[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12297-12299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4846]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0061; FRL-9337-7]


Petition To Demonstrate Paperwork Reduction Act Compliance of the 
Endocrine Disruptor Screening Program; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is seeking public comment on a December 7, 2011 petition 
from the Chemical Producers & Distributors Association (CPDA), the 
Halogenated Solvents Industry Alliance, Inc., and the People for the 
Ethical Treatment of Animals (PETA). The petition requested that the 
Agency abide by the Paperwork Reduction Act and Office of Management 
and Budget Terms of Clearance for the approved Information Collection 
Request (ICR) of the first list of 67 chemicals to receive orders under 
the Endocrine Disruptor Screening Program by demonstrating the 
information being sought has practical utility and is not duplicative 
before proceeding with Tier 1 screening orders for additional 
chemicals.

DATES: Comments must be received on or before May 29, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2012-0061, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental

[[Page 12298]]

Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. 
Crystal Dr. Arlington, VA. Deliveries are only accepted during the 
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays). Special arrangements 
should be made for deliveries of boxed information. The Docket Facility 
telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2012-0061. EPA's policy is that all comments received will be included 
in the docket without change and may be made available online 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, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr. Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Jane Smith, Pesticide Re-Evaluation 
Division, Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 
telephone number: (703) 308-0048; fax number: (703) 308-8005; email 
address: <a href="/cdn-cgi/l/email-protection#3a4957534e5214505b545f174959554e4e7a5f4a5b145d554c"><span class="__cf_email__" data-cfemail="780b15110c10561219161d550b1b170c0c381d0819561f170e">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of 
interest to a wide range of stakeholders, including environmental, 
human health, and agricultural advocates; the chemical industry; 
pesticide users; and members of the public interested in the sale, 
distribution, or use of pesticides and other chemical substances; or if 
you are or may otherwise be involved in the testing of chemical 
substances for potential endocrine effects. Potentially affected 
entities identified by the North American Industrial Classification 
System (NAICS) codes, may include, but are not limited to:
    <bullet> Chemical manufacturers, importers and processors (NAICS 
code 325), e.g., persons who manufacture, import or process chemical 
substances.
    <bullet> Pesticide, fertilizer, and other agricultural chemical 
manufacturing (NAICS code 3253), e.g., persons who manufacture, import 
or process pesticide, fertilizer and agricultural chemicals.
    <bullet> Scientific research and development services (NAICS code 
5417), e.g., persons who conduct testing of chemical substances for 
endocrine effects.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine section 408(p) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA). If you have any questions regarding the 
applicability of this action to a particular entity, consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. 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.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What action is the agency taking?

    In October 2009, the Agency initiated the Endocrine Disruptor 
Screening Program (EDSP) Tier 1 screening for the first list of 67 
chemicals by issuing orders between October 29, 2009, and February 26, 
2010, pursuant to the authority provided to EPA under section 408(p)(5) 
of FFDCA. The orders require the testing of chemicals through 11 Tier 1 
screening assays. The purpose of the 11 Tier 1 screening assays is to 
determine the potential for a chemical

[[Page 12299]]

to interact with estrogen, androgen and thyroid hormone systems. Based 
on the data from the 11 Tier 1 assays, should the determination be made 
that the chemical is shown to interact, additional Tier 2 testing may 
be required.
    EPA is seeking public comment on a December 6, 2011 petition from 
the Chemical Producers & Distributors Association (CPDA), the 
Halogenated Solvents Industry Alliance, Inc., and the People for the 
Ethical Treatment of Animals (PETA). The petition requested that the 
Agency abide by the Paperwork Reduction Act and Office of Management 
and Budget Terms of Clearance for the approved Information Collection 
Request (ICR) of the first list of 67 chemicals to receive orders under 
the Endocrine Disruptor Screening Program by demonstrating that the 
information collected: (1) Has practical utility in that it can 
distinguish whether a chemical has the potential to interact with the 
endocrine system or not; (2) has practical utility before proceeding 
with more Tier 1 screening orders for additional chemicals; and (3) is 
not duplicative of other information collection activities by the 
Agency but also is not duplicative of existing information.

B. What is the agency's authority for taking this action?

    This action is taken under the authority of FFDCA section 408(p), 
21 U.S.C. 346a(d)(3).

List of Subjects

    Environmental protection, EDSP, Endocrine Disruptors Screening 
Program, FFDCA orders, List 1 chemicals, Pesticides.

    Dated: February 15, 2012.
Michael Goodis,
Acting Director, Pesticides Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2012-4846 Filed 2-28-12; 8:45 am]
BILLING CODE 6560-50-P


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