Ahead of a critical international meeting on the regulation of dangerous chemicals, environmental groups are asking the Obama administration to press for the banning of a pesticide linked to neurological disorders.
The pesticide at issue: lindane.
Representatives of 158 countries meet next month to debate whether lindane should be added to a list of chemicals targeted for a global phaseout under the 2001 Stockholm Convention on Persistent Organic Pollutants. The United States has signed but not ratified the treaty.
Environmentalists are asking the administration to push governments to add lindane to the treaty's list of restricted chemicals. The treaty currently targets 12 chemicals -- the so-called Dirty Dozen -- for restrictions that would lead to an eventual ban. When treaty members meet, they will discuss whether nine chemicals, including lindane, should be added to the treaty.
Because it has not ratified the treaty, the United States participates as an observer -- a powerful one.
"Even though the U.S. is not party to the treaty, it definitely influences the conversation," said Kristin Schafer, associate director for advocacy with the Pesticide Action Network, which sent a letter to the State Department and the Food and Drug Administration last week asking for support on a complete ban on the pesticide.
So far, the State Department and FDA have favored a ban on lindane in agriculture -- U.S. EPA banned agricultural lindane use in 2006 -- but have pushed for an exemption for pharmaceutical uses to treat lice and scabies. India is the only other country that is pushing for an exemption for lindane, Schafer said.
Lindane is a neurotoxic organochlorine pesticide linked to seizures, developmental disabilities and hormone disruption. Environmentalists say safer alternatives exist and that bans in at least 52 countries have not resulted in outbreaks of lice or scabies.
A State Department official said in an e-mail that the department is working with FDA to "review the U.S. position with respect to a potential public health exemption" for lindane.
FDA has approved lindane's use for lice and scabies as a "second-line therapy," for when alternative treatments fail. The agency said most adverse effects from the pesticide occur when it is misused, so products are limited to 1- and 2-ounce packages.
"While FDA believes that the benefits of lindane outweigh the risks when used as directed, given the potential for neurotoxicity, patients should only be treated with these medications if other treatments are not tolerable or other approved therapies have failed," the agency says on its Web site. An FDA spokeswoman said the agency has not changed its position.
Morton Grove Pharmaceuticals manufactures shampoos and lotions with lindane for lice and scabies treatment.
"We think there is an appropriate use for lindane," said Jerry Jabbour, spokesman for Wockhardt USA, which purchased Morton Grove in 2007. "There are not environmental issues associated with it in the small amounts that are used, and there's a real need for it."
He acknowledged that there are risks associated with lindane because it is a pesticide, which is why FDA has strict labeling and application requirements.
"Lindane is a pesticide that works when it is used properly," Jabbour said. "There's a reason it's a second-line therapy, and it needs to be used according to labeling requirements."
In 2002, California banned the pharmaceutical use of lindane because of concerns about water quality. In the years following the ban, scientists surveyed 400 California pediatricians and found that eliminating pharmaceutical lindane improved water quality and did not adversely affect public health, said Ann Heil, supervising engineer for the Sanitation Districts of Los Angeles County.
Schafer said California's experience should serve as a model for the United States as it formulates its position.
"Up to now, their argument has been that they didn't want to lose this as a tool in the toolbox because it's important in particular uses," Schafer said. "Our argument is very clear. It has been banned in California since 2002, so there are clearly alternatives, because there haven't been huge outbreaks of lice or scabies. It's been a seven-year experiment."
But Jabbour said lindane concentrations are so low in water that it is not a health concern and that the company is considering a possible challenge to the California ban.
Even if the international community decides to ban lindane, the United States would not be required to regulate because it has not signed onto the treaty. Such a move could put pressure on Congress to ratify the treaty, Schafer said. Lawmakers must amend the Federal Insecticide, Fungicide and Rodenticide Act and the Toxic Substances Control Act to allow U.S. participation.
"It would increase the pressure in international arenas if the United States is the only country continuing to use lindane by making it difficult to maintain that position," Schafer said.