This information collection is approved for the 67 chemicals published by EPA at 74 Fed. Reg. 17579 (April 15, 2009).
OMB appreciates the continuing dialog with respect to the practical utility of the Tier I battery of EDSP assays and the role that the results from these first 67 chemicals will play in ensuring practical utility for subsequent groups of chemicals. Nonetheless, under the principles of the PRA, EPA should 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.
For this reason, and to further validate EPAÂs burden estimates, OMB 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 or at the time of submission of revision of this information collection to cover additional chemicals.
In addition, in 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.
Inventory as of this Action
Requested
Previously Approved
10/31/2012
36 Months From Approved
1,287
0
0
161,415
0
0
0
0
0
This new ICR covers the information collection activities associated with Tier 1 screening of 67 chemicals identified 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 endocrine screening of all pesticide chemicals.
US Code:
21 USC 346a(p)
Name of Law: section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
US Code: 21 USC 346a(p) Name of Law: section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
This ICR represents the initial implementation of a statutory mandate that imposes paperwork burdens on chemical companies.
$1,137,236
No
No
Uncollected
Uncollected
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 6300-05-C Data Submitters
2249.01_Amendment-F2_Optional-Qs-2009-09-18.pdf
Data Submitters