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