Document ID: EPA-HQ-OPPT-2007-1081-0016
Agency: epa
Document Type: Notice
Title: 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
Posted Date: 2009-04-15T04:00Z

[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

[[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]

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