committee on Consumer Products.

"So I think they are relaying on questionable science, and conclusions are drawn that are not supported by the science," he added.

EWG and other advocacy groups have targeted phthalates in recent years due to some studies linking them with developmental and reproductive effects. Concern has centered largely on the ubiquitous presence of the substances.

Controversy surrounding the ingredients spurred the Cosmetic Ingredient Review Expert Panel to re-open its review of phthalates in 2002 in order to assess new data, but the panel reaffirmed its 1984 ruling that the substances are safe as used in cosmetics (¹ (Also see "Phthalates Group “Safe As Used” In Cosmetics, CIR Concludes" - HBW Insight, 25 Nov, 2002.), p. 3).

Regardless, some states, including California, have proposed passing bills to ban the use of the substances in consumer products, and many companies have voluntarily reformulated their products, EWG points out.

"These changes are driven by public pressure that stems from legitimate concerns over the health risks that EPA has failed to define," EWG says. "But the changes affect only a handful of states and only a fraction of phthalate-laden products, and they fail to uniformly protect public health."

During a Jan. 11 interview with "The Rose Sheet," Houlihan discussed the reformulation trend among companies and EWG's efforts in pressuring more firms to remove the substances from their products.

"It makes a lot of sense for companies to proactively phase out [the substances] from their product even before that phase out is mandatory," Houlihan said, pointing to a ban of certain phthalates in Europe under the Seventh Amendment to the Cosmetics Directive.

While many companies claim it is too challenging to formulate products without the substances, Houlihan notes that EWG has "looked at thousands of labels of products and know that it is possible to reformulate products" to be phthalate-free.

In addition to addressing phthalates, Houlihan discussed EWG's goals in 2008, noting it will continue to focus on initiatives to educate consumers on the safety of consumer products and lobbying for legislation to ensure safety.

The group's primary education database tool, Skin Deep, will be updated with new entries on a regular basis, she said. The site currently provides safety ratings for 25,000 consumer products.

"We'll also advocate on Capitol Hill for federal reform on cosmetic safety standards," Houlihan said, noting Senator John Kerry (D-Mass.) has committed to taking the lead on the effort.

In September, Kerry urged FDA to allow public participation in an international harmonization effort, and in December urged the agency to take immediate action to reduce public exposure to lead in lipstick (² (Also see "Senators Request FDA Inquiry Into Lead Discovered In Lipstick Products" - HBW Insight, 3 Dec, 2007.), p. 4).

Also in 2008, EWG plans to support activity behind The Kids Safe Chemical Act, which was introduced in 2005 and would empower EPA to require firms to conduct tests of chemicals in their products.

Co-authored by Senator Frank R. Lautenberg (D-N.J.) and Senator Jim Jeffords (I-Vt.), the act would require companies to show their products are safe before they are placed on the market rather than presume a substance is safe until proven dangerous.

"That would have a lot of influence on what is used in cosmetics," Houlihan said.

- Eileen Francis ([email protected])