In accordance with 5 CFR 1320, this information collection has been approved for an additional 3 years for the 67 chemicals published by EPA at 74 Fed. Reg. 17579 (April 15, 2009). OMB supports the EPAâs efforts 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, when they are determined sufficient to satisfy the test orders. OMB still requests that EPA provide a report re-estimating the burden of this information collection based on responses to the Tier I test orders, including the use of cost-sharing and data compensation, the submission and acceptance of existing data and OSRI, and description of any instances in which submission of OSRI was deemed insufficient to satisfy the testing order. OMB requests this report prior to the issuance of the test orders for additional chemicals in Tier I. OMB acknowledges the EPAâs outreach to the public and peer reviewers and encourages continuous efforts for stakeholder involvement while developing the protocols on whether a chemical must proceed to Tier II, including the Weight of the Evidence Approach and Standard Evaluation Procedures.
Inventory as of this Action
Requested
Previously Approved
07/31/2016
36 Months From Approved
07/31/2013
385
0
1,287
98,403
0
161,415
190
0
0
This renewal ICR covers the information collection activities associated with Tier 1 screening of 67 chemicals identified on List 1 under the Endocrine Disruptor Screening Program (EDSP). The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires the 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. 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 the 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 these activities over the next three (3) years. As such, the paperwork burdens are adjusted to reflect the planned progression associated with the information collection activities covered by the ICR, which are unchanged from the approved ICR. Please note, however, that the structure of the ICR has been changed to incorporate a more logical IC break-out that would match that used in the ICR submission system.
US Code:
21 USC 346a(p)
Name of Law: section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
This request represents a decrease of the annualized burden by 63,012 hours from that currently in the OMB inventory (from 161,415 hours to 98,403 hours). This change is an adjustment in burden estimates due to the planned progression of the collection activities associated with the initial list of chemicals to be screened under the EDSP. This change is an adjustment.
$889,148
No
No
No
No
No
Uncollected
Angela Hofmann
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form EPA Form No. 6300- Order Recipients - Manufacturers and Importers of Pesticide Inert Ingredients
2249.03_Attachment_I.pdf
2249.03_ss_2012-10-25.docx
Consortium Participants - Manufacturers and Importers of Pesticide Inert Ingredients