In Rare Step, OMB Urges EPA To Accept Data In Lieu Of Endocrine Tests

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Date: October 13, 2009 -

The White House Office of Management & Budget (OMB) is requiring EPA “to the greatest extent possible” to accept existing toxicity data in lieu of requiring new tests for chemicals subject to the agency’s endocrine disrupting screening program (EDSP) -- a rare exercise of OMB’s authority under the Paperwork Reduction Act (PRA).

The move is winning praise from industry officials, who have worried that EPA would impose significant new test burdens when existing data is available. “We’re pleased OMB recognizes the relevance of the vast amount of data previously collected. . . . Referencing these data on reproductive and developmental toxicity allows EPA to meet the program’s requirements and minimizes unnecessary financial, time, and resource burdens on both the agency and industry,” Jay Vroom, president of Crop Life America, said in an Oct. 7 statement.

And a PRA expert says it is rare for OMB to set such conditions in an approval of a data collection request.

Congress required EPA in the 1996 Food Quality Protection Act (FQPA) to create the EDSP to screen for and determine chemicals’ potential for disrupting human hormones.

EPA has only recently completed the 11 assays that are available to test chemicals in the first tier of the program and earlier this year asked OMB to approve an information collection request (ICR) -- required by the paperwork law -- to require companies whose chemicals are subject to the first round of EDSP testing to develop data.

The 11 assays that EPA included in the first tier of the screening program are intended to determine if any of the 67 pesticides the agency has initially tagged for testing have the potential to interact with the endocrine, androgen or thyroid hormones and should go on to a second, more costly round of tests to provide information for hazard assessment.

However, EPA has not provided guidance on what results will lead a chemical to be flagged for tier two testing. Nor has the second tier been finalized; EPA is still working to validate the assays it has said it will include.

Industry representatives have long questioned the validity of some of the tests, arguing that though EPA has validated all of them, the agency has not been able to produce negative results when it should have done so for some of the assays included in the first tier.

During a conference last month, industry representatives charged that running one chemical through the first tier of assays could cost more than $1 million, while noting that manufacturers already have existing data that provides the same information as the first tier of the EDSP. Representatives urged EPA staff present at the meeting to provide industry with a guide to how the agency will determine what data could be submitted instead of running chemicals through the tier one assays. EPA indicated they were unlikely to do so (Risk Policy Report, Sept. 15).

But in its Oct. 2 approval of the ICR, OMB is requiring EPA to “promote and encourage test order recipients to submit Other Scientifically Relevant Information (OSRI) in lieu of performing all or some of the Tier I assays, and EPA should accept OSRI as sufficient to satisfy the test orders to the greatest extent possible,” according to the notice of OMB action released Oct. 2. EPA sent the EDSP test orders to OMB for approval last April. The notice is available on InsideEPA.com.

OMB also placed a requirement on EPA to take additional public comment on the program and the guidance the agency uses to decide if a chemical should move from tier one to tier two. “[I]n order to ensure that EPA has maximized the practical utility of the Tier I assays as the program moves forward, EPA should ensure sufficient opportunity prior to submission of any revision to this collection for public comment and peer review of the EPA tools to be developed to guide agency decisions on whether a chemical must proceed to Tier II, including the Weight of the Evidence Approach and Standard Evaluation Procedures,” according to the OMB notice.

“I think OMB set up a reasonable and transparent solution that represents the limitations of our current knowledge,” says a pesticide industry source.

The source is particularly encouraged because OMB has set up what the source called a “test program,” giving EPA approval for three years to send industry test orders for the first 67 pesticides.

But OMB is also requiring the agency to submit a new estimate of the cost and time burden the test orders will place on industry based on information the companies provide on the 67 chemicals -- before the agency seeks OMB permission to expand the EDSP to other chemicals.

The industry source says such an expansion is likely because FQPA allows EPA to also require testing of “any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such substance.”

“In order for the agency to expand to additional chemicals -- and they’re required to do so -- in order to move forward under their mandate they need to submit a new information collection request and a new burden estimate,” the source says. -- Maria Hegstad

Source: Risk Policy Report via InsideEPA.com

Date: October 13, 2009

Issue: Vol. 16, No. 41

RISK-16-41-1