[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Pages 70568-70570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28815]



[EPA-HQ-OPPT-2007-1081; FRL-8849-3]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Addendum for the Second List of Chemicals; Tier 1 
Screening of Certain Chemicals Under the Endocrine Disruptor Screening 
Program (EDSP); EPA ICR No. 2249.02, OMB Control No. 2070-0176

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), this document announces that EPA is planning to 
submit a request an addendum to an existing approved Information 
Collection Request (ICR) to the Office of Management and Budget (OMB). 
This addendum simply covers the burden for a new list of chemicals to 
receive and respond to EDSP Orders. The activities articulated in the 
original ICR are not changing. This ICR addendum, entitled ``Addendum 
for the Second List of Chemicals; Tier 1 Screening of Certain Chemicals 
Under the Endocrine Disruptor Screening Program (EDSP)'' and identified 
by EPA ICR No. 2249.02 and OMB Control No. 2070-0106. Before submitting 
the ICR to OMB for review and approval, EPA is soliciting comments on 
specific aspects of the proposed information collection.

DATES: Comments must be received on or before January 18, 2011.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2007-1081, 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-2007-1081. 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-
2007-1081. 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 e-
mail. 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 e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail 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, (7201M), Office of 
Science Coordination and Policy (OSCP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 
telephone number: (202) 564-8476; fax number: (202) 564-8482; e-mail 
address: [email protected].


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

A. Considerations Under the Paperwork Reduction Act (PRA)

    Pursuant to section 3506(c)(2)(A) of PRA, 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

[[Page 70569]]

burden for very small businesses affected by this collection.

B. Tips for Preparing Your Comments

    You may find the following suggestions helpful for preparing your 
    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.

C. Submitting CBI

    Do not submit CBI to EPA through regulations.gov or e-mail. Clearly 
mark the part or all of the information that you claim to be CBI. For 
CBI information in a disk or CD-ROM that you mail to EPA, mark the 
outside of the disk or CD-ROM as CBI and then identify electronically 
within the disk or CD-ROM the specific information that is claimed as 
CBI. In addition to one complete version of the comment that includes 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public docket. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.

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 FFDCA Sec.  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 
Classification System (NAICS) codes, the Agency has determined that 
potential respondents to this ICR may include, but is not limited to: 
Chemical Manufacturers and Processors (NAICS code 325), and 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: Addendum for the Second List of Chemicals; Tier 1 Screening 
of Certain Chemicals Under the Endocrine Disruptor Screening Program 
    ICR numbers: EPA ICR No. 2249.02, OMB Control No. 2070-0176.
    ICR status: This is an ICR addendum to an approved information 
collection activity. 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 be displayed by publication in the Federal Register 
and by inclusion of a Paperwork Reduction Notice on the related 
collection instrument, i.e., test orders, forms, etc.
    Abstract: This ICR addendum covers the information collection 
activities associated with Tier 1 screening of the second group of 
chemicals under the 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 and was established in 
response to growing scientific evidence that humans, domestic animals, 
and fish and wildlife species have exhibited adverse health 
consequences from exposure to environmental chemicals that interact 
with their endocrine systems.
    The EDSP, which was established in 1998, consists of a two-tiered 
approach to screen 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''), therefore, 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.
    EPA is submitting a request for an addendum to an approved ICR, EPA 
ICR No. 2249.01 and OMB Control No. 2070-0176 to OMB. This addendum 
simply covers the burden for a new list of chemicals to receive and 
respond to EDSP Orders. The activities articulated in the original ICR 
are not changing.
    Burden Statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 
1002.7 hours per response. 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 provides a detailed explanation of this estimate, which is 
only briefly summarized here:
    Estimated total number of potential respondents: 1,840.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 
Two or three responses per chemical: An initial response, a consortium 
response, and the final data submission. All respondents will provide 
an initial response, and some respondents may provide a second response 
if they lead a consortium only those that generates the data will 
complete the final data submission.
    Estimated total annual burden hours: 232,600 hours.
    Estimated total annual costs: $17,056,342.82.

IV. 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 to OMB. If you have any questions about this ICR or 
the approval process, please contact the technical person listed under 

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List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: September 28, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
[FR Doc. 2010-28815 Filed 11-16-10; 8:45 am]