[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Pages 47640-47641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19569]



[EPA-HQ-OPPT-2011-0966; FRL-9359-3]

Agency Information Collection Activities; Proposed Collection; 
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this 
document announces that EPA is planning to submit a request to renew an 
existing approved Information Collection Request (ICR) to the Office of 
Management and Budget (OMB). This ICR, entitled: ``Tier 1 Screening of 
Certain Chemicals Under the Endocrine Disruptor Screening Program 
(EDSP)'' and identified by EPA ICR No. 2249.03 and OMB Control No. 
2070-0176. Before submitting the ICR to OMB for review and approval, 
EPA is soliciting comments on specific aspects of the information 

DATES: Comments must be received on or before October 9, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2011-0966, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     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: OPPT Document Control Office (DCO), EPA 
East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention: 
Docket ID Number EPA-HQ-OPPT-2011-0966. The DCO is open from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the DCO is (202) 564-8930. Such deliveries are only accepted 
during the DCO's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0966. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or 
email. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an email 
comment directly to EPA without going through regulations.gov, your 
email address will be automatically captured and included as part of 
the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://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 http://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 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show 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.

FOR FURTHER INFORMATION CONTACT: William Wooge, Office of Science 
Coordination and Policy (OSCP) (7203M), 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.


I. What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of PRA (44 U.S.C. 3501 et seq.), 
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.

II. What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your 

[[Page 47641]]

    1. Explain your views as clearly as possible and provide specific 
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified 
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

III. What information collection activity or ICR does this action apply 

    Affected entities: Entities potentially affected by this ICR are 
those individuals and companies that receive an EDSP test order issued 
by the Agency. Under section 408(p)(5)(A) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA) (21 U.S.C. 346a(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 
Classification System (NAICS) codes, the Agency has determined that 
potential respondents to the information collection covered in this ICR 
may include, but is not limited to: Chemical manufacturers and 
processors (NAICS code 325); pesticide, fertilizer, and other 
agricultural chemical manufacturing (NAICS code 3253); producers & 
formulators of pesticide products (NAICS code 32532); producers of 
antifouling paints (NAICS code 32551); producers of antimicrobial 
pesticides (NAICS code 32561); producers of nitrogen stabilizers (NAICS 
code 32531); and producers of wood preservatives (NAICS code 32519).
    Title: Tier 1 Screening of Certain Chemicals Under the Endocrine 
Disruptor Screening Program (EDSP).
    ICR number: EPA ICR No. 2249.03.
    OMB control number: OMB Control No. 2070-0176.
    ICR status: The existing ICR approval is currently scheduled to 
expire on October 31, 2012. An agency may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
covered by the PRA, 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 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 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 FFDCA section 
408(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 through the Agency's Web site at http://www.epa.gov/endo.
    This ICR addresses the information collection activities for the 
first 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 first 
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 
these 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.
    As such, the renewal ICR does not include the proposed addendum 
that was issued for public comment in the Federal Register of November 
17, 2010 (75 FR 70568) (FRL 8849-3).
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to range between 
204 and 4,833 hours, depending on the respondent category, with an 
estimated cost between $17,076 and $278,966. Burden is defined in 5 CFR 
1320.3(b). The ICR provides a detailed explanation of this estimate, 
which is only briefly summarized here:
    Estimated total number of potential respondents: 264.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 106,416 hours.
    Estimated total annual costs: $6,152,254.

IV. Are there changes in the estimates from the last approval?

    There is a decrease of 54,999 hours in the total estimated 
respondent burden compared with that identified in the ICR currently 
approved by OMB. This decrease reflects EPA's adjustment in burden 
estimates due to the planned progression of the collection activities 
associated with the first list of chemicals to be screened under the 
EDSP. This change is an adjustment.

V. 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 notice 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. If you have any questions about this ICR or the 
approval process, please contact the person listed under FOR FURTHER 

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: July 31, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
[FR Doc. 2012-19569 Filed 8-8-12; 8:45 am]