Document ID: EPA-HQ-OPPT-2011-0966-0016
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program
Posted Date: 2012-10-30T04:00Z

[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Pages 65682-65683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26611]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2011-0966; FRL-9523-7]

Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Comment Request; Tier 1 Screening of Certain 
Chemicals Under the Endocrine Disruptor Screening Program (EDSP) 
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.), this document announces that an Information Collection 
Request (ICR) has been forwarded to the Office of Management and Budget 
(OMB) for review and approval. The ICR, which is abstracted below, 
describes the nature of the information collection activity and its 
expected burden and costs.

DATES: Additional comments may be submitted on or before November 29, 
2012.

ADDRESSES: Submit your comments, referencing Docket identification (ID) 
number (No.) EPA-HQ-OPPT-2011-0966, to (1) EPA online using 
www.regulations.gov (our preferred method) or by mail to: Pollution 
Prevention and Toxics Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460, and (2) OMB by mail to: Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB), Attention: 
Desk Officer for EPA, 725 17th Street NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: William Wooge, (7203M), Office of 
Science Coordination and Policy (OSCP), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 
telephone number: (202) 564-8476; fax number: (202) 564-8482; email 
address: wooge.william@epa.gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB 
for review and approval according to the procedures prescribed in 5 CFR 
1320.12. On August 9, 2012 (77 FR 47640), EPA sought comments on this 
renewal pursuant to 5 CFR 1320.8(d), and the ICR submitted to OMB 
includes EPA's responses to the four comments that were received. Any 
additional comments on the revised ICR should be submitted to EPA and 
OMB within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID 
No. EPA EPA-HQ-OPPT-2011-0966, which is available online at http://www.regulations.gov, or in person at the OPPT Docket in the EPA/DC, EPA 
West Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA/DC 
Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Reading 
Room is 202-566-1744, and the telephone number for the OPPT Docket is 
202-566-0280. Use www.regulations.gov to submit or view public 
comments, access the index listing of the contents of the public 
docket, and to access those documents in the public docket that are 
available electronically. Once in the system, select ``search,'' then 
key in the docket ID number identified for this ICR. Please note that 
EPA's policy is that public comments, whether submitted electronically 
or in paper, will be made available for public viewing in 
www.regulations.gov as EPA receives them and without change, unless the 
comment contains copyrighted material, confidential business 
information (CBI), or other information whose public disclosure is 
restricted by statute. For further information about the docket, go to 
www.regulations.gov.
    Title: Tier 1 Screening of Certain Chemicals Under the Endocrine 
Disruptor Screening Program (EDSP) (Renewal).

[[Page 65683]]

    ICR Numbers: EPA ICR No. 2249.03, OMB Control No. 2070-0176.
    ICR Status: This is a request to renew an existing approved 
collection. This ICR is scheduled to expire on October 31, 2012. Under 
OMB regulations, the Agency may continue to conduct or sponsor the 
collection of information while this submission is pending at OMB. An 
agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. The OMB control numbers for EPA's regulations 
in title 40 of the CFR, after appearing in the Federal Register, are 
listed in 40 CFR part 9 and included on the related collection 
instrument or form, if applicable.
    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 at http://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.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012-26611 Filed 10-29-12; 8:45 am]
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