[Federal Register Volume 78, Number 234 (Thursday, December 5, 2013)]
[Rules and Regulations]
[Pages 73097-73104]
[FR Doc No: 2013-28808]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 228

[EPA-R06-OW-2011-0712; FRL-9903-26-Region-6]

Ocean Dumping; Sabine-Neches Waterway (SNWW) Ocean Dredged
Material Disposal Site Designation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA today designates four new Ocean Dredged Material
Disposal Sites (ODMDS) located offshore of Texas for the disposal of
dredged material from the Sabine-Neches Waterway (SNWW) Channel
Improvement Project (CIP), which includes an extension of the Entrance
Channel into the Gulf of Mexico, pursuant to the Marine Protection,
Research and Sanctuaries Act, as amended (MPRSA). The designation of
these four disposal sites does not by itself authorize the disposal of
dredged material, but makes these sites available for use for dredged
material from the CIP if no environmentally preferable, practicable
alternative for managing that dredged material exists, and if analysis
of the dredged material indicates that it is suitable for open-water
disposal. This action is to designate adequate, environmentally-
acceptable ocean disposal site capacity for suitable dredged material
generated from new work (construction) and future maintenance dredging
from the SNWW CIP.

DATES: This rule is effective on January 6, 2014.

FOR FURTHER INFORMATION CONTACT: Jessica Franks, Ph.D., Marine and
Coastal Section (6WQ-EC), Environmental Protection Agency, Region 6,
1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733, telephone (214)
665-8335, fax number<PHONE_NUMBER>; email address
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

     A. Potentially Affected Entities
     B. Background
     C. Site Location
     D. Disposal Volume Limit
     E. Site Management and Monitoring Plan
     F. Ocean Dumping Site Designation Criteria
     General Selection Criteria
     Specific Selection Criteria
     G. Responses to Comments
     1. Concerns About Minimizing Ocean Disposal by
Maximizing Beneficial Re-use
     2. Concerns About a Consistency Determination
     3. Question on the Designation Process
     H. Regulatory Requirements
     National Environmental Policy Act (NEPA)
     Endangered Species Act Consultation
     Magnuson-Stevens Fishery Conservation and Management
Act of 1996
     Coastal Zone Management Act
     Coastal Barrier Improvement Act of 1990
     Administrative Review
     Executive Order 12886
     Paperwork Reduction Act
     Regulatory Flexibility Act, as Amended by the Small
Business Regulatory Enforcement Fairness Act of 1996
     Unfunded Mandates
     Executive Order 13132: Federalism
     Executive Order 13175: Consultation and Coordination
With Indian Tribal Governments
     Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
     Executive Order 13211: Actions That Significantly
Affect Energy Supply, Distribution, or Use Compliance With
Administrative Procedure Act
     National Technology Transfer Advancement Act
     Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low Income
Populations
     List of Subjects in 40 CFR Part 228

    The supporting document for these site designations is the Final
Environmental Impact Statement (EIS) for the Sabine-Neches Waterway
Channel Improvement Project: Southeast Texas and Southwest Louisiana
(SNWW CIP) dated March 2011, prepared by the U.S. Army Corps of
Engineers (also Corps or USACE). Appendix B of Volume III contains the
Ocean Dredged Material Disposal Sites Final Environmental Impact
Statement. The U.S. Army Corps of Engineers Final EIS for the SNWW CIP
was published in the Federal Register (FR) April 4, 2011 (Vol. 76, Nos.
43). That document is available for public inspection at the following
locations:
    1. Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733
    2. Federal e-Rulemaking Portal: http://www.regulations.gov.

A. Potentially Affected Entities

    Entities potentially affected by this action are persons,
organizations, or government bodies seeking to dispose of dredged
material in ocean waters offshore of Texas for the disposal of dredged
material from the Sabine-Neches Waterway, under the Marine Protection
Research and Sanctuaries Act, 33 U.S.C. 1401 et seq. The Final Rule
would be primarily of relevance to the US Army Corps of Engineers when
proposing to dispose of dredged material from the Sabine-Neches
Waterway. Potentially affected categories and entities include:

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                                             Examples of potentially
                Category                        affected entities
------------------------------------------------------------------------
Federal government.....................  U.S. Army Corps of Engineers
                                          Civil Works projects, and
                                          other Federal agencies.
Industry and general public............  Port authorities, marinas and
                                          harbors, shipyards and marine
                                          repair facilities, berth
                                          owners.
State, local and tribal governments....  Governments owning and/or
                                          responsible for ports,
                                          harbors, and/or berths,
                                          Government agencies requiring
                                          disposal of dredged material
                                          associated with public works
                                          projects.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide regarding entities likely to be affected by this action. For
questions regarding the applicability of this action to a particular
entity, please refer to the contact person listed in the preceding FOR
FURTHER INFORMATION CONTACT section.

B. Background

    Ocean disposal of dredged materials is regulated under Title I of
the Marine Protection, Research and Sanctuaries Act, 33 U.S.C. 1401 et
seq. (MPRSA). The EPA and the USACE share responsibility for the
management of ocean disposal of dredged material. Under Section 102 of
MPRSA, EPA is responsible for designating an acceptable location for
the ocean dredged material disposal sites (ODMDS). With concurrence
from EPA, the USACE issues permits under MPRSA Section 103 for ocean
disposal of dredged material deemed suitable according to EPA criteria
in MPRSA Section 102 and EPA regulations in 40 CFR part 227.
    Pursuant to its voluntary NEPA policy, published at 63 FR 58045
(October 29, 1998), EPA typically relies on the EIS process to enhance
public participation on the Final designation of an ODMDS. A site
designation EIS evaluates alternative sites and examines the potential
environmental impacts associated with disposal of dredged material at
various locations. Such an EIS first demonstrates the need for the
ODMDS designation action (40 CFR 6.203(a) and 40 CFR 1502.13) by
describing available or potential aquatic and non-aquatic (i.e., land-
based) alternatives and the consequences of not designating a site--the
No Action Alternative. Once the need for an ocean disposal site is
established, potential sites are screened for feasibility through a
Zone of Siting Feasibility (ZSF) process. Potential alternative sites
are then evaluated using EPA's ocean disposal criteria at 40 CFR part
228 and compared in the EIS. Of the sites that satisfy these criteria,
the site that best complies is selected as the preferred alternative
for designation through a rulemaking process published in the Federal
Register (FR).
    Formal designation of an ODMDS in the Federal Register and
codification in the Code of Federal Regulations does not constitute
approval of dredged material for ocean disposal. Site designation
merely identifies a suitable ocean location in the event that dredged
material is later approved for ocean disposal. Designation of an ODMDS
provides an ocean disposal alternative for consideration in the review
of each proposed dredging project. Before any ocean disposal may take
place, the dredging project proponent must demonstrate a need for ocean
disposal, including consideration of alternatives. Alternatives to
ocean disposal, including the option for beneficial re-use of dredged
material, are evaluated for each dredging project that may result in
the ocean disposal of dredged materials from such project. Ocean
disposal of dredged material is only allowed after both EPA and USACE
determine that the proposed activity is environmentally acceptable
under criteria codified at 40 CFR part 227 and 33 CFR part 336,
respectively. In addition, ongoing management of these ODMDS would be
subject to Site Management and Monitoring Plan(s) (SMMP) required by
MPRSA section 102(c)(3)(F) and (c)(4), which are discussed more fully
below.
    Decisions to allow ocean disposal are made on a case-by-case basis
through the MPRSA Section 103 permitting process, resulting in a USACE
permit or its equivalent process for USACE's Civil Works projects.
Material proposed for disposal at a designated ODMDS must conform to
EPA's permitting criteria for acceptable quality (40 CFR parts 225 and
227), as determined from physical, chemical, and bioassay/
bioaccumulation tests prescribed by national sediment testing protocols
(EPA and USACE 1991). Only clean non-toxic dredged material is
acceptable for ocean disposal. The newly designated sites will be
subject to ongoing monitoring and management to ensure continued
protection of the marine environment.
    Evaluation of the ODMDS under EPA's general and specific criteria
is described in the March 2011 ``Final Environmental Impact Statement
for Sabine-Neches Waterway Channel Improvement Project Southeast Texas
and Southwest Louisiana, Appendix B.'' The Final Rule provides
adequate, environmentally-acceptable ocean disposal site capacity for
suitable dredged material generated from new work (construction) and
future maintenance dredging along the SNWW Entrance Channel 13.2-mile
extension by formally designating the SNWW A-D sites as acceptable
ocean disposal locations for dredged material meeting applicable
requirements.
    The proposed rule for designation was published in the Federal
Register on June 27, 2013, as docket number EPA-R06-OW-2011-0712. The
comment

period closed on August 12, 2013. Comments received are addressed in
section G., below. Under NEPA, federal agencies prepare a public record
of decision (ROD) at the time of their decision on any action for which
an FEIS has been prepared. This final rulemaking notice serves the same
purpose as a ROD required under regulations promulgated by the Council
on Environmental Quality for federal agencies subject to NEPA (CEQ
Regulations 40 CFR 1505.2

C. Location

    As identified in Appendix B of the FEIS, the environmentally
preferred sites which EPA now designates are SNWW-A, which is located
21 miles from shore, SNWW-B, which is located 24 miles from shore,
SNWW-C, which is located 27 miles from shore, and SNWW-D, which is
located 30 miles from shore. Each of the ODMDS occupies an area of 5.3
square statute miles, with depths ranging from 44 to 46 feet. The
bottom topography is flat.

D. Disposal Volume Limit

    The action designates the SNWW A-D for a one-time placement of
approximately 18,737,000 cubic yards (cy) of new work (construction)
material plus approximately 37,725,000 cubic yards of maintenance
material over a 50-year period. The need for ongoing ocean disposal
capacity is based on modeling in the USACE SNWW CIP Engineering
Appendix.

E. Site Management and Monitoring Plan (SMMP)

    Continuing use of the sites requires verification that significant
impacts do not occur outside of the disposal site boundaries through
implementation of the SMMP developed as part of the Final EIS for the
Sabine-Neches Waterway Project. The SMMP provides a structured
framework to ensure that dredged material disposal activities will not
unreasonably degrade or endanger human health, welfare, the marine
environment, or economic potentialities (Section 103(a) of the MPRSA).
Two main objectives for management of SNWW A-D are: (1) To ensure that
only dredged material that satisfies the criteria set forth in 40 CFR
part 227, subparts B, C, D, E, and G and Sec.  228.4(e) and is suitable
for unrestricted placement at the ODMDS is, in fact, disposed at the
sites, and; (2) to avoid excessive mounding, either within the site
boundaries or in areas adjacent to the sites, as a direct result of
placement operations.
    The EPA and USACE Galveston District personnel will achieve SMMP
objectives by jointly administering the following activities in
accordance with MPRSA section 102(c)(3): (1) A baseline assessment of
conditions at the sites; (2) a program for monitoring the sites; (3)
special management conditions or practices to be implemented at the
sites that are necessary for protection of the environment; (4)
consideration of the quantity of dredged material to be discharged at
the sites, and the presence, nature, and bioavailability of the
contaminants in the material; (5) consideration of the anticipated use
of the sites over the long term, including the anticipated closure date
for the sites, if applicable, and any need for management of the sites
after the closure; and (6) a schedule for review and revision of the
SMMP.
    The SMMP requires periodic physical monitoring to confirm that
disposal material is deposited within the seafloor disposal boundary,
as well as bathymetric surveys to confirm that there is no excessive
mounding or short-term transport of material beyond the limits of the
ODMDS. The SMMP describes physical and chemical sediment and biological
monitoring requirements. Monitoring activities are required to be
conducted based on the Evaluation of Dredged Material Proposed for
Ocean Disposal Testing Manual, EPA 503/8-91/001 and the Joint EPA-USACE
Regional Implementation Agreement (RIA) procedures. Results will be
used to confirm that dredged material actually disposed at the sites
satisfies the criteria set forth in 40 CFR part 227, subparts B, C, D,
E, and G, and Sec.  228.4(e) and is suitable for unrestricted ocean
disposal. Other activities implemented through the SMMP to achieve
these objectives include: (1) Regulating quantities and types of
material to be disposed, including the time, rates, and methods of
disposal; and (2) recommending changes to site use requirements,
including disposal amounts or timing, based on periodic evaluation of
site monitoring results.

E. Ocean Dumping Site Designation Criteria

    Five general criteria and 11 specific site selection criteria are
used in the selection and approval of ocean disposal sites for
continued use (40 CFR 228.5 and 40 CFR 228.6(a)).

General Selection Criteria

    1. The dumping of materials into the ocean will be permitted only
at sites or in areas selected to minimize the interference of disposal
activities with other activities in the marine environment,
particularly avoiding areas of existing fisheries or shellfisheries,
and regions of heavy commercial or recreational navigation.
    The EPA selected SNWW A-D, including appropriate buffer zones, to
avoid sport and commercial fishing activities, as well as other areas
of biological sensitivity. The preferred ODMDS are outside the channel,
including the navigation channel buffer zone, and safety fairways, and
avoid known navigational obstructions, although they do infringe on two
Fairway Anchorage areas.
    2. Locations and boundaries of disposal sites will be so chosen
that temporary perturbations in water quality or other environmental
conditions during initial mixing caused by disposal operations anywhere
within the site can be expected to be reduced to normal ambient
seawater levels or to undetectable contaminant concentrations or
effects before reaching any beach, shoreline, marine sanctuary, or
known geographically limited fishery or shellfishery.
    The sizes for the buffer zones and for the SNWW A-D sites are based
on sediment transport modeling and the physical oceanographic
characterization of the Sabine Pass area. Modeling and
characterization, combined with the information on the expected quality
of the material to be dredged, ensures that perturbations caused by
placement are reduced to ambient conditions at the boundaries of the
site. Reports of the modeling and characterization are included in the
administrative record for this action.
    3. If at any time during or after disposal site evaluation studies,
it is determined that existing disposal sites presently approved on an
interim basis for ocean dumping do not meet the criteria for site
selection set forth in Sections 228.5 through 228.6, the use of such
sites will be terminated as soon as suitable alternate disposal sites
can be designated.
    This criterion does not apply to the Final Site designations
because they are not existing sites that had previously been approved
on an interim basis.
    4. The sizes of the ocean disposal sites will be limited in order
to localize for identification and control any immediate adverse
impacts and permit the implementation of effective monitoring and
surveillance programs to prevent adverse long-range impacts. The size,
configuration, and location of any disposal site will be determined as
a part of the disposal site evaluation or designation study.
    The sizes of the Final Sites are as small as possible to reasonably
meet the criteria stated in 40 CFR 228.5 and 40

CFR 228.6(a). The size for each Final ODMDS is 5.32 square statute
miles (4.02 square nautical miles). The SMMPs were designed to provide
adequate surveillance to prevent adverse long-range impacts.
    5. The EPA will, wherever feasible, designate ocean dumping sites
beyond the edge of the continental shelf and other such sites that have
been historically used.
    Cost, safety, and time factors plus difficulties with monitoring
and surveillance preclude the designation of any ODMDS beyond the edge
of the Continental Shelf off Sabine Pass (and the Gulf of Mexico
generally). Additionally, uncertainty about the resilience of the deep-
ocean benthic community indicates that an off-shelf disposal site could
threaten severe adverse impacts to that off-shelf benthic community.
The EPA did not identify an environmental advantage to an off-shelf
site designation, whereas possible adverse impacts to the human
environment could be more easily monitored at a nearshore site. The
existing ODMDS that have been used historically, while large enough to
accommodate future maintenance material, are cost prohibitive with
regard to disposal of dredged material from the channel extension.
Without designation of the four new ODMDS, this material would need to
be transported to the existing maintenance ODMDS. The end of the
existing channel is roughly 13 miles from the end of the proposed
extension, resulting in an increased travel distance of 26 miles for
each load of dredged material from the extension work. Construction
costs are expected to double under this scenario, making it impossible
to economically justify the SNWW CIP.

Specific Selection Criteria

    1. Geographical position, depth of water, bottom topography, and
distance from the coast.
    The four new ODMDS sites are bounded by the following coordinates
(Location North American Datum from 1983):

A                 ODMDS                  29[deg]24'47'' N, 93[deg]43'29'' W; 29[deg]24'47'' N, 93[deg]41'08'' W
                                         29[deg]22'48'' N, 93[deg]41'09'' W; 29[deg]22'49'' N, 93[deg]43'29'' W
B                 ODMDS                  29[deg]21'59'' N, 93[deg]43'29'' W; 29[deg]21'59'' N, 93[deg]41'08'' W
                                         29[deg]20'00'' N, 93[deg]41'09'' W; 29[deg]20'00'' N, 93[deg]43'29'' W
C                 ODMDS                  29[deg]19'11'' N, 93[deg]43'29'' W; 29[deg]19'11'' N, 93[deg]41'09'' W
                                         29[deg]17'12'' N, 93[deg]41'09'' W; 29[deg]17'12'' N, 93[deg]43'29'' W
D                 ODMDS                  29[deg]16'22'' N, 93[deg]43'29'' W; 29[deg]16'22'' N, 93[deg]41'10'' W
                                         29[deg]14'24'' N, 93[deg]44'10'' W; 29[deg]14'24'' N, 93[deg]43'29'' W

    The water depth at the SNWW A-D sites ranges from 44 to 46 feet and
the bottom topography is flat. SNWW-A is located 21 miles from shore,
SNWW-B is located 24 miles from shore, SNWW-C is located 27 miles from
shore and SNWW-D is located 30 miles from shore.
    2. Location in relation to breeding, spawning, nursery, feeding, or
passage areas of living resources in adult or juvenile phases.
    Due to the marine open water locale of the SNWW A-D sites, the
presence of aerial, pelagic, or benthic living resources is likely
within the area of the sites. The location of the ODMDS is between the
principal spawning areas and the estuarine nursery areas. The water
column and benthic effects associated with ocean disposal of dredged
material at the ODMDS would not adversely affect the passage of
organisms to and from the spawning-nursery areas through the waters
above the disposal sites. Localized and intermittent dredged material
disposal operations are unlikely to adversely affect migration,
feeding, or nesting of marine mammals and sea turtles.
    3. Location in relation to beaches and other amenity areas.
    The SNWW A-D sites are over 21 miles from any beach and Sabine Bank
is at least 1.7 miles from the nearest of the ODMDS. According to the
dredged material transport model (available in the administrative
record), the maximum distance for the mounded dredged material to reach
ambient depth is 1,081 feet. Doubling this distance would provide a
buffer of 0.4 mile, only a fraction of the 1.7 miles to Sabine Bank.
    4. Types and quantities of wastes proposed to be disposed of, and
proposed methods of release, including methods of packaging the waste,
if any.
    Only suitable dredged material from the SNWW Entrance Channel 13.2
mile extension may be disposed at the sites. Dredged material proposed
for ocean disposal is subject to strict testing requirements
established by the EPA and USACE, and only clean (non-toxic) dredged
materials from the SNWW Entrance Channel 13.2 mile extension would be
allowed to be disposed of at the SNWW A-D sites. Approximately 18.7 mcy
of new work material will be dredged during the construction of 13.2-
mile extension of the Entrance Channel. Maintenance material per
dredging cycle is estimated at three mcy for a total of 37.7 mcy over a
period of 50 years. Dredged material is expected to be released from
hopper dredges.
    5. Feasibility of surveillance and monitoring.
    Surveillance and monitoring are feasible at the SNWW A-D sites. The
SMMP prepared for the sites consists of (1) a method for recording the
location of each discharge; (2) bathymetric surveys; and, (3) grain-
size analysis, sediment chemistry characterization, and benthic
infaunal analysis at selected stations.
    6. Dispersal, horizontal transport, and vertical mixing
characteristics of the area, including prevailing current direction and
velocity, if any.
    These three physical oceanographic parameters were used by the U.S.
Army Corps of Engineers to develop the necessary buffer zones for the
exclusion analysis and to determine the adequacy of size of the SNWW A-
D sites. Predominant longshore currents, and thus predominant longshore
transport, are to the west. Long-term mounding has not historically
occurred in the existing nearby ODMDS. Therefore, steady longshore
transport and occasional storms, including hurricanes, are expected to
remove the disposed material from the sites through dispersal,
horizontal transport, and vertical mixing.
    7. Existence and effects of current and previous discharges and
dumping in the area (including cumulative effects).
    The Final Environmental Impact Statement (EIS) discusses the
results of chemical and bioassay testing of samples collected to
support the proposed Waterway Extension and surrounds, and concluded
that there were no indications of water or sediment quality problems in
the ZSF, including the proposed disposal sites. Testing of dredged
material collected and tested from past maintenance dredging indicates
that the material dredged from the channel was acceptable for ocean
disposal according to the evaluation criteria published at 40 CFR part
227. Based on current direction and modeling of the new work and
maintenance material, the SNWW A-D sites are situated to prevent
discharged material from reentering the

channel and to ensure that any mounding poses no obstruction to
navigation. No cumulative mounding has been detected at the existing
ODMDS and there is no reason to expect any at the SNWW A-D ODMDS.
    8. Interference with shipping, fishing, recreation, mineral
extraction, desalination, fish and shellfish culture, areas of special
scientific importance, and other legitimate uses of the ocean.
    The interference considerations that are pertinent to the present
situation are shipping, mineral extraction, commercial and recreational
fishing, and recreational areas. The SNWW A-D ODMDS will not interfere
with these or other legitimate uses of the ocean because the exclusion
processes used to identify the sites was designed to prevent the
selection of sites that would cause any such interference. Ocean
disposal of dredged material in the past has not interfered with other
uses.
    9. Existing water quality and ecology of the site as determined by
available data or by trend assessment or baseline surveys.
    The FEIS to support the proposed Waterway Extension project cited a
baseline study, which used sediment samples from the area of the
proposed Extension and the ZSF. No adverse water or sediment quality
concerns were indicated. Sampled and characterized, benthos of the
area, is dominated by polychaetes (57.7%) and included abundant
populations of malacostracans (18.3%) and bivalves (7.7%). Density
ranged from 4,055 organisms/square foot at Station 3 (north of ODMDS A)
up to 30,265 organisms/square foot at Station 26 (center of ODMDS B).
Areas of moderately high sand content (68 to 91%) supported the highest
densities, located near ODMDS B and ODMDS C, near the center of the
ZSF. In general, the water and sediment quality is good throughout the
ZSF and in the existing (historically used) ODMDS. There have been no
long-term adverse impacts on water and sediment quality or benthos at
the existing ODMDS, and none are expected with use of the SNWW A-D
sites.
    10. Potentiality for the development or recruitment of nuisance
species in the disposal site.
    With disturbances to any benthic community, opportunistic species
would initially recolonize the area. At this location, however, these
species would not be nuisance species, i.e., they would not interfere
with other legitimate uses of the ocean, they would not be human
pathogens, and they would not be non-indigenous species. The placement
of dredged material in the past has not attracted or promoted
development or recruitment of nuisance species, and the placement of
the dredged material from new work and future maintenance dredged
material should not attract or promote the development or recruitment
of nuisance species.
    11. Existence at or in close proximity to the site of any
significant natural or cultural features of historical importance.
    Historic records generated by the former Minerals Management
Service (MMS) indicate that no historic shipwrecks are mapped within
the limits of the SNWW A-D ODMDS, but remote-sensing surveys have not
been conducted. Ocean disposal of dredged material is not expected to
adversely affect any unrecorded wrecks given the depth of water through
which the material would settle and the expected depth of burial at the
time of disposal, particularly given the dispersive nature of the
seabed environment in this portion of the Gulf. The distribution,
depth, and dispersion of dredged material within these ODMDS have been
evaluated by numerical modeling (PBS&J, 2006). Hopper dredges would
drop dredged material onto the ODMDS, forming mound fields with
individual mounds totaling no more than five feet in height. The
effects of the deposition of material on any undiscovered feature would
be cushioned by settling through water depths ranging from 30 to 45
feet. Previous monitoring of existing placement areas and studies of
bottom ocean currents has shown that the material would disperse
between channel maintenance cycles and not accumulate. The SNWW A-D
ODMDS are located in Federal waters (i.e., outside of adjacent State
jurisdiction).

G. Responses to Comments

    The proposed rule for designation was published in the Federal
Register on June 27, 2013, as docket number EPA-R06-OW-2011-0712. The
comment period closed on August 12, 2013. The EPA received four
comments on the proposed rule from three entities and one individual.
These comments are responded to here.

1. Concerns About Minimizing Ocean Disposal by Maximizing Beneficial
Re-Use

    Two commenters expressed concerns about using new dredged material
for beneficial use instead of placement in the ODMDS SNWW A-D
designated areas. The Louisiana Department of Wildlife and Fisheries
recommended using new work material beneficially. An individual
commenter expressed concern that disposal of dredged material would
increase hypoxia in the Gulf of Mexico and recommended beneficial use
of dredged material.
    Disposal or re-use placement alternatives that could practicably
meet the purpose and need of a dredging project must be evaluated at
the time of project-specific permitting. Timing and logistics can
affect the practicability of dredged material disposal or beneficial
use alternatives. For an individual project, ocean disposal is
permitted only when other alternatives are not practicable. However,
determining the availability of alternatives for individual dredging
projects is independent of this ODMDS designation action, and such
comments are not further addressed here.

2. Concerns About a Consistency Determination

    The Louisiana Department of Natural Resources (LDNR), Office of
Coastal Management, commented that this designation action ``will
require the preparation of a consistency determination in accordance
with section 307(c) of the Coastal Zone Management Act.'' Pursuant to
section 307(c)(1) of the Coastal Zone Management Act, federal
activities that affect a state's coastal zone must be consistent to the
maximum extent practicable with the enforceable policies of the state's
approved coastal zone management program. To implement that
requirement, federal agencies prepare coastal consistency
determinations and submit them to the appropriate state agencies, which
may concur in or object to a consistency determination. In connection
with its preparation of the EIS on the Sabine-Neches Waterway Channel
Improvement Project, the Corps of Engineers prepared a coastal
consistency determination on its proposed navigation projects and the
ODMDS designation, which it submitted to the Louisiana Department of
Natural Resources (LDNR) and the Texas General Land Office (TGLO), the
agencies implementing approved coastal zone management plans for their
respective states. On March 30, 2010, TGLO concurred in the Corps
consistency determination. By letter of March 31, 2010, LDNR concurred
on condition that the Corps submit a supplemental consistency
determination to LDNR after the project planning and design process,
which results in a more detailed description of project features. The
LDNR's letter also generally opposed EPA's ODMDS designation, noting
that the designation would provide the Corps an option

other than beneficial use for disposal of dredged material. More
detailed plans and descriptions of the proposed navigation projects may
be needed for LDNR and the Corps to resolve potential issues on the
practicability of beneficial use of dredged materials in Louisiana's
coastal zone. However, such issues are independent of EPA's proposed
ODMDS designations, which only make an offshore disposal option
available when the Corps deems beneficial use that might otherwise be
required by a state CZM program impracticable. The EPA supports
beneficial use of dredged material, but ODMDS designations do not in
any way require that the Corps forego beneficial use in favor of ocean
disposal.
    Moreover, the closest of any of the four ODMDS is approximately 20
miles off the Texas coast at its nearest point. Predominant longshore
currents in the ODMDS locations flow from east to west and dredged
material transport modeling shows that any dredged materials discharged
to them will not thus enter or otherwise affect Louisiana's coastal
zone. Because this ODMDS designation will not affect any land or water
use or natural resource of Louisiana's coastal zone, no coastal
consistency determination need be prepared for this action.

3. Question on the Designation Process

    One commenter from the U.S. Coast Guard asked for clarification on
the Rule-Making process for the designation of the ODMDS A-D sites. The
EPA provided clarification to the commenter.

G. Regulatory Requirements

1. National Environmental Policy Act (NEPA)

    Pursuant to section 102(2)(C) of the National Environmental Policy
Act of 1969 (NEPA), federal agencies are generally required to prepare
an environmental impact statement (EIS) on major federal actions
significantly affecting the quality of the human environment. Under the
doctrine of functional equivalency, EPA designations of ODMDS under
MPRSA are not subject to NEPA requirements. The EPA believes the NEPA
process enhances public participation on such designations and the
potential effects of these designations were fully analyzed in an EIS
on the Sabine-Neches Waterway Channel Improvement Project: Southeast
Texas and Southwest Louisiana (SNWW CIP). The Corps of Engineers was
the lead agency on that EIS and EPA was a cooperating agency.
    Notice of the draft EIS was published in the Federal Register on
December 24, 2009, and the document was available for review and
comment through March 10, 2010. In addition, public meetings on the EIS
were held in Beaumont, Texas and Lake Charles, Louisiana. Comments
included concerns on pipeline relocation, marsh ecology, beneficial use
of dredged material, and increased danger from storms. Few comments
were received on designation of the ODMDS. Detailed responses to
comments were published in Appendix A of the final EIS, notice of which
was published in the Federal Register on March 4, 2012. The EPA has
relied on information from the EIS and its technical appendices in its
consideration and application of ocean dumping criteria to the four
ODMDS this Rule designates.

2. Endangered Species Act Consultation

    During development of the SNWW CIP project EIS referenced above,
USACE and EPA consulted with the U.S. Fish and Wildlife Service (USFWS)
and the National Marine Fisheries Service (NMFS) pursuant to the
provisions of the Endangered Species Act (ESA), regarding the potential
for designation and use of the ocean disposal sites to jeopardize the
continued existence of any Federally-listed species. The consultation
process is documented in the EIS.
    Of the Threatened or Endangered Species noted in the biological
assessment for the SNWW CIP, only sea turtles and whales are found as
far offshore as the SNWW A-D ODMDS. The NMFS issued a biological
opinion on August 13, 2007, that site designation is not likely to
jeopardize the continued existence of any Federally-listed species.

3. Magnuson-Stevens Fishery Conservation and Management Act of 1996

    The designation of the SNWW A-D ODMDS will not adversely affect
essential fish habitat. By letter dated March 8, 2010, the National
Marine Fisheries Service concurred with the USACE findings that
beneficial features associated with the project would offset any
adverse impacts of the Waterway Expansion project.

4. Coastal Zone Management Act

    Pursuant to section 307(c)(1) of the Coastal Zone Management Act,
federal activities that affect a state's coastal zone must be
consistent to the maximum extent practicable with the enforceable
policies of the state's approved Coastal Zone Management (CZM) program.
To implement that requirement, federal agencies prepare coastal
consistency determinations and submit them to the appropriate state
agencies, which may concur in or object to a consistency determination.
    In connection with its preparation of the EIS on the Sabine-Neches
Waterway Channel Improvement Project, the Corps prepared a coastal
consistency determination on its proposed navigation projects and the
ODMDS designation, which it submitted to the Louisiana Department of
Natural Resources (LDNR) and the Texas General Land Office (TGLO), the
agencies implementing approved coastal zone management plans for their
respective states. On March 30, 2010, TGLO concurred in the Corps
consistency determination. By letter of March 31, 2010, LDNR concurred
on condition that the Corps submit a supplemental consistency
determination to LDNR after the project planning and design process,
resulting in a more detailed description of project features. The
LDNR's letter also generally opposed EPA's ODMDS designation, claiming
it would provide the Corps an option other than beneficial use for
disposal of dredged material.
    More detailed plans and descriptions of the proposed navigation
projects may be needed for LDNR and the Corps to resolve potential
issues on the practicability of beneficial use of dredged materials in
Louisiana's coastal zone. Such issues are independent of EPA's proposed
ODMDS designations, however, which only make an offshore disposal
option available when the Corps deems beneficial use that might
otherwise be required by a state CZM program impracticable. The EPA
supports beneficial use of dredged material, but ODMDS designations do
not in any way require that the Corps forego beneficial use in favor of
ocean disposal.
    Moreover, the closest of any of the four SNWW A-D ODMDS is
approximately 20 miles off the Texas coast at its nearest point.
Predominant longshore currents in the SNWW A-D ODMDS locations flow
from east to west. Dredged material transport modeling shows that any
dredged materials discharged to the SNWW A-D ODMDS will not thus enter
or otherwise affect Louisiana's coastal zone. Because the SNWW A-D
ODMDS designations will not affect any land or water use or natural
resource of Louisiana's coastal zone, a coastal consistency
determination is not needed.

5. Coastal Barrier Improvement Act of 1990

    The Coastal Barrier Improvement Act is intended to protect fish and
wildlife resources and habitat, prevent loss of human life, and
preclude the expenditure of Federal funds that may induce development
on coastal barrier islands and adjacent nearshore areas. The Coastal
Barrier Improvement Act of 1990 was enacted to reauthorize the Coastal
Barrier Resources Act (CBRA) of 1982. Exceptions to the Federal
expenditure restrictions include maintenance or constructed
improvement(s) to existing Federal navigational channels and related
structures (e.g., jetties), including the disposal of dredged materials
related to maintenance and construction; therefore, project activities
related to disposal are exempt from the prohibitions set forth in this
act, as noted in the Final EIS for the SNWW CIP, Vol. II.

H. Administrative Review

    This rule designates ocean dredged material disposal sites pursuant
to Section 102 of the MPRSA. This action complies with applicable
executive orders and statutory provisions as follows:

1. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993) EPA must
determine whether the regulatory action is ``significant,'' and
therefore subject to office of Management and Budget (OMB) review and
other requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to lead to a
rule that may:
    (a) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way, the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local or Tribal governments or communities;
    (b) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (c) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligations of
recipients thereof: Or
    (d) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    This Final Rule should have minimal impact on State, local, or
Tribal governments or communities. Consequently, EPA has determined
that this Final Rule is not a ``significant regulatory action'' under
the terms of Executive Order 12866.

2. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., is intended to
minimize the reporting and recordkeeping burden on the regulated
community, as well as to minimize the cost of Federal information
collection and dissemination. In general, the Act requires that
information requests and record-keeping requirements affecting ten or
more non-Federal respondents be approved by OMB. Since the Final Rule
would not establish or modify any information or recordkeeping
requirements, but only clarifies existing requirements, it is not
subject to the provisions of the Paperwork Reduction Act.

3. Regulatory Flexibility Act, as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996

    The Regulatory Flexibility Act (RFA) provides that whenever an
agency promulgates a final rule under 5 U.S.C. 553, the agency must
prepare a regulatory flexibility analysis (RFA) unless the head of the
agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities (5 U.S.C. 604
and 605). The site designation and management actions would only have
the effect of setting maximum annual disposal volume and providing a
continuing disposal option for dredged material. Consequently, EPA's
action will not impose any additional economic burden on small
entities. For this reason, the Regional Administrator certifies,
pursuant to section 605(b) of the RFA, that the Final Rule will not
have a significant economic impact on a substantial number of small
entities.

4. Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub.
L. 104-4) establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. This Final Rule contains no Federal
mandates (under the regulatory provisions of Title II of the UMRA) for
State, local or Tribal governments or the private sector that may
result in estimated costs of $100 million or more in any year. It
imposes no new enforceable duty on any State, local or Tribal
governments or the private sector nor does it contain any regulatory
requirements that might significantly or uniquely affect small
government entities. Thus, the requirements of section 203 of the UMRA
do not apply to this Final Rule.

5. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), 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'' are 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 does not have federalism implications. It will not
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,
as specified in Executive Order 13132.

6. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
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.'' This Final Rule does not have
Tribal implications, as defined in Executive Order 13175.

7. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This Executive Order (62 FR 19885, April 23, 1997) applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, EPA must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by EPA. This Final Rule is not subject
to the Executive Order because it is not economically significant as
defined in Executive Order 12866, and because EPA does not have reason
to believe the

environmental health or safety risks addressed by this action present a
disproportionate risk to children.

8. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use Compliance With Administrative Procedure
Act

    This Final 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)) because it is not a
significant regulatory action under Executive Order 12866. The Final
Rule would only have the effect of setting maximum annual disposal
volumes and providing a continuing disposal option for dredged
material. Thus, EPA concluded that this Final Rule is not likely to
have any adverse energy effects.

9. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. This Final Rule does not involve technical
standards. Therefore, EPA is not considering the use of any voluntary
consensus standards.

10. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low Income Populations

    Executive Order 12898 (59 FR 7629) directs Federal agencies to
determine whether the Final Rule would have a disproportionate adverse
impact on minority or low-income population groups within the project
area. The Final Rule would not significantly affect any low-income or
minority population.

List of Subjects in 40 CFR Part 228

    Environmental protection, Water pollution control.

    Dated: October 31, 2013.
Ron Curry,
Regional Administrator, Region 6.

    In consideration of the foregoing, EPA amends part 228, chapter I
of title 40 of the Code of Federal Regulations as follows:

PART 228--CRITERIA FOR THE MANAGEMENT OF DISPOSAL SITES FOR OCEAN
DUMPING

0
1. The authority citation for part 228 continues to read as follows:

    Authority:  33 U.S.C. 1412 and 1418.

0
2. Section 228.15 is amended by adding paragraphs (j)(22) through (25)
to read as follows:

Sec.  228.15  Dumping sites designated on a final basis.

* * * * *
    (j) * * *
    (22) Sabine-Neches, TX Dredged Material Site A.
    (i) Location: 29[deg]24'47'' N., 93[deg]43'29'' W.; 29[deg]24'47''
N., 93[deg]41'08'' W.; 29[deg]22'48'' N., 93[deg]41'09'' W.;
29[deg]22'49'' N., 93[deg]43'29'' W.; thence to point of beginning.
    (ii) Size: approximately 5.3 square miles.
    (iii) Depth: Ranges from 44 to 46 feet.
    (iv) Primary Use: Dredged material.
    (v) Period of Use: Continuing use.
    (vi) Restrictions: Disposal shall be limited to dredged material
from the Sabine-Neches 13.2 mile Extension Channel that complies with
EPA's Ocean Dumping Regulations. Dredged material that does not meet
the criteria set forth in 40 CFR part 227 shall not be placed at the
site. Disposal operations shall be conducted in accordance with
requirements specified in a Site Management and Monitoring Plan
developed by EPA and USACE, to be reviewed periodically, at least every
10 years.
    (23) Sabine-Neches, TX Dredged Material Site B.
    (i) Location: 29[deg]21'59'' N., 93[deg]43'29'' W.; 29[deg]21'59''
N., 93[deg]41'08'' W.; 29[deg]20'00'' N., 93[deg]41'09'' W.;
29[deg]20'00'' N., 93[deg]43'29'' W.; thence to point of beginning.
    (ii) Size: approximately 5.3 square miles.
    (iii) Depth: Ranges from 44 to 46 feet.
    (iv) Primary Use: Dredged material.
    (v) Period of Use: Continuing use.
    (vi) Restrictions: Disposal shall be limited to dredged material
from the Sabine-Neches 13.2 mile Extension Channel that complies with
EPA's Ocean Dumping Regulations. Dredged material that does not meet
the criteria set forth in 40 CFR part 227 shall not be placed at the
site. Disposal operations shall be conducted in accordance with
requirements specified in a Site Management and Monitoring Plan
developed by EPA and USACE, to be reviewed periodically, at least every
10 years.
    (24) Sabine-Neches, TX Dredged Material Site C.
    (i) Location: 29[deg]19'11'' N., 93[deg]43'29'' W.; 29[deg]19'11''
N, 93[deg]41'09'' W.; 29[deg]17'12'' N., 93[deg]41'09'' W.;
29[deg]17'12'' N., 93[deg]43'29'' W.; thence to point of beginning.
    (ii) Size: approximately 5.3 square miles.
    (iii) Depth: Ranges from 44 to 46 feet.
    (iv) Primary Use: Dredged material.
    (v) Period of Use: Continuing use.
    (vi) Restrictions: Disposal shall be limited to dredged material
from the Sabine-Neches 13.2 mile Extension Channel that complies with
EPA's Ocean Dumping Regulations. Dredged material that does not meet
the criteria set forth in 40 CFR part 227 shall not be placed at the
site. Disposal operations shall be conducted in accordance with
requirements specified in a Site Management and Monitoring Plan
developed by EPA and USACE, to be reviewed periodically, at least every
10 years.
    (25) Sabine-Neches, TX Dredged Material Site D.
    (i) Location: 29[deg]16'22'' N., 93[deg]43'29'' W.; 29[deg]16'22''
N., 93[deg]41'10'' W.; 29[deg]14'24'' N., 93[deg]44'10'' W.;
29[deg]14'24'' N., 93[deg]43'29'' W.; thence to point of beginning.
    (ii) Size: approximately 5.3 square miles.
    (iii) Depth: Ranges from 44 to 46 feet.
    (iv) Primary Use: Dredged material.
    (v) Period of Use: Continuing use.
    (vi) Restrictions: Disposal shall be limited to dredged material
from the Sabine-Neches 13.2 mile Extension Channel that complies with
EPA's Ocean Dumping Regulations. Dredged material that does not meet
the criteria set forth in 40 CFR part 227 shall not be placed at the
site. Disposal operations shall be conducted in accordance with
requirements specified in a Site Management and Monitoring Plan
developed by EPA and USACE, to be reviewed periodically, at least every
10 years.
* * * * *
[FR Doc. 2013-28808 Filed 12-4-13; 8:45 am]
BILLING CODE 6560-50-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [Tony Kish;<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:

[Bayer CropScience]

[Insert petition number]

 Summary of Petitions

EPA has received pesticide petitions ([insert petition number]) from
[Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC
27709] proposing, pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
[180.579] by establishing a tolerance for [indirect or inadvertent]
residues of [fenamidone (4H-imidazol-4- one,
3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-, (S)-) and
its metabolite RPA 717879 (2,4-imidazolidinedione, 5-methyl-5-phenyl)]
in or on the raw agricultural commodities [Corn, field, forage] at
[0.50] parts per million (ppm), [Corn, field, grain] at [0.02] ppm,
[Corn, stover] at [0.35] ppm, [Corn, sweet, forage] at [0.15] ppm,
[Corn, sweet, kernel plus cob with husks removed] at [0.20] ppm,
[Soybean, forage] at [0.20] ppm, [Soybean, hay] at [0.20] ppm, and
[Soybean, seed] at [0.02] ppm. EPA has determined that the petition
contains data or information regarding the elements set forth in section
408(d)(2) of the FFDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition.  Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.  [The plant metabolism of fenamidone (RPA407213)
was evaluated in five distinct crops (lettuce, tomatoes, potatoes,
carrots and grapes) and is adequately understood.  In all cases, the
primary residue was the parent compound.  The only significant
metabolite was RPA410193 (17% of the total radioactive residue (TRR) in
grapes, 9% of the total radioactive residue (TRR) in tomatoes, <1% of
the total radioactive residue (TRR) in lettuce (mostly in the wrapper
leaves), and <1% of the total radioactive residue (TRR) in potatoes
(haulm or tubers)), and RPA406012 (4.5% of TRR in carrot tops).
RPA412708 and RPA412636 were minor metabolites reported in the lettuce
and potato studies and may account for part of the unidentified residue
reported in the grape and tomato metabolism studies.]

	2. Analytical method.  [Although residue levels approaching the
proposed tolerances are unlikely, independently validated enforcement
methods are available for determining residues of fenamidone and
relevant metabolites.  Residues are first extracted from the crop matrix
by blending or shaking with a mixture of acetonitrile and water.  After
filtration, an aliquot of the extract is rotary evaporated to near
dryness, then diluted with water.  Cleanup is accomplished on a HR-P
polymeric solid phase extraction (SPE) cartridge and an amino SPE
cartridge.  Residues are quantified by HPLC with tandem mass
spectrometric detection (LC/MS/MS).  The method limits of quantification
(LOQ) are 0.02 ppm or lower for fenamidone, and its metabolites, RPA
412636, RPA 412708, and RPA 410193 in test raw agricultural commodities
and processed fractions.]

3. Magnitude of residues.  [Field residue trials were conducted to
determine the magnitude of fenamidone residue in corn and soybeans
planted as rotational crops following treatment of fenamidone to soil.
The number of trials is equal to or greater than that described in EPA's
review of Bayer CropScience’s field rotational crop study protocol
(EPA-OPP document D337553).]

B. Toxicological Profile

1. Acute toxicity.  [A complete battery of acute toxicity studies for
fenamidone has been conducted.  Fenamidone has very low acute toxicity
by the oral, dermal and inhalation routes of exposure.  Fenamidone was
moderately irritating to the eye and non-irritating to the skin.  The
dermal sensitization study in guinea pigs was negative.  In an acute
neurotoxicity study in rats, fenamidone was not neurotoxic at doses up
to the limit dose of 2000 mg/kg.  The NOEL was 500 mg/kg for males and
125 mg/kg for females.]

	2. Genotoxicty.  [Fenamidone is not considered to be mutagenic based on
a battery of in vitro and in vivo mutagenicity studies.]

	3. Reproductive and developmental toxicity.  [A teratology study was
conducted using rats, with a resulting NOEL for maternal and
developmental toxicity of 150 mg/kg/day.  The LOEL was 1000 mg/kg/day,
based on significantly decreased body weight and food consumption in
dams, and decreased fetal body weights with slightly delayed skeletal
ossification secondary to maternal toxicity.  A rabbit teratology study
resulted in a maternal NOEL of 10 mg/kg/day and a developmental NOEL of
100 mg/kg/day (HDT).  The maternal LOEL was 30 mg/kg/day, based on
increased maternal liver weights at 30 and 100 mg/kg/day.  Fenamidone
demonstrates no potential to cause developmental toxicity in mammals.  A
two-generation reproduction study was conducted with rats with a
resulting NOEL for maternal and offspring toxicity of 5.15 mg/kg/day.
The maternal NOEL was based on decreased body weight and food
consumption.  The pup NOEL is based on F1 pup body weight decrease. The
reproductive NOEL was >328.3 mg/kg/day (males) and >459.6 mg/kg/day
(females).  Fenamidone is not considered a reproductive toxicant at
non-maternally toxic dose levels and shows no evidence of endocrine
effects. A developmental neurotoxicity study was conducted with rats.
The maternal NOAEL was 429 mg/kg/day and the offspring NOAEL was 92.3
mg/kg/day, based on decreased body weights during post-weaning.]

4. Subchronic toxicity.  [In a 13-week subchronic feeding study in rats,
the NOEL was 68.27 mg/kg/day (males) and 83.33 mg/kg/day (females).  The
LOEL was 343.93 mg/kg/day for males and 380.63 mg/kg/day for females
based on adaptive liver changes at 68.27 mg/kg/day and increased liver
and thyroid weights at the highest dose tested.  In a 13 week subchronic
feeding study in mice, the NOEL was 44.5mg/kg/day (males) and 54.1
mg/kg/day (females).  The LOEL was 220.2 mg/kg/day (males) and 273.9
mg/kg/day (females) based on increased liver weight at the high dose. In
a 28 day subchronic dermal study in rabbits, treatment produced a slight
decrease in food consumption and body weight in males at 1000 mg/kg/day.
 In a 13-week study in dogs, the NOEL was 100 mg/kg/day and the LOEL was
500 mg/kg/day.  In a subchronic neurotoxicity study in rats, there was
no evidence of neurotoxicity at dosage levels up to 5000 ppm (395.6 and
414.2 mg/kg/day), the MTD.  The NOEL for the study was 1000 ppm
(equivalent to 74.2 and 83.4 mg/kg/day).]

5. Chronic toxicity.  [A 1-year oral study with dogs resulted in a NOEL
of 100 mg/kg/day for both sexes, based on significantly increased liver
weights and biliary hyperplasia in the high dose.  The LOEL was 1000
mg/kg/day.  A 2-year combined chronic toxicity/ carcinogenicity study in
rats resulted in a NOEL for systemic toxicity of 2.83 mg/kg/day (males)
and 3.36 mg/kg/day (females).  The LOEL was 7.07 mg/kg/day (males) and
9.24 mg/kg/day (females).  No statistically significant, linear dose
response was observed for any tumor incidence.  A 104-week combined
carcinogenicity study in mice resulted in a NOEL of 9.5 mg/kg/day
(males) and 12.6 mg/kg/day (females).  The LOEL for carcinogenicity was
47.5 mg/kg/day (males) and 63.8 mg/kg/day (females).  The NOEL is based
on non-neoplastic liver changes and decreased body weight gain at the
top two dose levels.  Fenamidone demonstrates no potential for
carcinogenic effects in mammals.]

	6. Animal metabolism.  [Metabolism studies conducted with goat and hen
demonstrate that fenamidone is rapidly metabolized and excreted.
Residue levels in edible animal tissues (meat, milk and eggs) are
negligible and do accumulate in those tissues.  The metabolic pathway
proceeds via cleavage of the amino-phenyl group and the thiomethyl group
with further metabolism by hydroxylation.  There is also evidence to
indicate that glucuronide and sulfate conjugates are formed.  A single
low dose (3 mg/kg), a single high dose (300 mg/kg) and a low dose (3
mg/kg) administered for 15 consecutive days were fed to rats.
Fenamidone was relatively well absorbed at a nominal dose of 3 mg/kg in
both sexes and intensively metabolized by phase I (oxidation, reduction
and hydrolysis) and II (conjugation) reactions.  The elimination of
radiolabeled fenamidone was relatively rapid with the majority of the
administered dose being excreted via the biliary route (for the low dose
experiments).  The comparison of the levels of radioactivity recovered
in bile kinetic and ADME studies suggested that a part of the
radioactivity excreted via the bile could be reabsorbed and subsequently
re-excreted via the urine.  High levels of radioactivity measured in
blood samples from the tissue kinetics also supported this hypothesis.
At the high dose level fenamidone was not very well absorbed:  Some
50-60% of the radioactivity was present as parent compound in the feces.
 Radioactivity was widely distributed in the tissues with predominance
in the thyroids, blood, liver, kidneys, fat and pancreas.  Fenamidone is
therefore expected to be rapidly and extensively metabolized and
excreted in mammals.]

	7. Metabolite toxicology.  [The major dietary metabolites of
fenamidone, RPA 412708, RPA 410193 and RPA 412636 were evaluated for
mammalian toxicity in an acute oral toxicity study, a 90-day repeated
dose study and in genotoxicity tests.  The metabolites are considered to
be of comparable toxicity to the parent fenamidone.]

	8. Endocrine disruption.  [Chronic, lifespan, and multi-generational
bioassays in mammals and acute and subchronic studies on aquatic
organisms and wildlife did not reveal endocrine effects.  Any endocrine
related effects would have been detected in this definitive array of
required tests.  The probability of any such effect due to agricultural
uses of fenamidone is negligible.]

C. Aggregate Exposure

1. Dietary exposure.  [A dietary exposure assessment was conducted for
fenamidone what included all current and proposed uses of fenamidone.
Therefore the aggregate exposure would consist of any potential
exposures to fenamidone residues from inadvertent residues in corn and
soybean in addition to the previously registered crops. The acute
reference dose (aRfD) of 1.25 mg/kg bw/day is based on a NOAEL of
125mg/kg bw/day from the acute neurotoxicity study in rat and the
standard 100X uncertainty factor (10X interspecies and 10X
intraspecies). The chronic RfD (cRfD) of 0.03 mg/kg bw/day is based on a
NOAEL of 2.83 mg/kg bw/day from the two-year rat chronic study and the
UF of 100X.]

	i. Food.  [Acute and chronic dietary analyses were conducted to
estimate exposure to potential fenamidone residues in/on the crops and
crop groups mentioned above. Tier III analyses were conducted for both
the acute and chronic scenarios using the DEEM( (Exponent, Inc.)
software.  The acute dietary exposure estimates at the 99.9th percentile
of exposure for the US Population was 3.5% of the acute Reference Dose
(aRfD).  The population subgroup with the highest exposure was Infants
at 14% of the aRfD.  Chronic dietary exposure estimates from potential
residues of fenamidone for the US Population was 3% of the chronic RfD
(cRfD).  The sub-population with the highest exposure was Children 1-2
at 9% of the cRfD.]

	ii. Drinking water.  [US EPA’s Standard Operating Procedure (SOP) for
Drinking Water Exposure and Risk Assessments was used to perform the
drinking water assessment.  This SOP uses a variety of tools to conduct
drinking water assessments, including water models such as SCI-GROW,
FIRST, PRZMS/EXAMS, and available monitoring data.  If monitoring data
are not available, then the models are used to predict potential
residues in surface and ground water and the highest levels are assumed
to be the drinking water residue.  In the case of fenamidone, monitoring
data do not exist, therefore SCI-GROW and FIRST were used to estimate a
water residue.  The calculated drinking water levels of comparison
(DWLOC) for acute and chronic exposure for all adults and children
exceed the modeled drinking water estimated environmental concentration
(EEC).  The acute DWLOC values are 42210 ppb for the general population,
10747 ppb for infants and 11360 ppb for children 1-2, compared to  the
worst-case acute drinking water EEC of  178 ppb from the June 21, 2007
EPA HED risk assessment.  The chronic DWLOC values are 947 ppb for the
general population, 265 ppb for infants and 255 ppb for children 1-2,
compared to a worst-case chronic drinking water EEC of 178 ppb from the
above EPA reference.  These drinking water levels of comparison are
based on conservative dietary (food) exposures and are typically
expected to be much higher under actual use scenarios.]

	2. Non-dietary exposure.  [Fenamidone is not registered for residential
uses (food or non-food), thereby eliminating any potential for
residential exposure or non-occupational exposure.]

D. Cumulative Effects

[Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and other substances that have a
common mechanism of toxicity.  There is no available data to determine
whether fenamidone has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment.  Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fenamidone does not appear to produce a toxic metabolite produced by
other substances.  For the purposes of this tolerance petition,
therefore, it has not been assumed that fenamidone has a common
mechanism of toxicity with other substances.]

E. Safety Determination

	1. U.S. population.  [Using the assumptions and data described above,
based on the completeness and reliability of the toxicity data, it is
concluded that the dietary exposure from the proposed uses of fenamidone
will utilize at most 3.5% of the aRfD and 3% of the cRfD for the US
Population. EPA generally has no concern for exposures below 100% of the
RfD because the RfD represents the level at or below which daily
aggregate exposure over a lifetime will not pose appreciable risk to
human health.  Drinking water levels of comparison based on the dietary
and aggregate exposures are greater than highly conservative estimated
levels, and would be expected to be well below the 100% level of the
RfD, if they occur at all.  Therefore, there is a reasonable certainty
that no harm will occur to the US Population from aggregate exposure
(food and drinking water) to residues of fenamidone.]

	2. Infants and children.  [In consideration of the toxicology database
as discussed above, EPA has determined that there is no extra
sensitivity of infants and children, and therefore the default FQPA
safety factor can be removed.  Using the assumptions and data described
in the exposure section above, the percent of the aRfD and cRfD that
will be used for exposure to residues of fenamidone in food for infants
and children (the most highly exposed subgroups) is 14% (acute
assessment for infants) and 9% (chronic assessment for children 1-2),
respectively. There are no non-dietary concerns for infants and
children.  As with adults, drinking water levels of comparison are
higher than the worst case drinking water estimated concentrations and
are expected to use well below 100% of the reference dose, if they occur
at all.  Therefore, there is a reasonable certainty that no harm will
occur to infants and children from aggregate exposure to residues of
fenamidone.]

F. International Tolerances

[Codex MRLs are not yet established for fenamidone.]

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