[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Page 11703]
[FR Doc No: 2022-04378]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-1102-000]

Sierra Energy Storage, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Sierra Energy Storage, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is March 16, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: February 24, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-04378 Filed 3-1-22; 8:45 am]
BILLING CODE 6717-01-P


<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="Document">
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67628
Federal Register/Vol. 67, No. 215 /Wednesday, November 6, 2002 /Notices
8
See note 3.
Task
Hourly rate
Burden hours
Labor cost
Determine care instructions .........................................................................................................
$20.00
709,500
$14,190,000
Draft and order labels ..................................................................................................................
13.00
33,000
429,000
Attach labels ................................................................................................................................
8
3.00
5,311,100
15,933,300
Total ......................................................................................................................................
........................
........................
30,552,300
Staff
8
believes that there are no
current start-up costs or other capital
costs associated with the Rule. Because
the labeling of textile products has been
an integral part of the manufacturing
process for decades, manufacturers have
in place the capital equipment
necessary to comply with the RuleÕs
labeling requirements. Based on
knowledge of the industry, staff believes
that much of the information required
by the Rule would be included on the
product label even absent those
requirements.
John D. Graubert,
Acting General Counsel.
[FR Doc. 02Ð28160 Filed 11Ð5Ð02; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N–1526]
Robert A. Fiddes; Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the act) debarring Dr.
Robert A. Fiddes for 20 years from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on a finding that Dr. Fiddes
was convicted of a felony under Federal
law for conspiring to make false
statements to a government agency, and
was a material participant in offenses
for which three other people are being
debarred. Dr. Fiddes has failed to
request a hearing and, therefore, has
waived his opportunity for a hearing
concerning this action.
DATES:
This order is effective November
6, 2002.
ADDRESSES:
Submit applications for
termination of debarment to the Dockets
Management Branch (HFAÐ305), Food
and Drug Administration, 5630 Fishers
Lane, rm., 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mary Catchings, Center for Drug
Evaluation and Research (HFDÐ7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301Ð594Ð
2041.
SUPPLEMENTARY INFORMATION:
I. Background
On September 30, 1997, the U.S.
District Court for the Central District of
California accepted Dr. FiddesÕ plea and
entered judgment against him for one
count of conspiring to make false
statements to a government agency, the
FDA, in violation of 18 U.S.C. 371 and
1001. This conspiracy conviction was
based on Dr. Fiddes participating in,
directing, and encouraging the
submission of false information to
sponsors in required reports for clinical
studies used by FDA to evaluate the
safety and effectiveness of drug
products.
As a result of this conviction, FDA
served Dr. Fiddes by certified mail on
June 6, 2002, a notice proposing to
debar him for 20 years from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal also
offered Dr. Fiddes an opportunity for a
hearing on the proposal. The debarment
proposal was based on findings: (1)
Under section 306(b)(2)(B)(i)(II) of the
act (21 U.S.C. 335a(b)(2)(B)(i)(II)) that
Dr. Fiddes was convicted of a felony
under Federal law for conspiracy to
make false statements to a government
agency and, (2) under section
306(b)(2)(B)(iii) of the act that Dr.
Fiddes was a material participant in
offenses leading to the conviction and
debarment of three other individuals.
Dr. Fiddes was provided 30 days to file
objections and to request a hearing. Dr.
Fiddes did not request a hearing. His
failure to request a hearing constitutes a
waiver of his opportunity for a hearing
and a waiver of any contentions
concerning his debarment.
II. Findings and Order
Therefore, the Director, Center for
Drug Evaluation and Research, under
section 306(b)(2)(B) of the act, and
under authority delegated to her (21
CFR 5.99), finds that Dr. Robert A.
Fiddes: (1) Has been convicted of a
felony under Federal law for conspiring
to make false statements to a
government agency, and (2) was a
material participant in offenses leading
to the conviction and debarment of
three other individuals.
As a result of the foregoing findings,
Dr. Robert A. Fiddes is debarred for 20
years (4 periods of 5 years, to run
consecutively, based on his conviction
of a Federal felony and his role as a
material participant in the offenses
leading to the conviction and debarment
of three other individuals) from
providing services in any capacity to a
person that has an approved or pending
drug product application under section
505, 512, or 802 of the act (21 U.S.C.
355, 360b, or 382), or under section 351
of the Public Health Service Act (42
U.S.C. 262) (see sections 306(c)(1)(B)
and (c)(2)(A)(iii) and 201(dd) of the act
(21 U.S.C. 321(dd))). Any person with
an approved or pending drug product
application who knowingly uses the
services of Dr. Fiddes, in any capacity,
during his period of debarment, will be
subject to civil money penalties. If Dr.
Fiddes, during his period of debarment,
provides services in any capacity to a
person with an approved or pending
drug product application, he will be
subject to civil money penalties. In
addition, FDA will not accept or review
any abbreviated new drug applications
submitted by or with the assistance of
Dr. Fiddes during his period of
debarment.
Any application by Dr. Fiddes for
termination of debarment under section
306(d)(4) of the act should be identified
with Docket No. 00NÐ1526 and sent to
the Dockets Management Branch (see
ADDRESSES
). All such submissions are to
be filed in four copies. The public
availability of information in these
submissions is governed by 21 CFR
10.20(j). Publicly available submissions
may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: October 15, 2002.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 02Ð28256 Filed 11Ð5Ð02; 8:45 am]
BILLING CODE 4160–01–S
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[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59723-59724]
[FR Doc No: 2016-20781]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-[2016-0036]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT

ACTION: Notice of final disposition.

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SUMMARY: FMCSA confirms its decision to exempt 68 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on May 26, 2016. The exemptions
expire on May 26, 2018.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
e.t., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On April 25, 2016, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 68 individuals and requested
comments from the public (81 FR 24161. The public comment period closed
on May 25, 2016, and no comments were received.
    FMCSA has evaluated the eligibility of the 68 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A

Report to Congress on the Feasibility of a Program to Qualify
Individuals with Insulin-Treated Diabetes Mellitus to Operate in
Interstate Commerce as Directed by the Transportation Act for the 21st
Century.'' The report concluded that a safe and practicable protocol to
allow some drivers with ITDM to operate CMVs is feasible. The September
3, 2003 (68 FR 52441), Federal Register notice in conjunction with the
November 8, 2005 (70 FR 67777), Federal Register notice provides the
current protocol for allowing such drivers to operate CMVs in
interstate commerce.
    These 68 applicants have had ITDM over a range of 1 to 40 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the April 25, 2016, Federal Register
notice and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Conclusion

    Based upon its evaluation of the 68 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above 949 CFR
391.64(b)):

Thomas H. Adams, Jr. (PA)
Hobert P. Bates (TX)
Spencer L. Bates (VT)
Erik E. Baumgart (NE)
Robert T. Birch (PA)
Frank A. Borchers (NJ)
Paul J. Boucher (ME)
Nathan P. Broussard (KS)
Rodney J. Brown (VA)
Nicholas M. Catizone (MA)
Michael J. Christians (MN)
Joseph C. Cook (PA)
Stephen L. Davis (MO)
Henry L. Dickerson (AR)
Julius D. Duncan (FL)
William R. Faller (PA)
Stephen L. Fehr (IL)
Donald H. Feller (IN)
Stephen P. Glenning (FL)
Kevin B. Green (TN)
Dusty R. Grover (ID)
Robert W. Guccion (IA)
Richard A. Guzman (FL)
Andy H. Harnden (WA)
Russell D. Hartley (KS)
Dale L. Heisler, Jr. (PA)
Pablo R. Hernandez, II (MS)
James S. Hill (WA)
Eric D. Hulst (SD)
Stephen J. Hyde, Sr. (MA)
Steven G. Jackson (IN)
Michelle Jenkins (MA)
Robert C. Jones (VA)
Christopher P. Joyce (MD)
Paul M. Joyce (MA)
Steven W. Keech (PA)
Stephen W. Kerby (MD)
Elmer K. Kreier (WI)
Richard D. Kurtz (PA)
David O. Ludwig (ND)
Marvin D. Mitchell (WA)
Jack D. Moore (WV)
Matthew A. Neidermeier (FL)
Thomas M. Noon (MI)
Ronald A. Ortiz (CA)
Michael V. Palmer (NY)
LeRonne Peques (IL)
John D. Penrod (SD)
Michael A. Peppers (CA)
Noah I. Peterson (MN)
Thomas M. Peterson (NE)
Gregory S. Potter (MO)
Lisa M. Reynolds (CO)
Martina M. Sanchez (NY)
Brian A. Sexton (ME)
Daniel J. Sing (OH)
Mark W. Smith (PA)
Larry E. Sorrells (VA)
Eric J. Tavares (RI)
Michael R. Thomen (OH)
Michael F. Tibbetts (ME)
Charles E. Tillman, Jr. (FL)
Monte D. Trout (WA)
Aaron M. Trudeau (MT)
Thomas M. Waldron (MA)
David M. Wilfeard, II (NY)
Deborah C. Williams (NJ)
James R. Wolf (PA)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: August 17, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-20781 Filed 8-29-16; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12499-12500]
[FR Doc No: 2016-05219]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2016-N-0001]

Tenth Annual Drug Information Association/Food and Drug
Administration Statistics Forum--2016; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

SUMMARY: The Food and Drug Administration (FDA), in co-sponsorship with
the Drug Information Association (DIA), is announcing a public
conference entitled ``Tenth Annual DIA/Food and Drug Administration
Statistics Forum--2016.'' This public conference is intended to be an
open forum for the timely discussion of topics of mutual theoretical
and practical interest to statisticians and clinical trialists who
develop and review new drugs and biologics. A primary focus for this
public conference will be to establish an ongoing dialogue between
industry and regulatory Agencies--emphasizing the regulatory and
statistical challenges associated with innovative approaches to the
design and analysis of clinical trials and measuring the progress being
made in designing and implementing innovative solutions.

DATES: The main meeting will be held over 3 days: April 25, 2016, from
1 p.m. to 5:30 p.m.; April 26, 2016, from 8:30 a.m. to 5 p.m.; and
April 27, 2016, from 8:30 a.m. to 3:30 p.m. On April 25, there will
also be pre-meeting tutorials from 8:30 a.m. to 12 p.m. and a
scientific working group session from 5:40 p.m. to 7 p.m.

ADDRESSES: The meeting will be held at the Marriott Bethesda North
Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, MD
20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Meredith Kaganovskiy, DIA, 800
Enterprise Rd., Horsham, PA 19044,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Stephen Wilson, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3630, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA and DIA will sponsor an open public discussion between
industry, academia, contract research organizations, regulatory
scientists, and other parties on topics related to the innovative
statistical methodologies and quantitative approaches used by sponsors
to provide evidence for the approval of new therapies.
    The forum will provide a unique opportunity for all of the relevant
stakeholders to collaboratively describe the issues and discuss
appropriate solutions. It is important that all of the stakeholders
examine their roles in making the necessary changes and improvements in
the framework used to develop evidence for the regulatory decisions and
work to foster a mutual understanding of relevant scientific issues and
challenges.
    The conference will benefit FDA by enhancing communication with the
broader statistical community.
    The goals of the program are as follows:

 Explore and implement innovative statistical solutions to
important issues associated with the quantitative evidence needed for
the regulatory review of therapeutic drugs and biologics
 Describe the application of statistical methodologies and
thinking regarding the development of new therapeutic biologics and
drugs
 Assess the impact of regulations and guidance on statistical
practice
 Discuss ideas for improving the communication between industry
statisticians and regulatory reviewers

    A description of the planned activities of the working groups can
be found at http://www.diaglobal.org/en/conference-listing/meetings/2016/04/dia-fda-statistics-2016-forum.

II. Registration and Accommodations

A. Registration

    There is a registration fee to attend this meeting. The
registration fee is to help defray the costs of the event; including
meeting facilities, program materials, refreshments, staff time and
administrative overhead, and costs involved in getting speakers to the
events; and will not result in any profits. Seats are limited, and
registration will be on a first-come, first-served basis. On-site
registration will be available to the extent that space is available on
the day of the conference. Please note: Registration will open at 7:30
a.m. each day.
    To register, please complete registration online at http://www.diaglobal.org/en/conference-listing/meetings/2016/04/dia-fda-statistics-2016-forum/register. (FDA has verified the Web address, but
is not responsible for subsequent changes to the Web site after this
document publishes in the Federal Register.) The costs of registration
for the different categories of attendees are as follows:

------------------------------------------------------------------------
                           Category                               Cost
------------------------------------------------------------------------
Industry Representatives......................................    $1,350
Charitable Nonprofit/Academic (Full time).....................       675
Government (Full time)........................................       405
Tutorial Fees.................................................       405
------------------------------------------------------------------------

    All registrants will be required to pay the applicable fee, with
the exception of a limited number of speakers/organizers who will have
a complimentary registration.

B. Accommodations

    Attendees are responsible for their own hotel accommodations.
Attendees making reservations at the Bethesda North Marriot Hotel and
Conference Center, 5701 Marinelli Rd., North Bethesda, MD 20852 are
eligible for a reduced rate of $199, not including applicable taxes.
    The Marriott Bethesda North Hotel and Conference Center has a
limited

number of rooms available at the discounted rate of $199 per night
until April 1, 2016, or until the block is filled. To receive the
reduced rate, hotel reservations must be made with onPeak, https://compass.onpeak.com/e/72FOR16, and not directly with the hotel. If you
need special accommodations due to a disability, please contact
<EMAIL_ADDRESS>at least 7 days in advance.

    Dated: March 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05219 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Rules and Regulations]
[Page 25533-25539]
[DOCID:fr07my08-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0398; FRL-8362-2]

Spirodiclofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of
spirodiclofen in or on hop, dried cones. Interregional Research Project
Number 4 (IR-4) requested this tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 7, 2008. Objections and
requests for hearings must be received on or before July 7, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also

Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0398. 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. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 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 Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide 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. 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. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0398 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before July 7, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0398, 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'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<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8134-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E7204) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that
40 CFR 180.608 be amended by establishing tolerances for residues of
the insecticide/miticide spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate, in or on hop, dried
cones at 30 parts per million (ppm). That notice referenced a summary
of the petition prepared by Bayer CropScience, the registrant, which is
available to the public in the docket, http://www.regulations.gov.
There were no comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has

reviewed the available scientific data and other relevant information
in support of this action. EPA has sufficient data to assess the
hazards of and to make a determination on aggregate exposure for the
petitioned-for tolerances for residues of spirodiclofen on hop, dried
cones at 30 ppm. EPA's assessment of exposures and risks associated
with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Spirodiclofen has a low acute toxicity via oral, dermal or
inhalation routes. It is not an eye or dermal irritant; however, it is
a potential skin sensitizer. Following oral administration,
spirodiclofen is rapidly absorbed, metabolized and excreted via urine
and feces. The most sensitive target organ of spirodiclofen is the
adrenal gland. Adrenal effects (e.g., increased adrenal weights,
increased incidence and severity of small cytoplasmic vacuolation in
the cortex of adrenal glands) were observed in rats, dogs and mice with
the dog being the most sensitive species.
    There was no evidence of neurotoxicity in the acute neurotoxicity
study in rats. In the subchronic neurotoxicity study in rats,
functional-observational-battery (FOB) effects and decreased motor and
locomotor activities were observed in females at the high dose only.
The effects were considered to be due to the large decrease in body
weight in these animals. In one of two developmental neurotoxicity
(DNT) studies in rats, a decrease in retention (memory) was observed in
the postnatal day (PND) 60 females only. These effects were not seen in
a repeated DNT study conducted using the same doses and experimental
conditions.
    There was no evidence (qualitative or quantitative) of increased
susceptibility in the rabbit developmental toxicity study or the rat
reproduction toxicity study following in utero or postnatal exposure to
spirodiclofen. However, evidence of quantitative susceptibility was
observed in a rat developmental toxicity study where an increased
incidence of slight dilatation of the renal pelvis was observed at a
dose (1,000 milligrams/kilogram/day (mg/kg/day)) which did not cause
any maternal toxicity. The results of the two DNT studies for
spirodiclofen also suggest increased susceptibility. In the first
study, memory and brain morphometric differences were observed at doses
that did not result in maternal toxicity. While these effects were not
seen in the second DNT study, body weight changes were seen at non-
maternally toxic doses.
    EPA has classified spirodiclofen as ``likely to be carcinogenic to
humans'' by the oral route of exposure, based on evidence of testes
Leydig cell adenomas in male rats, uterine adenomas and/or
adenocarcinoma in female rats, and liver tumors in mice. EPA has
determined that quantification of human cancer risk using a linear low-
dose extrapolation approach is appropriate.
    Specific information on the studies received and the nature of the
adverse effects caused by spirodiclofen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in the document Spirodiclofen. Petition No. 7E7204.
Human Health Risk Assessment for Use on Hops at pages 45-48 in docket
ID number EPA-HQ-OPP-2007-0398.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spirodiclofen used for
human risk assessment can be found at http://www.regulations.gov in the
document Spirodiclofen. Petition No. 7E7204. Human Health Risk
Assessment for Use on Hops at page 34 in docket ID number EPA-HQ-OPP-
2007-0398.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spirodiclofen, EPA considered exposure under the
petitioned-for tolerances as well as all existing spirodiclofen
tolerances in 40 CFR 180.608. EPA assessed dietary exposures from
spirodiclofen in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for spirodiclofen; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that all food
commodities contain residues at the average field trial level. EPA also
assumed average field trial residues for feed commodities in
calculating anticipated livestock dietary burdens and anticipated
residues in meat and milk. Residue estimates were further refined using
available experimentally-derived processing factors as well as
projected percent crop treated (PPCT) information for several crops.
    iii. Cancer. EPA has classified spirodiclofen as ``likely to be
carcinogenic to humans'' by the oral route of exposure and determined
that quantification of human cancer risk

using a linear low-dose extrapolation approach is appropriate. Cancer
risk was assessed using the same exposure assumptions as discussed in
Unit III.C.1.ii. above.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used projected percent crop treated (PPCT) information
for the new crop (hops) as well as several currently registered crops
(apples, grapes, oranges and peaches). Since spirodiclofen has only
been registered on these crops since 2005, PCT estimates based on
actual usage data were not deemed sufficient indicators of potential
usage on currently registered crops. The Agency used PPCT information
as follows: Hops 92%; apples 15%; grapes 7%; oranges (except temple)
14%; peaches 10%.
    EPA estimates PPCT for spirodiclofen use by assuming that the PCT
during the pesticide's initial 5 years of use on a specific use site
will not exceed the average PCT of the dominant or market leader
pesticide (i.e. the one with the greatest PCT) on that site over the
three most recent surveys. Comparisons are only made among pesticides
of the same pesticide types (i.e., the dominant insecticide on the use
site is selected for comparison with the new insecticide/miticide).
Since spirodiclofen is a miticide, EPA identified miticides that are
the market leaders to project PCT. Petroleum distillate and petroleum
oil were excluded as market leaders and the next miticide market leader
was chosen. The PCTs included in the average may be for the same
pesticide or for different pesticides, since the same or different
pesticides may dominate for each year selected. Typically, EPA uses
U.S. Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS) as the source for raw PCT data, because it is publicly
available and does not have to be calculated from available data
sources. When a specific use site is not surveyed by USDA/NASS, EPA
uses proprietary data and calculates the estimated PCT.
    These estimated PPCTs, based on the average PCT of the market
leaders, are appropriate for use in chronic dietary risk assessment.
This method of estimating PPCT for a new use of a registered pesticide
or a new pesticide produces a high-end estimate that is unlikely, in
most cases, to be exceeded during the initial five years of actual use.
The predominant factors that bear on whether the PPCT could be exceeded
are whether the new pesticide use or new pesticide is more efficacious
or controls a broader spectrum of pests than the dominant pesticide(s).
All relevant information currently available regarding the predominant
factors has been considered for the use of spirodiclofen on hops;
oranges, except temple; grapes, all; peaches; and apples; and it is
unlikely that these spirodiclofen uses will exceed the estimated PPCTs
during the next 5 years, because the target pest range of the market
leaders is generally broader than spirodiclofen's, often including both
insect and mite pests. Furthermore, the Agency has received no Section
18 emergency exemption requests for spirodiclofen and there are no
readily discernible resistance issues with target pest mites, which
might indicate an increased need for spirodiclofen on these crops.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which spirodiclofen may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spirodiclofen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of spirodiclofen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
spirodiclofen for chronic exposures for non-cancer assessments are
estimated to be 4.99 parts per billion (ppb) for surface water and 0.44
ppb for ground water; the EDWCs of spirodiclofen for chronic exposures
for cancer assessments are estimated to be 1.67 ppb for surface water
and 0.44 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 4.99 ppb was used to
assess the contribution to drinking water. For cancer dietary risk
assessment, the water concentration of value 1.67 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).

Spirodiclofen is not registered for any specific use patterns that
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found spirodiclofen to share a common mechanism of
toxicity with any other substances, and spirodiclofen does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
spirodiclofen does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for spirodiclofen includes prenatal developmental
toxicity studies in rats and rabbits, a 2-generation reproduction
toxicity study in rats and two developmental neurotoxicity (DNT)
studies in rats. There was no evidence (qualitative or quantitative) of
increased susceptibility in the rabbit developmental toxicity study or
the rat reproduction toxicity study following in utero or postnatal
exposure to spirodiclofen. However, evidence of quantitative
susceptibility was observed in the rat developmental toxicity study
where an increased incidence of slight dilatation of the renal pelvis
was observed at a dose (1,000 mg/kg/day) which did not cause any
maternal toxicity. The results of the two available DNT studies for
spirodiclofen also suggest increased susceptibility. In the first
study, memory and brain morphometric differences were observed at doses
that did not result in maternal toxicity. While these effects were not
seen in the second DNT study, body weight changes were seen at non-
maternally toxic doses.
    The degree of concern is low for the quantitative susceptibility
seen in the prenatal developmental and DNT studies in the rat for the
following reasons:
    The renal pelvic dilation seen in the rat developmental toxicity
study was slight and observed only at the limit dose without
statistical significance or dose response. Renal pelvic dilation was
considered to be a developmental delay and not a severe developmental
effect. The low background incidence of renal pelvic dilations seen in
this study may be idiosyncratic to this strain (Wistar) of rats, since
they are commonly seen at higher incidences in other strains (Sprague-
Dawley or Fisher). In addition, doses selected for risk assessment of
spirodiclofen are much lower than the dose that caused these
developmental delays.
    The degree of concern for the increased susceptibility seen in the
second DNT study is also low, because there is a well established
NOAEL, the toxicity is marginal (slight changes in body weights) and
all developmental/functional parameters were comparable to controls. In
addition, doses selected for risk assessment of spirodiclofen are much
lower than the dose that caused these marginal changes in the body
weights of offspring in the second DNT study.
    In the first DNT study, no significant differences were noted
between treated and control groups in reproductive parameters (litter
size, sex ratio, number of deaths, live birth, viability and
lactation), and no treatment-related clinical signs were observed at
any dose in either sex. No treatment-related differences in functional
observational battery (FOB), motor activity or locomotor activity were
observed during the pre-weaning and post-weaning periods; and no
treatment-related differences in the passive avoidance tests were
observed at any dose. The trials to criterion for the memory phase of
the water maze test showed a treatment-related effect at all doses for
postnatal day (PND) 60 females. The memory effects occurred only in
adults and were not seen in younger animals; therefore, these effects
do not raise a concern for susceptibility.
    On postmortem examination, differences in certain morphometric
measurements (caudate putamen, parietal cortex, hippocampal gyrus and
dentate gyrus) were observed at the high dose, the only dose for which
morphometric measurements were made. The magnitude of these effects was
minute but statistically significant. The lack of measurements at the
mid- and low doses precluded establishment of a clear NOAEL or a
determination as to the toxicological significance of these minor
changes at the high dose. Therefore, EPA requested similar morphometric
analyses at the mid- and low doses in both sexes. Since inappropriate
preservation of brain tissues from the first study precluded additional
morphometric analyses, the registrant elected to conduct a second DNT
study using the same doses and experimental conditions. The
morphometric differences observed in the first DNT study were not seen
in the second study. EPA has no concern for the increased
susceptibility seen in the first DNT study because:
     The magnitude of the morphometric changes was minor.
     They occurred at the high dose; the doses selected for
risk assessment are significantly lower than the dose at which these
effects were seen.
     No other neurotoxic effects were observed in young pups in
the first DNT study.
     The results were not reproduced in the second study
conducted using identical doses and experimental conditions. The
results of the second study suggest that the findings in the first
study are spurious and not toxicologically significant.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for chronic dietary exposures, the only
exposures considered in this risk assessment, since an acute dietary
endpoint has not been identified for spirodiclofen and there are no
residential uses that would result in short-term or intermediate-term
non-dietary exposures. The decision to reduce the FQPA SF to 1X for
chronic dietary exposures is based on the following findings:
    i. The toxicity database for spirodiclofen is complete.
    ii. Based on the results of acute, subchronic and developmental
neurotoxicity studies in rats (see units III.A. and III.D.2.), EPA has
concluded that spirodiclofen is unlikely to be a neurotoxic or
developmentally

neurotoxic compound and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There was no evidence (qualitative or quantitative) of
increased susceptibility in the rabbit developmental toxicity study or
the rat reproduction toxicity study following in utero or postnatal
exposure to spirodiclofen. The degree of concern is low for the
quantitative susceptibility seen in the prenatal developmental and DNT
studies in the rat, and the Agency did not identify any residual
uncertainties after establishing toxicity endpoints and traditional
uncertainty factors to be used in the risk assessment of spirodiclofen.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were refined using
reliable PPCT information and anticipated residue values calculated
from residue field trial results. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to spirodiclofen in drinking water. Residential exposures are
not expected. These assessments will not underestimate the exposure and
risks posed by spirodiclofen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spirodiclofen is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
spirodiclofen from food and water will utilize 3.2% of the cPAD for
infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for spirodiclofen.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposures take into account short-term and
intermediate-term residential exposures plus chronic exposure to food
and water (considered to be a background exposure level). Spirodiclofen
is not registered for any use patterns that would result in residential
exposure. Therefore, the short-term/intermediate-term aggregate risk is
the sum of the risk from exposure to spirodiclofen through food and
water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in Unit III.C.1.iii. for cancer, EPA has
concluded that exposure to spirodiclofen from food and water will
result in a lifetime cancer risk of 3 x 10-6 for the U.S.
population.
    EPA generally considers cancer risks in the range of
10-6 or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the log scale; for example,
risks falling between 3.16 x 10-7 and 3.16 x 10-6
are expressed as risks in the range of 10-6. Considering the
precision with which cancer hazard can be estimated, the
conservativeness of low-dose linear extrapolation, and the rounding
procedure described above, cancer risk should generally not be assumed
to exceed the benchmark LOC of the range of 10-6 until the
calculated risk exceeds approximately 3 x 10-6. Since the
calculated cancer risk for spirodiclofen does not exceed this level,
estimated cancer risk is considered to be negligible.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to spirodiclofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatography (LC)/mass
spectrometry (MS)/MS method) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    No maximum residue limits (MRLs) have been established by Canada,
Mexico or Codex for spirodiclofen on hops.

V. Conclusion

    Therefore, a tolerance is established for residues of
spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-
yl 2,2-dimethylbutanoate, in or on hop, dried cones at 30 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of

power and responsibilities among the various levels of government or
between the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 24, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.608 is amended by alphabetically adding the following
commodity to the table in paragraph (a)(1) to read as follows:

Sec.  180.608  Spirodiclofen; tolerances for residues.

    (a) * * *.
    (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Hop, dried cones.....................................                 30
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-9826 Filed 5-6-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)]
[Rules and Regulations]
[Pages 69113-69115]
[FR Doc No: 2015-28339]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3224; Directorate Identifier 2015-CE-026-AD;
Amendment 39-18290; AD 2015-20-11]
RIN 2120-AA64

Airworthiness Directives; Schempp-Hirth Flugzeugbau GmbH Gliders

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: The FAA is correcting an airworthiness directive (AD) that
published in the Federal Register. That AD applies to certain Schempp-
Hirth Flugzeugbau GmbH Models Duo Discus and Duo Discus T gliders. The
Model Duo Discus gliders were incorrectly referenced as powered
sailplanes in the Applicability section. This document corrects that
error and refers to both models as just gliders as in previous ADs. In
all other respects, the original document remains the same; however we
are publishing the entire rule in the Federal Register.

DATES: This final rule is effective November 18, 2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3224; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Airworthiness Directive 2015-20-11,
Amendment 39-18290 (80 FR 61722, October 14, 2015), currently requires
inspecting and replacing the airbrake bell crank and the airbrake drive
funnels and inspecting the airbrake control system for proper clearance
and making necessary adjustments.

    As published, the Model Duo Discus gliders were incorrectly
referenced as powered sailplanes in the Applicability section. This
could cause confusion because the Model Duo Discus does not have an
engine. This document corrects that error and refers to both models as
just gliders as in previous ADs.
    Although no other part of the preamble or regulatory information
has been corrected, we are publishing the entire rule in the Federal
Register.
    The effective date of this AD remains November 18, 2015.

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

 2015-20-11 Schempp-Hirth Flugzeugbau GmbH: Amendment 39-18290;
Docket No. FAA-2015-3224; Directorate Identifier 2015-CE-026-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective on November
18, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Schempp-Hirth Flugzeugbau GmbH Model Duo
Discus gliders, serial numbers 1 through 639, and Model Duo Discus T
gliders, serial numbers 1 through 110 and 112 through 247,
certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as excessive load
on the air brake system. We are issuing this AD to prevent
uncontrolled actuation of the air brakes (symmetric or asymmetric),
which could result in reduced control.

(f) Actions and Compliance

    Unless already done, do the actions in paragraph (f)(1) through
(f)(5) of this AD.
    (1) Within 40 days after November 18, 2015 (the effective date
of this AD) and repetitively thereafter at intervals not to exceed
100 hours time-in-service until the terminating replacement action
required in paragraphs (f)(2) and (f)(3) of this AD (as applicable)
is done, inspect the airbrake bell crank, the airbrake drive
funnels, and the airbrake control system.
    (i) Inspect the airbrake bell crank and the airbrake drive
funnels for cracks and damage following Action 1 in Schempp-Hirth
Flugzeugbau GmbH Technical Note No. 380 -2/396-17/868-22/890-14,
Revision 1, issued July 13, 2015 (published as a single document).
    (ii) Inspect the airbrake control system for proper clearance
following Paragraph 2.d. of Schempp-Hirth Flugzeugbau GmbH Working
instruction for Technical Note No. 380-2/396-17/868-22/890-14,
Ausgabe (English translation: issue) 1, Datum (English translation:
dated) May 11, 2015.
    (2) If cracks or damage is found on the airbrake bell cranks or
the airbrake drive funnels during any inspection required in
paragraph (f)(1) of this AD, before further flight, replace each
cracked or damaged part with a reinforced part. Installing a
reinforced part terminates the repetitive inspections required in
paragraph (f)(1) of this AD for that part.
    (i) For replacement of the airbrake bell cranks, follow Picture
2: Reinforced version of airbrake bell crank according to HS 11-
50.016, Revision a or later, in Schempp-Hirth Flugzeugbau GmbH
Working instruction for Technical Note No. 380-2/396-17/868-22/890-
14, Ausgabe (English translation: issue) 1, Datum (English
translation: dated) May 11, 2015.
    (ii) For replacement of the airbrake drive funnels, follow
Picture 5: Airbrake drive funnel in fuselage ``Reinforcement of
airbrake drive funnel according to drawing S14RB703, Revision a, in
Schempp-Hirth Flugzeugbau GmbH Working instruction for Technical
Note No. 380-2/396-17/868-22/890-14, Ausgabe (English translation:
issue) 1, Datum (English translation: dated) May 11, 2015.
    (3) If no cracks or damage were found on the airbrake bell
cranks or the airbrake drive funnels during any inspection required
in paragraph (f)(1) of this AD, within 12 months after November 18,
2015 (the effective date of this AD), replace each of the airbrake
bell cranks and airbrake drive funnels with a reinforced part. These
replacements terminate the repetitive inspections required in
paragraph (f)(1) of this AD.
    (i) For replacement of the airbrake bell cranks, follow Picture
2: Reinforced version of airbrake bell crank according to HS 11-
50.016, Revision a or later, in Schempp-Hirth Flugzeugbau GmbH
Working instruction for Technical Note No. 380-2/396-17/868-22/890-
14, Ausgabe (English translation: issue) 1, Datum (English
translation: dated) May 11, 2015.
    (ii) For replacement of the airbrake drive funnels, follow
Picture 5: Airbrake drive funnel in fuselage, ``Reinforcement of
airbrake drive funnel according to drawing S14RB703, Revision a,''
in Schempp-Hirth Flugzeugbau GmbH Working instruction for Technical
Note No. 380-2/396-17/868-22/890-14, Ausgabe (English translation:
issue) 1, Datum (English translation: dated) May 11, 2015.
    (4) If the airbrake control system is found to not have proper
clearance during the inspection required in paragraph (f)(1) of this
AD, before further flight, make all necessary corrective adjustments
following Paragraph 2.d. of Schempp-Hirth Flugzeugbau GmbH Working
instruction for Technical Note No. 380-2/396-17/868-22/890-14,
Ausgabe (English translation: issue) 1, Datum (English translation:
dated) May 11, 2015.
    (5) As of November 18, 2015 (the effective date of this AD),
only install an airbrake bell crank or an airbrake drive funnel that
corresponds to Picture 2: Reinforced version of airbrake bell crank
according to HS 11-50.016, Revision a or later, and Picture 5:
Airbrake drive funnel in fuselage, ``Reinforcement of airbrake drive
funnel according to drawing S14RB703, Revision a,'' in Schempp-Hirth
Flugzeugbau GmbH Working instruction for Technical Note No. 380-2/
396-17/868-22/890-14, Ausgabe (English translation: issue) 1, Datum
(English translation: dated) May 11, 2015, as applicable.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any glider
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2015-0139R1, dated July 15, 2015, for related information. You may
examine the MCAI on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-3224-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Schempp-Hirth Flugzeugbau GmbH Technical Note No. 380 -2/
396-17/868-22/890-14, Revision 1, issued July 13, 2015 (published as
a single document).
    (ii) Schempp-Hirth Flugzeugbau GmbH Working instruction for
Technical Note No. 380-2/396-17/868-22/890-14, Ausgabe (English
translation: issue) 1, Datum (English translation: dated) May 11,
2015.
    (3) For Schempp-Hirth Flugzeugbau GmbH service information
identified in this AD, contact Schempp-Hirth Flugzeugbau GmbH,

Krebenstrasse 25, 73230 Kirchheim/Teck, Germany; telephone: +49 7021
7298-0; fax: +49 7021 7298-199; email<EMAIL_ADDRESS>
Internet: http://www.schempp-hirth.com.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-3224.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on November 2, 2015.
Melvin Johnson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-28339 Filed 11-6-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Notices]
[Page 49468]
[FR Doc No: 2011-20263]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL11-57-000]

Louisiana Public Service Commission v. Entergy Corporation,
Entergy Services, Inc., Entergy Louisiana, LLC, Entergy Arkansas, Inc.,
Entergy Mississippi, Inc., Entergy New Orleans, Inc., Entergy Gulf
States Louisiana, L.L.C., Entergy Texas, Inc.; Notice of Complaint

    Take notice that on August 4, 2011, the Louisiana Public Service
Commission (Complainant) filed a formal complaint against Entergy
Corp., Entergy Services, Inc., Entergy Louisiana, L.L.C., Entergy
Arkansas, Inc., Entergy Mississippi, Inc., Entergy New Orleans, Inc.,
Entergy Gulf States Louisiana, LLC, and Entergy Texas, Inc.
(collectively, Entergy or Respondent) pursuant to sections 206 and 306
of the Federal Power Act, 16 U.S.C. 824e and 825(e) and 18 CFR 386.206
of the Commission's Rules of Practice and Procedures, seeking to change
the rates included in the Entergy rough equalization bandwidth formula
found in Service Schedule MSS-3 of the Entergy System Agreement related
to the Little Gypsy Repowering Project cancellation costs.
    The Louisiana Public Service Commission certifies that copies of
the complaint were served on the contacts for Entergy Corporation,
Entergy Services, Inc., Entergy Louisiana, L.L.C., Entergy Arkansas,
Inc., Entergy Mississippi Inc., Entergy New Orleans, Inc., Entergy Gulf
States Louisiana, Inc., and Entergy Texas, Inc. as listed on the
Commission's list of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on August 24, 2011.

    Dated: August 4, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-20263 Filed 8-9-11; 8:45 am]
BILLING CODE 6717-01-P