[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Notices]
[Pages 49473-49475]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20287]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0656; FRL-8884-3]


Petition to Maximize Practical Utility of List 1 Chemicals 
Screened Through EPA's Endocrine Disruptor Screening Program; Notice of 
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA is seeking public comment on a June 21, 2011, petition 
from CropLife America (CLA), Consumer Specialty Products Association 
(CSPA), and the Responsible Industry for a Sound Environment (RISE) 
requesting the Agency develop and publish guidance explaining the 
criteria by which EPA will make its decisions on data received in 
response to the test orders issued under the Endocrine Disruptor 
Screening Program.

DATES: Comments must be received on or before October 11, 2011.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2011-0656, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental 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-
2011-0656. 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-

[[Page 49474]]

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, 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, PRD, 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; e-mail address: smith.jane-scott@epa.gov.

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:
     Chemical manufacturers, importers and processors (NAICS 
code 325), e.g., persons who manufacture, import or process chemical 
substances.
     Pesticide, fertilizer, and other 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.
    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 FFDCA. If you have any 
questions regarding the applicability 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 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.
    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 the Federal Food, Drug, and Cosmetic Act (FFDCA). The orders require 
the testing of chemicals through eleven (11) Tier 1 screening assays. 
The purpose of the eleven (11) Tier 1 screening assays is to determine 
the potential for a chemical to interact with estrogen, androgen and 
thyroid hormone systems. Based on the data from the 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 June 21, 2011, petition from 
CropLife America, Consumer Specialty Products Association and the 
Responsible Industry for a Sound Environment requesting that the 
Agency:
    (1) Publish guidance explaining the criteria by which EPA will make 
its decisions on data received in response to the test orders issued 
under the Endocrine Disruptor Screening Program;
    (2) Provide sufficient time for list 1 chemical test order 
recipients to prepare and submit their Tier 1 screening results in 
compliance with the guidance once developed; and
    (3) Fully analyze the Tier 1 screening data received in response to 
the list 1 test orders and revise the guidance to be developed to 
reflect what is learned by

[[Page 49475]]

the analysis in order to ensure scientifically sound determinations and 
to protect the public health and the environment.

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, Endocrine Disruptor Screening Program, 
EDSP, EDSP Orders, List 1 Chemicals, Tier 1 Guidance, weight of 
evidence.

    Dated: August 3, 2011.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2011-20287 Filed 8-9-11; 8:45 am]
BILLING CODE 6560-50-P