[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Pages 65682-65683]
From the Federal Register Online via the Government Publishing 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: [email protected].
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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