No. 27 Monday, February 10, 2003	Page A-13
ISSN 1521-9402
News
Pesticides EPA Will Consider All Studies in Decisions On Regulation of Chemicals, Official Says

As it makes regulatory decisions on chemicals, the Environmental Protection Agency will consider all relevant data including information from scientific tests that have not been formally validated by national or international panels, according to a top EPA official.

Steven Johnson, assistant administrator for prevention, pesticides, and toxic substances, spoke at a Jan. 31 briefing on the agency's Interim Reregistration Eligibility Decision (IRED) on atrazine (22 DEN A-14, 02/3/03 ).

He was answering questions about the agency's response to a data correction petition filed by a regulatory watchdog group and agricultural grower organizations concerning the agency's risk assessment for atrazine (234 DEN A-10, 12/5/02 ).

In their Nov. 25 petition, the Center for Regulatory Effectiveness, Kansas Corn Growers Association, and the Triazine Network, argued that EPA's assessment of atrazine's risks violates federal information-quality standards because the agency's risk assessment relied, in part, upon unvalidated scientific tests to reach its conclusion that atrazine caused hormonal changes.

"[T]here are no validated test methods for assessing any such effects," the petitioners said, referring to the fact that some data EPA used in its assessment of atrazine resulted from tests that are not part of the standard battery of tests the agency has approved for regulatory testing.

"[T]he Data Quality Act's Objectivity, Reproducibility, and Utility Standards require that EPA use validated tests to assess both human health and environmental endocrine effects," the petitioners said.

Under what is known as the Data Quality Act, a rider to the Treasury and General Government Appropriations Act for Fiscal Year 2001 (PL 106-554), OMB issued governmentwide guidelines to ensure the quality of federally disseminated information (67 Fed. Reg. 8452; 9 DEN B-1, 01/14/02 ). EPA and other agencies have issued their own guidance describing how they will comply with OMB's standards that require, among other criteria, that information be reliable and reproducible.


Johnson: 'We Use All Data.'

Johnson told reporters: "We use all data."

Factors such as whether a particular test has been validated will be taken into consideration as the agency decides what weight it may give particular studies, he continued.

However, many studies EPA analyzes as it makes regulatory decisions result from state-of-the-art testing procedures being used at universities or other research establishments, Johnson said.

The tests these researchers use may not have gone through formal validation procedures established by national and international organizations, he conceded. But, Johnson stressed, "to exclude studies or protocols on the basis that they are not validated is inappropriate."

The U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the European Center for the Validation of Alternative Methods (ECVAM) are among the organizations that have established formal validation procedures for toxicity tests.

In a letter dated Jan. 30, EPA formally responded to the atrazine data correction petition. The letter does not discuss the issue of validated versus unvalidated studies, which Jim Tozzi, a board member of the Center for Regulatory Effectiveness, told BNA was the heart of the issue.

Instead, EPA's letter states that the agency considers the data correction request to be a comment on its draft IRED.

"Accordingly, we will respond to your Request for Correction in a 'Request to Comment' document that will accompany the IRED for Atrazine that we expect to release shortly," said Marcia Mulkey, director of EPA's Office of Pesticide Programs. As of Feb. 7, EPA had not yet published the IRED.

EPA's letter did address the assertion by the center and grower groups that there is no reliable evidence that atrazine causes endocrine effects in the environment.

EPA is still deliberating on the reliability, reproducibility, and significance of data on the potential effects of atrazine on frogs, Mulkey said. EPA will discuss the studies it has received on atrazine and possible effects on frogs at the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel meeting in June, the letter said.

Some scientific research has reported that frogs exposed to atrazine have underdeveloped testes and both male and female reproductive organs (hermaphroditism) (208 DEN A-6, 10/28/02 ).

Other studies had not found these effects, Johnson said, describing the data as conflicting information warranting SAP's review.

Based on the advice EPA receives from the panel, the agency may amend its environmental risk assessment for atrazine and the ecological IRED for the herbicide, which the agency expects to issue by Oct. 31, Mulkey's letter said.


Data Called Unreliable

Tozzi said the organizations that petitioned EPA to correct its atrazine risk assessment will tell the SAP that the agency cannot regulate atrazine on the basis of the reported hormonal effects because subsequent researchers have failed in their attempts to replicate the results. That means the research is not reliable, Tozzi said.

It is inappropriate scientifically and legally to use unreliable information, Tozzi continued

OMB's data quality guidelines require federally disseminated information to be reliable, he said. The center believes that compliance with OMB's guidelines is judicially reviewable, so if EPA regulates atrazine on the basis of unreliable data, the agency could be sued and a court would be expected to rule in the petitioners' favor, Tozzi said, calling such a favorable court ruling a "slam dunk."



By Pat Phibbs

Copyright © 2003 by The Bureau of National Affairs, Inc., Washington D.C.