OMB endocrine directive draws industry cheers, enviro jeers

The Office of Management and Budget has instructed U.S. EPA to use existing toxicity data rather than require companies to conduct new tests to determine whether chemicals can damage the human endocrine system.

At issue in the White House directive is the Endocrine Disruptor Screening Program created by the 1998 Food Quality Protection Act to identify chemicals that can disrupt reproductive systems.

EPA started the program in April with the announcement of the first 67 pesticides for screening with a "Tier 1" goal of identifying possible endocrine disruptors and requiring that they be tested by their manufacturers. The program's second tier is aimed at determining safe exposure levels for such chemicals.

OMB issued the directive last week, after EPA submitted a request for additional information. The White House approved EPA's request to collect additional data for the 67 chemicals but warned the agency that it should "to the greatest extent possible" accept existing data to satisfy test requirements.

The OMB directive, which observers say contained unusually strong language, is being hailed by industry groups that had been concerned about the prospects for expensive testing mandates.


"We've held the position that the information collected under FIFRA [the Federal Insecticide, Fungicide and Rodenticide Act] includes enough detailed information on reproductive and developmental toxicity," said Eric Janus, director of human health policy for CropLife America, a pesticide industry group. "It answers the questions that ... screening is trying to get: What's the potential for interaction with certain hormonal systems?"

CropLife had petitioned EPA this year and expressed concern that "unnecessary and redundant testing" could occur if the agency does not review data already submitted by pesticide registrants. EPA rejected the petition, saying it would ensure that each chemical is tested just once. The agency said it also plans to review all information on chemicals submitted by manufacturers, including submissions that cite existing data, and would develop standard evaluating procedures for chemicals.

But many environmental groups and scientists say OMB's directive will undermine the endocrine program.

"This is really short-sighted of OMB, and it indicated to me they don't understand the science or the toxicology," said Peter deFur, an environmental scientist who has served on three federal advisory committees for the program. "They've got a complete blank there. The language I've seen is just shocking for its failure to understand the basic biology behind the endocrine disruptor discussion that's been going on for 20 years now."

While data on pesticides are substantial, deFur said tests the chemicals have undergone were not designed to address their potential effects on hormonal systems.

"When you design an experiment, the toxicological assays are asking a specific question: Do these chemicals interfere with hormonal systems?" deFur said. "That's not the question that was addressed when toxicology assays were first designed."

OMB is also requiring that EPA estimate again the burden of collecting chemical information based on responses it gets to the Tier 1 requirements, which must include cases in which EPA has determined that existing data do not satisfy the testing requirements, before the agency can require data from more chemicals.

"We look at this as OMB setting up a pilot project," Croplife's Janus said. "To expand the program, they're going to have to go back with this report before anyone submits any additional information. They want to see how this first go-round works."

Click here to read OMB's directive.

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