[Pharmwaste] OMB Endocrine Directive Draws Industry Cheers, Enviro Jeers

Tenace, Laurie Laurie.Tenace at dep.state.fl.us
Fri Oct 16 08:31:22 EDT 2009

OMB Endocrine Directive Draws Industry Cheers, Enviro Jeers 
A link to OMB's Directive is at the web site.

By SARA GOODMAN of Greenwire
Published: October 15, 2009 
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

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

"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."

Laurie Tenace
Environmental Specialist
Waste Reduction Section
Florida Department of Environmental Protection
2600 Blair Stone Rd., MS 4555
Tallahassee FL 32399-2400
P: 850.245.8759
F: 850.245.8811
Laurie.Tenace at dep.state.fl.us 

Mercury: http://www.dep.state.fl.us/waste/categories/mercury/default.htm 

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