Antimicrobial Chemical Case Revived by Court

MANHATTAN (CN) - Environmentalists can sue to compel regulation of triclosan, a common ingredient in antibiotic soap, toothpaste and other products, the 2nd Circuit ruled.

The U.S. Food and Drug Administration has been studying the chemical since animal studies associated it with hormone alteration, but the agency insists that the chemical "is not currently known to be hazardous to humans."

In a federal complaint, the Natural Resources Defense Council, or NRDC, said that the agency's delays in its review process violate the Administrative Procedure Act and leaves potentially dangerous substances unregulated.

One of the organization's members, Diana Owens, has served as a veterinary technician for an animal clinic for 20 years. She estimates that she washes her hands more than 50 times a day using soap that has triclosan, which she fears puts her at increased risk of ovarian cancer.

NRDC scientist Sarah Jensen testified that the health risks could be wider, ranging from spleen changes, liver damage and the blood disorder methemoglobinemia.

The FDA fended off the claims by asserting that the risks of triclosan have not been proven, and the group's members could avoid any alleged harms by using regular soap.

U.S. District Judge Alvin Hellerstein ultimately dismissed the NRDC's complaint for lack of standing, but the 2nd Circuit reversed on March 15.

The unanimous three-judge panel likened the NRDC's claims to the case over the mad cow disease scare, Baur v. Veneman.

In that case, Michael Barr had petitioned the U.S. Department of Agriculture to reduce the public's exposure to the infection by forbidding farmers to use meat from downed cows.

Although a federal judge initially chided Baur for being unable to prove his exposure to the disease, the 2nd Circuit said that the standard was potential for harm, not demonstrated exposure, and revived the lawsuit.

Triclosan triggers the same reasoning, the federal appeals court said.

"Here, FDA has stated that triclosan presents 'valid concerns,' and FDA has nominated triclosan for a toxicology study, including a study of its carcinogenicity," Judge Rosemary Pooler wrote for a three-member panel. "Further, the record evidence shows that FDA admits that it has insufficient data on triclosan's long-term health effects and that FDA itself is concerned about the long-term effects of triclosan exposure. Just as the government in Baur could not confirm that meat from downed cattle was not infected with BSE, the government in the instant case cannot confirm that exposure to triclosan-containing soaps is safe for humans."

The panel was equally unimpressed by the FDA's argument that Owens could have avoided the risk by buying regular soap. Even a "small financial loss" for the purchase would constitute harm, the judges said.

The FDA dodged claims over another similar chemical, triclocarbon, however, because the NRDC could not show that its members were exposed to it.

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