[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Rules and Regulations]
[Pages 36827-36833]
[FR Doc No: 2019-16065]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1998-0006; FRL-9997-20-Region 2]

National Oil and Hazardous Substance Pollution Contingency Plan
National Priorities List: Deletion of the Peter Cooper Superfund Site

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA), Region 2, is
publishing a direct final notice of deletion of the Peter Cooper
Superfund Site (Site) located in the Village of Gowanda, Cattaraugus
County, New York from the National Priorities List (NPL). The NPL,
promulgated pursuant to the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980, as amended (CERCLA),, which is
the National Oil and Hazardous Substances Pollution Contingency Plan
(NCP). This direct final deletion is being published by the EPA with
the concurrence of the State of New York, through the Department of
Environmental Conservation (NYSDEC), because the EPA has determined
that all appropriate response under CERCLA, other than operation and
maintenance, monitoring, and five-year reviews, have been completed.
However, this deletion does not preclude future actions under
Superfund.

DATES: This direct final deletion will be effective September 30, 2019
unless the EPA receives adverse comments by August 29, 2019. If adverse
comments are received, the EPA will publish a timely withdrawal of the
direct final deletion in the Federal Register informing the public that
the deletion will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1998-0006, by one of the following methods:
     https://www.regulations.gov. Follow on-line instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. The EPA may publish any comment received
to its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For

additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.
     Email<EMAIL_ADDRESS>     Mail: Sherrel Henry, Remedial Project Manager, U.S.
Environmental Protection Agency, Region 2, 290 Broadway, 20th Floor,
New York, New York 10007-1866.
     Hand delivery: Superfund Records Center, 290 Broadway,
18th Floor, New York, NY 10007-1866 (telephone:<PHONE_NUMBER>). Such
deliveries are only accepted during the Docket's normal hours of
operation (Monday to Friday from 9:00 a.m. to 5:00 p.m.) excluding
federal holidays and special arrangements should be made for deliveries
of boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
1998-0006. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at https://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be CBI or other information whose disclosure is restricted by
statute. Do not submit information that you consider to be CBI or
otherwise protected through https://www.regulations.gov or email. The
https://www.regulations.gov website is an ``anonymous access'' system,
which means the EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to the EPA without going through https://www.regulations.gov, your email 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, the 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 the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses.
    Docket: All documents in the docket are listed in the https://www.regulations.gov index. 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 the hard
copy. Publicly available docket materials are available either
electronically in https://www.regulations.gov or in hard copy at:
    U.S. Environmental Protection Agency, Region 2, Superfund Records
Center, 290 Broadway, Room 1828, New York, New York 10007-1866, (212)
637-4308, Hours: Monday through Friday: 9:00 a.m. through 5:00 p.m.
    Information for the Site is also available for viewing at the Site
Administrative Record Repositories located at: Gowanda Free Library, 56
W. Main Street, Gowanda, New York 14138,<PHONE_NUMBER>, Hours: Monday
through Friday: 9:00 a.m. through 5:00 p.m.

FOR FURTHER INFORMATION CONTACT: Ms. Sherrel D. Henry, Remedial Project
Manager, U.S. Environmental Protection Agency, Region 2, 290 Broadway,
20th Floor, NY, NY 10007-1866,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Site Deletion
V. Deletion Action

I. Introduction

    EPA Region 2 is publishing this direct final Notice of Deletion of
the Peter Cooper Superfund Site (Site) from the NPL. The NPL
constitutes Appendix B of 40 CFR part 300, which is the National Oil
and Hazardous Substances Pollution Contingency Plan (NCP), which the
EPA promulgated pursuant to section 105 of CERCLA. The EPA maintains
the NPL as the list of sites that appear to present a significant risk
to public health, welfare, or the environment. Sites on the NPL may be
the subject of remedial actions financed by the Hazardous Substance
Superfund (Fund). As described in 300.425(e) (3) of the NCP, sites
deleted from the NPL remain eligible for Fund-financed remedial actions
if future conditions warrant such actions.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III discusses procedures that the EPA is
using for this action. Section IV discusses the Site and demonstrates
how it meets the deletion criteria. Section V discusses EPA's action to
delete the Site from the NPL unless adverse comments are received
during the public comment period.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), EPA will consider, in
consultation with the state, whether any of the following criteria have
been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. all appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible parties is
appropriate; or
    iii. the remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Pursuant to CERCLA section 121 (c) and the NCP, EPA conducts five-
year reviews to ensure the continued protectiveness of remedial actions
where hazardous substances, pollutants, or contaminants remain at a
site above levels that allow for unlimited use and unrestricted
exposure. EPA conducts such five-year reviews even if a site is deleted
from the NPL. EPA may initiate further action to ensure continued
protectiveness at a deleted site if new information becomes available
that indicates it is appropriate. Whenever there is a significant
release from a site deleted from the NPL, the deleted site may be
restored to the NPL without application of the hazard ranking system.

III. Deletion Procedures

    The following procedures apply to deletion of the Site:
    (1) EPA consulted with the State of New York prior to developing
this direct final Notice of Deletion and the Notice of Intent to Delete
co-published today in the ``Proposed Rules'' section of the Federal
Register.
    (2) EPA has provided New York State 30 working days for review of
this notice and the parallel Notice of Intent to Delete prior to their
publication today, and the state, through the NYSDEC, has concurred on
the deletion of the Site from the NPL.
    (3) Concurrently with the publication of this direct final Notice
of Deletion, a notice of the availability of the parallel Notice of
Intent to Delete is being published in a major local newspaper, Dunkirk
Observer. The newspaper notice announces the 30-day public comment
period concerning the Notice

of Intent to Delete the Site from the NPL.
    (4) EPA placed copies of documents supporting the proposed deletion
in the deletion docket and made these items available for public
inspection and copying at the Site information repositories identified
above.
    (5) If adverse comments are received within the 30-day public
comment period on this deletion action, EPA will publish a timely
notice of withdrawal of this direct final Notice of Deletion before its
effective date and will prepare a response to comments and continue
with the deletion process on the basis of the Notice of Intent to
Delete and the comments already received.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Deletion of a site from
the NPL does not in any way alter EPA's right to take enforcement
actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist EPA management. Section
300.425(e)(3) of the NCP states that the deletion of a site from the
NPL does not preclude eligibility for future response actions, should
future conditions warrant such actions.

IV. Basis for Site Deletion

    The following information provides EPA's rationale for deleting the
Site from the NPL:

Site Background and History

    The Peter Cooper Site, EPA ID No. NYD980530265, is located off
Palmer Street, in the Village of Gowanda, Cattaraugus County, New York,
approximately 30 miles south of Buffalo, New York. The Site consists of
an inactive landfill and land associated with the former Peter Cooper
Corporation (PCC) animal glue and adhesives manufacturing plant. The
Site is bound to the north by Cattaraugus Creek (Creek), to the south
by Palmer Street, to the west by a former hydroelectric dam and wetland
area, and to the east by residential properties. Regionally, the
Village of Gowanda is located both in Erie County and Cattaraugus
County and is separated by Cattaraugus Creek. In Erie County, the
Village of Gowanda is included in the Town of Collins. The Town of
Collins is bordered by the Seneca Nation of Indians Cattaraugus
Reservation to the west. In Cattaraugus County, the Village of Gowanda
is in the Town of Persia. The Site is located in an area characterized
by mixed industrial-commercial/residential usage.
    For purposes of the remedial investigation and feasibility study
(RI/FS), the Site was divided into two sections. The western section,
called the inactive landfill area (ILA), is approximately 15.6 acres in
size and includes an additional five acres referred to as the
``elevated fill subarea.'' The westernmost portion of the elevated fill
subarea is located on property owned by the New York State Electric &
Gas Corporation (NYSEG). The eastern section of the Site, the former
manufacturing plant area (FMPA), is approximately 10.4 acres.
    From 1904 to 1972, PCC and its predecessor, Eastern Tanners Glue
Company, manufactured animal glue at the Site. When the animal glue
product line was terminated, PCC continued to produce synthetic
industrial adhesives until the plant closed in 1985. The wastes from
PCC's glue production were disposed of on the elevated fill subarea.
Between 1925 and October 1970, PCC used the northwest portion of the
property to pile sludge remaining after the animal glue manufacturing
process. These wastes, known as ``cookhouse sludge'' because of a
cooking cycle that occurred just prior to extraction of the glue, are
derived primarily from chrome-tanned hides obtained from tanneries. The
waste material has been shown to contain elevated levels of chromium,
arsenic, zinc, and several organic compounds.
    In June 1971, the New York State Supreme Court (8th J.D.
Cattaraugus County) ordered PCC to remove all or part of the waste pile
and terminate discharges into the Creek. In 1972, PCC reportedly
removed approximately 38,600 tons of waste pile material and
transferred it to a separate site in Markhams, New York. Between 1972
and 1975, the remaining waste pile at the Site was graded by PCC,
covered with a 6-inch clay barrier layer and 18 to 30 inches of soil,
and vegetated with grass. Stone rip-rap and concrete blocks were placed
along the bank of the Creek to protect the fill material from scouring
or falling into the Creek.
    In July 1976, the assets of the original PCC, including the
manufacturing plant and property located in Gowanda, were purchased by
Rousselot Gelatin Corporation and its parent, Rousselot, S.A., of
France. Rousselot Gelatin was renamed Peter Cooper Corporation, and
this newly-formed PCC sold the Site to JimCar Development, Inc. in
April 1988. The property was subsequently transferred to the Gowanda
Area Redevelopment Corporation (GARC) in 2009. Excluding the portion of
the Site owned by NYSEG, the remainder of the property is presently
owned by GARC. From 1981 to 1983, NYSDEC conducted several
investigations at the facility and identified the presence of arsenic,
chromium and zinc in soil and sediment samples. As a result of this
investigation, NYSDEC oversaw PCC's development of an RI/FS for the
Site. However, because the waste detected at the Site did not meet the
New York State statutory waste definition in effect in 1991 for an
inactive hazardous waste disposal site, NYSDEC removed the Site from
its Registry of Inactive Hazardous Waste Sites, and a remedy was not
selected.
    In 1996, EPA collected and analyzed soil, groundwater, surface
water, and sediment samples from the Site. Results of the sampling and
analysis confirmed contamination, including the presence of arsenic,
chromium, and other hazardous substances.
    During these Site assessments, EPA personnel observed that the
existing retaining wall was subject to severe erosion. It was
determined that the retaining wall and rip-rap had to be repaired or
upgraded to prevent the continued erosion of landfill materials into
the Creek. On October 24, 1996, EPA and NYSEG entered into an
administrative order on consent (AOC). Pursuant to the AOC, NYSEG
installed approximately 150 feet of rip-rap revetment along the south
bank of the Cattaraugus Creek and adjacent to the landfill to prevent
further erosion of materials from the landfill into the Creek.
    Based on this information, the Site was proposed to the NPL on
September 25, 1997 (62 FR 50450) and placed on the NPL on March 6, 1998
(63 FR 11332).

Remedial Investigation and Feasibility Study

    In April 2000, EPA issued a unilateral administrative order (UAO)
to fourteen respondents to perform the RI/FS of the Site, subject to
EPA oversight. Media sampled during the RI included landfill gas,
groundwater, surface water, sediment, soil, waste material, and seepage
emanating from the landfill.
    From 2000 to 2001, the UAO respondents, through their consultants,
Benchmark Environmental Engineering and Science PLLC (Benchmark) and
Geomatrix Consultants, performed a comprehensive RI to define the
nature and extent of contamination at the Site. The final RI report was
submitted to EPA in November 2003. The scope of the RI included the
following activities: the replacement of four wells from the existing
network of 10 monitoring wells in the ILA and the installation of six
new wells in the FMPA; surface water and sediment investigations of the
Creek; sludge fill characterization of the

ILA, by conducting three different activities (geophysical surveys,
test pits, and soil borings) to establish the limits of buried waste
fill material; an existing landfill cover evaluation by excavating 24
test holes to determine cover system thickness and characteristics; a
surface soil investigation of the ILA and FMPA, consisting of 30 soil
samples collected from zero to six inches below ground surface (bgs); a
subsurface soil investigation of the ILA and FMPA consisting of 23 soil
samples collected from three to 12 feet bgs; a landfill gas
investigation of the elevated fill area of the ILA; and a leachate seep
investigation of the elevated fill area of the ILA.
    An FS was then completed by the UAO respondents, and a report was
submitted to EPA in June 2005. The FS Report identified and evaluated
remedial alternatives to address soil contamination for the Site,
consistent with the guidelines presented in Guidance for conducting RI/
FS under CERCLA. A preferred alternative was presented to the public
for review and comment in July 2005. Results of the RI and FS were
summarized in the Record of Decision (ROD) issued by EPA in September
2005.
    Concurrent with completion of the RI/FS activities, the Village of
Gowanda in association with the University at Buffalo Center for
Integrated Waste Management developed a Reuse Assessment and Concept
Plan for the Site, in which it was concluded that the ``highest and
best use'' of the property would be as a multi-use recreational
facility. The Reuse Assessment and Concept Plan, funded in part by the
USEPA through its Superfund Redevelopment Initiative, envisions a
publicly-available Site incorporating elements such as a walking/biking
trail, fishing access, outdoor picnic areas, small boat launch, and
other related recreational features.

Selected Remedy

    Based upon the results of the RI/FS, a Proposed Plan, and a Public
Meeting, a Remedy was selected in September 2005. For this Site,
remedial action objectives (RAOs) were only established for soil. The
RAOs for soil are (1) to reduce or eliminate any direct contact threat
associated with the contaminant soils/fill, (2) to minimize or
eliminate contaminant migration from contaminated soils to the
groundwater and surface water, and (3) to minimize or eliminate
contaminant migration from groundwater to the Creek.
    The elements of the selected remedy are:
     Excavating three hot spot areas and consolidating waste
from these areas within the elevated fill subarea, capping the five-
acre elevated fill subarea of the inactive landfill area with a low
permeability, equivalent design barrier cap, consistent with the
requirements of 6 New York Codes, Rules and Regulations (NYCRR) Part
360, including seeding with a mixture of seeds to foster natural
habitat;
     Conducting post-excavation confirmatory soil sampling;
     Backfilling of excavated areas with clean fill; collecting
the leachate seeps, pretreating the leachate as necessary, then
discharging the leachate to the public owned treatment works (POTW)
collection system for further treatment and discharge. As a
contingency, if treatment of the leachate seep at the POTW is not
available, the leachate would be treated and discharged to Cattaraugus
Creek. Since the installation of the cap and groundwater diversion
system (described below) should reduce leachate generation, the volume
of seep leachate requiring treatment is anticipated to be reduced or
nearly eliminated over time;
     Installing a groundwater diversion system to limit
groundwater migration through the elevated fill subarea. The remedy
provides for the potential that if additional data collected in the
remedial design phase of the project support the conclusion that
installation of a diversion wall will result in a minimal increase in
the collection of contaminants by the leachate collection system, the
diversion wall would not be installed;
     Installing a passive gas venting system for proper venting
of the five-acre elevated fill subarea of the ILA;
     Stabilizing the banks of the Creek;
     Performing long-term operation and maintenance including
inspections and repairs of the landfill cap, gas venting, and leachate
systems;
     Performing air monitoring, surface water and groundwater
quality monitoring; and
     Evaluating Site conditions at least once every five years
to determine if the remedy remains protective.
    The remedy also included institutional controls such as restrictive
covenants and environmental easements for limiting future use of the
Site and the groundwater to ensure that the implemented remedial
measures will not be disturbed and that the Site will not be used for
purposes incompatible with the completed remedial action. The
institutional controls will be managed, in part, through a Site
Management Plan (SMP) to ensure appropriate handling of subsurface
soils during redevelopment.
    To ensure that engineering controls and institutional controls
remain in place and effective for the protection of public health and
the environment, an annual certification, commencing from the date of
implementation, has been required to be performed by the parties
responsible for implementing the remediation.
    Consistent with the future use of the property, following issuance
of the ROD, the Village of Gowanda and the UAO recipients entered into
discussions concerning the Village's redevelopment goals. An agreement
was reached, and GARC took ownership of the Site and agreed to perform
certain post-remedial operation and maintenance and monitoring
activities in exchange for provision of specific, non-remedial
construction activities and funding by the respondents to facilitate
park redevelopment. Non-remedial construction activities that were
slated to be performed by the UAO recipients, concurrent with remedial
activities, are listed below.
     Removal of up to 1,000 tons of non-hazardous construction
and demolition debris from the former manufacturing plant area of the
site, with disposal of the materials beneath the elevated fill subarea
cover (in a manner to prevent settlement) or off-site disposal at a
permitted disposal facility.
     Construction of a clean utility corridor (i.e., waterline)
to facilitate utility service to a future, multi-use building,
pavilion, or other park development.
     Elevated fill subarea cover system grading and contouring
to facilitate Site development plans. This involved creating a benched
area along the Creek side of the landfill that may provide a level area
for future construction of a bike or walking path.

Response Actions

    In 2009, EPA concluded consent decree (CD) negotiations with a
subgroup of the UAO recipients, identified as the performing settling
defendants (PSDs), related to the performance of the design and
implementation of the remedy called for in the ROD. On February 12,
2009, the CD was entered in United States District Court. On March 15,
2009, Benchmark was approved as the supervising contractor to conduct
the remedial design (RD) and implement the remedy at the Site. The ROD
included provisions for the evaluation of the construction of a
diversion wall around the elevated fill area in the event the wall
would affect the planned remedial

actions. In accordance with the ROD, EPA and NYSDEC concurred with the
findings of an analysis performed by the PSDs, prior to the entry of
the CD, that the installation of an upgradient groundwater diversion
wall around the elevated fill subarea would not materially alter the
effectiveness of the planned remedial measures; therefore, the
diversion wall component of the ROD was not implemented.
    In accordance with the requirements of the CD, the PSDs prepared a
RD work plan. The RD work plan outlined the following remedial
construction measures: Mobilization; site preparation, including
hotspot excavation; groundwater/seep collection; and cover system
construction (barrier layer material placement and compaction, topsoil
and seeding, and passive gas venting). In 2009, the RD report and
design plans and specifications were implemented under a design build
contract for Site remediation. The RD report identified materials to be
employed for major remedial components, construction requirements,
quality control requirements, and measures to protect workers, the
surrounding community, and the environment during the remedial work.
    In the Summer of 2009, the PSDs conducted certain preparatory
activities at the Site to facilitate the remedial construction. These
activities included the removal of small trees, shrubs, brush, and
stumps. Clearing and grubbing in and around the area of the elevated
fill area was performed with a hydro ax. The staged trees, stumps, and
brush were ground into mulch and were hauled off-site for processing at
a permitted facility.
    The excavation of the three ``hotspot'' areas of contaminated soil/
fill was completed in August 2009. Soil excavated from these impacted
areas was hauled to the elevated fill subarea of the ILA for placement
and compaction prior to placing the soil cover system. The excavated
areas were then backfilled with clean soil. Confirmatory sampling of
the excavation sidewalls and bottom indicated arsenic and VOC
concentrations that remained were below the Site cleanup goals.
    Construction of the seep/groundwater collection system was
substantially completed in November 2009. The collection system
includes the Creek bank regrading and bedrock channel excavation, the
pump station installation, the pretreatment building construction, the
force main piping, and the sanitary sewer tie-in. The seep/groundwater
collection system was placed into full-time operation in May 2010, with
operation and maintenance duties transferred to GARC.
    The remedial measures for the elevated fill subarea involved re-
grading the adjacent bank (excluding the riprap-stabilized area on
NYSEG's property) and removal of concrete blocks and boulders to
provide a more uniform slope for reduced erosion potential. A seep
collection trench was then excavated into the surface of the weathered
shale bedrock at the toe of the slope to intercept and collect the
seeps. A perforated drainage pipe and granular media envelope collect
and transmit water to a packaged leachate pump station. The slope of
the regraded bank is lined with a geocomposite drainage layer, leading
to the collection trench, covered by a geomembrane liner to prevent
seep breakout and mitigate Creek and surface water infiltration during
high water conditions. The liner extends vertically to the 100-year
floodplain elevation and is protected from erosion by a surface layer
of medium and large riprap over a non-woven geotextile fabric and
gravel bed. Collected seep water and shallow groundwater are conveyed
from the pump station by a force main to a pretreatment building where
an oxidant delivery system is available to mitigate hydrogen sulfide
odors, as needed. Pretreated seeps/groundwater is discharged to the
Village of Gowanda's sanitary sewer collection system on Palmer Street
for treatment at the Village POTW consistent with the approved
discharge permit.
    The final cap system, installed from August 2009 to July 2010,
includes all the construction components in the approved RD report.
Containment/isolation with soil cover enhancement involved the
following: clearing and grubbing the approximate five-acre elevated
fill subarea; moderate regrading and/or filling of low spots across the
five-acre area to facilitate runoff; supplementing existing cover to
provide for a minimum 18-inch thickness of a recompacted soil barrier
layer and placement of six inches of topsoil over the five-acre area;
and reseeding of the elevated fill subarea cover to provide for a good
stand of grass that will foster natural habitat. Cover soils were
tested to assure conformance with contaminant levels established under
state law.
    Following construction of the cap, five passive gas vents were
installed through the sludge fill in the elevated fill subarea to
relieve gas buildup beneath the cover system. The vents were
constructed with individual risers that extend to a sufficient height
above ground surface to promote atmospheric dispersion of odor-causing
constituents and prevent direct inhalation of vented gases by
trespassers or future recreational Site users.
    EPA and NYSDEC conducted a final inspection of the constructed
remedy on September 9, 2010. Based on the results of the inspection, it
was determined that the Site construction was complete and that the
remedy was implemented consistent with the ROD. In the final inspection
EPA concluded that the PSDs constructed the remedy in accordance with
the RD plans and specifications, and no further response (other than
the operation and maintenance of the cap and cover, and long-term
groundwater monitoring) is anticipated. EPA approved the remedial
action report (RAR) for the Site on June 17, 2011. The RAR documented
all the remedial activities conducted at the Site and included as-built
drawings to document Site conditions at completion. The PSDs and GARC,
the latter being the current property owner, are sharing
responsibilities for management of the Site in accordance with the SMP.
The ROD called for the development of a SMP to provide for the proper
management of all post-construction remedy components including an
environmental easement that describes the institutional controls
incorporated into the remedy and the requirement for certification that
the institutional controls remain effective and in place.
    As mention above, the environmental easement and/or restrictive
covenant was designed to restrict the use of on-Site groundwater as a
source of potable or process water and to restrict activities on the
Site that could compromise the integrity of the cap. The restrictions
are memorialized in an environmental easement filed with the
Cattaraugus County Clerk on March 30, 2009.
    Currently all areas of the Site designated for passive recreational
use have been covered with a minimum of one foot of clean, vegetated
cover soil or pavement, and those designated for active recreational
use have been covered with a minimum of two feet of clean, vegetated
cover soil or pavement. Inspections were performed by GARCs designated
engineer to verify that the minimum required soil thicknesses were
achieved. As part of the redevelopment efforts, the following Park
amenities and improvements were constructed during 2016 and 2017:
     Regulation (90 foot diamond) ballfield:
     Playground and equipment
     Paved parking area and extension of asphalt path
     Ballfield backstop

     24' x 24' gazebo

Verification of Cleanup Levels

    Data are collected and reviewed to ensure that the RAOs are met
following implementation of the remedial action. For this Site, RAOs
were only established for soil. The RAOs for soil are (1) to reduce or
eliminate any direct contact threat associated with the contaminant
soils/fill, (2) to minimize or eliminate contaminant migration from
contaminated soils to the groundwater and surface water, and (3) to
minimize or eliminate contaminant migration from groundwater to the
Creek. These RAOs and the associated cleanup levels set forth in the
ROD were met upon completion of the remedial construction, as
documented in the RAR for the Site dated September 2010. Because of the
limited remaining risks from exposure to the groundwater and surface
water at this Site, institutional controls are deemed necessary to
address any potential future exposure. Specifically, deed restrictions
have been imposed to prevent the use of groundwater as a source of
potable or process water unless groundwater quality standards are met.
Long-term monitoring will be conducted to ensure that the selected Site
remedy is protective of human health and the environment. Groundwater
and surface water will be monitored as part of the post-construction
response activities to ensure that the contamination is attenuating,
and groundwater quality continues to improve.
    Groundwater monitoring was performed during 10 separate events in
June 2011, January 2012, June 2012, January 2013, June 2013, June 2014,
October 2015, October 2016, November 2017 and October 2018. Groundwater
samples were collected from five monitoring wells (MWs) at the Site.
Samples were analyzed for inorganic parameters (total metals), VOCs
(chlorinated aliphatics only), and water quality parameters (ammonia,
hardness, chloride, total sulfide). Total metals analyses included
hexavalent chromium, total chromium, arsenic, and manganese.
Groundwater results were compared to the more stringent of the State or
federal promulgated standards.
    VOC concentrations were either not detected (nondetect) or below
the state Groundwater Quality Standards and Guidance Values (GWQS/GV)
at all monitoring well locations, with the exception of
tetrachloroethene (PCE) and cis-1,2-dichloroethene (cis-1,2- DCE). PCE
was detected above the GWQS of 5 ug/L, with concentrations ranging from
5.9 micrograms per liter (ug/L) to 13 ug/L. Cis-1,2-DCE was detected
above the GWQS of 5 ug/L with concentrations ranging from 5.4 ug/L to
8.5 ug/L. These sporadic, slight VOC exceedances of GWQS criteria are
not considered significant, and do not constitute a contaminant plume
requiring response action.
    Concentrations reported for hexavalent chromium were nondetect or
below GWQS at all monitoring locations. Total chromium was reported as
nondetect or below the GWQS of 0.05 milligram/liter (mg/L) at all
monitored locations, with the exception of two minor exceedances of
0.056 mg/L and 0.054 mg/L. These sporadic, slight exceedances of total
chromium GWQS criteria are not considered significant.
    Arsenic was reported above the federal Maximum Contaminant Levels
(MCLs) of 0.010 mg/L, with concentrations ranging from 0.011 mg/L to
0.043 mg/L. Arsenic was also detected in the upgradient well, so the
exceedances in on-site wells are not considered to be Site-related.
Manganese was detected above the GWQS of 0.03 mg/L with concentrations
ranging from 0.37 mg/L to 6.6 mg/L. The manganese screening criteria is
a secondary MCL. Secondary MCLs do not require regulatory actions since
they represent aesthetic parameters. They will continue to be
monitored.
    The water quality parameters reported for all sampling events were
nondetect or below the GWQS for sulfide and chloride at all sampling
locations. Ammonia was detected above the GWQS of 2 mg/L during all
monitoring events at concentrations ranging from 3.5 mg/L to 10.8 mg/L.
However, ammonia was also detected in the upgradient monitoring well,
so the exceedances are not considered to be Site-related. The
groundwater data review indicates that the low levels of contamination
in Site groundwater are attenuating and groundwater quality has
improved compared to baseline levels measured prior to commencement of
remedial activities. In general, the data indicate minor/seasonal
changes in concentration for the monitored parameters at each of the
sample locations with no upward trending. These data support the
assumption set forth in the ROD that the groundwater contamination is
localized and the decrease in frequency indicates that limited residual
groundwater contamination has attenuated. The environmental easement
placed on the Site property restricts the use of groundwater as a
source of potable or process water unless groundwater quality standards
are met. Groundwater quality will continue to be monitored in
accordance with the SMP.
    Surface water samples were collected from three locations along the
Creek at the same time as the groundwater samples were obtained from
June 2011 through October 2018. Samples were also analyzed for
inorganic parameters (total metals), VOCs (chlorinated aliphatics only)
and water quality parameters (ammonia, hardness, chloride, total
sulfide). Total metals analyses include hexavalent chromium, total
chromium, arsenic, and manganese.
    VOCs, sulfide, and chloride were not detected during any surface
water sampling event. Ammonia was detected above the Surface Water
Quality Standards (SWQS) of 0.035 mg/L and iron and manganese were
detected above the SWQS of 0.30 mg/L. Although ammonia, iron and
manganese concentrations were reported above standards, this appears
attributable to naturally occurring conditions as evidenced by their
presence of concentrations above the standards in the upstream surface
water sample. In addition, iron does not have a primary standard, and
is not considered a contaminant of concern for the Site.
    The surface water data review indicates few exceedances of the
standards with no observed impact from the Site to the Creek. This
indicates that there is no contaminated groundwater plume emanating
from the landfill area. Surface water quality will continue to be
monitored in accordance with the SMP.

Operation and Maintenance

    A long-term monitoring program in being implemented that was
designed to ensure that the implemented remedy remains effective. The
majority of the long-term monitoring program, which is being conducted
by Benchmark under contract to the PSDs, includes the following: Annual
inspection of the landfill cover system; monitoring of the gas venting
system; inspection of groundwater level monitoring; collection of
groundwater samples from selected wells; collection of surface water
samples from the Creek at three locations and groundwater samples from
five wells; and providing annual reports on these activities to NYSDEC
and EPA. The Groundwater/Seep Collection and Pretreatment systems are
monitored semi-annually by the Village of Gowanda, on behalf of GARC.

Five-Year Review

    Because hazardous substances, pollutants, or contaminants remain at
the Site above levels that would otherwise allow for unlimited use and
unrestricted exposure, a statutory five-

year review is required. The first five-year review was completed in
April 2015. In the review EPA concluded that the remedy is functioning
as intended and is protective of human health and the environment. The
five-year review did not include any issues or recommendations. The
next five-year review will be completed before April 2020.

Community Involvement

    Public participation activities for this Site have been satisfied
as required in CERCLA 113(k) and Section 117. As part of the remedy
selection process, the public was invited to comment on EPA's proposed
remedies. All other documents and information that EPA relied on or
considered in recommending this deletion are available for the public
to review at the information repositories identified above.

Determination That the Site Meets the Criteria for Deletion in the NCP

    EPA, with the concurrence of the State of New York through NYSDEC,
has determined that all required and appropriate response actions have
been implemented by the responsible parties. The criteria for deletion
from the NPL (40 CFR 300.425(e)(1)(I)) are met. The implemented remedy
achieves the protection specified in the ROD(s) for all pathways of
exposure. All selected remedial and removal action objectives and
associated cleanup levels are consistent with agency policy and
guidance. No further Superfund response is needed to protect human
health and the environment.

V. Deletion Action

    The EPA, with concurrence of the State of New York through the
NYSDEC, has determined that all appropriate response actions under
CERCLA, other than operation and maintenance, monitoring and five-year
reviews have been completed. Therefore, EPA is deleting the Site from
the NPL.
    Because EPA considers this action to be noncontroversial and
routine, EPA is proposing to delete the Site without prior publication.
This action will be effective September 30, 2019, unless EPA receives
adverse comments by August 29, 2019. If adverse comments are received
within the 30-day public comment period, EPA will publish a timely
withdrawal of this direct final notice of deletion before the effective
date of the deletion, and the deletion will not take effect. EPA will
prepare a response to comments and continue with the deletion process,
as appropriate, on the basis of the notice of intent to delete and the
comments already received. If there is no withdrawal of this direct
final notice of deletion, there will be no additional opportunity to
comment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: July 16, 2019.
Peter D. Lopez,
Regional Administrator, Region 2.

    For the reasons set out in this document, 40 CFR part 300 is
amended as follows:

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626,
77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3
CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp.,
p. 193.

Subpart L--National Oil and Hazardous Substances Pollution
Contingency Plan; Involuntary Acquisition of Property by the
Government

Appendix B to Part 300 [Amended]

0
2. Table 1 of Appendix B to part 300 is amended by removing the entry:
``NY, Peter Cooper, Gowanda''.

[FR Doc. 2019-16065 Filed 7-29-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Rules and Regulations]
[Pages 53264-53265]
[FR Doc No: 2016-19001]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-1074; Airspace Docket No. 16-ASO-3]

Revocation of Class D Airspace; North, SC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action removes Class D Airspace at North, SC, as the
North Air Force Auxiliary Field Air Traffic Control Tower is no longer
staffed, and the controlled Class D airspace area is no longer
required.

DATES: Effective 0901 UTC, November 10, 2016. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Z, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/airtraffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.9Z at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it removes Class D airspace at North Air Force Auxiliary Field,
North, SC.

History

    On March 28, 2016, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to remove Class D airspace at
North Air Force Auxiliary Field, North, SC., (81 FR 17111) FAA 2016-
1074. No comments were received.
    Class D airspace designations are published in paragraphs 5000 of
FAA Order 7400.9Z dated August 6, 2015, and effective September 15,
2015, which is incorporated by reference in 14 CFR part 71.1. The Class
D airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Z, Airspace Designations and
Reporting Points, dated August 6, 2015, and effective September 15,
2015. FAA Order 7400.9Z is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B,
C, D, and E airspace areas, air traffic service routes, and reporting
points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 removes Class D airspace at North Air Force Auxiliary Field,
North, SC. The air traffic control tower is no longer in use.
Therefore, the Class D airspace area is no longer necessary.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist

that warrant preparation of an environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z,
Airspace Designations and Reporting Points, dated August 6, 2015,
effective September 15, 2015, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO SC D North, SC [Removed]

    Issued in College Park, Georgia, on August 4, 2016.
Joey L. Medders,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2016-19001 Filed 8-11-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Pages 21846-21847]
[FR Doc No: 2020-08258]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC20-15-000]

Commission Information Collection Activities (FERC-510); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of information collection and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the proposed extension of
currently approved information collection, FERC-510 (Application for
Surrender of a Hydropower License).

DATES: Comments on the collection of information are due June 19, 2020.

ADDRESSES: You may submit comments (identified by Docket No. IC20-15-
000) by either of the following methods:
     eFiling at Commission's website: http://www.ferc.gov/docs-filing/efiling.asp
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, at Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER>
(toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>and telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Title: FERC-510, Application for Surrender
of a Hydropower License.
    OMB Control No.: 1902-0068.
    Type of Request: Three-year extension of the FERC-510 information
collection requirements with no changes to the current reporting and
recordkeeping requirements.
    Abstract: The information collected under the requirements of FERC-
510 is used by the Commission to implement the statutory provisions of
sections 4(e), 6, and 13 of the Federal Power Act (FPA) (16 U.S.C.
797(e), 799 and 806). Section 4(e) gives the Commission authority to
issue licenses for the purposes of constructing, operating and
maintaining dams, water conduits, reservoirs, powerhouses, transmission
lines or other power project works necessary or convenient for
developing and improving navigation, transmission and utilization of
power using bodies of water over which Congress has jurisdiction.
Section 6 gives the Commission the authority to prescribe the
conditions of licenses including the revocation or surrender of the
license. Section 13 defines the Commission's authority to delegate time
periods for when a license must be terminated if project construction
has not begun. Surrender of a license may be desired by a licensee when
a licensed project is retired or not constructed or natural
catastrophes have damaged or destroyed the project facilities.
    FERC-510 is the application for the surrender of a hydropower
license. The information is used by Commission staff to determine the
broad impact of such surrender. The Commission will issue a notice
soliciting comments from the public and other agencies and conduct a
careful review of the application before issuing an order for Surrender
of a License. The order is the result of an analysis of the information
produced (i.e., dam safety, public safety, and environmental concerns,
etc.), which is examined to determine whether any conditions must be
satisfied before granting the surrender. The order implements the
existing regulations and is inclusive for surrender of all types of
hydropower licenses issued by FERC and its predecessor, the Federal
Power Commission. The Commission implements these mandatory filing
requirements in the Code of Federal Regulations (CFR) under 18 CFR 6.1-
6.4.
    Type of Respondent: Private or Municipal Hydropower Licensees.
    Estimate of Annual Burden \1\: The Commission estimates the total
annual burden and cost \2\ for this information collection as follows:
---------------------------------------------------------------------------

    \1\ ``Burden'' is 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. For additional
information, refer to Title 5 Code of Federal Regulations 1320.3.
    \2\ The Commission staff thinks that the average respondent for
this collection is similarly situated to the Commission, in terms of
salary plus benefits. The FERC 2019 average salary plus benefits for
one FERC full-time equivalent (FTE) is $167,091/year (or $80.00/
hour).

                                                                        FERC-510
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Annual number
   Number of       of responses   Total number of     Average  burden hrs. & cost  ($) per    Total annual  burden hrs. &  total annual      Cost per
  respondents     per respondent      responses                     response                                  cost  ($)                   respondent ($)
(1)                         (2)    (1)*(2) = (3)   (4)......................................  (3)*(4) = (5)............................       (5) / (1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
             8                1                8   80 hrs.; $6,400..........................  640 hrs.; $51,200........................          $6,400
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: April 14, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-08258 Filed 4-17-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Notices]
[Page 67505-67506]
[DOCID:fr14no08-73]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

November 7, 2008.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at 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. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
                  Docket No.                    File date                  Presenter or requester
----------------------------------------------------------------------------------------------------------------
Prohibited:
    1. EL08-34-000...........................     10-29-08  Derek Bandera.
    EL08-47-000..............................
    2. ER08-1209-000.........................     10-30-08  Michael G. Henry.\1\
Exempt:
    1. Project No. 2210-169..................     10-28-08  John and Kimberly Puterio.
    2. Docket No. 2677-000...................     10-27-08  Arie DeWaal.
----------------------------------------------------------------------------------------------------------------
\1\ Slide presentation from ISO New England, Inc.--only brought to SOC from Michael G. Henry for entry into the
  non-decisional record for referenced dockets.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-27044 Filed 11-13-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42902-42903]
[FR Doc No: 2018-18339]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3092]

Hematologic Malignancy and Oncologic Disease: Considerations for
Use of Placebos and Blinding in Randomized Controlled Clinical Trials
for Drug Product Development; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Hematologic Malignancy and Oncologic Disease: Considerations for Use
of Placebos and Blinding in Randomized Controlled Clinical Trials for
Drug Product Development.'' This draft guidance provides
recommendations to industry regarding the use of placebos and blinding
in randomized controlled clinical trials in development programs for
drug or biological products for the treatment of hematologic
malignancies and oncologic diseases regulated by the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation
and Research (CBER).

DATES: Submit either electronic or written comments on the draft
guidance by October 23, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-3092 for Hematologic Malignancy and Oncologic Disease:
Considerations for Use of Placebos and Blinding in Randomized
Controlled Clinical Trials for Drug Product Development. Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the

heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Hematologic Malignancy and Oncologic Disease: Considerations
for Use of Placebos and Blinding in Randomized Controlled Clinical
Trials for Drug Product Development.'' This draft guidance provides
recommendations to industry regarding the use of placebos and blinding
in randomized controlled clinical trials in development programs for
drug or biological products for the treatment of hematologic
malignancies and oncologic diseases regulated by CDER and CBER.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the use of
placebos and blinding in randomized controlled clinical trials for drug
product development for hematologic malignancy and oncologic disease.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in 21 CFR part 312 (Investigational New Drug
Application) has been approved under OMB control number 0910-0014. The
collections of information in 21 CFR parts 50 and 56 (Protection of
Human Subjects: Informed Consent; Institutional Review Boards) have
been approved under OMB control number 0910-0755.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: August 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18339 Filed 8-23-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 25, 2010 (Volume 75, Number 100)]
[Notices]
[Page 29350-29352]
[DOCID:fr25my10-66]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0260]

Draft Guidance for Industry: Questions and Answers Regarding the
Reportable Food Registry as Established by the Food and Drug
Administration Amendments Act of 2007 (Edition 2); Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of availability and request for comments.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled

``Questions and Answers Regarding the Reportable Food Registry as
Established by the Food and Drug Administration Amendments Act of 2007
(Edition 2).'' The draft guidance provides information to the industry
in complying with the Reportable Food Registry requirements prescribed
by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Further, the draft guidance addresses inquiries that the agency has
received through its Reportable Food Registry help desk and/or by other
means since the implementation of the Reportable Food Registry on
September 8, 2009, and provides information on the new Safety Reporting
Portal. The agency is also seeking comments from industry on the
Reportable Food Registry requirements, and specifically on the issue of
``transfer'' as discussed in the current Edition 1, and draft Edition 2
guidance.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comments on
the draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by July 26, 2010.

ADDRESSES:  Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Office of Food Defense, Communication and Emergency Response (HFS-005),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Faye Feldstein, Center for Food Safety
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, the President signed into law the Food and
Drug Administration Amendments Act of 2007 (FDAAA). This law amends the
Federal Food, Drug, and Cosmetic Act (the act) by creating a new
section 417 (21 U.S.C. 350f), Reportable Food Registry. Section 417 of
the act requires the Secretary of Health and Human Services (the
Secretary) to establish within FDA a Reportable Food Registry. The
congressionally-identified purpose of the Reportable Food Registry is
to provide a ``reliable mechanism to track patterns of adulteration in
food [which] would support efforts by the Food and Drug Administration
to target limited inspection resources to protect the public health''
(Pubic Law 110-085, section 1005(a)(4)). The Secretary has delegated to
the Commissioner of Food and Drugs the responsibility for administering
the act, including section 417. To further the development of the
Reportable Food Registry, section 417 of the act requires FDA to
establish an electronic portal by which instances of reportable food
must be submitted to FDA by responsible parties and may be submitted by
public health officials. After receipt of reports through the
electronic portal, FDA is required to review and assess the information
submitted for purposes of identifying reportable food, submitting
entries to the Reportable Food Registry, issuing an alert or
notification as FDA deems necessary, and exercising other existing food
safety authorities under the act to protect the public health. The
requirements under the Reportable Food Registry became effective on
September 8, 2009.
    In the Federal Register of June 11, 2009, FDA announced the
availability of a draft guidance entitled ``Questions and Answers
Regarding the Reportable Food Registry as Established by the Food and
Drug Administration Amendments Act of 2007'' and gave interested
parties an opportunity to submit comments by July 27, 2009 (74 FR
27803). The agency reviewed and evaluated these comments and issued a
final guidance on September 9, 2009 (74 FR 46434). This draft guidance
is the second edition of that guidance entitled ``Questions and Answers
Regarding the Reportable Food Registry as Established by the Food and
Drug Administration Amendments Act of 2007 (Edition 2)'' and responds
to inquiries that the agency has received through its Reportable Food
Registry help desk and/or by other means since the implementation of
the Reportable Food Registry on September 8, 2009, and informs industry
about the new Safety Reporting Portal. The Safety Reporting Portal is a
joint FDA-National Institutes of Health (NIH) system that facilitates
the process of reporting several categories of safety information to
the FDA and the NIH. As of May 24, 2010, the Reportable Food electronic
portal will be a part of the Safety Reporting Portal.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the topics
discussed. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternate approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance were approved under OMB
control numbers 0910-0643 and 0910-0645. This guidance also refers to
previously approved collections of information found in FDA
regulations. The collection of information in 21 CFR 7.46 has been
approved under OMB control number 0910-0249.

III. Request for Comments

    In addition, although the industry is encouraged to submit comments
regarding any of the requirements under the Reportable Food Registry,
the agency is seeking comments specifically with regard to the meaning
of the word ``transfer'' as it appears in section 417(d)(2)(B) of the
act. The meaning of the word ``transfer'' in this context was discussed
in Edition 1 of the guidance at Question and Answer numbers 27 and 28,
and in the draft Edition 2 guidance at Question and Answer numbers E.4
and E.5.
    Section 417(d)(2) of the act provides an exemption from the
requirement that a responsible party submit a reportable food report.
In order for the exemption to apply, the adulteration must have
originated with the responsible party, the responsible party must have
detected the adulteration ``prior to any transfer to another person''
of the article of food, and the responsible party must have corrected
the adulteration or destroyed the food. However, Congress did not
provide a definition for the term ``transfer'' as it is used in section
417(d)(2)(B) of the act. In Edition 1 of the guidance at Question and
Answer numbers 27 and 28, and in the draft Edition 2 guidance at
Question and Answer numbers E.4 and E.5, FDA said that a transfer to
another person occurs when the responsible person releases the food to
another person. In this document, FDA is asking for comment on whether
this interpretation of the term ``transfer'' is appropriate, and if
not,

what other interpretations of the term ``transfer'' as it is used in
section 417(d)(B)(2) of the act would be more appropriate.
Specifically, we are requesting comment on whether the interpretation
of the term ``transfer'' should be dependent upon possession of the
food, whether the interpretation should be dependent on ownership of
the food, or whether there are other interpretations we should
consider, such as a combination of possession and/or ownership.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: May 19, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-12456 Filed 5-24-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: October 18, 2006 (Volume 71, Number 201)]
[Rules and Regulations]
[Page 61410-61413]
[DOCID:fr18oc06-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0792; FRL-8098-5]

Flumioxazin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for
residues of flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-
2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione
in or on alfalfa forage and alfalfa hay. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on alfalfa. This regulation establishes a maximum
permissible level for residues of flumioxazin in this food commodity.

The tolerance expires and is revoked on December 31, 2009.

DATES: This regulation is effective October 18, 2006. Objections and
requests for hearings must be received on or before December 18, 2006,
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-2006-0792. All documents in the
docket are listed on the regulations.gov Web site. 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 either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, 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:
     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 provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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 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 the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0792 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 on or
before December 18, 2006.
    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 your copies, identified by docket ID
number EPA-HQ-OPP-2006-0792, 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
Building), 2777 S. Crystal Drive, 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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for residues of the herbicide,
flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione in or on
alfalfa forage at 0.13 parts per million (ppm) and alfalfa hay at 0.45
ppm. These tolerances expire and are revoked on December 31, 2009. EPA
will publish a document in the Federal Register to remove the revoked
tolerance from the Code of Federal Regulations (CFR). EPA is also
removing an expired tolerance for residues of flumioxazin on sweet
potato, roots.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . .''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Flumioxazin on Alfalfa and FFDCA
Tolerances

    [Arizona states that herbicides currently available for use in
Arizona alfalfa have not been effective either because they provided
poor control of groundsel, had poor crop safety, or undesirable
plantback intervals. Losses resulting from groundsel infestation of
alfalfa are generated not by actual yield losses due to groundsel
infestation but rather they are due to loss of sale of alfalfa for
horse and cattle feed. There is an approximate 85% reduction in the net
revenue for alfalfa producers because alfalfa infested with groundsel
is not marketable feed for cattle and horses because groundsel is
highly toxic for these animals]. EPA has authorized under FIFRA section
18 the use of flumioxazinon alfalfa for control of common groundsel
(Senecio vulgarius) in Arizona. After having reviewed the submission,
EPA concurs that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of flumioxazin in or on
alfalfa. In doing so, EPA considered the safety standard in section
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerances
under section 408(l)(6) of the FFDCA would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing these tolerances without notice and opportunity
for public comment as provided in section 408(l)(6) of the FFDCA.
Although these tolerances expire and are revoked on December 31, 2009,
under section 408(l)(5) of the FFDCA, residues of the pesticide not in
excess of the amounts specified in the tolerances remaining in or on
alfalfa forage and alfalfa hay after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
these tolerances at the time of that application. EPA will take action
to revoke these tolerances earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
    Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether flumioxazin
meets EPA's registration requirements for use on alfalfa or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of flumioxazin by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than Arizona to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for flumioxazin, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    Consistent with section 408(b)(2)(D) of the 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
flumioxazin and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for residues of flumioxazin in or on alfalfa forage at 0.13
ppm and alfalfa hay at 0.45 ppm.
    On May 3, 2006 the Agency published a Final Rule (71 FR 25951, FRL-
8057-5) establishing tolerances for residues of flumioxazin, 2-[7-
fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione in or on pome fruit crop
group 11, stone fruit crop group 12 and strawberry. When the Agency
conducted the risk assessments in support of those tolerance actions,
the Agency also assessed the use of flumioxazin on alfalfa under
section 18 of FIFRA. Therefore, establishing the alfalfa tolerances
will not change the most recent estimated aggregate risks resulting
from use of flumioxazin, as discussed in the May 3, 2006 Federal
Register. Refer to the May 3, 2006 Federal Register document for a
detailed discussion of the aggregate risk assessments and determination
of safety. EPA relies upon those risk assessments and the findings made
in the Federal Register document in support of this action.
     Based on the risk assessments discussed in the final rule
published in the Federal Register of May 3, 2006, EPA concludes that
there is a reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
flumioxazin residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography-nitrogen
phosphorus detection) 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

    There are no Codex, Canadian or Mexican maximum residue limits
established for flumioxazin on alfalfa.

VI. Conclusion

    Therefore, tolerances are established for residues of flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on alfalfa forage
at 0.13 ppm and alfalfa hay at 0.45 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section
408 of the FFDCA. 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 due to
its lack of significance, 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). 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., or 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). 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); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). 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). Since tolerances and exemptions that are
established on the basis of a FIFRA section 18 exemption under section
408 of the FFDCA, such as the tolerances 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.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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).

 Subjects in 40 CFR Part 180

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

    Dated: October 5, 2006.
Lois Rossi,
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 180.568 is amended by revising the table in paragraph (b) to
read as follows:

Sec.  180.568  Flumioxazin; tolerances for residues.

* * * * *
     (b) * * *

------------------------------------------------------------------------
                                                            Expiration/
                  Commodity                    Parts per    revocation
                                                million        date
------------------------------------------------------------------------
Alfalfa, forage..............................       0.13        12/31/09
Alfalfa, hay.................................       0.45        12/31/09
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-17138 Filed 10-17-06; 8:45 am]

BILLING CODE 6560-50-S