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EPA Seeks ICR Renewal To Complete Critical First Round Review For EDSP

Posted: November 1, 2012

EPA is asking the Office of Management and Budget (OMB) to renew its data collection authority so it can finish gathering data on the first batch of chemicals slated for review by its Endocrine Disruptor Screening Program (EDSP) -- just before its existing information collection request (ICR) expired.

In an Oct. 30 Federal Register notice, EPA said it submitted its proposal to renew the current ICR to OMB for approval, as required by the Paperwork Reduction Act, prior to the ICR's expiration on Oct. 31.

But EPA says there will be no gap in its ability to require companies to test chemicals and submit the data to the agency because “under OMB regulations, the agency may continue to conduct or sponsor the collection of information while [the proposed ICR] submission is pending at OMB.”

An EPA spokeswoman says that OMB's rules allow agencies to continue collecting data under the expired ICR as long as the ICR renewal is pending at OMB. “Since the ICR renewal is pending at OMB, the existing ICR approval is automatically extended month-to-month until OMB acts on the pending request,” the spokeswoman says.

Some industry lawyers, however, are raising doubts about whether EPA can continue to collect the data while OMB reviews the proposed ICR, saying the OMB regulations may not apply to this ICR renewal.

One source says that EPA and other agencies can win automatic month-to-month extensions if their renewal requests are submitted 60 days before the ICR expires – which EPA has not done in this case. And the source adds that the ICR cannot automatically be extended because OMB regulations prohibit ICRs that last more than three years– which would be the case for this ICR, which OMB first approved in 2009.

Such a gap in authority could serve as a bump in the road for EPA ahead of what a top official says will be a “critical year” for the long-delayed chemical testing program as officials prepare to convene several peer review panels on the program's data analysis and testing methods and seek to clear a major hurdle by finishing gathering data on the first batch of chemicals subjected to screening.

EDSP is a two-tiered program that seeks to screen chemicals for potential endocrine-disrupting activity, the ability of chemicals to interfere with or mimic hormones in the body.

Tier 1 would employ a battery of five in vitro and six whole-animal in vivo assays to identify substances' potential to interact with the endocrine system. Following a weight-of-evidence analysis, any flagged chemicals could undergo more rigorous screening in a second round of animal-based tests that would seek to confirm endocrine-disrupting activity and obtain dose-response information that could help support risk assessments and regulatory decisions.

But EPA has struggled to get the program off the ground since its authorization in 1996. The agency still has not validated the Tier 1 battery for regulatory use, let alone put any chemicals through the full program. EPA in 2009 issued test orders for its first list of 67 chemicals – pesticide active and inert ingredients – to undergo Tier 1 screening and to aid with validation of the Tier 1 battery, but the agency still has yet to finish collecting and analyzing the information.

Data Collection

The current ICR is needed for EPA to have authority to collect that data on the first list of chemicals. Moreover, OMB has said it will not authorize EPA to collect EDSP test data for its second list of chemicals until it has analyzed data from the List 1 chemicals and subjected the data, the Tier 1 assays and relevant weight-of-evidence guidance, to peer review. OMB also has said the steps are needed to ensure the “practical utility” of the data and thus justify additional ICRs for future chemical lists. OMB also required EPA to consider already-available “other scientifically relevant information” and recalculate the burdens of supplying the needed test-order data later on.

EPA last August proposed renewing the ICR, which applies only to data on List 1 chemicals from tests involving the Tier 1 screening battery of EDSP. The ICR renewal also revised upward the agency's estimates of the paperwork burdens faced by companies to generate and submit data to EPA, as OMB had requested.

Industry and animal-group representatives argued in their comments that EPA was still underestimating the data burdens and suggested that EPA look to industry for actual data on Tier 1 screening costs from already-completed List 1 data generation.

Some, like the Center for Regulatory Effectiveness (CRE), an industry group, had suggested in comments on EPA's initial proposal that OMB should not approve an ICR request of any kind until peer reviews of the agency's guidance are completed. Such rigor of review is necessary, the group said in its comments, to comply with EPA and OMB data quality guidelines and the paperwork law.

But EPA in response to the first round of public comments defends its data-burden estimation, saying that industry still has yet to submit that actual data to the agency.“The EPA will review and consider any detailed information related to this issue when it is submitted,” the agency writes. “The agency has based all estimates on currently vetted information.”

EPA also rejected CRE's charge that the ICR should not be approved until the guidance document has been peer reviewed. EPA says in its comments that it has met the OMB criterion requiring the “practical utility” of the data, saying that “EPA has already considered the potential interaction of a chemical with the endocrine system in making certain pesticide registration decision. For example, the EPA considered data from prototypes of the assays included in the current EDSP Tier 1 screen, along with other existing data, in preparing the risk assessments of procymidone and vinclozolin.”

A CRE source says that if agency's data gathering power has expired, OMB can, in rare cases, grant emergency approvals. But EPA's request likely would not meet OMB criteria, which include prevention of “public harm” and interference with the agency's ability to perform its duties or meet a statutory or court-ordered deadline, the CRE source says -- Puneet Kollipara (pkollipara@iwpnews.com)

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