
[Federal Register Volume 78, Number 121 (Monday, June 24, 2013)]
[Notices]
[Pages 37803-37804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15035]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2013-0171; FRL-9386-3]


Agency Information Collection Activities; Proposed Collection; 
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this 
document announces that EPA is planning to submit an Information 
Collection Request (ICR) to the Office of Management and Budget (OMB). 
The ICR, titled: ``Tier 2 Data Collection for Certain Chemicals Under 
the Endocrine Disruptor Screening Program (EDSP)'' and identified by 
EPA ICR No. 2479.01 and OMB Control No. 2070--New, represents a new 
request related to the next phase of an existing program. Before 
submitting the ICR to OMB for review and approval, EPA is soliciting 
comments on specific aspects of the proposed information collection 
that is summarized in this document. The ICR and accompanying material 
are available in the docket for public review and comment.

DATES: Comments must be received on or before August 23, 2013.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2013-0171, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Teresa Green, Office of Science 
Coordination and Policy (7203M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8440; email address: green.teresa@epa.gov.

SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), 
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses. In particular, EPA is requesting comments from 
very small businesses (those that employ less than 25) on examples of 
specific additional efforts that EPA could make to reduce the paperwork 
burden for very small businesses affected by this collection.
    5. EPA is specifically requesting comments on the duration of the 
time allotted for the Reproduction and Fertility Effects test (OCSPP 
Guideline 870.3800). The Agency is considering a range from 24 to 48 
months, but for the purpose of the ICR calculations, it is assumed that 
all work will be completed within the 3-year duration of the ICR.

II. What Information Collection Activity or ICR does this action apply 
to?

    Title: Tier 2 Data Collection for Certain Chemicals Under the 
Endocrine Disruptor Screening Program (EDSP).
    ICR number: EPA ICR No. 2479.01.
    OMB control number: 2070-New.
    ICR status: This ICR covers new information collection activities

[[Page 37804]]

associated with the next phase of an existing program. 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 Code of Federal Regulations (CFR), after appearing in the 
Federal Register when approved, are listed in 40 CFR part 9, are 
displayed either by publication in the Federal Register or by other 
appropriate means, such as on the related collection instrument or 
form, if applicable. The display of OMB control numbers for certain EPA 
regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR covers the information collection activities 
associated with Tier 2 data collection activities for certain 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 hormone 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 through the Agency's Web site at http://www.epa.gov/endo.
    This ICR addresses the information collection activities for those 
chemicals that were screened under Tier 1 of the EDSP and are now 
proceeding to testing under Tier 2 of the EDSP. The ICR covers the full 
range of information collection activities associated with Tier 2 of 
the EDSP, including the paperwork activities associated with the 
issuance of Tier 2 orders, initial responses from order recipients, 
paperwork activities associated with generating the data requested, and 
submitting the data to EPA pursuant to the order. Under the PRA, the 
ICR is intended to cover a 3-year period.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to range between 
204 and 9,750 hours, depending on the respondent category, with an 
estimated burden cost between $18,842 and $602,488. Burden is defined 
in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related 
materials, provides a detailed explanation of the collection activities 
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Entities potentially affected by the 
collection activities in this ICR are those individuals and companies 
that receive an EDSP Tier 2 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.''
    Estimated total number of potential respondents: 210.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 110,750 hours.
    Estimated total annual costs: $7,375,603. This primarily represents 
estimated burden cost, with related administrative costs of $104. Given 
the nature of the activities, there are no costs estimated for capital 
investment or maintenance and operational costs.

III. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to 
announce the submission of the ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the person listed under FOR 
FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Chemicals, Endocrine disruptors, 
Pesticides and pests, Reporting and recordkeeping.

    Dated: May 14, 2013.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2013-15035 Filed 6-21-13; 8:45 am]
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