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); EPA ICR No. 2249.01, OMB Control No. 2070-New, 17477-17479 [E9-8676]
Download as PDF
Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices
(202) 564–8257; fax number: (202) 564–
8251; e-mail address:
sherlock.scott@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Notice Apply to Me?
This action is directed to the public
in general. This action may, however, be
of interest to you if you are conducting,
or may be required to conduct testing of
chemical substances under TSCA. Since
other entities may also be interested, the
Agency has not attempted to describe all
the specific entities that may be affected
by this action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
rwilkins on PROD1PC63 with PROPOSALS
B. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPPT–2003–0004. All documents in the
docket are listed in the docket’s index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy. Publicly
available docket materials are available
electronically at https://
www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
Federal holidays. The telephone number
of the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket Facility is
(202) 566–0280. Docket visitors are
required to show a photographic
identification, pass through a metal
detector, and sign the EPA visitor log.
All visitor bags are processed through
an X-ray machine and subject to search.
Visitors will be provided an EPA/DC
badge that must be visible at all times
in the building and returned upon
departure.
2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr.
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16:44 Apr 14, 2009
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II. What Action is the Agency Taking?
Under Contract Number (EP–W–08–
034), contractor (CSC) of 15000
Conference Center Drive, Chantilly, VA;
Insight Global of 1420 Spring Hill Road,
Suite 130, McLean, VA; and KForce,
Incorporated of 12010 Sunset Hill Road,
Suite 200, Reston, VA will assist the
Office of Pollution Prevention and
Toxics (OPPT) in providing services and
support to meet the needs of
management, research, programmatic,
and administrative staff (users) located
at Headquarters office in Washington,
D.C. metropolitan area and other
locations. Service will also be provided
to employees at alternate work
locations. The contractor will also assist
in acquisition, configuration,
installation, management, support,
redeployment/refresh/replacement, and
coordination of disposal of personal
computers (PCs), USB Notes drives, and
networked printers for each supported
end user. Furthermore, they will assist
in coordinating the acquisition of,
configuring, installing, managing,
supporting, and coordinating disposal of
peripherals, personal digital assistants
(PDAs), AAA tokens, software and
Blackberrys. Finally, they will be
supporting tasks associated with
provisioning and maintaining hardware
and software that is to be provisioned
on a per seat basis (ITS-UP seat),
specifically computers with operating
systems and networked printing
services, installation, configuration,
upgrading; coordination with other
service providers; and ensuring proper
operations.
In accordance with 40 CFR 2.306(j),
EPA has determined that under Contract
Number (EP–W–08–034), CSC and its
subcontractors will require access to CBI
submitted to EPA under all sections of
TSCA to perform successfully the duties
specified under the contract. CSC and
its subcontractors’ personnel will be
given access to information submitted to
EPA under all sections of TSCA. Some
of the information may be claimed or
determined to be CBI.
EPA is issuing this notice to inform
all submitters of information under all
sections of TSCA that EPA may provide
CSC and subcontractors access to these
CBI materials on a need-to-know basis
only. All access to TSCA CBI under this
contract will take place at EPA
Headquarters; Regional EPA Offices;
Field Offices; and EPA at Research
Triangle Park, NC.
CSC and its subcontractors will be
authorized access to TSCA CBI at EPA
Headquarters; Regional EPA Offices;
Field Offices; and EPA at Research
Triangle Park, NC, provided they
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17477
comply with the provisions of the EPA
TSCA CBI Protection Manual.
Access to TSCA data, including CBI,
will continue until May 1, 2012. If the
contract is extended, this access will
also continue for the duration of the
extended contract without further
notice.
CSC and its subcontractors’ personnel
will be required to sign nondisclosure
agreements and will be briefed on
appropriate security procedures before
they are permitted access to TSCA CBI.
List of Subjects
Environmental protection,
Confidential business information.
Dated: March 18, 2009.
Matthew Leopard,
Acting Director, Information Management
Division, Office of Pollution Prevention and
Toxics.
[FR Doc. E9–8341 Filed 4–14–09; 8:45 a.m.]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2007–1081; FRL–8412–2]
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);
EPA ICR No. 2249.01, OMB Control No.
2070–New
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
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. This request
involves a new collection activity. The
ICR, which is abstracted in this
document, describes the nature of the
information collection activity and its
expected burden and costs.
DATES: Additional comments may be
submitted on or before May 15, 2009.
ADDRESSES: Submit your comments,
referencing docket ID Number EPA–
HQ–OPPT–2007–1081: (1) to EPA
online using https://www.regulations.gov
(our preferred method) or by mail to:
Document Control Office (DCO), Office
of Pollution Prevention and Toxics
(OPPT), Environmental Protection
Agency, Mail Code: 7407T, 1200
Pennsylvania Ave., NW., Washington,
DC 20460, and (2) to OMB at: Office of
E:\FR\FM\15APN1.SGM
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17478
Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices
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, Office of Science
Coordination and Policy (OSCP),
Mailcode 7201M, 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.
EPA has
submitted the following ICR to OMB for
review and approval according to the
procedures prescribed in 5 CFR 1320.12.
On December 13, 2007 (72 FR 70839),
EPA sought comments on the draft ICR
pursuant to 5 CFR 1320.8(d), and
received several comments during the
comment period. EPA has responded to
the comments on the ICR by
incorporating changes into the ICR and
has also prepared a separate response to
comment document that is available in
the docket for this ICR. Any additional
comments related to this ICR should be
submitted to EPA and OMB within 30
days of this notice.
Docket Information: EPA has
established a public docket for this ICR
under Docket ID No. EPA–HQ–OPPT–
2007–1081, which is available for online
viewing at https://www.regulations.gov,
or in person at the OPPT Docket in the
EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA
Docket Center 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 EPA’s electronic docket and
comment system at https://
www.regulations.gov to submit or view
public comments, access the index
listing the contents of the docket, and to
access those documents in the docket
that are available electronically. Please
note that EPA’s policy is that public
comments, whether submitted
electronically or in paper, will be made
available for public viewing in https://
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 electronic
docket, go to https://
www.regulations.gov.
rwilkins on PROD1PC63 with PROPOSALS
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
16:44 Apr 14, 2009
Jkt 217001
Title: Tier 1 Screening of Certain
Chemicals under the Endocrine
Disruptor Screening Program (EDSP).
ICR Numbers: EPA ICR No. 2249.01,
OMB Control No. 2070-new.
ICR Status: This ICR is for a new
information collection activity that is
not contained in a regulation. Under the
PRA, 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
number for this ICR will appear in the
Federal Register when approved, and
will be displayed on the related
collection instruments, i.e., the Tier 1
Order and Initial Response Forms.
Abstract: This ICR covers the
information collection activities
associated with Tier 1 screening of the
first group of chemicals 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. The Agency
established the EDSP in 1998 (63 FR
71541, December 28, 1998) to consist of
a two-tiered approach for evaluating all
pesticide chemicals for potential
endocrine disrupting effects. The
purpose of Tier 1 screening (referred to
as ‘‘screening’’) is to identify substances
that have the potential to interact with
the estrogen, androgen, or thyroid
hormone systems using a battery of
assays. The purpose of Tier 2 testing
(referred to as ‘‘testing’’), is to identify
and establish a dose-response
relationship for any adverse effects that
might result from the interactions
identified through the Tier 1 assays.
Additional information about the EDSP
is available through the Agency’s Web
site at https://www.epa.gov/scipoly/
oscpendo/index.htm.
The focus of this ICR is on the
information collection activities
associated with the Tier 1 screening of
the first group of chemicals identified
for initial screening under the EDSP.
After an opportunity for public
comment on a draft list, the Agency has
identified a final list of chemicals to be
the first to undergo Tier 1 screening.
(This list appears in a separate notice
published in today’s Federal Register.)
This list should not be construed as a
list of known or likely endocrine
disruptors. Nothing in the approach for
generating the initial list provides a
basis to infer that by simply being on
this list these chemicals are suspected to
interfere with the endocrine systems of
humans or other species, and it would
be inappropriate to do so. The first
group of chemicals identified for testing
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Fmt 4703
Sfmt 4703
includes pesticide active ingredients
and High Production Volume (HPV)
chemicals used as pesticide inerts. More
information on the EPA’s priority
setting approach and the list of
chemicals is available at https://
www.epa.gov/scipoly/oscpendo/
prioritysetting.
This ICR does not cover the
information collection activities related
to Tier 2 testing because that testing is
not expected to occur until the Tier 2
tests complete validation as required by
FFDCA. EPA will prepare a separate ICR
to address the information collection
activities associated with Tier 2 testing.
In addition, subsequent Tier 1 screening
of additional chemicals not selected for
the initial round will be addressed
separately, either in a separate ICR or in
an amendment to this ICR. In either
case, EPA will follow the notice and
comment process prescribed by the
Paperwork Reduction Act (PRA) to first
seek public comment on the new or
revised ICR before submitting it to OMB
for review and approval under the PRA.
Burden Statement: The annualized
public reporting and recordkeeping
burden for this collection of information
is estimated to average 1003 hours per
response, although individual
respondent burden varies based on their
individual activities. Burden means the
total time, effort, or financial resources
expended by persons to generate,
maintain, retain, or disclose or provide
information to or for a Federal Agency.
This includes the time needed to review
instructions; develop, acquire, install,
and utilize technology and systems for
the purposes of collecting, validating,
and verifying information, processing
and maintaining information, and
disclosing and providing information;
adjust the existing ways to comply with
any previously applicable instructions
and requirements which have
subsequently changed; train personnel
to be able to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
The ICR, a copy of which is available
in the docket, provides a detailed
explanation of this estimate, which is
only briefly summarized here:
Respondents/Affected Entities:
Entities potentially affected by this ICR
are those entities that may 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.’’
Using the North American Industrial
E:\FR\FM\15APN1.SGM
15APN1
Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices
Classification System (NAICS) codes,
the Agency has determined that
potential respondents to this ICR may
include, but is not limited to:
• Chemical manufacturing (NAICS
code 325), e.g., persons who
manufacture, import or process
chemical substances.
• Agricultural chemical
manufacturing (NAICS code 3253), e.g.,
persons who manufacture, import or
process pesticide, fertilizer and
agricultural chemicals.
• Scientific research and
development services (NAICS code
5417), e.g., persons who conduct testing
of chemical substances for endocrine
effects.
Estimated Total Number of Potential
Respondents: 390.
Frequency of Response: On occasion.
Estimated Total Average Number of
Responses for Each Respondent: Two or
three responses per chemical: An initial
response, an interim study report, if
applicable, and the final data
submission. All respondents will
provide an initial response. Some
respondents may form a consortium to
provide the data, in which case the
consortium will also provide an initial
response. Only those respondents that
generate the data, either individually or
through the consortium, will complete
an interim study report and the final
data submission.
Estimated Total Annual Burden
Hours: 108,364 hours.
Estimated Total Annual Costs:
$7,478,116. This includes an estimated
annualized cost of $236 for non-burden
hour or delivery costs.
Changes in Burden Estimates: This is
a new collection.
List of Subjects
Environmental protection, Reporting
and recordkeeping requirements.
Dated: April 8, 2009.
Robert Gunter,
Acting Director, Collection Strategies
Division.
[FR Doc. E9–8676 Filed 4–14–09; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
rwilkins on PROD1PC63 with PROPOSALS
[FRL–8791–9]
Agency Information Collection
Activities OMB Responses
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: This document announces the
Office of Management and Budget’s
VerDate Nov<24>2008
16:44 Apr 14, 2009
Jkt 217001
(OMB) responses to Agency Clearance
requests, in compliance with the
Paperwork Reduction Act (44 U.S.C.
3501 et seq.). 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 are listed in 40 CFR part 9
and 48 CFR chapter 15.
FOR FURTHER INFORMATION CONTACT: Rick
Westlund (202) 566–1682, or e-mail at
westlund.rick@epa.gov and please refer
to the appropriate EPA Information
Collection Request (ICR) Number.
SUPPLEMENTARY INFORMATION:
OMB Responses to Agency Clearance
Requests
OMB Approvals
EPA ICR Number 2263.02; NSPS for
Petroleum Refineries for which
Construction, Reconstruction, or
Modification Commenced after May 14,
2007 (Final Rule); in 40 CFR part 60,
subpart Ja; was approved 03/11/2009;
OMB Number 2060–0602; expires 12/
31/2011.
EPA ICR Number 2303.02; NESHAP
for Ferroalloys Production Area Source
Facilities (Final Rule); in 40 CFR part
63, subpart YYYYYY; was approved 03/
23/2009; OMB Number 2060–0625;
expires 03/31/2012.
EPA ICR Number 1983.05; NESHAP
for Carbon Black, Ethylene, Cyanide,
and Spandex (Renewal); in 40 CFR part
63, subpart YY; was approved 03/23/
2009; OMB Number 2060–0489; expires
03/31/2012.
EPA ICR Number 0229.19; National
Pollutant Discharge Elimination System
(NPDES) Program (Renewal); in 40 CFR
122.21, 122.26, 122.41, 122.42, 122.44,
122.45, 122.47, 122.48, 122.62, 122.63,
123.21–123.29, 123.35, 123.43–123.45,
123.62–123.64, 124.5, 124.53, 123.54,
131.1, 131.5, 131.21, part 132, 403.17,
403.18, part 423, part 430, part 434, part
435, part 439, 465.03, 466.03, 467.03
and part 501; was approved 03/30/2009;
OMB Number 2040–0004; expires 03/
31/2012.
EPA ICR Number 0270.43; Public
Water System Supervision Program
(Renewal); in 40 CFR parts 141 and 142;
was approved 03/30/2009; OMB
Number 2040–0090; expires 03/31/2012.
Short Term Extension of Expiration
Date
EPA ICR Number 1911.02; Data
Acquisition for Anticipated Residue and
Percent of Crop Treated; a short term
extension of the expiration date was
granted by OMB on 03/23/2009; OMB
Number 2070–0164; expires 06/30/2009.
PO 00000
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Fmt 4703
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17479
EPA ICR Number 1504.05; Data
Generation for Pesticide Reregistration;
a short term extension of the expiration
date was granted by OMB on 03/23/
2009; OMB Number 2070–0107; expires
06/30/2009.
EPA ICR Number 0922.07; Data Callins for the Special Review and
Registration Review Programs; a short
term extension of the expiration date
was granted by OMB on 03/23/2009;
OMB Number 2070–0057; expires 06/
30/2009.
EPA ICR Number 2097.05; The
National Primary Drinking Water
Regulations; Long Term 2 Enhanced
Surface Water Treatment Rule; a short
term extension of the expiration date
was granted by OMB on 03/31/2009;
OMB Number 2040–0266; expires 06/
30/2009.
EPA ICR Number 1426.09; EPA
Worker Protection Standards for
Hazardous Waste Operations and
Emergency Response; a short term
extension of the expiration date was
granted by OMB on 03/30/2009; OMB
Number 2050–0105; expires 06/30/2009.
OMB Comments Filed
EPA ICR Number 2336.01; Turbidity
Monitoring Requirements for
Construction Sites Regulated by the
Effluent Limitations Guidelines and
Standards for the Construction and
Development Point Source Category
(Proposed Rule); on 03/27/2009, OMB
filed comment.
Dated: April 9, 2009.
Robert Gunter,
Acting Director, Collection Strategies
Division.
[FR Doc. E9–8669 Filed 4–14–09; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–0639; FRL–8352–8]
Final Test Guidelines; Notice of
Availability of Several Revised Test
Guidelines
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: With this notice, EPA is
announcing the availability of several
revised or updated test guidelines for
the unified library of harmonized test
guidelines issued by the Office of
Prevention, Pesticides and Toxic
Substances (OPPTS). The OPPTS
Harmonized Test Guidelines are for use
in the testing of chemical substances or
pesticides where appropriate to develop
E:\FR\FM\15APN1.SGM
15APN1
Agencies
[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17477-17479]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8676]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2007-1081; FRL-8412-2]
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); EPA
ICR No. 2249.01, OMB Control No. 2070-New
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
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. This request involves a new collection
activity. The ICR, which is abstracted in this document, describes the
nature of the information collection activity and its expected burden
and costs.
DATES: Additional comments may be submitted on or before May 15, 2009.
ADDRESSES: Submit your comments, referencing docket ID Number EPA-HQ-
OPPT-2007-1081: (1) to EPA online using https://www.regulations.gov (our
preferred method) or by mail to: Document Control Office (DCO), Office
of Pollution Prevention and Toxics (OPPT), Environmental Protection
Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., NW., Washington, DC
20460, and (2) to OMB at: Office of
[[Page 17478]]
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, Office of Science
Coordination and Policy (OSCP), Mailcode 7201M, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 564-8476; fax number: (202) 564-8482; e-
mail 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 December 13, 2007 (72 FR 70839), EPA sought comments on the
draft ICR pursuant to 5 CFR 1320.8(d), and received several comments
during the comment period. EPA has responded to the comments on the ICR
by incorporating changes into the ICR and has also prepared a separate
response to comment document that is available in the docket for this
ICR. Any additional comments related to this ICR should be submitted to
EPA and OMB within 30 days of this notice.
Docket Information: EPA has established a public docket for this
ICR under Docket ID No. EPA-HQ-OPPT-2007-1081, which is available for
online viewing at https://www.regulations.gov, or in person at the OPPT
Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center 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 EPA's electronic docket and comment system at https://www.regulations.gov to submit or view public comments, access the index
listing the contents of the docket, and to access those documents in
the docket that are available electronically. Please note that EPA's
policy is that public comments, whether submitted electronically or in
paper, will be made available for public viewing in https://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 electronic
docket, go to https://www.regulations.gov.
Title: Tier 1 Screening of Certain Chemicals under the Endocrine
Disruptor Screening Program (EDSP).
ICR Numbers: EPA ICR No. 2249.01, OMB Control No. 2070-new.
ICR Status: This ICR is for a new information collection activity
that is not contained in a regulation. Under the PRA, 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 number for this ICR will appear in the
Federal Register when approved, and will be displayed on the related
collection instruments, i.e., the Tier 1 Order and Initial Response
Forms.
Abstract: This ICR covers the information collection activities
associated with Tier 1 screening of the first group of chemicals 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. The Agency established the EDSP in 1998 (63 FR
71541, December 28, 1998) to consist of a two-tiered approach for
evaluating all pesticide chemicals for potential endocrine disrupting
effects. The purpose of Tier 1 screening (referred to as ``screening'')
is to identify substances that have the potential to interact with the
estrogen, androgen, or thyroid hormone systems using a battery of
assays. The purpose of Tier 2 testing (referred to as ``testing''), is
to identify and establish a dose-response relationship for any adverse
effects that might result from the interactions identified through the
Tier 1 assays. Additional information about the EDSP is available
through the Agency's Web site at https://www.epa.gov/scipoly/oscpendo/index.htm.
The focus of this ICR is on the information collection activities
associated with the Tier 1 screening of the first group of chemicals
identified for initial screening under the EDSP. After an opportunity
for public comment on a draft list, the Agency has identified a final
list of chemicals to be the first to undergo Tier 1 screening. (This
list appears in a separate notice published in today's Federal
Register.) This list should not be construed as a list of known or
likely endocrine disruptors. Nothing in the approach for generating the
initial list provides a basis to infer that by simply being on this
list these chemicals are suspected to interfere with the endocrine
systems of humans or other species, and it would be inappropriate to do
so. The first group of chemicals identified for testing includes
pesticide active ingredients and High Production Volume (HPV) chemicals
used as pesticide inerts. More information on the EPA's priority
setting approach and the list of chemicals is available at https://www.epa.gov/scipoly/oscpendo/prioritysetting.
This ICR does not cover the information collection activities
related to Tier 2 testing because that testing is not expected to occur
until the Tier 2 tests complete validation as required by FFDCA. EPA
will prepare a separate ICR to address the information collection
activities associated with Tier 2 testing. In addition, subsequent Tier
1 screening of additional chemicals not selected for the initial round
will be addressed separately, either in a separate ICR or in an
amendment to this ICR. In either case, EPA will follow the notice and
comment process prescribed by the Paperwork Reduction Act (PRA) to
first seek public comment on the new or revised ICR before submitting
it to OMB for review and approval under the PRA.
Burden Statement: The annualized public reporting and recordkeeping
burden for this collection of information is estimated to average 1003
hours per response, although individual respondent burden varies based
on their individual activities. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal Agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
The ICR, a copy of which is available in the docket, provides a
detailed explanation of this estimate, which is only briefly summarized
here:
Respondents/Affected Entities: Entities potentially affected by
this ICR are those entities that may 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.'' Using the North American Industrial
[[Page 17479]]
Classification System (NAICS) codes, the Agency has determined that
potential respondents to this ICR may include, but is not limited to:
Chemical manufacturing (NAICS code 325), e.g., persons who
manufacture, import or process chemical substances.
Agricultural chemical manufacturing (NAICS code 3253),
e.g., persons who manufacture, import or process pesticide, fertilizer
and agricultural chemicals.
Scientific research and development services (NAICS code
5417), e.g., persons who conduct testing of chemical substances for
endocrine effects.
Estimated Total Number of Potential Respondents: 390.
Frequency of Response: On occasion.
Estimated Total Average Number of Responses for Each Respondent:
Two or three responses per chemical: An initial response, an interim
study report, if applicable, and the final data submission. All
respondents will provide an initial response. Some respondents may form
a consortium to provide the data, in which case the consortium will
also provide an initial response. Only those respondents that generate
the data, either individually or through the consortium, will complete
an interim study report and the final data submission.
Estimated Total Annual Burden Hours: 108,364 hours.
Estimated Total Annual Costs: $7,478,116. This includes an
estimated annualized cost of $236 for non-burden hour or delivery
costs.
Changes in Burden Estimates: This is a new collection.
List of Subjects
Environmental protection, Reporting and recordkeeping requirements.
Dated: April 8, 2009.
Robert Gunter,
Acting Director, Collection Strategies Division.
[FR Doc. E9-8676 Filed 4-14-09; 8:45 am]
BILLING CODE 6560-50-P