[Federal Register: April 15, 2009 (Volume 74, Number 71)]
[Notices]
[Page 17477-17479]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap09-70]
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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.
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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. 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 http://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 http://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 http://
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 http://
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 http://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 http://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 http://
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
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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]
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