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Reg WeekSM: CRE Regulatory Action of the Week

American Chemistry Council Identifies Serious Deficiencies in EPA's HPV Rulemaking
The American Chemistry Council (ACC) has identified serious deficiencies in EPA's proposed HPV rulemaking. Although ACC made clear their strong support for the voluntary HPV Challenge Program, the Council's comments point out major problems with the proposed rule which EPA needs to address prior to taking any regulatory action.

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  • Read ACC's Comments to EPA.
  • Read Selected Quotes From ACC's Comments to EPA.
  • Read CRE comments on EPA's HPV Rulemaking.
  • Comment on Item
  • View past CRE Regulatory Action of the Week items

    CRE Review of the American Chemistry Council's Comments on EPA's HPV Rulemaking

    Several serious problems with EPA's proposed HPV test rule were identified by the American Chemistry Council in their comments to EPA. The critical HPV rulemaking deficiencies described by ACC include issues related to: 1) substantial shortcomings in EPA's cost analysis; and 2) EPA's failure to comply with essential elements of the data quality provisions of the Paperwork Reduction Act and OMB guidance on data quality.


    The American Chemistry Council's comments make two key points regarding EPA's economic analysis:

    • EPA Underestimation of Per-Chemical Testing Cost. ACC stated that actual per-chemical testing costs would likely be "considerably higher" than estimated by EPA.

    • Need for EPA to Aggregate the Cost of All Mandatory HPV Testing. EPA should have conducted an aggregate economic analysis examining the expected total testing costs for all 400-450 HPV substances subject to mandatory testing, not just the costs associated with the 37 chemicals named in the first HPV testing NPRM.

    According to ACC, the actual cost of the HPV mandatory testing program, "could be as high as two hundred million dollars - an amount far above the costs projected by EPA for the 37 chemicals included in this initial proposed test rule."


    Although ACC did not specifically address EPA's obligations under the Paperwork Reduction Act (PRA) or other good government laws, their comments did point out serious problems with the rulemaking which result from EPA's failure to comply with their duties under these laws.

    • Confusion of Hazard with Risk: EPA Has Not Demonstrated Practical Utility of Data Dissemination. The PRA, Data Quality Act and OMB guidance in Circular A-130 requires that government dissemination of data must satisfy the requirements of "practical utility" and be necessary for performance of the agency's statutory duties. ACC's comments highlight the likelihood that hazard data will be confusing and lack practical utility. The Council's comments state, "One of our principle concerns throughout this effort has been that EPA or others will confuse hazard data or assessments with risk..."

    • EPA Lacks an Adequate Plan for Managing and Using Data. EPA is required by the PRA to have a plan, and the necessary resources, for effectively using the HPV data. EPA has stated that, to evaluate potential health and environmental risks, the HPV data will be combined with exposure and use information. Therefore, the Agency's data management plan should include managing the exposure and use information. However, ACC noted that, "it appears that the Agency has not thought strategically about how it will manage or use the information that will be submitted." The Introduction to ACC's comments urged EPA to, "elaborate how it plans to utilize use and exposure information when submitted."

    • Duplication between HPV Testing and Other EPA TSCA Testing Programs. One of the key purposes of the PRA is to prevent needless duplication in government data collection exercises. However, ACC explains that, "...EPA has proposed numerous new test rules, testing initiatives and reporting requirements in addition to the HPV Challenge Program. These initiatives often overlap in terms of chemicals and timing... ACC is not aware of any serious or sustained effort to coordinate these activities..." ACC goes on to say that, "Together, these programs pose a significant potential for overlapping requirements, duplication, and other inefficiencies."


    • Economic Task Force. EPA should establish a task force to conduct a complete Regulatory Impact Analysis (RIA) as described in Executive Order 12866. As part of the RIA, the task force should determine the total cost of: 1) all anticipated mandatory HPV testing; and 2) the entire HPV initiative. The task force should request comment through a Notice of Inquiry published in the Federal Register to obtain key data elements including: detailed information on testing, data management, and data analysis costs; and the universe of chemicals subject to mandatory testing.

    • Development of a Revised Information Collection Request. EPA needs to develop a revised Information Collection Request (ICR). The revised ICR should clearly specify:

      • All planned uses of the proposed data collection. The plan should clearly distinguish between existing uses and proposed new uses of the data and should also clearly explain the practical utility of each proposed use of the data.

      • Precisely how the data would be managed and analyzed. When additional information, such as exposure data, is part of the Agency's analytic strategy, the data plan should explain how and when the Agency intends to obtain the data as well as how the overall data analysis would be performed.

      • The Agency resources that would be required to carry our the data management and use plan. The Plan should demonstrate that the Agency has sufficient resources to carry out the proposed plan.

    • 60 Day Public Comment Period on the Revised ICR. Once EPA revises the ICR, they are required by the PRA to open a 60 day public comment period on the proposed information collection.

    • Revised Notice of Proposed Rulemaking. Based on the information obtained from both the economic task force and from preparing the revised ICR (including information obtained from public comment), EPA needs to develop a new Notice of Proposed Rulemaking.

    Read Selected Quotes From ACC's Comments to EPA.

    Read ACC’s Comments to EPA.

    Read CRE comments on EPA's HPV Rulemaking.

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