[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Notices]
[Page 70839-70841]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de07-51]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2007-1081; FRL-8155-8]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Tier 1 Screening of Certain Chemicals Under the
Endocrine Disruptor Screening Program (EDSP); EPA ICR No. 2249.01, OMB
Control No. 2070-new
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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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 for a new Information Collection Request (ICR) to the
Office of Management and Budget (OMB). This ICR is entitled: ``Tier 1
Screening of Certain Chemicals Under the Endocrine Disruptor Screening
Program (EDSP)'' and identified by EPA ICR No. 2249.01 and OMB Control
No. 2070-new. Before submitting the ICR to OMB for review and approval
under the PRA, EPA is soliciting comments on specific aspects of the
proposed information collection.
DATES: Comments must be received on or before February 11, 2008.
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.
[[Page 70840]]
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 public 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 website 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 public 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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 Federal 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) (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (202) 564-8476; fax number: (202) 564-8482; e-mail
address: wooge.william@epa.gov.
SUPPLEMENTARY INFORMATION:
I. What Should I Consider when I Prepare My Comments for EPA?
A. Considerations Under the 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
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
comments:
1. Explain your views as clearly as possible and provide specific
examples.
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.
II. What Information Collection Activity or ICR Does this Action Apply
to?
Affected entities: Entities potentially affected by this action are
those individuals and companies that receive an EDSP test order issued
by the Agency. Under the Federal Food, Drug, and Cosmetic Act (FFDCA)
section 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
[[Page 70841]]
determined that potential respondents to 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 and 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 numbers: EPA ICR No. 2249.01, OMB Control No. 2070-new.
ICR status: This ICR is for a new 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 order and/or form.
Abstract: This new ICR covers the information collection activities
associated with Tier 1 screening of the first group of chemicals under
the EDSP. The EDSP is established under section 408(p) of the 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 currently implementing the EDSP in three major parts that
are being developed in parallel and with substantial work on each well
underway: 1) Assay validation; 2) Priority setting; and 3) Procedures.
This ICR is related to the third component of the EDSP, i.e., the
procedures for Tier 1 screening. This ICR is not intended to cover all
of the activities currently underway for the EDSP. Instead, the focus
of this ICR is on the information collection activities associated with
the Tier 1 screening of the 73 chemicals identified for initial
screening under the EDSP. A separate ICR will be developed to address
the information collection activities associated with Tier 2 testing.
In addition, subsequent Tier 1 screening of additional chemicals not
selected for the initial round will be addressed in a future ICR,
either when this ICR is amended in three years or in a separate ICR. In
either case, EPA will follow the notice and comment process prescribed
by the PRA to first seek public comment on the ICR before submitting it
to OMB for review and approval under the PRA.
Burden statement: The annualized public reporting and recordkeeping
burden for this collection of information is estimated to average 2,649
hours per response, although individual respondent burden varies based
on their individual activities. 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, a copy of which is available in the docket, provides a
detailed explanation of this estimate, which is only briefly summarized
here:
Estimated total number of potential respondents: 445.
Frequency of response: On occasion.
Estimated total average number of responses for each respondent:
Two responses per chemical: An initial response and the final data
submission. All respondents will provide an initial response, while
only those that generate the data will complete the final data
submission.
Estimated total annual burden hours: 93,655 hours.
Estimated total annual costs: $6,887,418. This includes an
estimated annualized cost of $267 for non-burden hour or delivery
costs.
III. What is the Next Step in the Process for this ICR?
EPA will consider the comments received and amend the ICR as
appropriate. Although included as attachments to the ICR, EPA has
issued a separate Federal Register document to solicit public review
and comments on the related draft policy describing the procedures for
responding to the 408(p) order, and the draft template for the 408(p)
order itself. In addition to considering comments submitted on the ICR,
EPA will also consider comments received on those documents in response
to that separate solicitation. Changes to those documents may result in
changes to the ICR as well. 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
person listed under FOR FURTHER INFORMATION CONTACT.
List of Subjects
Environmental protection, Reporting and recordkeeping requirements.
Dated: November 29, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-24163 Filed 12-12-07; 8:45 am]
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