Abstract:This is a renewal of an existing ICR covering the information collection activities associated with Tier 1 screening of chemicals under EPA's EDSP. The EDSP is established under section 408(p) of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a(p)), which requires EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. The EDSP consists of a two-tiered approach to screen chemicals for potential endocrine disrupting effects. The purpose of Tier 1 screening is to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems using a battery of assays. Substances that have the potential to interact with estrogen, androgen or thyroid systems may proceed to Tier 2, which is designed to identify any adverse endocrine-related effects caused by the substance, and establish a quantitative relationship between the dose and that endocrine effect. Additional information about the EDSP is available athttp://www.epa.gov/endo.
This ICR addresses the information collection activities for the initial list of chemicals screened under Tier 1 of the EDSP, and covers the full range of information collection activities associated with the issuance of and response to Tier 1 EDSP orders issued by EPA. The initial list was established in 2009, and consists of 67 pesticide active ingredients (PAIs) and pesticide inerts. As the renewal of an ongoing information collection activity approved under the PRA, this ICR addresses the paperwork burden associated with the continuation of the activities over the next three years. As such, the paperwork burdens are adjusted to reflect the planned progression associated with the information collection activities covered by the ICR. In addition, EPA has restructured the ICR to incorporate a presentation of the activities and related burden in a way that would match what is used in the ICR submission system.
Burden Statement:The annual public reporting and recordkeeping burden for this collection of information is estimated to range between 204 and 4,919 hours per response. Burden is defined in 5 CFR 1320.3(b).
Respondents/Affected Entities:Entities potentially affected by this ICR are those that receive an EDSP test order issued by the Agency. Under FFDCA section 408(p)(5)(A), EPA “shall issue” EDSP test orders “to a registrant of a substance for which testing is required * * * or to a person who manufactures or imports a substance for which testing is required.”
Frequency of Collection:On occasion.
Estimated No. of Respondents:385.
Estimated Total Annualized Burden:98,414 hours.
Estimated Total Annualized Cost:$6,301,807.
Changes in Burden Estimates:There is a decrease of 63,011 hours in the total estimated annualized burden compared with that currently approved by OMB (i.e., from 161,415 hours to 98,404 hours). This is an adjustment that reflects the planned progression of the collection activities associated with the initial chemicals to be screened under Tier 1 of the EDSP.
Director, Collection Strategies Division.